Design control considerations for biologic-device combination products.

PubMed

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting development of innovative, safe and effective combination products. It remains the manufacturer's responsibility to comply with the relevant requirements and regulations, and develop good business practices that clearly describe how these practices comply with FDA's final rule (21 CFR Part 4) and aligns with the company's already established quality system. Copyright © 2017 Elsevier B.V. All rights reserved.

iPad Learning Ecosystem: Developing Challenge-Based Learning Using Design Thinking

ERIC Educational Resources Information Center

Marin, Catalina; Hargis, Jace; Cavanaugh, Cathy

2013-01-01

In order to maximize college English language students' learning, product development, 21st Century skills and engagement with real world meaningful challenges, a course was designed to integrate Challenge Based Learning (CBL) and iPad mobile learning technology. This article describes the course design, which was grounded in design thinking, and…

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

PubMed

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

2015-01-01

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

Quality Assurance in the Presence of Variability

NASA Astrophysics Data System (ADS)

Lauenroth, Kim; Metzger, Andreas; Pohl, Klaus

Software Product Line Engineering (SPLE) is a reuse-driven development paradigm that has been applied successfully in information system engineering and other domains. Quality assurance of the reusable artifacts of the product line (e.g. requirements, design, and code artifacts) is essential for successful product line engineering. As those artifacts are reused in several products, a defect in a reusable artifact can affect several products of the product line. A central challenge for quality assurance in product line engineering is how to consider product line variability. Since the reusable artifacts contain variability, quality assurance techniques from single-system engineering cannot directly be applied to those artifacts. Therefore, different strategies and techniques have been developed for quality assurance in the presence of variability. In this chapter, we describe those strategies and discuss in more detail one of those strategies, the so called comprehensive strategy. The comprehensive strategy aims at checking the quality of all possible products of the product line and thus offers the highest benefits, since it is able to uncover defects in all possible products of the product line. However, the central challenge for applying the comprehensive strategy is the complexity that results from the product line variability and the large number of potential products of a product line. In this chapter, we present one concrete technique that we have developed to implement the comprehensive strategy that addresses this challenge. The technique is based on model checking technology and allows for a comprehensive verification of domain artifacts against temporal logic properties.

Tendon Tissue Engineering: Progress, Challenges, and Translation to the Clinic

PubMed Central

Shearn, Jason T.; Kinneberg, Kirsten R.C.; Dyment, Nathaniel A.; Galloway, Marc T.; Kenter, Keith; Wylie, Christopher; Butler, David L.

2013-01-01

The tissue engineering field has made great strides in understanding how different aspects of tissue engineered constructs (TECs) and the culture process affect final tendon repair. However, there remain significant challenges in developing strategies that will lead to a clinically effective and commercially successful product. In an effort to increase repair quality, a better understanding of normal development, and how it differs from adult tendon healing, may provide strategies to improve tissue engineering. As tendon tissue engineering continues to improve, the field needs to employ more clinically relevant models of tendon injury such as degenerative tendons. We need to translate successes to larger animal models to begin exploring the clinical implications of our treatments. By advancing the models used to validate our TECs, we can help convince our toughest customer, the surgeon, that our products will be clinically efficacious. As we address these challenges in musculoskeletal tissue engineering, the field still needs to address the commercialization of products developed in the laboratory. TEC commercialization faces numerous challenges because each injury and patient is unique. This review aims to provide tissue engineers with a summary of important issues related to engineering tendon repairs and potential strategies for producing clinically successful products. PMID:21625053

The future of HIV prevention: prospects for an effective anti-HIV microbicide.

PubMed

Nuttall, Jeremy; Romano, Joseph; Douville, Karen; Galbreath, Caroline; Nel, Annaléne; Heyward, William; Mitchnick, Mark; Walker, Saul; Rosenberg, Zeda

2007-03-01

Topical microbicides are self-administered products for prevention of HIV transmission, and they present one of the most promising strategies for combating the HIV-AIDS epidemic. The development of microbicides is a long and complicated process, with many hurdles that are unique to this class of product, including challenges in product design, in the conduct and design of clinical trials, and in obtaining licensure of a new class of products intended for use almost exclusively in developing countries. Once they have been registered, there are additional challenges to the marketing and distribution of microbicides. An overview of the types of microbicide currently in development, and a summary of the issues and the approaches being taken to address them, are provided.

Challenges facing developers of CAD/CAM models that seek to predict human working postures

NASA Astrophysics Data System (ADS)

Wiker, Steven F.

2005-11-01

This paper outlines the need for development of human posture prediction models for Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) design applications in product, facility and work design. Challenges facing developers of posture prediction algorithms are presented and discussed.

Leapfrogging Over the Status Quo: E-Learning and the Challenge of Adult Literacy.

ERIC Educational Resources Information Center

McCain, Mary

E-learning's potential for responding to the challenges of adult literacy was explored through a review of research and input from program managers, developers, and funders. The study identified adult literacy e-learning products, programs, and resources that are available or in development. Challenges to greater use of technology in adult…

Molecular basis of high viscosity in concentrated antibody solutions: Strategies for high concentration drug product development.

PubMed

Tomar, Dheeraj S; Kumar, Sandeep; Singh, Satish K; Goswami, Sumit; Li, Li

2016-01-01

Effective translation of breakthrough discoveries into innovative products in the clinic requires proactive mitigation or elimination of several drug development challenges. These challenges can vary depending upon the type of drug molecule. In the case of therapeutic antibody candidates, a commonly encountered challenge is high viscosity of the concentrated antibody solutions. Concentration-dependent viscosity behaviors of mAbs and other biologic entities may depend on pairwise and higher-order intermolecular interactions, non-native aggregation, and concentration-dependent fluctuations of various antibody regions. This article reviews our current understanding of molecular origins of viscosity behaviors of antibody solutions. We discuss general strategies and guidelines to select low viscosity candidates or optimize lead candidates for lower viscosity at early drug discovery stages. Moreover, strategies for formulation optimization and excipient design are also presented for candidates already in advanced product development stages. Potential future directions for research in this field are also explored.

Progress and challenges in viral vector manufacturing

PubMed Central

van der Loo, Johannes C.M.; Wright, J. Fraser

2016-01-01

Promising results in several clinical studies have emphasized the potential of gene therapy to address important medical needs and initiated a surge of investments in drug development and commercialization. This enthusiasm is driven by positive data in clinical trials including gene replacement for Hemophilia B, X-linked Severe Combined Immunodeficiency, Leber's Congenital Amaurosis Type 2 and in cancer immunotherapy trials for hematological malignancies using chimeric antigen receptor T cells. These results build on the recent licensure of the European gene therapy product Glybera for the treatment of lipoprotein lipase deficiency. The progress from clinical development towards product licensure of several programs presents challenges to gene therapy product manufacturing. These include challenges in viral vector-manufacturing capacity, where an estimated 1–2 orders of magnitude increase will likely be needed to support eventual commercial supply requirements for many of the promising disease indications. In addition, the expanding potential commercial product pipeline and the continuously advancing development of recombinant viral vectors for gene therapy require that products are well characterized and consistently manufactured to rigorous tolerances of purity, potency and safety. Finally, there is an increase in regulatory scrutiny that affects manufacturers of investigational drugs for early-phase clinical trials engaged in industry partnerships. Along with the recent increase in biopharmaceutical funding in gene therapy, industry partners are requiring their academic counterparts to meet higher levels of GMP compliance at earlier stages of clinical development. This chapter provides a brief overview of current progress in the field and discusses challenges in vector manufacturing. PMID:26519140

Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment

PubMed Central

Wright, J. Fraser

2014-01-01

Adeno-associated virus (AAV)-based vectors expressing therapeutic genes continue to demonstrate great promise for the treatment of a wide variety of diseases and together with other gene transfer vectors represent an emerging new therapeutic paradigm comparable in potential impact on human health to that achieved by recombinant proteins and vaccines. A challenge for the current pipeline of AAV-based investigational products as they advance through clinical development is the identification, characterization and lot-to-lot control of the process- and product-related impurities present in even highly purified preparations. Especially challenging are AAV vector product-related impurities that closely resemble the vector itself and are, in some cases, without clear precedent in established biotherapeutic products. The determination of acceptable levels of these impurities in vectors prepared for human clinical product development, with the goal of new product licensure, requires careful risk and feasibility assessment. This review focuses primarily on the AAV product-related impurities that have been described in vectors prepared for clinical development. PMID:28548061

Development of textile-based high-tech products: the new challenge.

PubMed

da Rocha, Ana Maria M F

2004-01-01

The new generation of smart textiles is represented by fibers, yarns, fabrics and other resulting products that have special properties, regarding mechanical, chemical, electrical and thermal performances. These high-tech products, being able to respond to external stimuli through the integration of electronic components, phase change materials, shape memory materials or nano materials, enabled the development of different active and functional products. These products when combining the functions of medium, carrier and interface for micro-systems applications represent the ideal connecting channel between humans and the environment. This is a field of innovation that broadened the scope of the traditional textile and apparel products to high-tech textiles, designed to meet specific needs, involving different technologies and produced according to required properties, like personal protection, safety, leisure or health wear. The development of smart wear is a new challenge for the textile and clothing industry: it has to develop products based not only on design, fashion and comfort concepts but also in terms of functions. Moreover these products must be easy to care and durable.

SHARP's systems engineering challenge: rectifying integrated product team requirements with performance issues in an evolutionary spiral development acquisition

NASA Astrophysics Data System (ADS)

Kuehl, C. Stephen

2003-08-01

Completing its final development and early deployment on the Navy's multi-role aircraft, the F/A-18 E/F Super Hornet, the SHAred Reconnaissance Pod (SHARP) provides the war fighter with the latest digital tactical reconnaissance (TAC Recce) Electro-Optical/Infrared (EO/IR) sensor system. The SHARP program is an evolutionary acquisition that used a spiral development process across a prototype development phase tightly coupled into overlapping Engineering and Manufacturing Development (EMD) and Low Rate Initial Production (LRIP) phases. Under a tight budget environment with a highly compressed schedule, SHARP challenged traditional acquisition strategies and systems engineering (SE) processes. Adopting tailored state-of-the-art systems engineering process models allowd the SHARP program to overcome the technical knowledge transition challenges imposed by a compressed program schedule. The program's original goal was the deployment of digital TAC Recce mission capabilities to the fleet customer by summer of 2003. Hardware and software integration technical challenges resulted from requirements definition and analysis activities performed across a government-industry led Integrated Product Team (IPT) involving Navy engineering and test sites, Boeing, and RTSC-EPS (with its subcontracted hardware and government furnished equipment vendors). Requirements development from a bottoms-up approach was adopted using an electronic requirements capture environment to clarify and establish the SHARP EMD product baseline specifications as relevant technical data became available. Applying Earned-Value Management (EVM) against an Integrated Master Schedule (IMS) resulted in efficiently managing SE task assignments and product deliveries in a dynamically evolving customer requirements environment. Application of Six Sigma improvement methodologies resulted in the uncovering of root causes of errors in wiring interconnectivity drawings, pod manufacturing processes, and avionics requirements specifications. Utilizing the draft NAVAIR SE guideline handbook and the ANSI/EIA-632 standard: Processes for Engineering a System, a systems engineering tailored process approach was adopted for the accelerated SHARP EMD prgram. Tailoring SE processes in this accelerated product delivery environment provided unique opportunities to be technically creative in the establishment of a product performance baseline. This paper provides an historical overview of the systems engineering activities spanning the prototype phase through the EMD SHARP program phase, the performance requirement capture activities and refinement process challenges, and what SE process improvements can be applied to future SHARP-like programs adopting a compressed, evolutionary spiral development acquisition paradigm.

Short communication: role of Mycoplasma arginini in mastitis caused by Streptococcus dysgalactiae.

PubMed

Stipkovits, Laszlo; Somogyi, Maria; Asvanyi, Balazs; Toth, Agnes; Szathmary, Susan

2013-03-01

We performed a comparative study on the development of mastitis induced by Mycoplasma arginini or Streptococcus dysgalactiae after challenging the cows. Mycoplasma arginini did not cause any clinical symptoms on its own, resulting in only a transient increase of somatic cell count (SCC; increase ranging from 0.5 × 10(6) to 0.8 × 10(6) cells/mL) and a slight decrease of milk production (10%) for 5 d. In contrast, Strep. dysgalactiae induced more severe clinical signs in animals and SCC increased to 1.60 × 10(6) to 2.11 × 10(6) cells/mL for 10 d. In addition, milk production decreased (22.9 to 27.0%) for 10 d. After 3 mo (2 mo after the first challenge), animals that were challenged previously with M. arginini were rechallenged with Strep. dysgalactiae. Severe clinical mastitis developed, with very high SCC (5.00 × 10(6) to 21.5 × 10(6) cells/mL), and a very significant reduction of milk production (28.6 to 68.7%), which lasted more than 4 wk, was observed. The severe clinical mastitis developed not only in cows inoculated with Strep. dysgalactiae andM. arginini in the same udder quarter but also in cows infected in the quarter previously not challenged with mycoplasma. Cows challenged first with Strep. dysgalactiae and rechallenged with M. arginini 2 mo later developed only slight changes in both SCC and milk production, similar to those when the cows were challenged with M. arginini alone. We conclude that M. arginini infection does not cause remarkable mastitis (characterized by decrease in milk production and increase of SCC) but it significantly predisposes animals to infection with Strep. dysgalactiae, leading to severe clinical mastitis. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Measuring healthcare productivity - from unit to system level.

PubMed

Kämäräinen, Vesa Johannes; Peltokorpi, Antti; Torkki, Paulus; Tallbacka, Kaj

2016-04-18

Purpose - Healthcare productivity is a growing issue in most Western countries where healthcare expenditure is rapidly increasing. Therefore, accurate productivity metrics are essential to avoid sub-optimization within a healthcare system. The purpose of this paper is to focus on healthcare production system productivity measurement. Design/methodology/approach - Traditionally, healthcare productivity has been studied and measured independently at the unit, organization and system level. Suggesting that productivity measurement should be done in different levels, while simultaneously linking productivity measurement to incentives, this study presents the challenges of productivity measurement at the different levels. The study introduces different methods to measure productivity in healthcare. In addition, it provides background information on the methods used to measure productivity and the parameters used in these methods. A pilot investigation of productivity measurement is used to illustrate the challenges of measurement, to test the developed measures and to prove the practical information for managers. Findings - The study introduces different approaches and methods to measure productivity in healthcare. Practical implications - A pilot investigation of productivity measurement is used to illustrate the challenges of measurement, to test the developed measures and to prove the practical benefits for managers. Originality/value - The authors focus on the measurement of the whole healthcare production system and try to avoid sub-optimization. Additionally considering an individual patient approach, productivity measurement is examined at the unit level, the organizational level and the system level.

Fertilizer use and wheat yield in Central and Eastern European countries from 1986 to 2005 and its implication for developing sustainable fertilizer management practices

USDA-ARS?s Scientific Manuscript database

Central-Eastern European countries (CEE) face economic and political challenges that have implications for agricultural production. The challenge for agriculturalists is to increase agricultural production after years of misguided policies and resource constraints (primarily nutrients). We tested th...

Challenges in Introducing New Products: A Case Study on the New Product Development Process

ERIC Educational Resources Information Center

Rankin, Robert; Mintu-Wimsatt, Alma

2017-01-01

The case is based on an actual product introduction, and is designed to provide instruction on the new product development process. With the cost to launch new products estimated at least US $15 million and new product failure rates ranging from 40% to 80%, it is imperative that students learn how to determine the financial and market feasibility…

Consumer exposure scenarios: development, challenges and possible solutions.

PubMed

Van Engelen, J G M; Heinemeyer, G; Rodriguez, C

2007-12-01

Exposure scenarios (ES) under REACH (Registration, Evaluation, and Authorisation of Chemicals; new EU legislation) aim to describe safe conditions of product and substance use. Both operational conditions and risk management measures (RMMs) are part of the ES. For consumer use of chemicals, one of the challenges will be to identify all of the consumer uses of a given chemical and then quantify the exposure derived from each of them. Product use categories can be established to identify in a systematic fashion how products are used. These product categories comprise products that are used similarly (e.g. paints, adhesives). They deliver information about product use characteristics, and provide an easy-to-handle tool for exchanging standardised information. For practical reasons, broad ES will have to be developed, which cover a wide range of products and use. The challenge will be to define them broadly, but not in a way that they provide such an overestimation of exposure that a next iteration or a more complex model is always needed. Tiered and targeted approaches for estimation of exposure at the right level of detail may offer the best solution. RMMs relevant for consumers include those inherent to product design (controllable) and those that are communicated to consumers as directions for use (non-controllable). Quantification of the effect of non-controllable RMMs on consumer exposure can prove to be difficult. REACH requires aggregation of exposure from all relevant identified sources. Development of appropriate methodology for realistic aggregation of exposure will be no small challenge and will likely require probabilistic approaches and comprehensive databases on populations' habits, practices and behaviours. REACH regulation aims at controlling the use of chemicals so that exposure to every chemical can be demonstrated to be safe for consumers, workers, and the environment when considered separately, but also when considered in an integrated way. This integration will be another substantial challenge for the future.

Map design and production issues for the Utah Gap Analysis Project

USGS Publications Warehouse

Hutchinson, John A.; Wittmann, J.H.

1997-01-01

The cartographic preparation and printing of four maps for the Utah GAP Project presented a wide range of challenges in cartographic design and production. In meeting these challenges, the map designers had to balance the purpose of the maps together with their legibility and utility against both the researchers' desire to show as much detail as possible and the technical limitations inherent in the printing process. This article describes seven design and production issues in order to illustrate the challenges of making maps from a merger of satellite data and GIS databases, and to point toward future investigation and development.

Challenges in measuring and valuing productivity costs, and their relevance in mood disorders

PubMed Central

Lensberg, Benedikte R; Drummond, Michael F; Danchenko, Natalya; Despiégel, Nicolas; François, Clément

2013-01-01

Lost productivity is often excluded from economic evaluations, which may lead to an underestimation of the societal benefits of treatment. However, there are multiple challenges in reliably estimating and reporting productivity losses. This article explores the main challenges, ie, selecting an appropriate valuation method (ie, human capital, friction cost, or multiplier), avoiding double counting, and accounting for equity. It also discusses the use of presenteeism instruments and their application in clinical trials, with a specific focus on their relevance in individuals with mood disorders. Further research and discussion is required on the development of reliable techniques for measuring and valuing productivity changes due to presenteeism. PMID:24273412

Strategies and challenges for nursery production: Perspectives on where we're going and where we've been

Treesearch

Diane L. Haase

2010-01-01

During the past century, seedling production has changed in accordance with technology and new knowledge. Many strategies have been developed to address challenges associated with pests, environmental conditions, and customer demands. Although the underlying concepts for growing seedlings have remained relatively constant, technological advances have enabled nurseries...

Presidential Green Chemistry Challenge: 2004 Greener Reaction Conditions Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2004 award winner, Buckman Laboratories International, developed Optimyze technology, which uses an esterase enzyme to remove sticky contaminants from paper products prior to recycling.

Presidential Green Chemistry Challenge: 2007 Designing Greener Chemicals Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2007 award winner, Cargill, developed biobased polyols for polyurethane applications, including flexible foams. Cargill makes BiOH polyols from vegetable oils, not petroleum products.

Presidential Green Chemistry Challenge: 2006 Academic Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2006 award winner, Professor Galen J. Suppes, developed a process to convert waste glycerin from biodiesel production into propylene glycol to replace ethylene glycol in antifreeze.

Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products

PubMed Central

Zhao, Yuan; Stepto, Hannah; Schneider, Christian K

2017-01-01

Gene therapy is a rapidly evolving field. So far, there have been >2,400 gene therapy products in clinical trials and four products on the market. A prerequisite for producing gene therapy products is ensuring their quality and safety. This requires appropriately controlled and standardized production and testing procedures that result in consistent safety and efficacy. Assuring the quality and safety of lentivirus-based gene therapy products in particular presents a great challenge because they are cell-based multigene products that include viral and therapeutic proteins as well as modified cells. In addition to the continuous refinement of a product, changes in production sites and manufacturing processes have become more and more common, posing challenges to developers regarding reproducibility and comparability of results. This paper discusses the concept of developing a first World Health Organization International Standard, suitable for the standardization of assays and enabling comparison of cross-trial and cross-manufacturing results for this important vector platform. The standard will be expected to optimize the development of gene therapy medicinal products, which is especially important, given the usually orphan nature of the diseases to be treated, naturally hampering reproducibility and comparability of results. PMID:28747142

Biologics industry challenges for developing diagnostic tests for the National Veterinary Stockpile.

PubMed

Hardham, J M; Lamichhane, C M

2013-01-01

Veterinary diagnostic products generated ~$3 billion US dollars in global sales in 2010. This industry is poised to undergo tremendous changes in the next decade as technological advances move diagnostic products from the traditional laboratory-based and handheld immunologic assays towards highly technical, point of care devices with increased sensitivity, specificity, and complexity. Despite these opportunities for advancing diagnostic products, the industry continues to face numerous challenges in developing diagnostic products for emerging and foreign animal diseases. Because of the need to deliver a return on the investment, research and development dollars continue to be focused on infectious diseases that have a negative impact on current domestic herd health, production systems, or companion animal health. Overcoming the administrative, legal, fiscal, and technological barriers to provide veterinary diagnostic products for the National Veterinary Stockpile will reduce the threat of natural or intentional spread of foreign diseases and increase the security of the food supply in the US.

Microfluidics-Enabled Diagnostic Systems: Markets, Challenges, and Examples.

PubMed

Becker, Holger; Gärtner, Claudia

2017-01-01

Microfluidics has become an important tool for the commercial product development in diagnostics. This article will focus on current technical demands during the development process such as material and integration challenges. Furthermore, we present data on the diagnostics market as well as examples of microfluidics-enabled systems currently under commercial development or already on the market.

Molecular basis of high viscosity in concentrated antibody solutions: Strategies for high concentration drug product development

PubMed Central

Tomar, Dheeraj S.; Kumar, Sandeep; Singh, Satish K.; Goswami, Sumit; Li, Li

2016-01-01

ABSTRACT Effective translation of breakthrough discoveries into innovative products in the clinic requires proactive mitigation or elimination of several drug development challenges. These challenges can vary depending upon the type of drug molecule. In the case of therapeutic antibody candidates, a commonly encountered challenge is high viscosity of the concentrated antibody solutions. Concentration-dependent viscosity behaviors of mAbs and other biologic entities may depend on pairwise and higher-order intermolecular interactions, non-native aggregation, and concentration-dependent fluctuations of various antibody regions. This article reviews our current understanding of molecular origins of viscosity behaviors of antibody solutions. We discuss general strategies and guidelines to select low viscosity candidates or optimize lead candidates for lower viscosity at early drug discovery stages. Moreover, strategies for formulation optimization and excipient design are also presented for candidates already in advanced product development stages. Potential future directions for research in this field are also explored. PMID:26736022

Navigating sticky areas in transdermal product development.

PubMed

Strasinger, Caroline; Raney, Sam G; Tran, Doanh C; Ghosh, Priyanka; Newman, Bryan; Bashaw, Edward D; Ghosh, Tapash; Shukla, Chinmay G

2016-07-10

The benefits of transdermal delivery over the oral route to combat such issues of low bioavailability and limited controlled release opportunities are well known and have been previously discussed by many in the field (Prausnitz et al. (2004) [1]; Hadgraft and Lane (2006) [2]). However, significant challenges faced by developers as a product moves from the purely theoretical to commercial production have hampered full capitalization of the dosage forms vast benefits. While different technical aspects of transdermal system development have been discussed at various industry meetings and scientific workshops, uncertainties have persisted regarding the pharmaceutical industry's conventionally accepted approach for the development and manufacturing of transdermal systems. This review provides an overview of the challenges frequently faced and the industry's best practices for assuring the quality and performance of transdermal delivery systems and topical patches (collectively, TDS). The topics discussed are broadly divided into the evaluation of product quality and the evaluation of product performance; with the overall goal of the discussion to improve, advance and accelerate commercial development in the area of this complex controlled release dosage form. Published by Elsevier B.V.

Toward a Sustainable Agriculture

USDA-ARS?s Scientific Manuscript database

Future trends in population growth, energy use, climate change, and globalization will challenge agriculturists to develop innovative production systems that are highly productive and environmentally sound. Furthermore, future agricultural production systems must possess an inherent capacity to adap...

Presidential Green Chemistry Challenge: 2007 Greener Synthetic Pathways Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2007 award winners, Professor Kaichang Li, Columbia Forest Products, and Hercules, developed an adhesive for wood composites based on soy flour instead of resins with formaldehyde.

Platform based design of EAP transducers in Danfoss PolyPower A/S

NASA Astrophysics Data System (ADS)

Sarban, Rahimullah; Gudlaugsson, Tómas V.

2013-04-01

Electroactive Polymer (EAP) has gained increasing focus, in research communities, in last two decades. Research within the field of EAP has, so far, been mainly focused on material improvements, characterization, modeling and developing demonstrators. As the EAP technology matures, the need for a new area of research namely product development emerges. Product development can be based on an isolated design and production for a single product or platform design where a product family is developed. In platform design the families of products exploits commonality of platform modules while satisfying a variety of different market segments. Platform based approach has the primary benefit of being cost efficient and short lead time to market when new products emerges. Products development based on EAP technology is challenging both technologically as well as from production and processing point of view. Both the technological and processing challenges need to be addressed before a successful implementation of EAP technology into products. Based on this need Danfoss PolyPower A/S has, in 2011, launched a EAP platform project in collaboration with three Danish universities and three commercial organizations. The aim of the project is to develop platform based designs and product family for the EAP components to be used in variety of applications. This paper presents the structure of the platform project as a whole and specifically the platform based designs of EAP transducers. The underlying technologies, essential for EAP transducers, are also presented. Conceptual design and solution for the concepts are presented as well.

Links between livestock production, the environment and sustainable development.

PubMed

Pradbre, J-P

2014-12-01

This study examines the prospects for strong growth in the supply and demand for animal products worldwide, especially in developing countries, where 80% of the world's population lives. Based on scientific publications, statistics and field observations, it reviews greenhouse gas emission levels from livestock, the ability of ruminant livestock systems to sequester carbon and the capacity of the livestock industry to meet the challenge of sustainable development and to share its benefits while minimising impacts to climate change. Special attention is paid to the situation of the 800 million livestock farmers in the world living at the extreme end of poverty. The study underlines the importance of improving livestock productivity and the interdependence of the economic, environmental and social components of sustainable development. It highlights how, in the least developed countries and most lower-middle-income countries, the pressure exerted by animal diseases hampers efforts to improve livestock productivity. Poor livestock farmers have not sufficiently benefited from development policies and need support to adopt technological advances to meet the challenges of sustainable development and poverty reduction.

Additive manufacturing in production: challenges and opportunities

NASA Astrophysics Data System (ADS)

Ahuja, Bhrigu; Karg, Michael; Schmidt, Michael

2015-03-01

Additive manufacturing, characterized by its inherent layer by layer fabrication methodology has been coined by many as the latest revolution in the manufacturing industry. Due to its diversification of Materials, processes, system technology and applications, Additive Manufacturing has been synonymized with terminology such as Rapid prototyping, 3D printing, free-form fabrication, Additive Layer Manufacturing, etc. A huge media and public interest in the technology has led to an innovative attempt of exploring the technology for applications beyond the scope of the traditional engineering industry. Nevertheless, it is believed that a critical factor for the long-term success of Additive Manufacturing would be its ability to fulfill the requirements defined by the traditional manufacturing industry. A parallel development in market trends and product requirements has also lead to a wider scope of opportunities for Additive Manufacturing. The presented paper discusses some of the key challenges which are critical to ensure that Additive Manufacturing is truly accepted as a mainstream production technology in the industry. These challenges would highlight on various aspects of production such as product requirements, process management, data management, intellectual property, work flow management, quality assurance, resource planning, etc. In Addition, changing market trends such as product life cycle, mass customization, sustainability, environmental impact and localized production will form the foundation for the follow up discussion on the current limitations and the corresponding research opportunities. A discussion on ongoing research to address these challenges would include topics like process monitoring, design complexity, process standardization, multi-material and hybrid fabrication, new material development, etc.

A comprehensive study on regulatory requirements for development and filing of generic drugs globally

PubMed Central

Handoo, Shweta; Arora, Vandana; Khera, Deepak; Nandi, Prafulla Kumar; Sahu, Susanta Kumar

2012-01-01

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. PMID:23373001

Development of vaccines for bio-warfare agents.

PubMed

Rosenthal, S R; Clifford, J C M

2002-01-01

There is a recognized need for the development of new vaccines (as well as other biologicals and drugs) to counteract the effects of a potential bio-terrorist or bio-warfare event in the U.S. domestic population and military forces. Regulation of products to protect against potential bio-warfare agents poses unique challenges since the usual measures of efficacy that require exposure to natural disease may not currently be possible, for epidemiological and ethical reasons. To help to address this issue, the FDA has published and requested comments on a proposed animal rule intended to address certain efficacy issues for new agents for use against lethal or permanently disabling toxic substances. Recent product development activity has focused on Bacillus anthracis (anthrax) and variola major (smallpox), agents that are regarded as highest priority in posing a risk to national security. FDA resources exist to assist vaccine developers with regard to the novel challenges posed in the dinical development of these products.

Translational research and the evolving landscape for biomedical innovation.

PubMed

Kaitin, Kenneth I

2012-10-01

This article addresses current challenges facing pharmaceutical and biopharmaceutical developers, including the expiration of patents on many high-revenue-generating products, increasing competition in the marketplace, low public support, high regulatory hurdles, and the increasing time, cost, and risk of new product development. To meet these challenges, drug developers are looking to new models of innovation to improve efficiency, lower risk, and increase output. These new models include codevelopment agreements with small companies, multicompany consortia, and strategic partnerships with academic research centers. In the United States and the European Union, the government is supporting these efforts by creating incentives for academic centers to foster translational research and become more "commercially minded". The goal for all stakeholders is to reduce the barriers to product development and bring new medicines to market in a timely and cost-efficient manner.

Application of probiotics in food products--challenges and new approaches.

PubMed

Jankovic, I; Sybesma, W; Phothirath, P; Ananta, E; Mercenier, A

2010-04-01

The probiotic research conducted over the past 20 years has resulted in a valuable source of data related to health beneficial effects of probiotics. Nevertheless, documentation of probiotic benefits remains challenging, especially in functional foods that are designed for the generally healthy population that, however, regularly experiences episodes of 'suboptimal' health. In addition, in view of today's application of probiotics in an increasing variety of food matrixes, process optimization and product design need to take into account cell viability and probiotic function altogether. To meet this challenge, medium to high-throughput bioassays - based on the identification of active compounds and their mechanism of action - have to be developed and their predictive value established. Together with validated biomarkers for health and disease, this should help rationalize probiotic product development and associated health claim substantiation in human studies. Copyright 2010 Elsevier Ltd. All rights reserved.

Forming Mandrels for X-Ray Mirror Substrates

NASA Technical Reports Server (NTRS)

Blake, Peter N.; Saha, Timo; Zhang, Will; O'Dell, Stephen; Kester, Thomas; Jones, William

2011-01-01

Future x-ray astronomical missions, like the International X-ray Observatory (IXO), will likely require replicated mirrors to reduce both mass and production costs. Accurately figured and measured mandrels - upon which the mirror substrates are thermally formed - are essential to enable these missions. The challenge of making these mandrels within reasonable costs and schedule has led the Goddard and Marshall Space Flight Centers to develop in-house processes and to encourage small businesses to attack parts of the problem. Both Goddard and Marshall have developed full-aperture polishing processes and metrologies that yield high-precision axial traces of the finished mandrels. Outside technologists have been addressing challenges presented by subaperture CNC machining processes: particularly difficult is the challenge of reducing mid-spatial frequency errors below 2 nm rms. The end-product of this approach is a realistic plan for the economically feasible production of mandrels that meet program requirements in both figure and quantity.

Flow chemistry syntheses of natural products.

PubMed

Pastre, Julio C; Browne, Duncan L; Ley, Steven V

2013-12-07

The development and application of continuous flow chemistry methods for synthesis is a rapidly growing area of research. In particular, natural products provide demanding challenges to this developing technology. This review highlights successes in the area with an emphasis on new opportunities and technological advances.

The Google Online Marketing Challenge and Research Opportunities

ERIC Educational Resources Information Center

Neale, Larry; Treiblmaier, Horst; Henderson, Vani; Hunter, Lee; Hudson, Karen; Murphy, Jamie

2009-01-01

The Google Online Marketing Challenge is an ongoing collaboration between Google and academics, to give students experiential learning. The Challenge gives student teams US$200 in AdWords, Google's flagship advertising product, to develop online marketing campaigns for actual businesses. The end result is an engaging in-class exercise that…

Farms and Learning Partnerships in Farming Systems Projects: A Response to the Challenges of Complexity in Agricultural Innovation

ERIC Educational Resources Information Center

Crawford, Anne; Nettle, Ruth; Paine, Mark; Kabore, Carolyn

2007-01-01

Managing the competing interests of productivity growth, environmental concerns, landscape change and societal expectations presents challenges for agricultural industries. Innovation projects supporting knowledge development to address these challenges often involve partnerships with commercial farms, a methodology which promises much but has…

A Role-Playing Game for a Software Engineering Lab: Developing a Product Line

ERIC Educational Resources Information Center

Zuppiroli, Sara; Ciancarini, Paolo; Gabbrielli, Maurizio

2012-01-01

Software product line development refers to software engineering practices and techniques for creating families of similar software systems from a basic set of reusable components, called shared assets. Teaching how to deal with software product lines in a university lab course is a challenging task, because there are several practical issues that…

Development and application of modern agricultural biotechnology in Botswana: The potentials, opportunities and challenges

PubMed Central

Batlang, Utlwang; Tsurupe, Gorata; Segwagwe, Amogelang; Obopile, Motshwari

2014-01-01

In Botswana, approximately 40% of the population live in rural areas and derive most of their livelihood from agriculture by keeping livestock and practising arable farming. Due to the nature of their farming practises livestock and crops are exposed to diseases and environmental stresses. These challenges offer opportunities for application of biotechnology to develop adaptable materials to the country's environment. On the other hand, the perceived risk of genetically modified organisms (GMOs) has dimmed the promise of the technology for its application in agriculture. This calls for a holistic approach to the application of biotechnology to address issues of biosafety of GMOs. We have therefore assessed the potentials, challenges and opportunities to apply biotechnology with specific emphasis on agriculture, taking cognisance of requirement for its research, development and application in research and teaching institutions. In order to achieve this, resource availability, infrastructure, human and laboratory requirements were analyzed. The analysis revealed that the country has the capacity to carry out research in biotechnology in the development and production of genetically modified crops for food and fodder crops. These will include gene discovery, genetic transformation and development of systems to comply with the world regulatory framework on biosafety. In view of the challenges facing the country in agriculture, first generation biotech crops could be released for production. Novel GM products for development may include disease diagnosis kits, animal disease vaccines, and nutrient use efficiency, drought, and pest and disease resistant food and fodder crops. PMID:25437237

Development and application of modern agricultural biotechnology in Botswana: the potentials, opportunities and challenges.

PubMed

Batlang, Utlwang; Tsurupe, Gorata; Segwagwe, Amogelang; Obopile, Motshwari

2014-07-03

In Botswana, approximately 40% of the population live in rural areas and derive most of their livelihood from agriculture by keeping livestock and practising arable farming. Due to the nature of their farming practises livestock and crops are exposed to diseases and environmental stresses. These challenges offer opportunities for application of biotechnology to develop adaptable materials to the country's environment. On the other hand, the perceived risk of genetically modified organisms (GMOs) has dimmed the promise of the technology for its application in agriculture. This calls for a holistic approach to the application of biotechnology to address issues of biosafety of GMOs. We have therefore assessed the potentials, challenges and opportunities to apply biotechnology with specific emphasis on agriculture, taking cognisance of requirement for its research, development and application in research and teaching institutions. In order to achieve this, resource availability, infrastructure, human and laboratory requirements were analyzed. The analysis revealed that the country has the capacity to carry out research in biotechnology in the development and production of genetically modified crops for food and fodder crops. These will include gene discovery, genetic transformation and development of systems to comply with the world regulatory framework on biosafety. In view of the challenges facing the country in agriculture, first generation biotech crops could be released for production. Novel GM products for development may include disease diagnosis kits, animal disease vaccines, and nutrient use efficiency, drought, and pest and disease resistant food and fodder crops.

Freeform Optics: current challenges for future serial production

NASA Astrophysics Data System (ADS)

Schindler, C.; Köhler, T.; Roth, E.

2017-10-01

One of the major developments in optics industry recently is the commercial manufacturing of freeform surfaces for optical mid- and high performance systems. The loss of limitation on rotational symmetry enables completely new optical design solutions - but causes completely new challenges for the manufacturer too. Adapting the serial production from radial-symmetric to freeform optics cannot be done just by the extension of machine capabilities and software for every process step. New solutions for conventional optics productions or completely new process chains are necessary.

Microtools for single-cell analysis in biopharmaceutical development and manufacturing.

PubMed

Love, Kerry Routenberg; Bagh, Sangram; Choi, Jonghoon; Love, J Christopher

2013-05-01

Biologic drugs are promoting growth in the biopharmaceutical industry. Despite the clinical benefits of these drugs, the time and costs required to bring new biologics to market still are substantial. Three key challenges, among others, persist in the development of biologic drugs: namely, establishing product similarity, product toxicity, and global accessibility. New classes of microtools that facilitate the isolation and interrogation of single cells have the potential to impact each of these challenges. This opinion considers recent examples of microtools with demonstrated or potential utility to address problems in these areas. Integrating these advanced technologies into the development of new biologics could greatly reduce time and costs required to bring alternative products to market, and thus expand their global availability. Copyright © 2013 Elsevier Ltd. All rights reserved.

Promoting Pluralism.

ERIC Educational Resources Information Center

Zijp, W.

1998-01-01

Rural agricultural development is facing challenges of poverty, hunger, and environmental quality, necessitating sustainable, profitable, and productive practices. Extension education is challenged to increase diversity, relevance, and financial support. Examples of World Bank innovations illustrate some pathways for agricultural extension. (SK)

Presidential Green Chemistry Challenge: 2006 Designing Greener Chemicals Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2006 award winner, S.C. Johnson & Son, developed Greenlist, a rating system for environmental and health effects of ingredients. SC Johnson uses it to reformulate many of its products.

[The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

PubMed

Berger, A; Schüle, S; Flory, E

2011-07-01

Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

Pork Production System and its Development in Mainland China

USDA-ARS?s Scientific Manuscript database

Livestock production and marketing have been driven by the growing consumer demand for high quality and low cost animal protein. As a result, intensive livestock industries have been rapidly developing globally. International trade creates new opportunities and challenges for U.S. animal agriculture...

The advent of biosimilars: challenges and risks.

PubMed

Müller, Rüdiger; Renner, Christoph; Gabay, Cem; Cassata, Giuseppe; Lohri, Andreas; Hasler, Paul

2014-01-01

Biosimilars represent a new class of medicinal products that will have significant impact on clinical use. They are identical on an amino acid sequence level to existing reference biopharmaceutical products (originals). However, they may exhibit differences on a protein level. This paper provides a brief overview of biosimilar development and describes the risk and challenges that should be considered during the admission of biosimilars into the clinic.

Industrial Adoption of Model-Based Systems Engineering: Challenges and Strategies

NASA Astrophysics Data System (ADS)

Maheshwari, Apoorv

As design teams are becoming more globally integrated, one of the biggest challenges is to efficiently communicate across the team. The increasing complexity and multi-disciplinary nature of the products are also making it difficult to keep track of all the information generated during the design process by these global team members. System engineers have identified Model-based Systems Engineering (MBSE) as a possible solution where the emphasis is placed on the application of visual modeling methods and best practices to systems engineering (SE) activities right from the beginning of the conceptual design phases through to the end of the product lifecycle. Despite several advantages, there are multiple challenges restricting the adoption of MBSE by industry. We mainly consider the following two challenges: a) Industry perceives MBSE just as a diagramming tool and does not see too much value in MBSE; b) Industrial adopters are skeptical if the products developed using MBSE approach will be accepted by the regulatory bodies. To provide counter evidence to the former challenge, we developed a generic framework for translation from an MBSE tool (Systems Modeling Language, SysML) to an analysis tool (Agent-Based Modeling, ABM). The translation is demonstrated using a simplified air traffic management problem and provides an example of a potential quite significant value: the ability to use MBSE representations directly in an analysis setting. For the latter challenge, we are developing a reference model that uses SysML to represent a generic infusion pump and SE process for planning, developing, and obtaining regulatory approval of a medical device. This reference model demonstrates how regulatory requirements can be captured effectively through model-based representations. We will present another case study at the end where we will apply the knowledge gained from both case studies to a UAV design problem.

Developing a rich definition of the person/residence to support models of consumer product usage

EPA Science Inventory

Characterizing interindividual variation in combined chemical exposures from the use of consumer products is a challenge because of the complexity of these exposures. There are many products commercially available and individuals use combinations of products dictated by their spe...

Recent Advances and Challenges towards Sustainable Polyhydroxyalkanoate (PHA) Production.

PubMed

Kourmentza, Constantina; Plácido, Jersson; Venetsaneas, Nikolaos; Burniol-Figols, Anna; Varrone, Cristiano; Gavala, Hariklia N; Reis, Maria A M

2017-06-11

Sustainable biofuels, biomaterials, and fine chemicals production is a critical matter that research teams around the globe are focusing on nowadays. Polyhydroxyalkanoates represent one of the biomaterials of the future due to their physicochemical properties, biodegradability, and biocompatibility. Designing efficient and economic bioprocesses, combined with the respective social and environmental benefits, has brought together scientists from different backgrounds highlighting the multidisciplinary character of such a venture. In the current review, challenges and opportunities regarding polyhydroxyalkanoate production are presented and discussed, covering key steps of their overall production process by applying pure and mixed culture biotechnology, from raw bioprocess development to downstream processing.

Army Air Ambulance Blood Product Program in the Combat Zone and Challenges to Best Practices.

PubMed

Powell-Dunford, Nicole; Quesada, Jose F; Gross, Kirby R; Shackelford, Stacy A

2016-08-01

Identify challenges and best practices in the development of an austere air ambulance transfusion program. A search of PubMed using combinations of the key terms 'prehospital,' 'blood product,' 'red blood cells,' 'damage control resuscitation,' 'transfusion,' 'air ambulance,' 'medical evacuation,' and 'medevac' yielded 196 articles for further analysis, with 14 articles suitable for addressing the background of prehospital transfusion within a helicopter. Retrospective analysis of unclassified briefs, after action reports, and procedures was also undertaken along with interview of subject matter experts. The initial series of 15 transfusions were discussed telephonically among flight crew, trauma surgeons, and lab specialists. Review of Joint Theater System data was readily available for 84 U.S. Army air ambulance transfusions between May-December 2012, with December marking the redeployment of the 25(th) Combat Aviation Brigade. Standardized implementation enabled safe blood product administration for 84 causalities from May-December 2012 without blood product shortage, expiration, or transfusion reaction. Challenges included developing transfusion competency, achieving high quality blood support, countering the potential for anti-U.S. sentiment, and diversity in coalition transfusion practices. Blood product administration aboard the air ambulance is logistically complex, requiring blood bank integration. Repetitive training enabled emergency medical technicians (EMTs) with basic medical training to safely perform transfusion in accordance with clinical operating guidelines. In the austere environment, logistic factors are significant challenges and political sensitivities are important considerations. Best practices may facilitate new en route transfusion programs. Powell-Dunford N, Quesada JF, Gross KR, Shackelford SA. Army air ambulance blood product program in the combat zone and challenges to best practices. Aerosp Med Hum Perform. 2016; 87(8):728-734.

2009 Wood and Fiber Product Seminar : VTT and USDA joint activity

Treesearch

Ali Harlin; Minna Vikman

2010-01-01

Foward -- The development of high-value wood and fiber products is one of the most important challenges currently facing the forest industry. Traditional pulp and paper products are on a critical path in developed countries with prices and markets decreasing. Finland and the USA have faced the same problem, which is a fundamental reason for Industrial Biomaterials...

Biosimilars: Key regulatory considerations and similarity assessment tools

PubMed Central

Wang, Xiao‐Zhuo Michelle; Conlon, Hugh D.; Anderson, Scott; Ryan, Anne M.; Bose, Arindam

2017-01-01

Abstract A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences in purity, potency, and safety between the two products. The development of biosimilars is a challenging, multistep process. Typically, the assessment of similarity involves comprehensive structural and functional characterization throughout the development of the biosimilar in an iterative manner and, if required by the local regulatory authority, an in vivo nonclinical evaluation, all conducted with direct comparison to the reference product. In addition, comparative clinical pharmacology studies are conducted with the reference product. The approval of biosimilars is highly regulated although varied across the globe in terms of nomenclature and the precise criteria for demonstrating similarity. Despite varied regulatory requirements, differences between the proposed biosimilar and the reference product must be supported by strong scientific evidence that these differences are not clinically meaningful. This review discusses the challenges faced by pharmaceutical companies in the development of biosimilars. PMID:28842986

Development of a Rubber-Based Product Using a Mixture Experiment: A Challenging Case Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kaya, Yahya; Piepel, Gregory F.; Caniyilmaz, Erdal

2013-07-01

Many products used in daily life are made by blending two or more components. The properties of such products typically depend on the relative proportions of the components. Experimental design, modeling, and data analysis methods for mixture experiments provide for efficiently determining the component proportions that will yield a product with desired properties. This article presents a case study of the work performed to develop a new rubber formulation for an o-ring (a circular gasket) with requirements specified on 10 product properties. Each step of the study is discussed, including: 1) identifying the objective of the study and requirements formore » properties of the o-ring, 2) selecting the components to vary and specifying the component constraints, 3) constructing a mixture experiment design, 4) measuring the responses and assessing the data, 5) developing property-composition models, 6) selecting the new product formulation, and 7) confirming the selected formulation in manufacturing. The case study includes some challenging and new aspects, which are discussed in the article.« less

Biosensors for Sustainable Food Engineering: Challenges and Perspectives.

PubMed

Neethirajan, Suresh; Ragavan, Vasanth; Weng, Xuan; Chand, Rohit

2018-03-12

Current food production faces tremendous challenges from growing human population, maintaining clean resources and food qualities, and protecting climate and environment. Food sustainability is mostly a cooperative effort resulting in technology development supported by both governments and enterprises. Multiple attempts have been promoted in tackling challenges and enhancing drivers in food production. Biosensors and biosensing technologies with their applications, are being widely applied to tackling top challenges in food production and its sustainability. Consequently, a growing demand in biosensing technologies exists in food sustainability. Microfluidics represents a technological system integrating multiple technologies. Nanomaterials, with its technology in biosensing, is thought to be the most promising tool in dealing with health, energy, and environmental issues closely related to world populations. The demand of point of care (POC) technologies in this area focus on rapid, simple, accurate, portable, and low-cost analytical instruments. This review provides current viewpoints from the literature on biosensing in food production, food processing, safety and security, food packaging and supply chain, food waste processing, food quality assurance, and food engineering. The current understanding of progress, solution, and future challenges, as well as the commercialization of biosensors are summarized.

Future supply chains enabled by continuous processing--opportunities and challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Srai, Jagjit Singh; Badman, Clive; Krumme, Markus; Futran, Mauricio; Johnston, Craig

2015-03-01

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily "continuous processing"-based supply chain. The current predominantly "large batch" and centralized manufacturing system designed for the "blockbuster" drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more "flow-through" operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The significant opportunities to moving to a supply chain flow-through operating model, with substantial opportunities in inventory reduction, lead-time to patient, and radically different product assurance/stability regimes. Scenarios for decentralized production models producing a greater variety of products with enhanced volume flexibility. Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations. Clinical trial and drug product development cost savings that support more rapid scale-up and market entry models with early involvement of SC designers within New Product Development. The major supply chain and industrial transformational challenges that need to be addressed. The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Sustainability of cross-functional teams for marketing strategy development and implementation.

PubMed

Kono, Ken; Antonucci, Don

2006-01-01

This article presents a case study on a cross-functional team used for marketing strategy development and execution at a health insurance company. The study found a set of success factors that contributed to the initial success of the team, but the factors were not enough to maintain the team's high level of productivity over time. The study later identified a set of 8 factors that helped sustain the team's high-productivity level. The 2 sets (ie, success and its subsequent sustainability factors) are analyzed against a normative model of team effectiveness. All the factors are explained by the normative model except for 1 sustainability factor, "challenge motivator." In fact, the study found the "challenge motivator" to be the most critical factor to keep up the team's productivity over time. Apart from a performance crisis, the authors developed 3 "challenge motivators"--first, more granular market information that could unearth hidden performance issues; second, constant value creation to shareholders as the firm being publicly traded; and third, the firm's strategic mandate to meet and exceed customer expectations that puts ultimate performance pressure on the marketing strategy team.

Challenges and Strategies for E-Learning Development in the University of Payam Noor in Iran

ERIC Educational Resources Information Center

Mohamadzadeh, Mahnaz; Farzaneh, Jabraeal; Mousavi, Mina; Maghabl, Rouhallah

2012-01-01

Higher education in Iran is confronting with several challenges; Some of them are increasing demand for education and insufficiency of current programs to meet the growing needs, emerging information age and the necessity of achieving information literacy, speed up in knowledge production and the necessity of development of a lifelong and…

Evaluating Students' Perception of Group Work for Mobile Application Development Learning, Productivity, Enjoyment and Confidence in Quality

ERIC Educational Resources Information Center

Powell, Loreen M.; Wimmer, Hayden

2016-01-01

Teaching programming and mobile application development concepts can be challenging for instructors; however, teaching an interdisciplinary class with varied skill levels amplifies this challenge. To encompass a broad range of students, many instructors have sought to improve their lessons and methods by experimenting with group/team programming.…

Are current efforts sufficient to ensure healthy fish populations?

Treesearch

Bob Danehy; Andy Dolloff

2013-01-01

The maintenance and conservation of fish and wildlife populations in landscapes managed for timber production is a contemporary stewardship requirement and a challenge for forest managers. Best management practices (BMPs) have been developed to meet these challenges. Most BMPs were developed starting in the 1970s so the full impact and the success of those BMPs are not...

Toxicological challenges to microbial bioethanol production and strategies for improved tolerance

DOE PAGES

Akinsho, Hannah; Rydzak, Thomas; Borole, Abhijeet P.; ...

2015-09-30

Bioethanol production output has increased steadily over the last two decades and is now beginning to become competitive with traditional liquid transportation fuels due to advances in engineering, the identification of new production host organisms, and the development of novel biodesign strategies. A significant portion of these efforts has been dedicated to mitigating the toxicological challenges encountered across the bioethanol production process. From the release of potentially cytotoxic or inhibitory compounds from input feedstocks, through the metabolic co-synthesis of ethanol and potentially detrimental byproducts, and to the potential cytotoxicity of ethanol itself, each stage of bioethanol production requires the applicationmore » of genetic or engineering controls that ensure the host organisms remain healthy and productive to meet the necessary economies required for large scale production. In addition, as production levels continue to increase, there is an escalating focus on the detoxification of the resulting waste streams to minimize their environmental impact. Thus, this review will present the major toxicological challenges encountered throughout each stage of the bioethanol production process and the commonly employed strategies for reducing or eliminating potential toxic effects.« less

Managing Biases in Product Development Teams: A Tale of Two Rocks

ERIC Educational Resources Information Center

Keene, Michael A.

2017-01-01

The management of product development teams is a challenging task, especially when success hinges on the ability to guide technical and nontechnical personnel through an effective decision-making process. The "Tale of Two Rocks" exercise illustrates how differing motivations and beliefs about new technologies can affect the decisions…

Biosimilars advancements: Moving on to the future.

PubMed

Tsuruta, Lilian Rumi; Lopes dos Santos, Mariana; Moro, Ana Maria

2015-01-01

Many patents for the first biologicals derived from recombinant technology and, more recently, monoclonal antibodies (mAbs) are expiring. Naturally, biosimilars are becoming an increasingly important area of interest for the pharmaceutical industry worldwide, not only for emergent countries that need to import biologic products. This review shows the evolution of biosimilar development regarding regulatory, manufacturing bioprocess, comparability, and marketing. The regulatory landscape is evolving globally, whereas analytical structure and functional analyses provide the foundation of a biosimilar development program. The challenges to develop and demonstrate biosimilarity should overcome the inherent differences in the bioprocess manufacturing and physicochemical and biological characterization of a biosimilar compared to several lots of the reference product. The implementation of approaches, such as Quality by Design (QbD), will provide products with defined specifications in relation to quality, purity, safety, and efficacy that were not possible when the reference product was developed. Actually, the need to prove comparability to the reference product by the biosimilar industry has increased the knowledge about the product and the production-process associated by the use of powerful analytical tools. The technological challenges to make copies of biologic products while attending regulatory and market demands are expected to help innovation in the direction of attaining more productive manufacturing processes. © 2015 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

Electro-textile garments for power and data distribution

NASA Astrophysics Data System (ADS)

Slade, Jeremiah R.; Winterhalter, Carole

2015-05-01

U.S. troops are increasingly being equipped with various electronic assets including flexible displays, computers, and communications systems. While these systems can significantly enhance operational capabilities, forming reliable connections between them poses a number of challenges in terms of comfort, weight, ergonomics, and operational security. IST has addressed these challenges by developing the technologies needed to integrate large-scale cross-seam electrical functionality into virtually any textile product, including the various garments and vests that comprise the warfighter's ensemble. Using this technology IST is able to develop textile products that do not simply support or accommodate a network but are the network.

Harnessing functional food strategies for the health challenges of space travel—Fermented soy for astronaut nutrition

NASA Astrophysics Data System (ADS)

Buckley, Nicole D.; Champagne, Claude P.; Masotti, Adriana I.; Wagar, Lisa E.; Tompkins, Thomas A.; Green-Johnson, Julia M.

2011-04-01

Astronauts face numerous health challenges during long-duration space missions, including diminished immunity, bone loss and increased risk of radiation-induced carcinogenesis. Changes in the intestinal flora of astronauts may contribute to these problems. Soy-based fermented food products could provide a nutritional strategy to help alleviate these challenges by incorporating beneficial lactic acid bacteria, while reaping the benefits of soy isoflavones. We carried out strain selection for the development of soy ferments, selecting strains of lactic acid bacteria showing the most effective growth and fermentation ability in soy milk ( Streptococcus thermophilus ST5, Bifidobacterium longum R0175 and Lactobacillus helveticus R0052). Immunomodulatory bioactivity of selected ferments was assessed using an in vitro challenge system with human intestinal epithelial and macrophage cell lines, and selected ferments show the ability to down-regulate production of the pro-inflammatory cytokine interleukin-8 following challenge with tumour necrosis factor-alpha. The impact of fermentation on vitamin B1 and B6 levels and on isoflavone biotransformation to agluconic forms was also assessed, with strain variation-dependent biotransformation ability detected. Overall this suggests that probiotic bacteria can be successfully utilized to develop soy-based fermented products targeted against health problems associated with long-term space travel.

Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective.

PubMed

Hussong, David

2010-09-01

For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Halvorsen, T.

The next generation subsea developments will be facing a number of new challenges which have to be solved to maintain a cost-efficient solution for production of oil and gas: (1) Smaller fields, i.e. cost reduction through volume will no longer be valid. (2) Freedom in configuration of subsea development. The current idea of standardization will not be directly applicable for cost reduction. (3) Various water depth. The same technology should be applicable for both guideline- and guideline less water depth. (4) Development in new areas of the world where drilling rig deployable system is a must. (5) Various types ofmore » fluid processing may be required as an integral part of a subsea production system. The next generation subsea production system should be universal and applicable to any subsea field development. Kongsberg Offshore a.s. (KOS) have gained extensive experience in supplying standardized total subsea systems. The paper presents the approach taken by KOS to develop the next generation subsea system, and discussed the challenges associated with this.« less

Natural fiber production, harvesting, and preliminary processing: options and opportunities

USDA-ARS?s Scientific Manuscript database

The utilization of natural fibers and plant oils in bio-products introduces numerous logistical challenges not typically encountered with non-agricultural resources. Once it has been determined that a plant material is suitable for commercial development, the production, harvesting, and processing s...

Pricing medicines: theory and practice, challenges and opportunities.

PubMed

Gregson, Nigel; Sparrowhawk, Keiron; Mauskopf, Josephine; Paul, John

2005-02-01

The pricing of medicines has become one of the most hotly debated topics of recent times, with the pharmaceutical industry seemingly being attacked from all quarters. From a company perspective, determining the price for each new product is more crucial than ever, given the present dearth of new drug introductions. But how are pricing strategies developed in practice? What is value-based pricing and how are financial models of return on investment constructed? What are the challenges faced in setting the price for a particular product, and how will scientific and environmental trends provide future pricing challenges or opportunities?

Design and Analysis of Offshore Macroalgae Biorefineries.

PubMed

Golberg, Alexander; Liberzon, Alexander; Vitkin, Edward; Yakhini, Zohar

2018-03-15

Displacing fossil fuels and their derivatives with renewables, and increasing sustainable food production are among the major challenges facing the world in the coming decades. A possible, sustainable direction for addressing this challenge is the production of biomass and the conversion of this biomass to the required products through a complex system coined biorefinery. Terrestrial biomass and microalgae are possible sources; however, concerns over net energy balance, potable water use, environmental hazards, and uncertainty in the processing technologies raise questions regarding their actual potential to meet the anticipated food, feed, and energy challenges in a sustainable way. Alternative sustainable sources for biorefineries are macroalgae grown and processed offshore. However, implementation of the offshore biorefineries requires detailed analysis of their technological, economic, and environmental performance. In this chapter, the basic principles of marine biorefineries design are shown. The methods to integrate thermodynamic efficiency, investment, and environmental aspects are discussed. The performance improvement by development of new cultivation methods that fit macroalgae physiology and development of new fermentation methods that address macroalgae unique chemical composition is shown.

Getting Planetary Data into the Hands of Educators: Recommendations from a Community Discussion

NASA Astrophysics Data System (ADS)

Shipp, S.; Lowes, L.; Hammon, A.; Higbie, M.; Klug, S.; Lindstrom, M.; Stockman, S.; Wise, J.

2004-12-01

In March 2004 a community of approximately 60 researchers, formal and informal education specialists, classroom educators, data archivists, and educational product developers came together for a day-long conference to discuss the challenges in bringing planetary data into the classroom. The conference was hosted by the Solar System Exploration Education Forum and the South Central Organization of Researchers and Educators of NASA's Office of Space Science Support Network. The workshop was intended to: initiate a dialog among those interested in identifying paths for bringing planetary data to educators; better understand key challenges facing educators who are working with planetary data and issues with gaining access to data; identify common aspects of success of programs and products developed to make data accessible in educational venues; and finally, identify the remaining challenges and make recommendations for how the community should move forward to bring these data into the classroom. Presentations by researchers and educational specialists encompassed the facilitation of accessing data, effective use of data in the classroom, availability of data for use by the educational community, and paths for accessing and using mission data. Panel discussions explored the experiences of researchers, educators, and product developers in creating and implementing programs and products and the challenges remaining for integrating planetary data into educational environments. Discussion among participants resulted in a series of recommendations for the development and implementation of successful programs, including: 1) the intended audience should play an active role in the design and development process; 2) program and product implementation should incorporate adequate training and support for intended users; 3) data access needs to be made easier, perhaps requiring the filtering of raw data and new user interfaces; 4) product developers should present data within the context of a lesson or an exploration that is appropriate for the age level, with ties to standards, assessments, and connections to other disciplines such as language arts and math to ease the time burden on the classroom educator; 5) data need to be accessible within a broad context of important scientific questions and understanding; and 6) the potential community involved in the educational use of planetary data is large -- resources such as master-teachers, museums, pre-service faculty, minority organizations, amateur astronomers and others should be involved and leveraged. The complete list of recommendations, presentations, and participants can be found at (http://www.lpi.usra.edu/score). This conference was intended to initiate community dialog on the use of planetary data in the classroom. Future conferences and workshops are planned to continue the discussion of issues and challenges.

Employer and Employee Roles in Workplace-Based Career Development: The Challenge of Change in the Workplace. Workforce Brief #6.

ERIC Educational Resources Information Center

Hovey, Roy

To meet the challenge of a workplace shaped by technological change and global competition, employers and employees must identify their mutual interests in dealing with change and work together to plan career development programs that will benefit employers (by improving productivity and competitiveness) and employees (by enhancing their value in…

Organic livestock production: an emerging opportunity with new challenges for producers in tropical countries.

PubMed

Chander, M; Subrahmanyeswari, B; Mukherjee, R; Kumar, S

2011-12-01

Agrochemicals, veterinary drugs, antibiotics and improved feeds can increase the food supply while minimising production costs in various livestock production systems around the world. However, these days, quality-conscious consumers are increasingly seeking environmentally safe, chemical-residue-free healthy foods, along with product traceability and a high standard of animal welfare, which organic production methods are said to ensure. Organic production is not only a challenge for producers in developing countries, it offers new export opportunities as well. Organic agriculture is practised by 1.8 million producers in 160 countries, and production of organically grown food continues to increase steadily by 15% per year. Most tropical countries are now exporting organic agricultural products but, apart from organic beef from Brazil and Argentina, organic livestock products are yetto take off. Most trade in organic livestock products is restricted to the European Union and other developed nations. Nevertheless, tropical countries cannot afford to neglect this emerging system of animal production. Organic production is knowledge- and management-intensive. Producers must be well versed in organic production standards, principles and practices, which require a high degree of knowledge and skill. In organic production, it is not simply the final product but the whole production process that must be inspected and approved by the accredited certification bodies. Organic livestock farming is still evolving, and further research is needed to make it sustainable. In this paper, the authors review the prospects of organic animal husbandry and its possible constraints in developing and tropical countries.

Recent Advances and Challenges towards Sustainable Polyhydroxyalkanoate (PHA) Production

PubMed Central

Kourmentza, Constantina; Plácido, Jersson; Venetsaneas, Nikolaos; Burniol-Figols, Anna; Varrone, Cristiano; Gavala, Hariklia N.; Reis, Maria A. M.

2017-01-01

Sustainable biofuels, biomaterials, and fine chemicals production is a critical matter that research teams around the globe are focusing on nowadays. Polyhydroxyalkanoates represent one of the biomaterials of the future due to their physicochemical properties, biodegradability, and biocompatibility. Designing efficient and economic bioprocesses, combined with the respective social and environmental benefits, has brought together scientists from different backgrounds highlighting the multidisciplinary character of such a venture. In the current review, challenges and opportunities regarding polyhydroxyalkanoate production are presented and discussed, covering key steps of their overall production process by applying pure and mixed culture biotechnology, from raw bioprocess development to downstream processing. PMID:28952534

Microsoft's Tom Corddry on Multimedia, the Information Superhighway and the Future of Online.

ERIC Educational Resources Information Center

Herther, Nancy K.

1994-01-01

Tom Corddry, Microsoft Corporation's Creative Director for the Consumer Division, is interviewed about the Microsoft Home line of products and the development of related CD-ROM and multimedia products. Reasons for Microsoft's entry into the content market and its challenges, the market's future, and the company's interest in developing online…

Innovation and construction management in Brazil: Challenges of companies in times of quality and productivity

NASA Astrophysics Data System (ADS)

Barbosa, A. A. R.; Vilnītis, M.

2017-10-01

Considering the efforts to optimize productivity and quality in the construction through the potential existing in the respective companies, this study presents an approach for identification, management and priorities of improvements actions at construction sites focusing status on productivity, added value and innovation in the socioeconomic context and scenario of construction industry in Brazil. Technological advances in recent years have made the Brazilian construction industry gradually incorporate technologies and forms of management, despite its traditionally conservative character. In current days, the innovations are pursued with the quest for greater quality, productivity, safety and customer satisfaction, which have been increasingly competitive and global. Construction in Brazil occupies an important role in the economy, directly contributing to GDP and acting on an extensive productive chain of suppliers, commercialization services and maintenance. The Brazilian construction sector has undergone major changes in recent years, facilitated by factors such as the resumption of public investments, the creation of laws that facilitate real estate, investments and funding of external resources, and the efforts of the Brazilian Quality and Productivity Program - PBQP H. However, the sector faces problems of a lack of skilled labour to meet the growth needs of the sector. There are still problems and challenges of quality and productivity that prevent full sector development. The aspects of nonconformity, low quality, high tax burden, outsourcing and informality of the workforce have not been adequately addressed and resolved. Through the use of indicators of productivity and growth, the challenges of the Brazilian construction industry are discussed and the possible paths for the sector that allow its full development and to reduce the distance between the Brazilian construction industry and that of the developed countries.

Challenges in Teaching Modern Manufacturing Technologies

ERIC Educational Resources Information Center

Ngaile, Gracious; Wang, Jyhwen; Gau, Jenn-Terng

2015-01-01

Teaching of manufacturing courses for undergraduate engineering students has become a challenge due to industrial globalisation coupled with influx of new innovations, technologies, customer-driven products. This paper discusses development of a modern manufacturing course taught concurrently in three institutions where students collaborate in…

Building CHAOS: An Operating System for Livermore Linux Clusters

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garlick, J E; Dunlap, C M

2003-02-21

The Livermore Computing (LC) Linux Integration and Development Project (the Linux Project) produces and supports the Clustered High Availability Operating System (CHAOS), a cluster operating environment based on Red Hat Linux. Each CHAOS release begins with a set of requirements and ends with a formally tested, packaged, and documented release suitable for use on LC's production Linux clusters. One characteristic of CHAOS is that component software packages come from different sources under varying degrees of project control. Some are developed by the Linux Project, some are developed by other LC projects, some are external open source projects, and some aremore » commercial software packages. A challenge to the Linux Project is to adhere to release schedules and testing disciplines in a diverse, highly decentralized development environment. Communication channels are maintained for externally developed packages in order to obtain support, influence development decisions, and coordinate/understand release schedules. The Linux Project embraces open source by releasing locally developed packages under open source license, by collaborating with open source projects where mutually beneficial, and by preferring open source over proprietary software. Project members generally use open source development tools. The Linux Project requires system administrators and developers to work together to resolve problems that arise in production. This tight coupling of production and development is a key strategy for making a product that directly addresses LC's production requirements. It is another challenge to balance support and development activities in such a way that one does not overwhelm the other.« less

Potential of Continuous Manufacturing for Liposomal Drug Products.

PubMed

Worsham, Robert D; Thomas, Vaughan; Farid, Suzanne S

2018-05-21

Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g. improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application. This article is protected by copyright. All rights reserved.

Growth and development of ponderosa pine on sites of contrasting productivities: relative importance of stand density and shrub competition effects

Treesearch

Jianwei Zhang; William W. Oliver; Matt D. Busse

2006-01-01

Effects of stand density and shrub competition on growth and development were compared across a gradient of study sites. Challenge, the most productive site, is located in the foothills of the Sierra Nevada, northern California. Pringle Falls is of intermediate productivity in the rain shadow of the central Oregon Cascades. Trough Springs Ridge is the poorest site...

Marketed Marine Natural Products in the Pharmaceutical and Cosmeceutical Industries: Tips for Success

PubMed Central

Martins, Ana; Vieira, Helena; Gaspar, Helena; Santos, Susana

2014-01-01

The marine environment harbors a number of macro and micro organisms that have developed unique metabolic abilities to ensure their survival in diverse and hostile habitats, resulting in the biosynthesis of an array of secondary metabolites with specific activities. Several of these metabolites are high-value commercial products for the pharmaceutical and cosmeceutical industries. The aim of this review is to outline the paths of marine natural products discovery and development, with a special focus on the compounds that successfully reached the market and particularly looking at the approaches tackled by the pharmaceutical and cosmetic companies that succeeded in marketing those products. The main challenges faced during marine bioactives discovery and development programs were analyzed and grouped in three categories: biodiversity (accessibility to marine resources and efficient screening), supply and technical (sustainable production of the bioactives and knowledge of the mechanism of action) and market (processes, costs, partnerships and marketing). Tips to surpass these challenges are given in order to improve the market entry success rates of highly promising marine bioactives in the current pipelines, highlighting what can be learned from the successful and unsuccessful stories that can be applied to novel and/or ongoing marine natural products discovery and development programs. PMID:24549205

A Roundtable Discussion: Combination Products: Twice the Challenge?

PubMed

Baird, Nolan; Binion, Steven B; Cammack, Jon; Paine, Stephanie Del; Gonzales, Rosemary; Passut, Jena; Weiner, John Barlow Barr

2015-01-01

Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. FDA developed a regulation (final rule) on Current Good Manufacturing Practices (CGMP) for combination products that became effective July 22, 2013 (21 CFR Part 4). AAMI recently developed a technical information report (TIR) that provides information on how to effectively implement FDA's regulation. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. This article, a result of an discussion with industry and FDA representatives, explores the landscape of combination products, highlights important considerations in developing and seeking marketing clearance for these innovative products, and provides insight on trends in the area.

Chinese ethnic meat products: Continuity and development.

PubMed

Zeng, Weicai; Wen, Wenting; Deng, Yue; Tian, Yuanyuan; Sun, Honghu; Sun, Qun

2016-10-01

With their distinctive sensory characterizations and unique processing technologies, Chinese ethnic meat products possess great potential for development and continuity in modern China's meat industry. Due to the greater demand for meat products and higher quality and safety concerns in economically fast growing China, the development and continuity of ethnic meat products face its own unique challenges. In this review, the classification of typical ethnic products and their characteristics, and the research progress on their quality and processing technologies are discussed. The application of innovative and green technologies to improve the safety and quality of ethnic meat products for greater industrialization and sustainable development is highlighted. Furthermore, the strategy for promoting the production of Chinese ethnic meat products during the next five years is presented. Copyright © 2016 Elsevier Ltd. All rights reserved.

Nanotechnology in meat processing and packaging: potential applications - a review.

PubMed

Ramachandraiah, Karna; Han, Sung Gu; Chin, Koo Bok

2015-02-01

Growing demand for sustainable production, increasing competition and consideration of health concerns have led the meat industries on a path to innovation. Meat industries across the world are focusing on the development of novel meat products and processes to meet consumer demand. Hence, a process innovation, like nanotechnology, can have a significant impact on the meat processing industry through the development of not only novel functional meat products, but also novel packaging for the products. The potential benefits of utilizing nanomaterials in food are improved bioavailability, antimicrobial effects, enhanced sensory acceptance and targeted delivery of bioactive compounds. However, challenges exist in the application of nanomaterials due to knowledge gaps in the production of ingredients such as nanopowders, stability of delivery systems in meat products and health risks caused by the same properties which also offer the benefits. For the success of nanotechnology in meat products, challenges in public acceptance, economics and the regulation of food processed with nanomaterials which may have the potential to persist, accumulate and lead to toxicity need to be addressed. So far, the most promising area for nanotechnology application seems to be in meat packaging, but the long term effects on human health and environment due to migration of the nanomaterials from the packaging needs to be studied further. The future of nanotechnology in meat products depends on the roles played by governments, regulatory agencies and manufacturers in addressing the challenges related to the application of nanomaterials in food.

Nanotechnology in Meat Processing and Packaging: Potential Applications — A Review

PubMed Central

Ramachandraiah, Karna; Han, Sung Gu; Chin, Koo Bok

2015-01-01

Growing demand for sustainable production, increasing competition and consideration of health concerns have led the meat industries on a path to innovation. Meat industries across the world are focusing on the development of novel meat products and processes to meet consumer demand. Hence, a process innovation, like nanotechnology, can have a significant impact on the meat processing industry through the development of not only novel functional meat products, but also novel packaging for the products. The potential benefits of utilizing nanomaterials in food are improved bioavailability, antimicrobial effects, enhanced sensory acceptance and targeted delivery of bioactive compounds. However, challenges exist in the application of nanomaterials due to knowledge gaps in the production of ingredients such as nanopowders, stability of delivery systems in meat products and health risks caused by the same properties which also offer the benefits. For the success of nanotechnology in meat products, challenges in public acceptance, economics and the regulation of food processed with nanomaterials which may have the potential to persist, accumulate and lead to toxicity need to be addressed. So far, the most promising area for nanotechnology application seems to be in meat packaging, but the long term effects on human health and environment due to migration of the nanomaterials from the packaging needs to be studied further. The future of nanotechnology in meat products depends on the roles played by governments, regulatory agencies and manufacturers in addressing the challenges related to the application of nanomaterials in food. PMID:25557827

Biosensors for Sustainable Food Engineering: Challenges and Perspectives

PubMed Central

Ragavan, Vasanth; Weng, Xuan; Chand, Rohit

2018-01-01

Current food production faces tremendous challenges from growing human population, maintaining clean resources and food qualities, and protecting climate and environment. Food sustainability is mostly a cooperative effort resulting in technology development supported by both governments and enterprises. Multiple attempts have been promoted in tackling challenges and enhancing drivers in food production. Biosensors and biosensing technologies with their applications, are being widely applied to tackling top challenges in food production and its sustainability. Consequently, a growing demand in biosensing technologies exists in food sustainability. Microfluidics represents a technological system integrating multiple technologies. Nanomaterials, with its technology in biosensing, is thought to be the most promising tool in dealing with health, energy, and environmental issues closely related to world populations. The demand of point of care (POC) technologies in this area focus on rapid, simple, accurate, portable, and low-cost analytical instruments. This review provides current viewpoints from the literature on biosensing in food production, food processing, safety and security, food packaging and supply chain, food waste processing, food quality assurance, and food engineering. The current understanding of progress, solution, and future challenges, as well as the commercialization of biosensors are summarized. PMID:29534552

Usability Engineering Can Change Our Thinking

ERIC Educational Resources Information Center

Flowers, Jim

2014-01-01

Technology and engineering education and its predecessors have a long history of being effective programs for helping students learn about technology and technological design. Students are often asked to solve design challenges, develop product ideas, and create models or prototypes for products. They do not often set up tests with product users…

Presidential Green Chemistry Challenge: 2016 Designing Greener Chemicals and Specific Environmental Benefit: Climate Change Awards

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2016 award winner, Newlight Technologies, developed a net carbon negative plastic made from methane-based GHG. It is cheaper than petroleum-based plastic; used to make cell phone cases, furniture, and other products.

Forecasting long-term acorn production with and without oak decline using forest inventory data

Treesearch

Cathryn H. Greenberg; Chad E. Keyser; Leah C. Rathburn; Anita K. Rose; Todd M. Fearer; Henry W. McNab

2013-01-01

Acorns are important as wildlife food and for oak regeneration, but production is highly variable, posing a challenge to forest managers targeting acorn production levels. Forest managers need tools to predict acorn production capability tailored to individual landscapes and forest management scenarios, adjusting for oak mortality and stand development over time. We...

Can we compare the environmental performance of this product to that one? An update on the development of product category rules and future challenges toward alignment

EPA Science Inventory

When used to compare the relative environmental benefits of different products, life cycle-based, quantitative environmental claims, such as carbon footprints and environmental product declarations require common rules in order for claims to be comparable within a category. Produ...

Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries.

PubMed

Neergheen-Bhujun, Vidushi S

2013-01-01

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

Saccharomyces cerevisiae strains for second-generation ethanol production: from academic exploration to industrial implementation.

PubMed

Jansen, Mickel L A; Bracher, Jasmine M; Papapetridis, Ioannis; Verhoeven, Maarten D; de Bruijn, Hans; de Waal, Paul P; van Maris, Antonius J A; Klaassen, Paul; Pronk, Jack T

2017-08-01

The recent start-up of several full-scale 'second generation' ethanol plants marks a major milestone in the development of Saccharomyces cerevisiae strains for fermentation of lignocellulosic hydrolysates of agricultural residues and energy crops. After a discussion of the challenges that these novel industrial contexts impose on yeast strains, this minireview describes key metabolic engineering strategies that have been developed to address these challenges. Additionally, it outlines how proof-of-concept studies, often developed in academic settings, can be used for the development of robust strain platforms that meet the requirements for industrial application. Fermentation performance of current engineered industrial S. cerevisiae strains is no longer a bottleneck in efforts to achieve the projected outputs of the first large-scale second-generation ethanol plants. Academic and industrial yeast research will continue to strengthen the economic value position of second-generation ethanol production by further improving fermentation kinetics, product yield and cellular robustness under process conditions. © FEMS 2017.

Point-of-care diagnostics: extending the laboratory network to reach the last mile.

PubMed

Drain, Paul K; Rousseau, Christine

2017-03-01

More point-of-care (POC) diagnostic tests are becoming available for HIV diagnosis and treatment in resource-limited settings. These novel technologies have the potential to foster decentralized HIV care and treatment for the benefit of clinical laboratories, HIV clinics, and HIV-infected patients. There continue to be many business, technological, and operational challenges that limit product development and regulatory approval, which limits products available for the required operational and cost-effectiveness studies and delays policy adoption and implementation. Although the rapid HIV diagnostic test has been widely successful, the pathways for POC CD4 cell count and HIV viral load assay analyzers have been more challenging. We describe significant hurdles for product development, approval, and implementation, which include the business case, technical development, clinical impact, and integrating laboratory and clinical networks. The objective of this review is to highlight the obstacles for developing and implementing appropriate strategies for POC HIV testing assays to improve the clinical services for HIV-infected patients in resource-limited settings.

Saccharomyces cerevisiae strains for second-generation ethanol production: from academic exploration to industrial implementation

PubMed Central

Jansen, Mickel L. A.; Bracher, Jasmine M.; Papapetridis, Ioannis; Verhoeven, Maarten D.; de Bruijn, Hans; de Waal, Paul P.; van Maris, Antonius J. A.; Klaassen, Paul

2017-01-01

Abstract The recent start-up of several full-scale ‘second generation’ ethanol plants marks a major milestone in the development of Saccharomyces cerevisiae strains for fermentation of lignocellulosic hydrolysates of agricultural residues and energy crops. After a discussion of the challenges that these novel industrial contexts impose on yeast strains, this minireview describes key metabolic engineering strategies that have been developed to address these challenges. Additionally, it outlines how proof-of-concept studies, often developed in academic settings, can be used for the development of robust strain platforms that meet the requirements for industrial application. Fermentation performance of current engineered industrial S. cerevisiae strains is no longer a bottleneck in efforts to achieve the projected outputs of the first large-scale second-generation ethanol plants. Academic and industrial yeast research will continue to strengthen the economic value position of second-generation ethanol production by further improving fermentation kinetics, product yield and cellular robustness under process conditions. PMID:28899031

Development, Application, and Transition of Aerosol and Trace Gas Products Derived from Next-Generation Satellite Observations to Operations

NASA Technical Reports Server (NTRS)

Berndt, Emily; Naeger, Aaron; Zavodsky, Bradley; McGrath, Kevin; LaFontaine, Frank

2016-01-01

NASA Short-term Prediction Research and Transition (SPoRT) Center has a history of successfully transitioning unique observations and research capabilities to the operational weather community to improve short-term forecasts. SPoRTstrives to bridge the gap between research and operations by maintaining interactive partnerships with end users to develop products that match specific forecast challenges, provide training, and assess the products in the operational environment. This presentation focuses on recent product development, application, and transition of aerosol and trace gas products to operations for specific forecasting applications. Recent activities relating to the SPoRT ozone products, aerosol optical depth composite product, sulfur dioxide, and aerosol index products are discussed.

Future Supply Chains Enabled by Continuous Processing—Opportunities and Challenges. May 20–21, 2014 Continuous Manufacturing Symposium

PubMed Central

Srai, Jagjit Singh; Badman, Clive; Krumme, Markus; Futran, Mauricio; Johnston, Craig

2015-01-01

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily “continuous processing”-based supply chain. The current predominantly “large batch” and centralized manufacturing system designed for the “blockbuster” drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more “flow-through” operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The significant opportunities to moving to a supply chain flow-through operating model, with substantial opportunities in inventory reduction, lead-time to patient, and radically different product assurance/stability regimes. Scenarios for decentralized production models producing a greater variety of products with enhanced volume flexibility. Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations. Clinical trial and drug product development cost savings that support more rapid scale-up and market entry models with early involvement of SC designers within New Product Development. The major supply chain and industrial transformational challenges that need to be addressed. The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:840–849, 2015 PMID:25631279

Laboratory automation —some perspectives on the challenges in the implementation of the technology in pharmaceutical development

PubMed Central

North, Nigel; Smith, Simon

1998-01-01

The intensifying pressure on reducing the development time for new pharmaceutical products is resulting in an increasing need for laboratory automation. A key element for the successful implementation of robotics for drug product analysis is the establishment of a reliable process for interaction of the automation team with its various customers, for example development product team and manufacturing group. The reduction of cycle time for product development appears to be resulting in more stability studies to support NDA/MAA filings for several reasons. Key clinical information may not be available before initiation of the stability studies and simultaneous world-wide development may result in an increase in the number of product strength and pack options. PMID:18924828

Developing a Friendly and Productive Language Learning Environment (FPLE) Using the Learner as a Resource

ERIC Educational Resources Information Center

Masaazi, Fred M.

2015-01-01

This article addresses the need to develop a friendly and productive Language learning environment (FPLE) using the learners as a resource in schools in Uganda. This is in light of the persistent challenging reality that the teaching and learning of languages in schools appears to be still largely traditional, teacher-centered and…

Sustainability and Productivity Indicators with Sensitivity Truth Table for Unskilled Thai Labour Reverse Migration

ERIC Educational Resources Information Center

Panaingvait, Poj; Chakpitak, Nopasit; Yodmongkol, Pitipong; Sureephong, Paradorn; Nimmonrat, Acrapol

2014-01-01

Thailand, a developing country, had labours migrating from the agriculture into the industrial due to higher pay in the past. However the economic force has made the government policy to focus on creativity and developing technology towards automatic production. Unskilled Thai labours are facing a big challenge after retirement, which is called…

Vehicle Lightweighting: Challenges and Opportunities with Aluminum

NASA Astrophysics Data System (ADS)

Sachdev, Anil K.; Mishra, Raja K.; Mahato, Anirban; Alpas, Ahmet

Rising energy costs, consumer preferences and regulations drive requirements for fuel economy, performance, comfort, safety and cost of future automobiles. These conflicting situations offer challenges for vehicle lightweighting, for which aluminum applications are key. This paper describes product design needs and materials and process development opportunities driven by theoretical, experimental and modeling tools in the area of sheet and castings. Computational tools and novel experimental techniques used in their development are described. The paper concludes with challenges that lie ahead for pervasive use of aluminum and the necessary fundamental R&D that is still needed.

Internationalization of traditional Chinese medicine: current international market, internationalization challenges and prospective suggestions.

PubMed

Lin, Annie Xianghong; Chan, Ging; Hu, Yuanjia; Ouyang, Defang; Ung, Carolina Oi Lam; Shi, Luwen; Hu, Hao

2018-01-01

Through reviewing the current international market for traditional Chinese medicine (TCM), this paper identified the internationalization challenges for TCM, including unclear therapeutic material basis and mechanism, difficulty of quality control, low preparation level, registration/policy barriers, and shortage of intellectual property. To deal with these challenges, suggestions were given including: (1) product innovation of TCM (study the TCM by using the methods and means of western medicine; innovate the basic theory of TCM; develop TCM health product); (2) standard innovation of TCM; (3) building big data platform of Chinese medicine (big data platform of TCM preparation; big data platform on the quality of TCM).

Exploration Rover Concepts and Development Challenges

NASA Technical Reports Server (NTRS)

Zakrajsek, James J.; McKissock, David B.; Woytach, Jeffrey M.; Zakrajsek, June F.; Oswald, Fred B.; McEntire, Kelly J.; Hill, Gerald M.; Abel, Phillip; Eichenberg, Dennis J.; Goodnight, Thomas W.

2005-01-01

This paper presents an overview of exploration rover concepts and the various development challenges associated with each as they are applied to exploration objectives and requirements for missions on the Moon and Mars. A variety of concepts for surface exploration vehicles have been proposed since the initial development of the Apollo-era lunar rover. This paper provides a brief description of the rover concepts, along with a comparison of their relative benefits and limitations. In addition, this paper outlines, and investigates a number of critical development challenges that surface exploration vehicles must address in order to successfully meet the exploration mission vision. These include: mission and environmental challenges, design challenges, and production and delivery challenges. Mission and environmental challenges include effects of terrain, extreme temperature differentials, dust issues, and radiation protection. Design methods are discussed that focus on optimum methods for developing highly reliable, long-life and efficient systems. In addition, challenges associated with delivering a surface exploration system is explored and discussed. Based on all the information presented, modularity will be the single most important factor in the development of a truly viable surface mobility vehicle. To meet mission, reliability, and affordability requirements, surface exploration vehicles, especially pressurized rovers, will need to be modularly designed and deployed across all projected Moon and Mars exploration missions.

Chasing helminths and their economic impact on farmed ruminants.

PubMed

Charlier, Johannes; van der Voort, Mariska; Kenyon, Fiona; Skuce, Philip; Vercruysse, Jozef

2014-07-01

Global agriculture will be required to intensify production from a shrinking natural resource base. Helminth infections of ruminants are a major constraint on efficient livestock production. The current challenge is to develop diagnostic methods that detect the production impact of helminth infections on farms in order to target control measures and contribute to the global challenge of preserving food security. We review here our understanding of the effects of helminth infections and control practices on productivity and the diagnostic tools that can inform on this. By combining advances in helminth laboratory diagnostics and animal health economics, sustainable management of helminth infections can be integrated into the whole-farm economic context. Copyright © 2014 Elsevier Ltd. All rights reserved.

In vitro meat production system: why and how?

PubMed

Sharma, Shruti; Thind, Sukhcharanjit Singh; Kaur, Amarjeet

2015-12-01

Due to the nutritional importance and the sustained popularity of meat as a foodstuff, the livestock production sector has been expanding incessantly. This exponential growth of livestock meat sector poses a gigantic challenge to the sustainability of food production system. A new technological breakthrough is being contemplated to develop a substitute for livestock meat. The idea is to grow meat in a culture in the lab and manipulate its composition selectively. This paper aims to discuss the concept of In Vitro Meat production system, articulate the underlying technology and analyse the context of its implications, as proposed by several scientists and stakeholders. The challenges facing this emerging technology have also been discussed.

Efficient production of therapeutic doses of [131I]-metaiodobenzylguanidine for clinical use.

PubMed

Prabhakar, G; Mathur, Anupam; Shunmugam, G; Teje, Y D; Sachdev, S S; Sivaprasad, N

2011-01-01

[(131)I]-metaiodobenzylguanidine (mIBG) is a known radiopharmaceutical used for the treatment of neuroendocrine tumors. The development of therapeutic [(131)I]-mIBG doses at production level is highly challenging due to rapid product degradation and high radiation exposures to the production plant personnel. In the present work, a working module for the production of 10 doses (100 mCi each) in a single operation was developed following copper (I) assisted isotope exchange. The labeled product complies with the pharmaceutical specifications suitable for in-vivo patient use. Copyright © 2010 Elsevier Ltd. All rights reserved.

Global impacts of U.S. bioenergy production and policy: A general equilibrium perspective

NASA Astrophysics Data System (ADS)

Evans, Samuel Garner

The conversion of biomass to energy represents a promising pathway forward in efforts to reduce fossil fuel use in the transportation and electricity sectors. In addition to potential benefits, such as greenhouse gas reductions and increased energy security, bioenergy production also presents a unique set of challenges. These challenges include tradeoffs between food and fuel production, distortions in energy markets, and terrestrial emissions associated with changing land-use patterns. Each of these challenges arises from market-mediated responses to bioenergy production, and are therefore largely economic in nature. This dissertation directly addresses these opportunities and challenges by evaluating the economic impacts of U.S. bioenergy production and policy, focusing on both existing and future biomass-to-energy pathways. The analysis approaches the issue from a global, economy-wide perspective, reflecting two important facts. First, that large-scale bioenergy production connects multiple sectors of the economy due to the use of agricultural land resources for biomass production, and competition with fossil fuels in energy markets. Second, markets for both agricultural and energy commodities are highly integrated globally, causing domestic policies to have international effects. The reader can think of this work as being comprised of three parts. Part I provides context through an extensive review of the literature on the market-mediated effects of conventional biofuel production (Chapter 2) and develops a general equilibrium modeling framework for assessing the extent to which these phenomenon present a challenge for future bioenergy pathways (Chapter 3). Part II (Chapter 4) explores the economic impacts of the lignocellulosic biofuel production targets set in the U.S. Renewable Fuel Standard on global agricultural and energy commodity markets. Part III (Chapter 5) extends the analysis to consider potential inefficiencies associated with policy-induced competition for biomass between the electricity and transportation fuel sectors.

Key challenges and priorities for modelling European grasslands under climate change.

PubMed

Kipling, Richard P; Virkajärvi, Perttu; Breitsameter, Laura; Curnel, Yannick; De Swaef, Tom; Gustavsson, Anne-Maj; Hennart, Sylvain; Höglind, Mats; Järvenranta, Kirsi; Minet, Julien; Nendel, Claas; Persson, Tomas; Picon-Cochard, Catherine; Rolinski, Susanne; Sandars, Daniel L; Scollan, Nigel D; Sebek, Leon; Seddaiu, Giovanna; Topp, Cairistiona F E; Twardy, Stanislaw; Van Middelkoop, Jantine; Wu, Lianhai; Bellocchi, Gianni

2016-10-01

Grassland-based ruminant production systems are integral to sustainable food production in Europe, converting plant materials indigestible to humans into nutritious food, while providing a range of environmental and cultural benefits. Climate change poses significant challenges for such systems, their productivity and the wider benefits they supply. In this context, grassland models have an important role in predicting and understanding the impacts of climate change on grassland systems, and assessing the efficacy of potential adaptation and mitigation strategies. In order to identify the key challenges for European grassland modelling under climate change, modellers and researchers from across Europe were consulted via workshop and questionnaire. Participants identified fifteen challenges and considered the current state of modelling and priorities for future research in relation to each. A review of literature was undertaken to corroborate and enrich the information provided during the horizon scanning activities. Challenges were in four categories relating to: 1) the direct and indirect effects of climate change on the sward 2) climate change effects on grassland systems outputs 3) mediation of climate change impacts by site, system and management and 4) cross-cutting methodological issues. While research priorities differed between challenges, an underlying theme was the need for accessible, shared inventories of models, approaches and data, as a resource for stakeholders and to stimulate new research. Developing grassland models to effectively support efforts to tackle climate change impacts, while increasing productivity and enhancing ecosystem services, will require engagement with stakeholders and policy-makers, as well as modellers and experimental researchers across many disciplines. The challenges and priorities identified are intended to be a resource 1) for grassland modellers and experimental researchers, to stimulate the development of new research directions and collaborative opportunities, and 2) for policy-makers involved in shaping the research agenda for European grassland modelling under climate change. Copyright © 2016 Elsevier B.V. All rights reserved.

Processing Challenges and Opportunities of Camel Dairy Products

PubMed Central

Seifu, Eyassu; Ipsen, Richard; Kurtu, Mohamed Y.; Hansen, Egon Bech

2017-01-01

A review on the challenges and opportunities of processing camel milk into dairy products is provided with an objective of exploring the challenges of processing and assessing the opportunities for developing functional products from camel milk. The gross composition of camel milk is similar to bovine milk. Nonetheless, the relative composition, distribution, and the molecular structure of the milk components are reported to be different. Consequently, manufacturing of camel dairy products such as cheese, yoghurt, or butter using the same technology as for dairy products from bovine milk can result in processing difficulties and products of inferior quality. However, scientific evidence points to the possibility of transforming camel milk into products by optimization of the processing parameters. Additionally, camel milk has traditionally been used for its medicinal values and recent scientific studies confirm that it is a rich source of bioactive, antimicrobial, and antioxidant substances. The current literature concerning product design and functional potential of camel milk is fragmented in terms of time, place, and depth of the research. Therefore, it is essential to understand the fundamental features of camel milk and initiate detailed multidisciplinary research to fully explore and utilize its functional and technological properties. PMID:29109953

Current knowledge and future challenges in camelid reproduction.

PubMed

Tibary, A; Anouassi, A; Sghiri, A; Khatir, H

2007-01-01

Reproductive biology research on camelids offers some interesting peculiarities and challenges to scientists and animal production specialists. The objective of this paper is to review camelid reproduction, advances in reproductive physiology and reproductive biotechnologies in camelids and discuss some areas for further research. In the female, the focus has been on understanding follicular dynamics. This has allowed development of synchronization and superovulation strategies to support embryo transfer technologies which are now commonly used in camels. Some advances have been achieved in preservation of embryos by vitrification. Fertilization, early embryo development and embryo signaling for maternal recognition of pregnancy are still not fully understood. New information on the interaction of the developing embryo and the endometrium may shed some light on this signaling as well as the mechanism of prevention of luteolysis. The presence of a seminal ovulation-inducing factor (OIF) was confirmed in llamas and alpacas. Chronology of oocytes maturation has been described. In vitro production of embryos has been achieved resulting in successful pregnancies and births in the dromedary. These techniques offer a new tool for the production and study of interspecies/cross-species embryos and their effect on pregnancy. Male reproductive function remains poorly studied. Semen preservation and artificial insemination still present many challenges and are not used in production at the moment. The involvement of climatic and nutritional conditions as well as the role of leptin in the regulation of reproductive function need to be evaluated.

Development and regulation of biosimilars: current status and future challenges.

PubMed

Tsiftsoglou, Asterios S; Ruiz, Sol; Schneider, Christian K

2013-06-01

Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. The licencing of these products, however, relies on the experience gained with the original biopharmaceuticals. Critical issues related to this class of medicinal products include their terminology (to avoid confusion with generics and non-innovator copy versions that have not been tested according to the biosimilar guidelines), manufacturing, and regulation. The European Union (EU) has been the first to establish a regulatory framework for marketing authorization application (MAA) and has named these products biosimilars, a term also recently adopted by the US FDA. Unlike the conventional, more common small molecular weight human medicines and chemical generics, protein-based medicines exhibit higher molecular weight, complexity in structure and function that can be affected by changes in the manufacturing process. Therefore, biosimilars represent a relatively heterogeneous class of medicinal products that make their regulation quite challenging. According to the current understanding in the EU, a biosimilar is a copy version of an already authorized biopharmaceutical (or reference product) with similar biologic activity, physicochemical characteristics, efficacy, and safety, based on a full comparability exercise at quality, preclinical and clinical level to ensure similar efficacy and safety. Guidance has been provided through several Committee for Medicinal Products for Human Use (CHMP) guidelines as well as individual scientific advice requested from the European Medicines Agency (EMA) by various companies for the development and regulation of biosimilars. This review is mainly focused on the current status of regulation of biosimilars in the EU as well as on future challenges lying ahead for the improvement of the requirements needed for the marketing authorization of biosimilars. Emphasis is given on the quality requirements concerning these medicinal products (biologics).

Marketers Understanding Engineers and Engineers Understanding Marketers: The Opportunities and Constraints of a Cross-Discipline Course Using 3D Printing to Develop Marketable Innovations

ERIC Educational Resources Information Center

Reifschneider, Louis; Kaufman, Peter; Langrehr, Frederick W.; Kaufman, Kristina

2015-01-01

Marketers are criticized for not understanding the steps in the engineering research and development process and the challenges of manufacturing a new product at a profit. Engineers are criticized for not considering the marketability of and customer interest in such a product during the planning stages. With the development of 3D printing, rapid…

Manufacturing challenges in the commercial production of recombinant coagulation factor VIII.

PubMed

Jiang, R; Monroe, T; McRogers, R; Larson, P J

2002-03-01

Advances in gene technology have led to the development of a method to manufacture recombinant coagulation Factor VIII (rFVIII) for haemophilia A. Because rFVIII is a large and complex protein, its commercialization has required that many challenges in manufacturing, purification and processing be overcome. In order to license the first generation of rFVIII (Kogenate) in 1993, Bayer Corporation invested over 10 years in research and manufacturing development. Seven additional years were subsequently devoted to research and manufacturing improvements in order to accomplish the recent licensing of a second rFVIII product (KOGENATE Bayer or Kogenate FS). This product differs from its predecessor, in that human albumin is removed from the purification and the formulation steps. In addition, fewer chromatography steps are involved resulting in greater yields per mL of conditioned medium, and a solvent-detergent viral inactivation step replaces the heat-processing step used for the previous product. Despite these changes in the manufacturing, the protein backbone and carbohydrate structure of the final rFVIII molecule are identical. The complexity of the production processes is reflected by over 100 000 manufacturing data entries and by 600 quality control tests for each batch of rFVIII. Manufacturers are continuing to develop the next generation of rFVIII, which will be produced without the addition of any human or animal proteins or byproducts. Investments in research, development and manufacturing technology are expected to result in the development of new products with enhanced safety profiles, and in an increase in the production capacity for products that are chronically in short supply.

Good Student/Bad Student: Situated Identities in the Figured Worlds of School and Creative Multimodal Production

ERIC Educational Resources Information Center

Jocius, Robin

2017-01-01

This study situates young adolescents' multimodal composing practices within two figured worlds--school and creative multimodal production. In a microanalysis of two focal students' multimodal processes and products, I trace how pedagogical, interactional, and semiotic resources both reified and challenged students' developing identities as…

U.S. Productivity: The Challenges Ahead.

ERIC Educational Resources Information Center

Workforce Economics, 1999

1999-01-01

Despite the soaring stock market, low unemployment, and low inflation rate, the long-term prospects for U.S. economic health remain a cause for concern. Labor productivity has slowed since 1973. As a result of this slowdown, many companies are investing in work force development and new equipment to boost productivity. Long-term economic health…

Preparation of nonwoven and green composites from tannery solid wastes

USDA-ARS?s Scientific Manuscript database

The disposal of solid wastes, such as trimmings and splits generated in various manufacturing processes in a tannery, is a serious challenge to the hides and leather industries. Our effort to address this challenge is to develop new uses and novel biobased products from solid wastes to improve prosp...

The role of public-private partnerships in addressing the biomedical innovation challenge.

PubMed

Said, Maya; Zerhouni, Elias

2014-11-01

Without a step change in the productivity of pharmaceutical research and development, it will be difficult to tackle the public health challenges facing societies worldwide. Public–private partnerships could play a key role in achieving this step change, but they need to be well designed and led.

Halal Supply Chain Management Streamlined Practices: Issues and Challenges

NASA Astrophysics Data System (ADS)

Hijrah Abd Kadir, Muhammad; Zuraidah Raja Mohd Rasi, Raja; Omar, Siti Sarah; Manap, Zariq Imran Abdul

2016-11-01

The quickly developing worldwide halal in business sector has given a remarkable window of chance, which empowers Malaysia to the renowned halal centre in worldwide (known as Halal-hubs). Malaysia also has proactively taken a lead in halal activities, which is presently considered as the benchmark for a halal framework worldwide. Malaysia also set up the Halal Industry Development Corporation (HDC) which driving a wide range of halal activities since the demand of halal food has increased significantly which is very crucial for a Muslim in ensuring its authenticity and integrity. Even in parallel to this developments, many studies has been conducted because there are many issues still occurs in the food industry. The issue of consumer awareness and understanding the halal principles, mixing of halal and non- halal products, halal certification and logo compliance with Shariah law and lack of regulation and enforcement need the serious attention by all parties along the supply chain. The challenges occur mainly in the halal food segregation and halal traceability of the products. The unit of analysis in this study different halal stakeholders group which are JAKIM, Halal Development Centre (HDC), Raw Material Manufacturers, Retailers and Government Agencies. This paper attempt discusses the issues and challenges occurs in the halal supply chain and faced by the practitioners as well as the relevant parties involved in the industry especially for food products manufacturers. The study would like to give a basic information about the issues and challenges in the contribution of Halal Supply Chain Management (HSCM) as well as for the future studies.

Possibility of Exosome-Based Therapeutics and Challenges in Production of Exosomes Eligible for Therapeutic Application.

PubMed

Yamashita, Takuma; Takahashi, Yuki; Takakura, Yoshinobu

2018-01-01

Exosomes are cell-derived vesicles with a diameter 30-120 nm. Exosomes contain endogenous proteins and nucleic acids; delivery of these molecules to exosome-recipient cells causes biological effects. Exosomes derived from some types of cells such as mesenchymal stem cells and dendritic cells have therapeutic potential and may be biocompatible and efficient agents against various disorders such as organ injury. However, there are many challenges for the development of exosome-based therapeutics. In particular, producing exosomal formulations is the major barrier for therapeutic application because of their heterogeneity and low productivity. Development and optimization of producing methods, including methods for isolation and storage of exosome formulations, are required for realizing exosome-based therapeutics. In addition, improvement of therapeutic potential and delivery efficiency of exosomes are important for their therapeutic application. In this review, we summarize current knowledge about therapeutic application of exosomes and discuss some challenges in their successful use.

Library Subject Guides: A Content Management Case Study at the Open University, UK

ERIC Educational Resources Information Center

Wales, Tim

2005-01-01

Purpose: To share the experiences and challenges faced by the Open University Library (OUL) in developing a content management (CM) system for its subject guides. Design/methodology/approach: A summary of multi-format subject guide production at the OUL is provided to justify the decision to develop a new system for their production using a…

Symposium: Animal welfare challenges for today and tomorrow.

PubMed

Vizzier Thaxton, Yvonne; Christensen, Karen D; Mench, Joy A; Rumley, Elizabeth R; Daugherty, Christine; Feinberg, Bruce; Parker, Molly; Siegel, Paul; Scanes, Colin G

2016-09-01

The increasing separation of the public from production agriculture means there is often a lack of knowledge among consumers about current production practices and a perception that increased productivity and economic efficiency are necessarily associated with a decline in animal welfare. A symposium was organized to present information about animal welfare issues and the challenges they pose for both scientists and the poultry and allied industries. Companion papers provide information about understanding public attitudes and physiological/immunological approaches to welfare assessment, while this paper outlines current and future challenges to egg and meat production and industry responses to those challenges. For broiler chickens, increases in growth rate result in corollary increases in metabolic heat generation and water consumption, leading to the need for continuing improvements in housing, ventilation, and litter management. Stocking densities, lighting programs, muscle myopathies, and use of antibiotics are also areas that require research attention. In the layer industry, the key challenge is housing, with the industry undergoing a shift from conventional cage housing to alternatives like enriched colonies or cage-free. While these alternative systems have hen welfare advantages, there are also welfare disadvantages that require the development of mitigation strategies, and it is also essential to address associated issues including economic, environmental, egg safety, and worker health impacts. Concerns on the horizon include euthanasia of surplus male chicks and spent hens as well as beak-trimming. The humaneness of slaughter methods is an important welfare and consumer confidence issue, and the current regulations for poultry slaughter in the USA are discussed and compared to those for livestock. The poultry and allied industries, including retailers, are responding to these concerns by consulting with experts, developing science-based animal care standards and auditing programs, strengthening training and oversight programs, promoting research, and improving communication channels. In future, intensifying multi-disciplinary research efforts and developing mechanisms to improve communication between scientists and stakeholders, including the public, will be critical to addressing these issues. © 2016 Poultry Science Association Inc.

Agricultural Education for Sustainable Rural Development: Challenges for Developing Countries in the 21st Century.

ERIC Educational Resources Information Center

van Crowder, L.; Lindley, W. I.; Bruening, T. H.; Doron, N.

1998-01-01

Agricultural education institutions in developing countries must address immediate production needs as well as food security, sustainable agricultural, and rural development needs. This will mean moving to an interdisciplinary, systems approach that incorporates new topics. (Author/JOW)

Use of a design challenge to develop postural support devices for intermediate wheelchair users

PubMed Central

Tanuku, Deepti; Moller, Nathaniel C.

2017-01-01

The provision of an appropriate wheelchair, one that provides proper fit and postural support, promotes wheelchair users’ physical health and quality of life. Many wheelchair users have postural difficulties, requiring supplemental postural support devices for added trunk support. However, in many low- and middle-income settings, postural support devices are inaccessible, inappropriate or unaffordable. This article describes the use of the design challenge model, informed by a design thinking approach, to catalyse the development of an affordable, simple and robust postural support device for low- and middle-income countries. The article also illustrates how not-for-profit organisations can utilise design thinking and, in particular, the design challenge model to successfully support the development of innovative solutions to product or process challenges. PMID:28936418

Research Productivity: Some Paths Less Travelled

ERIC Educational Resources Information Center

Martin, Brian

2009-01-01

Conventional approaches for fostering research productivity, such as recruitment and incentives, do relatively little to develop latent capacities in researchers. Six promising unorthodox approaches are the promotion of regular writing, tools for creativity, good luck, happiness, good health and crowd wisdom. These options challenge conventional…

Challenges and opportunities for the commercialization of postharvest biocontrol

USDA-ARS?s Scientific Manuscript database

The past twenty years has seen the field of postharvest biocontrol evolve into a sophisticated science with global research programs worldwide, numerous yearly publications, patented technologies, and the development of new commercial products. The use of these products, however, still remains limi...

New Synthetic Methods for Hypericum Natural Products

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jeon, Insik

Organic chemistry has served as a solid foundation for interdisciplinary research areas, such as molecular biology and medicinal chemistry. An understanding of the biological activities and structural elucidations of natural products can lead to the development of clinically valuable therapeutic options. The advancements of modern synthetic methodologies allow for more elaborate and concise natural product syntheses. The theme of this study centers on the synthesis of natural products with particularly challenging structures and interesting biological activities. The synthetic expertise developed here will be applicable to analog syntheses and to other research problems.

[Fuel ethanol production from cassava feedstock].

PubMed

Huang, Ribo; Chen, Dong; Wang, Qingyan; Shen, Naikun; Wei, Yutuo; Du, Liqin

2010-07-01

The regions suitable for growing cassava include five provinces in Southern China, with Guangxi alone accounting for over 65% of the total cassava production in the country. In this article, the state-of-the-art development of fuel ethanol production from cassava in China is illustrated by the construction of the cassava fuel ethanol plant with its annual production capacity of 200 000 metric tons. And in the meantime, problems and challenges encountered in the development of China's cassava fuel ethanol are highlighted and the strategies to address them are proposed.

HTA programme response to the challenges of dealing with orphan medicinal products: Process evaluation in selected European countries.

PubMed

Nicod, Elena; Annemans, Lieven; Bucsics, Anna; Lee, Anne; Upadhyaya, Sheela; Facey, Karen

2017-03-28

Challenges commonly encountered in HTA of orphan medicinal products (OMPs) were identified in Advance-HTA. Since then, new initiatives have been developed to specifically address issues related to HTA of OMPs. This study aimed to understand why these new HTA initiatives in England, Scotland and at European-level were established and whether they resolve the challenges of OMPs. The work of Advance-HTA was updated with a literature review and a conceptual framework of clinical, regulatory and economic challenges for OMPs was developed. The new HTA programmes were critiqued against the conceptual framework and outstanding challenges identified. The new programmes in England and Scotland recognise the challenges identified in demonstrating the value of ultra-OMPs (and OMPs) and that they require a different process to standard HTA approaches. Wider considerations of disease and treatment experiences from a multi-stakeholder standpoint are needed, combined with other measures to deal with uncertainty (e.g. managed entry agreements). While approaches to assessing this new view of value of OMPs, extending beyond cost/QALY frameworks, differ, their criteria are similar. These are complemented by a European initiative that fosters multi-stakeholder dialogue and consensus about value determinants throughout the life-cycle of an OMP. New HTA programmes specific to OMPs have been developed but questions remain about whether they sufficiently capture value and manage uncertainty in clinical practice. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Challenges of Moving IPG into Production

NASA Technical Reports Server (NTRS)

Schulbach, Cathy

2004-01-01

Over the past 5-6 years, NASA has been developing the Information Power Grid and has a persistent testbed currently based on GT2.4.2. This presentation will begin with an overview of IPG status and services, discuss key milestones in IPG development, and present early as well as expected applications. The presentation will discuss some of the issues encountered in developing a grid including the tension between providing centralized and distributed computing. These issues also affect how the grid is moved into full production. Finally, the presentation will provide current plans for moving IPG into full production, including gaining broad user input, developing acceptance criteria from the production operations group, planning upgrades, and training users.

From the Lab to the Farm: An Industrial Perspective of Plant Beneficial Microorganisms

PubMed Central

Parnell, J. Jacob; Berka, Randy; Young, Hugh A.; Sturino, Joseph M.; Kang, Yaowei; Barnhart, D. M.; DiLeo, Matthew V.

2016-01-01

Any successful strategy aimed at enhancing crop productivity with microbial products ultimately relies on the ability to scale at regional to global levels. Microorganisms that show promise in the lab may lack key characteristics for widespread adoption in sustainable and productive agricultural systems. This paper provides an overview of critical considerations involved with taking a strain from discovery to the farmer’s field. In addition, we review some of the most effective microbial products on the market today, explore the reasons for their success and outline some of the major challenges involved in industrial production and commercialization of beneficial strains for widespread agricultural application. General processes associated with commercializing viable microbial products are discussed in two broad categories, biofertility inoculants and biocontrol products. Specifically, we address what farmers desire in potential microbial products, how mode of action informs decisions on product applications, the influence of variation in laboratory and field study data, challenges with scaling for mass production, and the importance of consistent efficacy, product stability and quality. In order to make a significant impact on global sustainable agriculture, the implementation of plant beneficial microorganisms will require a more seamless transition between laboratory and farm application. Early attention to the challenges presented here will improve the likelihood of developing effective microbial products to improve crop yields, decrease disease severity, and help to feed an increasingly hungry planet. PMID:27540383

Discovery and resupply of pharmacologically active plant-derived natural products: A review

PubMed Central

Linder, Thomas; Wawrosch, Christoph; Uhrin, Pavel; Temml, Veronika; Wang, Limei; Schwaiger, Stefan; Heiss, Elke H.; Rollinger, Judith M.; Schuster, Daniela; Breuss, Johannes M.; Bochkov, Valery; Mihovilovic, Marko D.; Kopp, Brigitte; Bauer, Rudolf; Dirsch, Verena M.; Stuppner, Hermann

2016-01-01

Medicinal plants have historically proven their value as a source of molecules with therapeutic potential, and nowadays still represent an important pool for the identification of novel drug leads. In the past decades, pharmaceutical industry focused mainly on libraries of synthetic compounds as drug discovery source. They are comparably easy to produce and resupply, and demonstrate good compatibility with established high throughput screening (HTS) platforms. However, at the same time there has been a declining trend in the number of new drugs reaching the market, raising renewed scientific interest in drug discovery from natural sources, despite of its known challenges. In this survey, a brief outline of historical development is provided together with a comprehensive overview of used approaches and recent developments relevant to plant-derived natural product drug discovery. Associated challenges and major strengths of natural product-based drug discovery are critically discussed. A snapshot of the advanced plant-derived natural products that are currently in actively recruiting clinical trials is also presented. Importantly, the transition of a natural compound from a “screening hit” through a “drug lead” to a “marketed drug” is associated with increasingly challenging demands for compound amount, which often cannot be met by re-isolation from the respective plant sources. In this regard, existing alternatives for resupply are also discussed, including different biotechnology approaches and total organic synthesis. While the intrinsic complexity of natural product-based drug discovery necessitates highly integrated interdisciplinary approaches, the reviewed scientific developments, recent technological advances, and research trends clearly indicate that natural products will be among the most important sources of new drugs also in the future. PMID:26281720

Discovery and resupply of pharmacologically active plant-derived natural products: A review.

PubMed

Atanasov, Atanas G; Waltenberger, Birgit; Pferschy-Wenzig, Eva-Maria; Linder, Thomas; Wawrosch, Christoph; Uhrin, Pavel; Temml, Veronika; Wang, Limei; Schwaiger, Stefan; Heiss, Elke H; Rollinger, Judith M; Schuster, Daniela; Breuss, Johannes M; Bochkov, Valery; Mihovilovic, Marko D; Kopp, Brigitte; Bauer, Rudolf; Dirsch, Verena M; Stuppner, Hermann

2015-12-01

Medicinal plants have historically proven their value as a source of molecules with therapeutic potential, and nowadays still represent an important pool for the identification of novel drug leads. In the past decades, pharmaceutical industry focused mainly on libraries of synthetic compounds as drug discovery source. They are comparably easy to produce and resupply, and demonstrate good compatibility with established high throughput screening (HTS) platforms. However, at the same time there has been a declining trend in the number of new drugs reaching the market, raising renewed scientific interest in drug discovery from natural sources, despite of its known challenges. In this survey, a brief outline of historical development is provided together with a comprehensive overview of used approaches and recent developments relevant to plant-derived natural product drug discovery. Associated challenges and major strengths of natural product-based drug discovery are critically discussed. A snapshot of the advanced plant-derived natural products that are currently in actively recruiting clinical trials is also presented. Importantly, the transition of a natural compound from a "screening hit" through a "drug lead" to a "marketed drug" is associated with increasingly challenging demands for compound amount, which often cannot be met by re-isolation from the respective plant sources. In this regard, existing alternatives for resupply are also discussed, including different biotechnology approaches and total organic synthesis. While the intrinsic complexity of natural product-based drug discovery necessitates highly integrated interdisciplinary approaches, the reviewed scientific developments, recent technological advances, and research trends clearly indicate that natural products will be among the most important sources of new drugs also in the future. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

From Prototype to Product: Making Participatory Design of mHealth Commercially Viable.

PubMed

Andersen, Tariq O; Bansler, Jørgen P; Kensing, Finn; Moll, Jonas

2017-01-01

This paper delves into the challenges of engaging patients, clinicians and industry stakeholders in the participatory design of an mHealth platform for patient-clinician collaboration. It follows the process from the development of a research prototype to a commercial software product. In particular, we draw attention to four major challenges of (a) aligning the different concerns of patients and clinicians, (b) designing according to clinical accountability, (c) ensuring commercial interest, and (d) dealing with regulatory constraints when prototyping safety critical health Information Technology. Using four illustrative cases, we discuss what these challenges entail and the implications they pose to Participatory Design. We conclude the paper by presenting lessons learned.

Leadership survey. An evaluation of health care executives' challenges.

PubMed

Thrall, T H; Hoppszallern, S

2001-01-01

Locating and keeping employees represents one of the greatest challenges facing health care leaders today. This is a key finding of the third Leadership Survey of executives in physician practices, managed care organizations and hospitals. The survey is sponsored by the Medical Group Management Association and Hospitals & Health Networks magazine. Other significant results: Practices put the most emphasis on teamwork, training and staff development as methods to combat labor shortages; practice executives count adequacy of reimbursements and physician productivity as top leadership challenges, along with the availability of qualified workers; practices choose print advertising and the addition of new products and services as the best ways for them to build market share.

Continuous downstream processing for high value biological products: A Review.

PubMed

Zydney, Andrew L

2016-03-01

There is growing interest in the possibility of developing truly continuous processes for the large-scale production of high value biological products. Continuous processing has the potential to provide significant reductions in cost and facility size while improving product quality and facilitating the design of flexible multi-product manufacturing facilities. This paper reviews the current state-of-the-art in separations technology suitable for continuous downstream bioprocessing, focusing on unit operations that would be most appropriate for the production of secreted proteins like monoclonal antibodies. This includes cell separation/recycle from the perfusion bioreactor, initial product recovery (capture), product purification (polishing), and formulation. Of particular importance are the available options, and alternatives, for continuous chromatographic separations. Although there are still significant challenges in developing integrated continuous bioprocesses, recent technological advances have provided process developers with a number of attractive options for development of truly continuous bioprocessing operations. © 2015 Wiley Periodicals, Inc.

Status of Solid State Lighting Product Development and Future Trends for General Illumination.

PubMed

Katona, Thomas M; Pattison, P Morgan; Paolini, Steve

2016-06-07

After decades of research and development on fabrication of efficient light-emitting diodes (LEDs) throughout the visible spectrum, LED-based lighting has reached unparalleled performance with respect to energy efficiency and has become the light source for virtually all new lighting products being designed today. The development of the core light sources and their subsequent integration into lighting systems continue to present unique challenges and opportunities for product designers. We review these systems and the current development status, as well as provide context for the trends in solid state lighting that are leading to the development of value-added lighting solutions that extend the domain of lighting beyond light generation, into fields as diverse as communications, healthcare, and agricultural production.

Novel excipients - Regulatory challenges and perspectives - The EU insight.

PubMed

Kozarewicz, Piotr; Loftsson, Thorsteinn

2018-05-21

Novel excipients are indispensable in development of modern, advanced drug delivery systems and biotechnology-derived drugs. Although numerous novel excipients are developed for pharmaceutical use, they are not frequently seen in medicinal products due to the strict regulatory requirements and perception that their use makes new product evaluation more complex with risk of delays in the approval process. Regulators regard novel excipients as new substances and whenever new excipient is used in a formulation it must be subjected to full evaluation, similarly to the one required for new active substance. Consequently, the amount of information required in support of the regulatory approval (i.e. marketing authorization) is much more complex and comprehensive than for established excipients. This short review provides an insight into the use of novel excipients in medicinal products approved in the European Union. In addition, barriers and challenges in development of novel excipients are being discussed as well as means to overcome those barriers. Copyright © 2018 Elsevier B.V. All rights reserved.

Immunity to airborne challenge with Venezuelan equine encephalitis virus develops rapidly after immunization with the attenuated vaccine strain TC-83.

PubMed

Phillpotts, R J

1999-05-14

Mice vaccinated subcutaneously with the attenuated vaccine strain of Venezuelan equine encephalitis virus (VEEV) rapidly develop immunity to subcutaneous or airborne challenge with virulent VEEV. The specificity of this immune response was demonstrated by challenge with a heterologous virus (St. Louis encephalitis virus). Examination of the levels of VEEV-specific antibody classes in serum and respiratory secretions suggested that the rapid development of immunity was coincident with the appearance of specific IgM and IgG (but not IgA) in the respiratory tract. In order to confirm the role of respiratory tract antibody, mice were passively immunised either intraperitoneally or intranasally with polyclonal VEEV-specific IgG. Intranasal administration of specific IgG significantly enhanced protection against airborne challenge. These results confirm the need to emphasise local antibody production in the development of improved VEEV vaccines.

Just-in-time adaptive disturbance estimation for run-to-run control of photolithography overlay

NASA Astrophysics Data System (ADS)

Firth, Stacy K.; Campbell, W. J.; Edgar, Thomas F.

2002-07-01

One of the main challenges to implementations of traditional run-to-run control in the semiconductor industry is a high mix of products in a single factory. To address this challenge, Just-in-time Adaptive Disturbance Estimation (JADE) has been developed. JADE uses a recursive weighted least-squares parameters estimation technique to identify the contributions to variation that are dependent on product, as well as the tools on which the lot was processed. As applied to photolithography overlay, JADE assigns these sources of variation to contributions from the context items: tool, product, reference tool, and reference reticle. Simulations demonstrate that JADE effectively identifies disturbances in contributing context items when the variations are known to be additive. The superior performance of JADE over traditional EWMA is also shown in these simulations. The results of application of JADE to data from a high mix production facility show that JADE still performs better than EWMA, even with the challenges of a real manufacturing environment.

Probiotics and prebiotics--perspectives and challenges.

PubMed

Figueroa-González, Ivonne; Quijano, Guillermo; Ramírez, Gerardo; Cruz-Guerrero, Alma

2011-06-01

Owing to their health benefits, probiotics and prebiotics are nowadays widely used in yogurts and fermented milks, which are leader products of functional foods worldwide. The world market for functional foods has grown rapidly in the last three decades, with an estimated size in 2003 of ca US$ 33 billion, while the European market estimation exceeded US$ 2 billion in the same year. However, the production of probiotics and prebiotics at industrial scale faces several challenges, including the search for economical and abundant raw materials for prebiotic production, the low-cost production of probiotics and the improvement of probiotic viability after storage or during the manufacturing process of the functional food. In this review, functional foods based on probiotics and prebiotics are introduced as a key biotechnological field with tremendous potential for innovation. A concise state of the art addressing the fundamentals and challenges for the development of new probiotic- and prebiotic-based foods is presented, the niches for future research being clearly identified and discussed. Copyright © 2011 Society of Chemical Industry.

Biobased films prepared from collagen solutions derived from un-tanned hides

USDA-ARS?s Scientific Manuscript database

The U.S. hide and leather industries are facing challenges of meeting environmental imperatives; quantifying, maintaining, and improving current hides and leather product quality; developing new processes and products; and improving utilization of waste. One of our contributions to address these on...

Guidelines to Design Engineering Education in the Twenty-First Century for Supporting Innovative Product Development

ERIC Educational Resources Information Center

Violante, Maria Grazia; Vezzetti, Enrico

2017-01-01

In the twenty-first century, meeting our technological challenges demands educational excellence, a skilled populace that is ready for the critical challenges society faces. There is widespread consensus, however, that education systems are failing to adequately prepare all students with the essential twenty-first century knowledge and skills…

Enhancing forest value productivity through fiber quality

Treesearch

D. Briggs

2010-01-01

Developing markets for carbon storage and bioenergy, shifting of the pulp and paper industry to biorefineries, and the potential of new technologies present the forest sector with exciting transformative opportunities and challenges. One of these challenges will be to understand the implications for fiber (wood) quality. This article provides a definitional context for...

The Dynamics of Multicultural NPD Teams in Virtual Environments

ERIC Educational Resources Information Center

Fain, Nusa; Kline, Miro

2013-01-01

Changes in the business environment, responses of companies to these changes and the available information and communication technologies (ICT) pose a number of challenges to present and future product developers, as well as to educational institutions. An appropriate response to these challenges is to create a solid basis for strategies to combat…

Social and ecological challenges of market-oriented shrimp farming in Vietnam.

PubMed

Lan, Ngo Thi Phuong

2013-01-01

Vietnam is one of the largest shrimp exporters in the world. Since 2010, Vietnam has earned about two billion dollars annually through shrimp exports. As a fertile area of greatest potential for agricultural production in Vietnam, the Mekong Delta has been a major contributor to the country's achievements, especially in the agricultural sector. During recent decades, trade liberation along with various policies in support of aquaculture has accelerated the development of shrimp production in the Delta. Based on an ethnographic study of shrimp farming in the Mekong Delta of Vietnam, I assert that along with great rewards arising from the expansion of shrimp farming areas, productivity, and export value, the shrimp industry has brought various environmental, economic and social challenges. Consequently, shrimp farming is a risky business and local inhabitants have relied on various strategies to cope with these challenges. Risk mitigation in shrimp production and labor migration are the two important strategies of local inhabitants for securing their livelihoods. Water pollution and poor quality post-larvae shrimp are direct consequences of market-oriented production.

The Establishment of a New Friction Stir Welding Process Development Facility at NASA/MSFC

NASA Technical Reports Server (NTRS)

Vaughn, Timothy P.

2012-01-01

The primary objective of full scale development is to mitigate scale-up issues before the vehicle ever reaches production and verify assembly design models. Only at full scale can the true challenges associated with production be identified and dealt with. Also, only at full scale can the delta shift between lab and subscale hardware manufacture and assembly be assessed.

Nanomaterials and Water Purification: Opportunities and Challenges

NASA Astrophysics Data System (ADS)

Savage, Nora; Diallo, Mamadou S.

2005-10-01

Advances in nanoscale science and engineering suggest that many of the current problems involving water quality could be resolved or greatly ameliorated using nanosorbents, nanocatalysts, bioactive nanoparticles, nanostructured catalytic membranes and nanoparticle enhanced filtration among other products and processes resulting from the development of nanotechnology. Innovations in the development of novel technologies to desalinate water are among the most exciting and promising. Additionally, nanotechnology-derived products that reduce the concentrations of toxic compounds to sub-ppb levels can assist in the attainment of water quality standards and health advisories. This article gives an overview of the use of nanomaterials in water purification. We highlight recent advances on the development of novel nanoscale materials and processes for treatment of surface water, groundwater and industrial wastewater contaminated by toxic metal ions, radionuclides, organic and inorganic solutes, bacteria and viruses. In addition, we discuss some challenges associated with the development of cost effective and environmentally acceptable functional nanomaterials for water purification.

Development of the metrology and imaging of cellulose nanocrystals

NASA Astrophysics Data System (ADS)

Postek, Michael T.; Vladár, András; Dagata, John; Farkas, Natalia; Ming, Bin; Wagner, Ryan; Raman, Arvind; Moon, Robert J.; Sabo, Ronald; Wegner, Theodore H.; Beecher, James

2011-02-01

The development of metrology for nanoparticles is a significant challenge. Cellulose nanocrystals (CNCs) are one group of nanoparticles that have high potential economic value but present substantial challenges to the development of the measurement science. Even the largest trees owe their strength to this newly appreciated class of nanomaterials. Cellulose is the world's most abundant natural, renewable, biodegradable polymer. Cellulose occurs as whisker-like microfibrils that are biosynthesized and deposited in plant material in a continuous fashion. The nanocrystals are isolated by hydrolyzing away the amorphous segments leaving the acid resistant crystalline fragments. Therefore, the basic raw material for new nanomaterial products already abounds in nature and is available to be utilized in an array of future materials. However, commercialization requires the development of efficient manufacturing processes and nanometrology to monitor quality. This paper discusses some of the instrumentation, metrology and standards issues associated with the ramping up for production and use of CNCs.

Using Functional Signature Ontology (FUSION) to Identify Mechanisms of Action for Natural Products

PubMed Central

Potts, Malia B.; Kim, Hyun Seok; Fisher, Kurt W.; Hu, Youcai; Carrasco, Yazmin P.; Bulut, Gamze Betul; Ou, Yi-Hung; Herrera-Herrera, Mireya L.; Cubillos, Federico; Mendiratta, Saurabh; Xiao, Guanghua; Hofree, Matan; Ideker, Trey; Xie, Yang; Huang, Lily Jun-shen; Lewis, Robert E.; MacMillan, John B.; White, Michael A.

2014-01-01

A challenge for biomedical research is the development of pharmaceuticals that appropriately target disease mechanisms. Natural products can be a rich source of bioactive chemicals for medicinal applications but can act through unknown mechanisms and can be difficult to produce or obtain. To address these challenges, we developed a new marine-derived, renewable natural products resource and a method for linking bioactive derivatives of this library to the proteins and biological processes that they target in cells. We used cell-based screening and computational analysis to match gene expression signatures produced by natural products to those produced by siRNA and synthetic microRNA libraries. With this strategy, we matched proteins and microRNAs with diverse biological processes and also identified putative protein targets and mechanisms of action for several previously undescribed marine-derived natural products. We confirmed mechanistic relationships for selected short-interfering RNAs, microRNAs, and compounds with functional roles in autophagy, chemotaxis mediated by discoidin domain receptor 2, or activation of the kinase AKT. Thus, this approach may be an effective method for screening new drugs while simultaneously identifying their targets. PMID:24129700

Turning science into health solutions: KEMRI’s challenges as Kenya’s health product pathfinder

PubMed Central

2010-01-01

Background A traditional pathway for developing new health products begins with public research institutes generating new knowledge, and ends with the private sector translating this knowledge into new ventures. But while public research institutes are key drivers of basic research in sub-Saharan Africa, the private sector is inadequately prepared to commercialize ideas that emerge from these institutes, resulting in these institutes taking on the role of product development themselves to alleviate the local disease burden. In this article, the case study method is used to analyze the experience of one such public research institute: the Kenya Medical Research Institute (KEMRI). Discussion Our analysis indicates that KEMRI’s product development efforts began modestly, and a manufacturing facility was constructed with a strategy for the facility’s product output which was not very successful. The intended products, HIV and Hepatitis B diagnostic kits, had a short product life cycle, and an abrupt change in regulatory requirements left KEMRI with an inactive facility. These problems were the result of poor innovation management capacity, variability in domestic markets, lack of capital to scale up technologies, and an institutional culture that lacked innovation as a priority. However, KEMRI appears to have adapted by diversifying its product line to mitigate risk and ensure continued use of its manufacturing facility. It adopted an open innovation business model which linked it with investors, research partnerships, licensing opportunities, and revenue from contract manufacturing. Other activities that KEMRI has put in place over several years to enhance product development include the establishment of a marketing division, development of an institutional IP policy, and training of its scientists on innovation management. Summary KEMRI faced many challenges in its attempt at health product development, including shifting markets, lack of infrastructure, inadequate financing, and weak human capital with respect to innovation. However, it overcame them through diversification, partnerships and changes in culture. The findings could have implications for other research institutes in Sub-Saharan Africa seeking to develop health products. Such institutes must analyze potential demand and uptake, yet be prepared to face the unexpected and develop appropriate risk-mitigating strategies. PMID:21144070

Turning science into health solutions: KEMRI's challenges as Kenya's health product pathfinder.

PubMed

Simiyu, Ken; Masum, Hassan; Chakma, Justin; Singer, Peter A

2010-12-13

A traditional pathway for developing new health products begins with public research institutes generating new knowledge, and ends with the private sector translating this knowledge into new ventures. But while public research institutes are key drivers of basic research in sub-Saharan Africa, the private sector is inadequately prepared to commercialize ideas that emerge from these institutes, resulting in these institutes taking on the role of product development themselves to alleviate the local disease burden. In this article, the case study method is used to analyze the experience of one such public research institute: the Kenya Medical Research Institute (KEMRI). Our analysis indicates that KEMRI's product development efforts began modestly, and a manufacturing facility was constructed with a strategy for the facility's product output which was not very successful. The intended products, HIV and Hepatitis B diagnostic kits, had a short product life cycle, and an abrupt change in regulatory requirements left KEMRI with an inactive facility. These problems were the result of poor innovation management capacity, variability in domestic markets, lack of capital to scale up technologies, and an institutional culture that lacked innovation as a priority.However, KEMRI appears to have adapted by diversifying its product line to mitigate risk and ensure continued use of its manufacturing facility. It adopted an open innovation business model which linked it with investors, research partnerships, licensing opportunities, and revenue from contract manufacturing. Other activities that KEMRI has put in place over several years to enhance product development include the establishment of a marketing division, development of an institutional IP policy, and training of its scientists on innovation management. KEMRI faced many challenges in its attempt at health product development, including shifting markets, lack of infrastructure, inadequate financing, and weak human capital with respect to innovation. However, it overcame them through diversification, partnerships and changes in culture. The findings could have implications for other research institutes in Sub-Saharan Africa seeking to develop health products. Such institutes must analyze potential demand and uptake, yet be prepared to face the unexpected and develop appropriate risk-mitigating strategies.

Wholesome Nutrition: an example for a sustainable diet.

PubMed

von Koerber, Karl; Bader, Nadine; Leitzmann, Claus

2017-02-01

'Wholesome Nutrition' is a concept of sustainable nutrition that was developed at the University of Giessen in the 1980s. In this concept, health and the ecologic, economic, social and cultural dimensions of nutrition are equally important. In 1992 at the UN-Conference on Environment and Development in Rio de Janeiro the definition of 'Sustainable Development' comprised the dimensions environment, economy and society. Additionally to these three 'classical' dimensions of sustainability, we included 'health' as the fourth dimension because nutrition has far reaching effects on human health. The fifth dimension, 'culture', became part of the sustainability dialogue since many years; the respective cultural background influences food habits. Presently, mankind has to cope with huge global challenges such as poverty and food insecurity in low-income countries as well as climate change. Therefore the objective is to identify prospects for actions to respond to these global challenges. The concept of 'Sustainable Nutrition' analyses the food supply chain at all stages from input-production and primary production to processing, distribution, preparation, consumption and waste disposal. The present analysis leads to the following seven principles: preference of plant-based foods, organic foods, regional and seasonal products, preference of minimally processed foods, Fair Trade products, resource-saving housekeeping and enjoyable eating culture. This concept is based on holistic thinking and has the potential to reduce the global challenges in the field of nutrition. Scientists, stakeholders, multipliers and consumers are asked to consider environmental, economic, social and cultural aspects in addition to the biological (health) aspects.

New biotechnological applications for Ashbya gossypii: Challenges and perspectives

PubMed Central

2017-01-01

ABSTRACT The filamentous fungus Ashbya gossypii has long been considered a paradigm of the White Biotechnology in what concerns riboflavin production. Its industrial relevance led to the development of a significant molecular and in silico modeling toolbox for its manipulation. This, together with the increasing knowledge of its genome and metabolism has helped designing effective metabolic engineering strategies for optimizing riboflavin production, but also for developing new A. gossypii strains for novel biotechnological applications, such as production of recombinant proteins, single cell oils (SCOs), and flavour compounds. With the recent availability of its genome-scale metabolic model, the exploration of the full biotechnological potential of A. gossypii is now in the spotlight. Here, we will discuss some of the challenges that these emerging A. gossypii applications still need to overcome to become economically attractive and will present future perspectives for these and other possible biotechnological applications for A. gossypii. PMID:27791453

Recent advances in the production of value added chemicals and lipids utilizing biodiesel industry generated crude glycerol as a substrate - Metabolic aspects, challenges and possibilities: An overview.

PubMed

Vivek, Narisetty; Sindhu, Raveendran; Madhavan, Aravind; Anju, Alphonsa Jose; Castro, Eulogio; Faraco, Vincenza; Pandey, Ashok; Binod, Parameswaran

2017-09-01

One of the major ecological concerns associated with biodiesel production is the generation of waste/crude glycerol during the trans-esterification process. Purification of this crude glycerol is not economically viable. In this context, the development of an efficient and economically viable strategy would be biotransformation reactions converting the biodiesel derived crude glycerol into value added chemicals. Hence the process ensures the sustainability and waste management in biodiesel industry, paving a path to integrated biorefineries. This review addresses a waste to wealth approach for utilization of crude glycerol in the production of value added chemicals, current trends, challenges, future perspectives, metabolic approaches and the genetic tools developed for the improved synthesis over wild type microorganisms were described. Copyright © 2017 Elsevier Ltd. All rights reserved.

[The Development of Social Innovations in Health Care and the Role of Science and Research].

PubMed

Richter, Stefanie

2017-12-01

In the course of demographic, epidemiological and social changes, various challenges arise concerning the organization of health care and health promotion for the population. Innovative approaches are needed to face these challenges. The focus in the theoretical work is on the analysis of the development of social innovations and on the role of science and research to solve social problems. First of all, the notion of innovation based on technologies will be expanded by social innovations. 2 approaches to promote social innovations are discussed: the systematic discovery and development of solutions in practice as well as the co-productive development in the terms of transdisciplinary research. It will be demonstrated that a cooperative and co-productive research and development process brings new requirements regarding scientific practice so that a discussion about the organisation and general conditions of transdisciplinary research and development in the health (service) research has to be strengthened. © Georg Thieme Verlag KG Stuttgart · New York.

Biobased films prepared from collagen solutions derived from un-tanned hides

USDA-ARS?s Scientific Manuscript database

The U.S. hide and leather industries are facing challenges of meeting environmental imperatives; quantifying, maintaining, and improving current hides and leather product quality; developing new processes and products; and improving utilization of waste. One of our efforts to address these new chal...

Developing Natural Solutions to Reducing Food Safety Pathogens in Organically Raised Poultry

USDA-ARS?s Scientific Manuscript database

Organic poultry production is one of the fastest growing segments of organic agriculture with a 20% increase/yr since the establishment of the National Organic Program (NOP). Restrictions on prophylactic antibiotics used for conventional poultry production raise unique challenges for organic produce...

Collaborative Computer Graphics Product Development between Academia and Government: A Dynamic Model

NASA Technical Reports Server (NTRS)

Fowler, Deborah R.; Kostis, Helen-Nicole

2016-01-01

Collaborations and partnerships between academia and government agencies are common, especially when it comes to research and development in the fields of science, engineering and technology. However, collaboration between a government agency and an art school is rather atypical. This paper presents the Collaborative Student Project, which aims to explore the following challenge: The ideation, development and realization of education and public outreach products for NASAs upcoming ICESat-2 mission in collaboration with art students.

Feeding nine billion: the challenge to sustainable crop production.

PubMed

Gregory, Peter J; George, Timothy S

2011-11-01

In the recent past there was a widespread working assumption in many countries that problems of food production had been solved, and that food security was largely a matter of distribution and access to be achieved principally by open markets. The events of 2008 challenged these assumptions, and made public a much wider debate about the costs of current food production practices to the environment and whether these could be sustained. As in the past 50 years, it is anticipated that future increases in crop production will be achieved largely by increasing yields per unit area rather than by increasing the area of cropped land. However, as yields have increased, so the ratio of photosynthetic energy captured to energy expended in crop production has decreased. This poses a considerable challenge: how to increase yield while simultaneously reducing energy consumption (allied to greenhouse gas emissions) and utilizing resources such as water and phosphate more efficiently. Given the timeframe in which the increased production has to be realized, most of the increase will need to come from crop genotypes that are being bred now, together with known agronomic and management practices that are currently under-developed.

Hydrolyzed whey protein prevents the development of food allergy to β-lactoglobulin in sensitized mice.

PubMed

Gomes-Santos, Ana Cristina; Fonseca, Roberta Cristelli; Lemos, Luisa; Reis, Daniela Silva; Moreira, Thaís Garcias; Souza, Adna Luciana; Silva, Mauro Ramalho; Silvestre, Marialice Pinto Coelho; Cara, Denise Carmona; Faria, Ana Maria Caetano

2015-01-01

Food allergy is an adverse immune response to dietary proteins. Hydrolysates are frequently used for children with milk allergy. However, hydrolysates effects afterwards are poorly studied. The aim of this study was to investigate the immunological consequences of hydrolyzed whey protein in allergic mice. For that, we developed a novel model of food allergy in BALB/c mice sensitized with alum-adsorbed β-lactoglobulin. These mice were orally challenged with either whey protein or whey hydrolysate. Whey-challenged mice had elevated levels of specific IgE and lost weight. They also presented gut inflammation, enhanced levels of SIgA and IL-5 as well as decreased production of IL-4 and IL-10 in the intestinal mucosa. Conversely, mice challenged with hydrolyzate maintained normal levels of IgE, IL-4 and IL-5 and showed no sign of gut inflammation probably due to increased IL-12 production in the gut. Thus, consumption of hydrolysate prevented the development of clinical signs of food allergy in mice. Copyright © 2015 Elsevier Inc. All rights reserved.

Acanthamoeba: An Overview of the Challenges to the Development of a Consensus Methodology of Disinfection Efficacy Testing for Contact Lens Care Products.

PubMed

Brocious, Jeffrey; Tarver, Michelle E; Hampton, Denise; Eydelman, Malvina

2018-04-24

With the increasing incidence of more pathogens that can cause microbial keratitis (MK), it is necessary to periodically reassess disinfection multipurpose solutions testing requirements to ensure that relevant organisms to challenge them are being used. Current testing protocols have included common pathogens such as Pseudomonas aeruginosa, Staphylococcus aureus, Serratia marcescens, Candida albicans, and Fusarium solani but have omitted less common pathogens such as Acanthamoeba. Specifically, Acanthamoeba sp. has recently been identified as a prevalent cause of MK in certain countries. Developing an appropriate protocol for this unique organism presents a challenge, given its two distinct life stages, methods to grow the organism, encystment techniques, and many other parameters that can affect testing outcomes. Therefore, the appropriate combination of these parameters is crucial to developing a protocol that ensures consistent, accurate results. The FDA has recognized the importance of establishing a standardized testing protocol for this pathogen and embarked on research efforts to provide a recommended testing protocol for testing contact lens care products.

Microbial production of plant hormones: Opportunities and challenges.

PubMed

Shi, Tian-Qiong; Peng, Hui; Zeng, Si-Yu; Ji, Rong-Yu; Shi, Kun; Huang, He; Ji, Xiao-Jun

2017-03-04

Plant hormones are a class of organic substances which are synthesized during the plant metabolism. They have obvious physiological effect on plant growth at very low concentrations. Generally, plant hormones are mainly divided into 5 categories: auxins, cytokinins, ethylene, gibberellins (GAs) and abscisic acid (ABA). With the deepening of research, some novel plant hormones such as brassinosteroid and salicylates have been found and identified. The plant hormone products are mainly obtained through plant extraction, chemical synthesis as well as microbial fermentation. However, the extremely low yield in plants and relatively complex chemical structure limit the development of the former 2 approaches. Therefore, more attention has been paid into the microbial fermentative production. In this commentary, the developments and technological achievements of the 2 important plant hormones (GAs and ABA) have been discussed. The discovery, producing strains, fermentation technologies, and their accumulation mechanisms are first introduced. Furthermore, progresses in the industrial mass scale production are discussed. Finally, guidelines for future studies for GAs and ABA production are proposed in light of the current progress, challenges and trends in the field. With the widespread use of plant hormones in agriculture, we believe that the microbial production of plant hormones will have a bright future.

Calculating the pre-consumer waste footprint: A screening study of 10 selected products.

PubMed

Laurenti, Rafael; Moberg, Åsa; Stenmarck, Åsa

2017-01-01

Knowledge about the total waste generated by the production of consumer goods can help raise awareness among policy-makers, producers and consumers of the benefits of closing loops in a future circular economy, avoiding unnecessary production and production steps and associated generation of large amounts of waste. In strict life cycle assessment practice, information on waste outputs from intermediate industrial processes of material and energy transformation is translated into and declared as potential environmental impacts, which are often not reported in the final results. In this study, a procedure to extract available intermediate data and perform a systematic pre-consumer waste footprint analysis was developed. The pre-consumer waste footprint concept was tested to analyse 10 generic products, which provided some novel and interesting results for the different product categories and identified a number of challenges that need to be resolved in development of the waste footprint concept. These challenges include standardised data declaration on waste in life cycle assessment, with a separation into waste categories illustrating the implicit environmental and scale of significance of waste types and quantities (e.g. hazardous waste, inert waste, waste for recycling/incineration) and establishment of a common definition of waste throughout sectors and nations.

Critical considerations for developing nucleic acid macromolecule based drug products.

PubMed

Muralidhara, Bilikallahalli K; Baid, Rinku; Bishop, Steve M; Huang, Min; Wang, Wei; Nema, Sandeep

2016-03-01

Protein expression therapy using nucleic acid macromolecules (NAMs) as a new paradigm in medicine has recently gained immense therapeutic potential. With the advancement of nonviral delivery it has been possible to target NAMs against cancer, immunodeficiency and infectious diseases. Owing to the complex and fragile structure of NAMs, however, development of a suitable, stable formulation for a reasonable product shelf-life and efficacious delivery is indeed challenging to achieve. This review provides a synopsis of challenges in the formulation and stability of DNA/m-RNA based medicines and probable mitigation strategies including a brief summary of delivery options to the target cells. Nucleic acid based drugs at various stages of ongoing clinical trials are compiled. Copyright © 2016. Published by Elsevier Ltd.

Index-based Crop Insurance for Climate Adaptation in the Developing World

NASA Astrophysics Data System (ADS)

Brown, M. E.; Osgood, D. E.; Carriquiry, M. A.

2011-12-01

Weather has always presented a challenge to small-scale farmers, particularly in regions where poverty and lack of infrastructure has restricted the development of financial instruments to limit risk. New 'index' insurance innovations in agriculture are beginning to enable even the poorest farmers to unlock major productivity gains (e.g. insuring loans for improved seeds). Although index insurance has the potential to greatly improve productivity in developing country agriculture, the principal technical challenge to up-scaling this product is "data poverty," the absence of weather data in low-income areas needed to design robust and affordable insurance products. Earth science, particularly remote sensing, has the potential to ameliorate data poverty. However, raw use of earth science model output leads to non-optimal indexes and many obstacles remain to transform earth science products into insurance solutions. Estimation uncertainty, limited availability of consistent time series, and difficulties of predicting loses based on remote observations are reviewed in this article. The importance of multidisciplinary approaches addressing the needs of stakeholders in simple to understand indexes is highlighted. The successful use of Earth science data to support the index insurance industry in currently poor and isolated communities in the developing world would transform the ability of small farmers to increase yields, household incomes and regional economies, if the growing gap between earth science and index insurance can be closed.

Bioreactor and process design for biohydrogen production.

PubMed

Show, Kuan-Yeow; Lee, Duu-Jong; Chang, Jo-Shu

2011-09-01

Biohydrogen is regarded as an attractive future clean energy carrier due to its high energy content and environmental-friendly conversion. It has the potential for renewable biofuel to replace current hydrogen production which rely heavily on fossil fuels. While biohydrogen production is still in the early stage of development, there have been a variety of laboratory- and pilot-scale systems developed with promising potential. This work presents a review of advances in bioreactor and bioprocess design for biohydrogen production. The state-of-the art of biohydrogen production is discussed emphasizing on production pathways, factors affecting biohydrogen production, as well as bioreactor configuration and operation. Challenges and prospects of biohydrogen production are also outlined. Copyright © 2011 Elsevier Ltd. All rights reserved.

Biodiesel biorefinery: opportunities and challenges for microbial production of fuels and chemicals from glycerol waste.

PubMed

Almeida, João R M; Fávaro, Léia C L; Quirino, Betania F

2012-07-18

The considerable increase in biodiesel production worldwide in the last 5 years resulted in a stoichiometric increased coproduction of crude glycerol. As an excess of crude glycerol has been produced, its value on market was reduced and it is becoming a "waste-stream" instead of a valuable "coproduct". The development of biorefineries, i.e. production of chemicals and power integrated with conversion processes of biomass into biofuels, has been singled out as a way to achieve economically viable production chains, valorize residues and coproducts, and reduce industrial waste disposal. In this sense, several alternatives aimed at the use of crude glycerol to produce fuels and chemicals by microbial fermentation have been evaluated. This review summarizes different strategies employed to produce biofuels and chemicals (1,3-propanediol, 2,3-butanediol, ethanol, n-butanol, organic acids, polyols and others) by microbial fermentation of glycerol. Initially, the industrial use of each chemical is briefly presented; then we systematically summarize and discuss the different strategies to produce each chemical, including selection and genetic engineering of producers, and optimization of process conditions to improve yield and productivity. Finally, the impact of the developments obtained until now are placed in perspective and opportunities and challenges for using crude glycerol to the development of biodiesel-based biorefineries are considered. In conclusion, the microbial fermentation of glycerol represents a remarkable alternative to add value to the biodiesel production chain helping the development of biorefineries, which will allow this biofuel to be more competitive.

Organic livestock production in Uganda: potentials, challenges and prospects.

PubMed

Nalubwama, Sylvia Muwanga; Mugisha, Anthony; Vaarst, Mette

2011-04-01

Development in organic farming has been stimulated by farmers and consumers becoming interested in healthy food products and sustainable environment. Organic agriculture is a holistic production management system which is based on the principles of health, ecology, care, and fairness. Organic development in Uganda has focused more on the crop sector than livestock sector and has primarily involved the private sector, like organic products export companies and non-governmental organizations. Agriculture in Uganda and many African countries is predominantly traditional, less mechanized, and is usually associated with minimum use of chemical fertilizers, pesticides, and drugs. This low external input agriculture also referred to as "organic by default" can create basis for organic farming where agroecological methods are introduced and present an alternative in terms of intensification to the current low-input/low-output systems. Traditional farming should not be confused with organic farming because in some cases, the existing traditional practices have consequences like overstocking and less attention to soil improvement as well as to animal health and welfare, which is contrary to organic principles of ecology, fairness, health, and care. Challenges of implementing sustainable organic practices in the Ugandan livestock sector threaten its future development, such as vectors and vector-borne diseases, organic feed insufficiency, limited education, research, and support to organic livestock production. The prospects of organic livestock development in Uganda can be enhanced with more scientific research in organic livestock production under local conditions and strengthening institutional support.

Preparing the Principal to Drive the Goals of Education for All: A Conceptual Case Developmental Model

ERIC Educational Resources Information Center

Hutton, Disraeli M.

2014-01-01

The Education for All (EFA) goals, established for countries to improve educational performance, are most challenging for many developing countries. Notwithstanding the challenges, each country must implement suitable programme intervention in order to accomplish these goals. Goal 6 calls for the overall improvement of the education product, which…

INNOVATIVE BIODIESEL PRODUCTION: A SOLUTION TO THE SCIENTIFIC, TECHNICAL, AND EDUCATIONAL CHALLENGES OF SUSTAINABILITY

EPA Science Inventory

Loyola's STEP students completed over 20 team projects: Developed a business plan for biodiesel production, created the LUC biodiesel website, created the Bio­shorts documentaries, tabled at environmental events, publicized and put on two Biodiesel Forums (2nd one pending,...

Aviation weather : FAA and the National Weather Service are considering plans to consolidate weather service offices, but face significant challenges.

DOT National Transportation Integrated Search

2009-07-01

The National Weather Services (NWS) weather products are a vital component of the Federal Aviation Administrations (FAA) air traffic control system. In addition to providing aviation weather products developed at its own facilities, NWS also pr...

Development of a method for estimating emissions from oil and gas production sites utilizing remote observations

EPA Science Inventory

There is a lack of information on emissions of ozone precursors, hazardous air pollutants, and greenhouse gases from oil and gas production operations, and measurement of these emissions presents many challenges. Assessment is complicated by the fugitive nature ofthe emissions, v...

Patient-reported outcomes to support medical product labeling claims: FDA perspective.

PubMed

Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

2007-01-01

This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

Water Exploration: An Online High School Water Resource Education Program

NASA Astrophysics Data System (ADS)

Ellins, K. K.; McCall, L. R.; Amos, S.; McGowan, R. F.; Mote, A.; Negrito, K.; Paloski, B.; Ryan, C.; Cameron, B.

2010-12-01

The Institute for Geophysics at The University of Texas at Austin and 4empowerment.com, a Texas-based for-profit educational enterprise, teamed up with the Texas Water Development Board to develop and implement a Web-based water resources education program for Texas high school students. The program, Water Exploration uses a project-based learning approach called the Legacy Cycle model to permit students to conduct research and build an understanding about water science and critical water-related issues, using the Internet and computer technology. The three Legacy Cycle modules in the Water Exploration curriculum are: Water Basics, Water-Earth Dynamics and People Need Water. Within each Legacy Cycle there are three different challenges, or instructional modules, laid out as projects with clearly stated goals for students to carry out. Each challenge address themes that map to the water-related “Big Ideas” and supporting concepts found in the new Earth Science Literacy Principles: The Big Ideas and Supporting Concepts of Earth Science. As students work through a challenge they follow a series of steps, each of which is associated (i.e., linked online) with a manageable number of corresponding, high quality, research-based learning activities and Internet resources, including scholarly articles, cyber tools, and visualizations intended to enhance understanding of the concepts presented. The culmination of each challenge is a set of “Go Public” products that are the students’ answers to the challenge and which serve as the final assessment for the challenge. The “Go Public” products are posted to a collaborative workspace on the Internet as the “legacy” of the students’ work, thereby allowing subsequent groups of students who take the challenge to add new products. Twenty-two science educators have been trained on the implementation of the Water Exploration curriculum. A graduate student pursuing a master’s degree in science education through The University of Texas’ UTEACH program is conducting research to track the teachers’ implementation of Water Exploration and assess their comfort with cyber-education through classroom observations, students and teacher surveys, and evaluation of students’ “Go Public” products.

[Synthetic biology toward microbial secondary metabolites and pharmaceuticals].

PubMed

Wu, Lin-Zhuan; Hong, Bin

2013-02-01

Microbial secondary metabolites are one of the major sources of anti-bacterial, anti-fungal, antitumor, anti-virus and immunosuppressive agents for clinical use. Present challenges in microbial pharmaceutical development are the discovery of novel secondary metabolites with significant biological activities, improving the fermentation titers of industrial microbial strains, and production of natural product drugs by re-establishing their biosynthetic pathways in suitable microbial hosts. Synthetic biology, which is developed from systematic biology and metabolic engineering, provides a significant driving force for microbial pharmaceutical development. The review describes the major applications of synthetic biology in novel microbial secondary metabolite discovery, improved production of known secondary metabolites and the production of some natural drugs in genetically modified or reconstructed model microorganisms.

Challenges and opportunities for meningococcal vaccination in the developing world.

PubMed

Shaker, Rouba; Fayad, Danielle; Dbaibo, Ghassan

2018-05-04

Meningococcal disease continues to be a life threatening infection with high morbidity and mortality even in appropriately treated patients. Meningococcal vaccination plays a major role in the control of the disease; however, implementing vaccination remains problematic in the developing world. The objective of this review is to identify the challenges facing the use of meningococcal vaccines in the developing world in order to discuss the opportunities and available solutions to improve immunization in these countries. Inadequate epidemiologic information necessary to implement vaccination and financial challenges predominate. Multiple measures are needed to achieve the successful implementation of meningococcal conjugate vaccination programs that protect against circulating serogroups in developing countries including enhanced surveillance systems, financial support and aid through grants, product development partnerships that are the end result of effective collaboration and communication between different interdependent stakeholders to develop affordable vaccines, and demonstration of the cost-effectiveness of new meningococcal vaccines.

Development of oil product toxicity benchmarks using SSDs

EPA Science Inventory

Determining the sensitivity of a diversity of species to spilled oil and chemically dispersed oil continues to be a significant challenge in spill response and impact assessment. We developed species sensitivity distributions (SSDs) of acute toxicity values using standardized te...

Genetically engineered crops for biofuel production: regulatory perspectives.

PubMed

Lee, David; Chen, Alice; Nair, Ramesh

2008-01-01

There are numerous challenges in realizing the potential of biofuels that many policy makers have envisioned. The technical challenges in making the production of biofuels economical and on a scale to replace a significant fraction of transportation fuel have been well described, along with the potential environmental concerns. The use of biotechnology can potentially address many of these technical challenges and environmental concerns, but brings significant regulatory hurdles that have not been discussed extensively in the scientific community. This review will give an overview of the approaches being developed to produce transgenic biofuel feedstocks, particularly cellulosic ethanol, and the regulatory process in the United States that oversees the development and commercialization of new transgenic plants. We hope to illustrate that the level of regulation for transgenic organisms is not proportional to their potential risk to human health or the environment, and that revisions to the regulatory system in the U.S. currently under consideration are necessary to streamline the process.

Modifying agricultural crops for improved nutrition.

PubMed

McGloughlin, Martina Newell

2010-11-30

The first generation of biotechnology products commercialized were crops focusing largely on input agronomic traits whose value was often opaque to consumers. The coming generations of crop plants can be grouped into four broad areas each presenting what, on the surface, may appear as unique challenges and opportunities. The present and future focus is on continuing improvement of agronomic traits such as yield and abiotic stress resistance in addition to the biotic stress tolerance of the present generation; crop plants as biomass feedstocks for biofuels and "bio-synthetics"; value-added output traits such as improved nutrition and food functionality; and plants as production factories for therapeutics and industrial products. From a consumer perspective, the focus on value-added traits, especially improved nutrition, is undoubtedly one of the areas of greatest interest. From a basic nutrition perspective, there is a clear dichotomy in demonstrated need between different regions and socioeconomic groups, the starkest being inappropriate consumption in the developed world and under-nourishment in Less Developed Countries (LDCs). Dramatic increases in the occurrence of obesity and related ailments in affluent regions are in sharp contrast to chronic malnutrition in many LDCs. Both problems require a modified food supply, and the tools of biotechnology have a part to play. Developing plants with improved traits involves overcoming a variety of technical, regulatory and indeed perception hurdles inherent in perceived and real challenges of complex traits modifications. Continuing improvements in molecular and genomic technologies are contributing to the acceleration of product development to produce plants with the appropriate quality traits for the different regions and needs. Crops with improved traits in the pipeline, the evolving technologies and the opportunities and challenges that lie ahead are covered. Copyright © 2010. Published by Elsevier B.V.

Desirable attributes of vaccines for deployment in low-resource settings.

PubMed

Chen, Dexiang; Zehrung, Darin

2013-01-01

A number of product development partnerships are actively developing new vaccines to combat infectious diseases in developing countries. To be effective, the products under development should not only be safe, efficacious, and affordable, but they should also have additional desirable technical attributes, including enhanced stability, efficient packaging, and improved ease of delivery. New technologies are now available to achieve these attributes; however, many of the technologies have yet to be adopted by the vaccine industry. This commentary discusses the opportunities and challenges associated with advancing such attributes, especially vaccine thermostability and dose sparing strategies, and the critical issues that must be addressed to bridge the gap between technology development and product development. Copyright © 2012 Wiley Periodicals, Inc.

Adding an Expert to the Team: The Expert Flight Plan Critic

ERIC Educational Resources Information Center

Gibbons, Andrew; Waki, Randy; Fairweather, Peter

2008-01-01

This paper reports the development of a practical tool that provides expert feedback to students following an extended simulation exercise in cross-country flight planning. In contrast to development for laboratory settings, the development of an expert instructional product for everyday use posed some interesting challenges, including dealing…

The Human Response to Technological Development.

ERIC Educational Resources Information Center

Ramey, Luellen

Technological development and our human potential are two of the greatest challenges facing humankind today. The appropriate response to technological development seems to be to shape it for positive and productive human uses. Just as America once shifted from an agricultural economy to an industrial economy, we are now shifting from an industrial…

Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm.

PubMed

Zalai, Dénes; Dietzsch, Christian; Herwig, Christoph

2013-01-01

In the last few years, several quality by design (QbD) studies demonstrated the benefit of systematic approaches for biopharmaceutical development. However, only very few studies identified biosimilars as a special case of product development. The targeted quality profile of biosimilars is strictly defined by the originator's product characteristic. Moreover, the major source of prior knowledge is the experience with the originator product itself. Processing this information in biosimilar development has a major effect on risk management and process development strategies. The main objective of this contribution is to demonstrate how risk management can facilitate the implementation of QbD in early-stage product development with special emphasis on fitting the reported approaches to biosimilars. Risk assessments were highlighted as important tools to integrate prior knowledge in biosimilar development. The risk assessment process as suggested by the International Conference on Harmonization (ICH Q9) was reviewed and three elements were identified to play a key role in targeted risk assessment approaches: proper understanding of target linkage, risk assessment tool compliance, and criticality threshold value. Adjusting these steps to biosimilar applications helped to address some unique challenges of these products such as a strictly defined quality profile or a lack of process knowledge. This contribution demonstrates the need for tailored risk management approaches for the risk-based development of biosimilars and provides novel tools for the integration of additional knowledge available for these products. The pharmaceutical industry is facing challenges such as profit loss and price competition. Companies are forced to rationalize business models and to cut costs in development as well as manufacturing. These trends recently hinder the implementation of any concepts that do not offer certain financial benefit or promise a long return of investment. Quality by design (QbD) is a concept that is currently struggling for more acceptance from the side of the pharmaceutical industry. To achieve this, the major goals of QbD have to be revisited and QbD tools have to be subsequently developed. This contribution offers an example as to how implement risk management in early-stage biosimilar development as part of the QbD concept. The main goal was to go beyond the conventional QbD workflow and to adjust risk management to the challenges of biosimilar products. Accordingly, instead of using methods like failure mode and effects analysis, recommendations of the ICH Q9 guideline were reviewed and put into practice by creating tailored risk assessment tools. The novelty of this contribution is to report those tailored tools ready-to-use for early bioprocess development of biosimilars along QbD principles.

The contribution of bacterial genome engineering to sustainable development.

PubMed

Reuß, Daniel R; Commichau, Fabian M; Stülke, Jörg

2017-09-01

The United Nations' Sustainable Development Goals define important challenges for the prosperous development of mankind. To reach several of these goals, among them the production of value-added compounds, improved economic and ecologic balance of production processes, prevention of climate change and protection of ecosystems, the use of engineered bacteria can make valuable contributions. We discuss the strategies for genome engineering and how they can be applied to meet the United Nations' goals for sustainable development. © 2017 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

New Sustainable Model of Biorefineries: Biofactories and Challenges of Integrating Bio- and Solar Refineries.

PubMed

Abate, Salvatore; Lanzafame, Paola; Perathoner, Siglinda; Centi, Gabriele

2015-09-07

The new scenario for sustainable (low-carbon) chemical and energy production drives the development of new biorefinery concepts (indicated as biofactories) with chemical production at the core, but flexible and small-scale production. An important element is also the integration of solar energy and CO2 use within biobased production. This concept paper, after shortly introducing the motivation and recent trends in this area, particularly at the industrial scale, and some of the possible models (olefin and intermediate/high-added-value chemicals production), discusses the opportunities and needs for research to address the challenge of integrating bio- and solar refineries. Aspects discussed regard the use of microalgae and CO2 valorization in biorefineries/biofactories by chemo- or biocatalysis, including possibilities for their synergetic cooperation and symbiosis, as well as integration within the agroenergy value chain. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Lignocellulosic ethanol production by starch-base industrial yeast under PEG detoxification

PubMed Central

Liu, Xiumei; Xu, Wenjuan; Mao, Liaoyuan; Zhang, Chao; Yan, Peifang; Xu, Zhanwei; Zhang, Z. Conrad

2016-01-01

Cellulosic ethanol production from lignocellulosic biomass offers a sustainable solution for transition from fossil based fuels to renewable alternatives. However, a few long-standing technical challenges remain to be addressed in the development of an economically viable fermentation process from lignocellulose. Such challenges include the needs to improve yeast tolerance to toxic inhibitory compounds and to achieve high fermentation efficiency with minimum detoxification steps after a simple biomass pretreatment. Here we report an in-situ detoxification strategy by PEG exo-protection of an industrial dry yeast (starch-base). The exo-protected yeast cells displayed remarkably boosted vitality with high tolerance to toxic inhibitory compounds, and with largely improved ethanol productivity from crude hydrolysate derived from a pretreated lignocellulose. The PEG chemical exo-protection makes the industrial S. cerevisiae yeast directly applicable for the production of cellulosic ethanol with substantially improved productivity and yield, without of the need to use genetically modified microorganisms. PMID:26837707

Lignocellulosic ethanol production by starch-base industrial yeast under PEG detoxification

NASA Astrophysics Data System (ADS)

Liu, Xiumei; Xu, Wenjuan; Mao, Liaoyuan; Zhang, Chao; Yan, Peifang; Xu, Zhanwei; Zhang, Z. Conrad

2016-02-01

Cellulosic ethanol production from lignocellulosic biomass offers a sustainable solution for transition from fossil based fuels to renewable alternatives. However, a few long-standing technical challenges remain to be addressed in the development of an economically viable fermentation process from lignocellulose. Such challenges include the needs to improve yeast tolerance to toxic inhibitory compounds and to achieve high fermentation efficiency with minimum detoxification steps after a simple biomass pretreatment. Here we report an in-situ detoxification strategy by PEG exo-protection of an industrial dry yeast (starch-base). The exo-protected yeast cells displayed remarkably boosted vitality with high tolerance to toxic inhibitory compounds, and with largely improved ethanol productivity from crude hydrolysate derived from a pretreated lignocellulose. The PEG chemical exo-protection makes the industrial S. cerevisiae yeast directly applicable for the production of cellulosic ethanol with substantially improved productivity and yield, without of the need to use genetically modified microorganisms.

Regulatory considerations for pluripotent stem cell therapies.

PubMed

Carpenter, Melissa K

2017-01-01

The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products. © 2017 Elsevier B.V. All rights reserved.

An avirulent Brachyspira hyodysenteriae strain elicits intestinal IgA and slows down spread of swine dysentery.

PubMed

Mahu, Maxime; Boyen, Filip; Canessa, Stefano; Zavala Marchan, Jackeline; Haesebrouck, Freddy; Martel, An; Pasmans, Frank

2017-10-05

Swine dysentery caused by Brachyspira hyodysenteriae, results in substantial economic losses in swine producing countries worldwide. Although a number of different vaccine approaches have been explored with regard to this disease, they show limitations and none of them have reached the market. We here determine the vaccine potential of a weakly haemolytic B. hyodysenteriae strain. The virulence of this strain was assessed in experimental infection trials and its protection against swine dysentery was quantified in a vaccination-challenge experiment using a seeder infection model. Systemic IgG production and local IgA production were monitored in serum and faeces respectively. Across all trials, pigs that were colonized by virulent, strongly haemolytic B. hyodysenteriae strains consistently developed swine dysentery, in contrast to none of the pigs colonized by the weakly haemolytic B. hyodysenteriae vaccine strain. In the seeder vaccination trial nearly all immunised animals developed swine dysentery on subsequent challenge with a virulent strain, but the speed of spread of swine dysentery and faecal score were significantly reduced in animals immunised with the weakly haemolytic strain compared to sham-immunised animals. The IgA response of immunised animals upon challenge with a virulent B. hyodysenteriae strain significantly correlated to a later onset of disease. The correlation between local IgA production and protection induced by a weakly haemolytic B. hyodysenteriae strain provides leads for future vaccine development against swine dysentery.

Student production: making a realistic stereo CG short film in six months

NASA Astrophysics Data System (ADS)

Ramasamy, Celambarasan

2010-02-01

This paper breaks down the R&D and production challenges faced on a stereoscopic CG short film that was developed on a six month time budget. Using this film as an example, the manner in which technical innovation and story telling techniques can be used to emphasize the strengths and hide the weaknesses of a limited timeframe student production is discussed.

Optical design for consumer products

NASA Astrophysics Data System (ADS)

Gupta, Anurag

2014-10-01

Optical engineers often limit their focus on meeting the provided targets on performance and geometry and assume that the specifications are largely non-negotiable. Such approach ignores the value proposition behind the product and the challenges associated with overall product design, manufacturing, business development and legal issues. As a result, the design effort can be expensive, time consuming and can result in product failure. We discuss a product based systems engineering approach that leads to an application specific optical design that is more effective and efficient to implement.

Software Product Lines: Report of the 2009 U.S. Army Software Product Line Workshop

DTIC Science & Technology

2009-04-01

record system was fielded in 2008. One early challenge for Overwatch was coming up with a funding model that would support core asset development (a...match the organizational model to the funding model . Product line architecture is essential. Address product line requirements up front. Put processes...when trying to move from a customer-driven, product-specific funding model to one in which at least some of the funds are allocated to the creation and

Development of anti-inflammatory drugs - the research and development process.

PubMed

Knowles, Richard Graham

2014-01-01

The research and development process for novel drugs to treat inflammatory diseases is described, and several current issues and debates relevant to this are raised: the decline in productivity, attrition, challenges and trends in developing anti-inflammatory drugs, the poor clinical predictivity of experimental models of inflammatory diseases, heterogeneity within inflammatory diseases, 'improving on the Beatles' in treating inflammation, and the relationships between big pharma and biotechs. The pharmaceutical research and development community is responding to these challenges in multiple ways which it is hoped will lead to the discovery and development of a new generation of anti-inflammatory medicines. © 2013 Nordic Pharmacological Society. Published by John Wiley & Sons Ltd.

Stability of Chitosan—A Challenge for Pharmaceutical and Biomedical Applications

PubMed Central

Szymańska, Emilia; Winnicka, Katarzyna

2015-01-01

Chitosan—one of the natural multifunctional polymers—due to its unique and versatile biological properties is regarded as a useful compound in medical and pharmaceutical technology. Recently, considerable research effort has been made in order to develop safe and efficient chitosan products. However, the problem of poor stability of chitosan-based systems restricts its practical applicability; thus, it has become a great challenge to establish sufficient shelf-life for chitosan formulations. Improved stability can be assessed by controlling the environmental factors, manipulating processing conditions (e.g., temperature), introducing a proper stabilizing compound, developing chitosan blends with another polymer, or modifying the chitosan structure using chemical or ionic agents. This review covers the influence of internal, environmental, and processing factors on the long-term stability of chitosan products. The aim of this paper is also to highlight the latest developments which enable the physicochemical properties of chitosan-based applications to be preserved upon storage. PMID:25837983

A Project Team Analysis Using Tuckman's Model of Small-Group Development.

PubMed

Natvig, Deborah; Stark, Nancy L

2016-12-01

Concerns about equitable workloads for nursing faculty have been well documented, yet a standardized system for workload management does not exist. A project team was challenged to establish an academic workload management system when two dissimilar universities were consolidated. Tuckman's model of small-group development was used as the framework for the analysis of processes and effectiveness of a workload project team. Agendas, notes, and meeting minutes were used as the primary sources of information. Analysis revealed the challenges the team encountered. Utilization of a team charter was an effective tool in guiding the team to become a highly productive group. Lessons learned from the analysis are discussed. Guiding a diverse group into a highly productive team is complex. The use of Tuckman's model of small-group development provided a systematic mechanism to review and understand group processes and tasks. [J Nurs Educ. 2016;55(12):675-681.]. Copyright 2016, SLACK Incorporated.

New product development: A batik multifunctional chair

NASA Astrophysics Data System (ADS)

Indrawati, Sri; Sukmaningsih, Nias

2017-11-01

The biggest challenge facing by Batik industry in ASEAN Economic Community (AEC) era is the greater number of fashion competitors both domestically and internationally. Based on that condition, the development of new product variants by considering product performance and price is needed. This research was conducted to develop batik products with a new target market. Products that being developed is batik multifunctional chair using integrated value engineering and analytic hierarchy process methods. This research has been done in several stages, ie. Information stage, creative stage, value analysis and product prototyping. The results of this research shows that the batik multifunctional chair product criteria are aesthetic (29%), multifunctional (34%) and ergonomic (37%). There are three new product design alternatives that successfully being developed. Based on value analysis, the product design alternatives that have the highest value is alternative design 2, the value is 2,37. The production cost for this design is Rp. 500.000,-. Alternative design 2 specification are using Mahoni wood, Batik parang rusak pattern with natural coloring process, can be used as table and fit with customer's body anthropometry. Then a batik multifunctional chair prototype is developed based on the best alternative design.

Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

PubMed

Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

2018-02-05

A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

Sources and transport pathways of micropollutants into surface waters - an overview

NASA Astrophysics Data System (ADS)

Stamm, Christian

2017-04-01

Micropollutants reach water bodies from a large range of sources through different transport pathways. They consist of hundreds or thousands of compounds rendering exposure assessment an analytical challenge. Prominent examples of micropollutants are wastewater-born pharmaceuticals and hormones or plant protection products originating from diffuse agricultural sources. This presentation reviews the possible origin of micropollutants and their transport pathways. It demonstrates that considering municipal wastewater and agriculture may fall short of comprising all relevant source-pathway combination in a given watershed by providing examples from industry, animal production, or leaching to groundwater. The diversity of source-pathway leads on the one hand to a large number of possible chemicals to be considered including parent compounds of end products, their transformation products, legacy compounds but also intermediates used during industrial synthesis processes. On the other hand, it leads to a wide range of temporal dynamics by which these compounds reach streams and rivers. This combination makes a comprehensive exposure assessment for micropollutants a real scientific challenge. An outlook into new development in sampling and analytics will suggest possible solution for this challenge.

Analysis of the gut bacterial communities in beef cattle and their association with feed intake, growth, and efficiency

USDA-ARS?s Scientific Manuscript database

The impetus behind the global food security challenge is direct, with the necessity to feed over 9 billion people by 2050. Developing a food-secure world, where people have access to a safe and sustainable food supply is the principal goal of this challenge. To achieve this end, beef production ent...

FUSION-Guided Hypothesis Development Leads to the Identification of N⁶,N⁶-Dimethyladenosine, a Marine-Derived AKT Pathway Inhibitor. | Office of Cancer Genomics

Cancer.gov

Chemicals found in nature have evolved over geological time scales to productively interact with biological molecules, and thus represent an effective resource for pharmaceutical development. Marine-derived bacteria are rich sources of chemically diverse, bioactive secondary metabolites, but harnessing this diversity for biomedical benefit is limited by challenges associated with natural product purification and determination of biochemical mechanism.

A Technical and Economic Review of Solar Hydrogen Production Technologies

ERIC Educational Resources Information Center

Wilhelm, Erik; Fowler, Michael

2006-01-01

Hydrogen energy systems are being developed to replace fossil fuels-based systems for transportation and stationary application. One of the challenges facing the widespread adoption of hydrogen as an energy vector is the lack of an efficient, economical, and sustainable method of hydrogen production. In the short term, hydrogen produced from…

How Do Children with Phonological Impairment Respond to Requests for Clarification Containing Polysyllables?

ERIC Educational Resources Information Center

Masso, Sarah; McCabe, Patricia; Baker, Elise

2014-01-01

Accurate production of polysyllables (words of three or more syllables) can be challenging for children with phonological impairment. Research with typically developing children has suggested that children can improve their polysyllable productions in response to requests for clarification containing an incorrect model of a target word (Gozzard et…

Ecosystem services: foundations, opportunities, and challenges for the forest products sector

Treesearch

Trista M. Patterson; Dana L. Coelho

2009-01-01

The ecosystem service concept has been proposed as a meaningful framework for natural resource management. In theory, it holds concomitant benefit and consequence for the forest product sector. However, numerous barriers impede practitioners from developing concrete and enduring responses to emerging ecosystem service markets, policies, and initiatives. Principal among...

Streamlining the Online Course Development Process by Using Project Management Tools

ERIC Educational Resources Information Center

Abdous, M'hammed; He, Wu

2008-01-01

Managing the design and production of online courses is challenging. Insufficient instructional design and inefficient management often lead to issues such as poor course quality and course delivery delays. In an effort to facilitate, streamline, and improve the overall design and production of online courses, this article discusses how we…

Adult Education in a Workplace Context: Recognising Production Workers' Responses and Partnership Challenges

ERIC Educational Resources Information Center

Wärvik, Gun-Britt

2016-01-01

This article is about a larger regional Swedish partnership programme that was established to develop site-based education for production workers. A partnership is seen as composed of different practice architectures. The actors involved represented larger transnational as well as smaller manufacturing companies, employers, the metal workers'…

Development of Durum Wwheat Germplasm with Enhanced Resistance to Fusarium Head Blight Derived from Emmer Wheat

USDA-ARS?s Scientific Manuscript database

Durum wheat (Triticum turgidum L. subsp. durum) is a unique class of commercial wheat specifically for making pasta products. Durum production has been seriously challenged by the Fusarium head blight (FHB) disease in the United States in the past decade. Although utilization of resistant cultivar...

Long-term influence of alternative forest management treatments on total ecosystem and wood product carbon storage

Treesearch

Joshua J. Puhlick; Aaron R. Weiskittel; Ivan J. Fernandez; Shawn Fraver; Laura S. Kenefic; Robert S. Seymour; Randall K. Kolka; Lindsey E. Rustad; John C. Brissette

2016-01-01

Developing strategies for reducing atmospheric CO2 is one of the foremost challenges facing natural resource professionals today. The goal of this study was to evaluate total ecosystem and harvested wood product carbon (C) stocks among alternative forest management treatments (selection cutting, shelterwood cutting, commercial clearcutting, and...

Synthetic biology strategies toward heterologous phytochemical production.

PubMed

Kotopka, Benjamin J; Li, Yanran; Smolke, Christina D

2018-06-13

Covering: 2006 to 2018Phytochemicals are important sources for the discovery and development of agricultural and pharmaceutical compounds, such as pesticides and medicines. However, these compounds are typically present in low abundance in nature, and the biosynthetic pathways for most phytochemicals are not fully elucidated. Heterologous production of phytochemicals in plant, bacterial, and yeast hosts has been pursued as a potential approach to address sourcing issues associated with many valuable phytochemicals, and more recently has been utilized as a tool to aid in the elucidation of plant biosynthetic pathways. Due to the structural complexity of certain phytochemicals and the associated biosynthetic pathways, reconstitution of plant pathways in heterologous hosts can encounter numerous challenges. Synthetic biology approaches have been developed to address these challenges in areas such as precise control over heterologous gene expression, improving functional expression of heterologous enzymes, and modifying central metabolism to increase the supply of precursor compounds into the pathway. These strategies have been applied to advance plant pathway reconstitution and phytochemical production in a wide variety of heterologous hosts. Here, we review synthetic biology strategies that have been recently applied to advance complex phytochemical production in heterologous hosts.

Global land use change, economic globalization, and the looming land scarcity.

PubMed

Lambin, Eric F; Meyfroidt, Patrick

2011-03-01

A central challenge for sustainability is how to preserve forest ecosystems and the services that they provide us while enhancing food production. This challenge for developing countries confronts the force of economic globalization, which seeks cropland that is shrinking in availability and triggers deforestation. Four mechanisms-the displacement, rebound, cascade, and remittance effects-that are amplified by economic globalization accelerate land conversion. A few developing countries have managed a land use transition over the recent decades that simultaneously increased their forest cover and agricultural production. These countries have relied on various mixes of agricultural intensification, land use zoning, forest protection, increased reliance on imported food and wood products, the creation of off-farm jobs, foreign capital investments, and remittances. Sound policies and innovations can therefore reconcile forest preservation with food production. Globalization can be harnessed to increase land use efficiency rather than leading to uncontrolled land use expansion. To do so, land systems should be understood and modeled as open systems with large flows of goods, people, and capital that connect local land use with global-scale factors.

Global land use change, economic globalization, and the looming land scarcity

PubMed Central

Lambin, Eric F.; Meyfroidt, Patrick

2011-01-01

A central challenge for sustainability is how to preserve forest ecosystems and the services that they provide us while enhancing food production. This challenge for developing countries confronts the force of economic globalization, which seeks cropland that is shrinking in availability and triggers deforestation. Four mechanisms—the displacement, rebound, cascade, and remittance effects—that are amplified by economic globalization accelerate land conversion. A few developing countries have managed a land use transition over the recent decades that simultaneously increased their forest cover and agricultural production. These countries have relied on various mixes of agricultural intensification, land use zoning, forest protection, increased reliance on imported food and wood products, the creation of off-farm jobs, foreign capital investments, and remittances. Sound policies and innovations can therefore reconcile forest preservation with food production. Globalization can be harnessed to increase land use efficiency rather than leading to uncontrolled land use expansion. To do so, land systems should be understood and modeled as open systems with large flows of goods, people, and capital that connect local land use with global-scale factors. PMID:21321211

Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges

PubMed Central

Knowles, Lori; Luth, Westerly; Bubela, Tania

2017-01-01

Abstract Personalized medicine (PM) aims to harness a wave of ‘omics’ discoveries to facilitate research and discovery of targeted diagnostics and therapies and increase the efficiency of healthcare systems by predicting and treating individual predispositions to diseases or conditions. Despite significant investment, limited progress has been made bringing PM to market. We describe the major perceived regulatory, intellectual property, and reimbursement challenges to the development, translation, adoption, and implementation of PM products into clinical care. We conducted a scoping review to identify (i) primary challenges for the development and implementation of PM identified in the academic literature; (ii) solutions proposed in the academic literature to address these challenges; and (iii) gaps that exist in that literature. We identified regulatory barriers to PM development and recommendations in 344 academic papers. Regulatory uncertainty was a cross-cutting theme that appeared in conjunction with other themes including: reimbursement; clinical trial regulation; regulation of co-development; unclear evidentiary requirements; insufficient incentives for research and development; incompatible information systems; and different regulation of different diagnostics. To fully realize the benefits of PM for healthcare systems and patients, regulatory, intellectual property, and reimbursement challenges need to be addressed in lock step with scientific advances. PMID:29868182

Systems biology solutions for biochemical production challenges.

PubMed

Hansen, Anne Sofie Lærke; Lennen, Rebecca M; Sonnenschein, Nikolaus; Herrgård, Markus J

2017-06-01

There is an urgent need to significantly accelerate the development of microbial cell factories to produce fuels and chemicals from renewable feedstocks in order to facilitate the transition to a biobased society. Methods commonly used within the field of systems biology including omics characterization, genome-scale metabolic modeling, and adaptive laboratory evolution can be readily deployed in metabolic engineering projects. However, high performance strains usually carry tens of genetic modifications and need to operate in challenging environmental conditions. This additional complexity compared to basic science research requires pushing systems biology strategies to their limits and often spurs innovative developments that benefit fields outside metabolic engineering. Here we survey recent advanced applications of systems biology methods in engineering microbial production strains for biofuels and -chemicals. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Radojcic, Riko; Nowak, Matt; Nakamoto, Mark

The status of the development of a Design-for-Stress simulation flow that captures the stress effects in packaged 3D-stacked Si products like integrated circuits (ICs) using advanced via-middle Through Si Via technology is outlined. The next set of challenges required to proliferate the methodology and to deploy it for making and dispositioning real Si product decisions are described here. These include the adoption and support of a Process Design Kit (PDK) that includes the relevant material properties, the development of stress simulation methodologies that operate at higher levels of abstraction in a design flow, and the development and adoption of suitablemore » models required to make real product reliability decisions.« less

Developing Technology Products - A Physicist's Perspective

NASA Astrophysics Data System (ADS)

Burka, Michael

2014-03-01

There are many physicists working in the industrial sector. We rarely have the word physicist in our job title; we are far more commonly called engineers or scientists. But, we are physicists, and we succeed because our training in physics has given us the habits of mind and the technical skills that one needs to solve complex technical challenges. This talk will explore the transition from physics research to technology product development using examples from my own career, first as a postdoctoral fellow and research scientist on the LIGO project, and then developing products in the spectroscopy, telecommunications, and medical device industries. Approaches to identifying and pursuing opportunities in industry will be discussed.

Metals and minerals as a biotechnology feedstock: engineering biomining microbiology for bioenergy applications.

PubMed

Banerjee, Indrani; Burrell, Brittany; Reed, Cara; West, Alan C; Banta, Scott

2017-06-01

Developing new feedstocks for the efficient production of biochemicals and biofuels will be a critical challenge as we diversify away from petrochemicals. One possible opportunity is the utilization of sulfide-based minerals in the Earth's crust. Non-photosynthetic chemolithoautotrophic bacteria are starting to be developed to produce biochemicals from CO 2 using energy obtained from the oxidation of inorganic feedstocks. Biomining of metals like gold and copper already exploit the native metabolism of these bacteria and these represent perhaps the largest-scale bioprocesses ever developed. The metabolic engineering of these bacteria could be a desirable alternative to classical heterotrophic bioproduction. In this review, we discuss biomining operations and the challenges and advances in the engineering of associated chemolithoautotrophic bacteria for biofuel production. The co-generation of biofuels integrated with mining operations is a largely unexplored opportunity that will require advances in fundamental microbiology and the development of new genetic tools and techniques for these organisms. Although this approach is presently in its infancy, the production of biochemicals using energy from non-petroleum mineral resources is an exciting new biotechnology opportunity. Copyright © 2017 Elsevier Ltd. All rights reserved.

Engineering microbial electrocatalysis for chemical and fuel production.

PubMed

Rosenbaum, Miriam A; Henrich, Alexander W

2014-10-01

In many biotechnological areas, metabolic engineering and synthetic biology have become core technologies for biocatalyst development. Microbial electrocatalysis for biochemical and fuel production is still in its infancy and reactions rates and the product spectrum are currently very low. Therefore, molecular engineering strategies will be crucial for the advancement and realization of many new bioproduction routes using electroactive microorganisms. The complex and unresolved biochemistry and physiology of extracellular electron transfer and the lack of molecular tools for these new non-model hosts for genetic engineering constitute the major challenges for this effort. This review is providing an insight into the current status, challenges and promising approaches of pathway engineering for microbial electrocatalysis. Copyright © 2014 Elsevier Ltd. All rights reserved.

Escherichia coli as a glycoprotein production host: recent developments and challenges.

PubMed

Jaffé, Stephen R P; Strutton, Benjamin; Levarski, Zdenko; Pandhal, Jagroop; Wright, Phillip C

2014-12-01

Chinese Hamster Ovary cells are the most popular host expression system for the large-scale production of human therapeutic glycoproteins, but, the race to engineer Escherichia coli to perform glycosylation is gathering pace. The successful functional transfer of an N-glycosylation pathway from Campylobacter jejuni to Escherichia coli in 2002 can be considered as the crucial first engineering step. Here, we discuss the recent advancements in the field of N-glycosylation of recombinant therapeutic proteins in E. coli cells, from the manipulation of glycan composition, to the improvement in glycosylation efficiency, along with the challenges that remain before E. coli can be available as an industry host cell for economically viable glycoprotein production. Copyright © 2014 Elsevier Ltd. All rights reserved.

Microalgal drying and cell disruption--recent advances.

PubMed

Show, Kuan-Yeow; Lee, Duu-Jong; Tay, Joo-Hwa; Lee, Tse-Min; Chang, Jo-Shu

2015-05-01

Production of intracellular metabolites or biofuels from algae involves various processing steps, and extensive work on laboratory- and pilot-scale algae cultivation, harvesting and processing has been reported. As algal drying and cell disruption are integral processes of the unit operations, this review examines recent advances in algal drying and disruption for nutrition or biofuel production. Challenges and prospects of the processing are also outlined. Engineering improvements in addressing the challenges of energy efficiency and cost-effective and rigorous techno-economic analyses for a clearer prospect comparison between different processing methods are highlighted. Holistic life cycle assessments need to be conducted in assessing the energy balance and the potential environmental impacts of algal processing. The review aims to provide useful information for future development of efficient and commercially viable algal food products and biofuels production. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety of plant-made pharmaceuticals: product development and regulatory considerations based on case studies of two autologous human cancer vaccines.

PubMed

Tusé, Daniel

2011-03-01

Guidelines issued by regulatory agencies for the development of plant-made pharmaceutical (PMP) products provide criteria for product manufacturing and characterization, safety determination, containment and mitigation of environmental risks. Features of plant-made products do not always enable an easy fit within the criteria subscribed to by regulators. The unconventional nature of plant-based manufacturing processes and peculiarities of plant biology relative to that of traditional biological production systems have led to special considerations in the regulatory scrutiny of PMP. Presented in this review are case studies of two plant-made autologous (patient-specific) cancer vaccines, the nature of which introduced challenges to conventional and standardized development and preclinical evaluation routes. The rationale presented to FDA by the sponsors of each vaccine to build consensus and obtain variances to existing guidelines is discussed. While development of many plant-made biologics can be accomplished within the existing regulatory framework, the development of specialized products can be defended with rational arguments based on strong science.

The synergy of the whole: building a global system for clinical trials to accelerate medicines development.

PubMed

Koski, Greg; Tobin, Mary F; Whalen, Matthew

2014-10-01

The pharmaceutical industry, once highly respected, productive, and profitable, is in the throes of major change driven by many forces, including economics, science, regulation, and ethics. A variety of initiatives and partnerships have been launched to improve efficiency and productivity but without significant effect because they have failed to consider the process as a system. Addressing the challenges facing this complex endeavor requires more than modifications of individual processes; it requires a fully integrated application of systems thinking and an understanding of the desired goals and complex interactions among essential components and stakeholders of the whole. A multistakeholder collaborative effort, led by the Alliance for Clinical Research Excellence and Safety (ACRES), a global nonprofit organization operating in the public interest, is now under way to build a shared global system for clinical research. Its systems approach focuses on the interconnection of stakeholders at critical points of interaction within 4 operational domains: site development and support, quality management, information technology, and safety. The ACRES initiatives, Site Accreditation and Standards, Product Safety Culture, Global Ethical Review and Regulatory Innovation, and Quality Assurance and Safety, focus on building and implementing systems solutions. Underpinning these initiatives is an open, shared, integrated technology (site and optics and quality informatics initiative). We describe the rationale, challenges, progress, and successes of this effort to date and lessons learned. The complexity and fragmentation of the intensely proprietary ecosystem of drug development, challenging regulatory climate, and magnitude of the endeavor itself pose significant challenges, but the economic, social, and scientific rewards will more than justify the effort. An effective alliance model requires a willingness of multiple stakeholders to work together to build a shared system within a noncompetitive space that will have major benefits for all, including better access to medicines, better health, and more productive lives. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

PubMed

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

Recent advances in small molecule drug delivery.

PubMed

Kidane, Argaw; Bhatt, Padmanabh P

2005-08-01

The majority of new drugs, and new drug products, being developed and marketed by the pharmaceutical industry are small molecules. Oral administration remains the most common route of delivering such drugs, typically in the form of immediate-release tablets or capsules. While the immediate-release dosage forms dominate the market today, more specialized and rationalized products incorporating the concepts of drug delivery are being developed to overcome the physicochemical, physiological and pharmacological challenges inherent with the drugs, and to improve the treatment regimens for the patients. Today, these specialized concepts are increasingly being applied to first-generation products and not just products intended for the life cycle management of the franchise.

Biodiesel biorefinery: opportunities and challenges for microbial production of fuels and chemicals from glycerol waste

PubMed Central

2012-01-01

The considerable increase in biodiesel production worldwide in the last 5 years resulted in a stoichiometric increased coproduction of crude glycerol. As an excess of crude glycerol has been produced, its value on market was reduced and it is becoming a “waste-stream” instead of a valuable “coproduct”. The development of biorefineries, i.e. production of chemicals and power integrated with conversion processes of biomass into biofuels, has been singled out as a way to achieve economically viable production chains, valorize residues and coproducts, and reduce industrial waste disposal. In this sense, several alternatives aimed at the use of crude glycerol to produce fuels and chemicals by microbial fermentation have been evaluated. This review summarizes different strategies employed to produce biofuels and chemicals (1,3-propanediol, 2,3-butanediol, ethanol, n-butanol, organic acids, polyols and others) by microbial fermentation of glycerol. Initially, the industrial use of each chemical is briefly presented; then we systematically summarize and discuss the different strategies to produce each chemical, including selection and genetic engineering of producers, and optimization of process conditions to improve yield and productivity. Finally, the impact of the developments obtained until now are placed in perspective and opportunities and challenges for using crude glycerol to the development of biodiesel-based biorefineries are considered. In conclusion, the microbial fermentation of glycerol represents a remarkable alternative to add value to the biodiesel production chain helping the development of biorefineries, which will allow this biofuel to be more competitive. PMID:22809320

NASA Technologies for Product Identification

NASA Technical Reports Server (NTRS)

Schramm, Fred, Jr.

2006-01-01

Since 1975 bar codes on products at the retail counter have been accepted as the standard for entering product identity for price determination. Since the beginning of the 21st century, the Data Matrix symbol has become accepted as the bar code format that is marked directly on a part, assembly or product that is durable enough to identify that item for its lifetime. NASA began the studies for direct part marking Data Matrix symbols on parts during the Return to Flight activities after the Challenger Accident. Over the 20 year period that has elapsed since Challenger, a mountain of studies, analyses and focused problem solutions developed by and for NASA have brought about world changing results. NASA Technical Standard 6002 and NASA Handbook 6003 for Direct Part Marking Data Matrix Symbols on Aerospace Parts have formed the basis for most other standards on part marking internationally. NASA and its commercial partners have developed numerous products and methods that addressed the difficulties of collecting part identification in aerospace operations. These products enabled the marking of Data Matrix symbols in virtually every situation and the reading of symbols at great distances, severe angles, under paint and in the dark without a light. Even unmarkable delicate parts now have a process to apply a chemical mixture called NanocodesTM that can be converted to a Data Matrix. The accompanying intellectual property is protected by 10 patents, several of which are licensed. Direct marking Data Matrix on NASA parts virtually eliminates data entry errors and the number of parts that go through their life cycle unmarked, two major threats to sound configuration management and flight safety. NASA is said to only have people and stuff with information connecting them. Data Matrix is one of the most significant improvements since Challenger to the safety and reliability of that connection. This presentation highlights the accomplishments of NASA in its efforts to develop technologies for automatic identification, its efforts to implement them and its vision on their role in space.

Leadership Skills for Department Chairs.

ERIC Educational Resources Information Center

Gmelch, Walter H.; Miskin, Val D.

This guide to leadership for college department chairs addresses three major challenges: (1) developing understanding and clarity about the motives and role of a department chair; (2) understanding the strategic planning process for creating a productive department; and (3) developing key leadership skills required for effectiveness. The first…

Development of aquatic toxicity benchmarks for oil products using species sensitivity distributions

EPA Science Inventory

Determining the sensitivity of a diversity of species to spilled oil and chemically dispersed oil continues to be a significant challenge in spill response and impact assessment. We used standardized tests from the literature to develop species sensitivity distributions (SSDs) of...

Demand-Side Job Development and System Change.

ERIC Educational Resources Information Center

Gilbride, Dennis; Stensrud, Robert

1999-01-01

Authors discuss demand-side job development as a model for improving and providing rehabilitation services to consumers and employers. It stresses quality employment outcomes, consumer choice and empowerment, and a productive partnership between consumer and counselor. Delineates systemic challenges this model poses to traditional vocational…

Special Gender Studies for Engineering?

ERIC Educational Resources Information Center

Ihsen, Susanne

2005-01-01

Today we are confronted with a new challenge in product development: "Diversity" needs to be implemented in the engineering design and development teams. Such diversity means to "mirror" within the teams the characteristics of different customer groups: the two genders, the different age groups, and the different cultural…

Drug-loaded erythrocytes: on the road toward marketing approval

PubMed Central

Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

2016-01-01

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available. PMID:26929599

Drug-loaded erythrocytes: on the road toward marketing approval.

PubMed

Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

2016-01-01

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.

A Software Product Line Process to Develop Agents for the IoT.

PubMed

Ayala, Inmaculada; Amor, Mercedes; Fuentes, Lidia; Troya, José M

2015-07-01

One of the most important challenges of this decade is the Internet of Things (IoT), which aims to enable things to be connected anytime, anyplace, with anything and anyone, ideally using any path/network and any service. IoT systems are usually composed of heterogeneous and interconnected lightweight devices that support applications that are subject to change in their external environment and in the functioning of these devices. The management of the variability of these changes, autonomously, is a challenge in the development of these systems. Agents are a good option for developing self-managed IoT systems due to their distributed nature, context-awareness and self-adaptation. Our goal is to enhance the development of IoT applications using agents and software product lines (SPL). Specifically, we propose to use Self-StarMASMAS, multi-agent system) agents and to define an SPL process using the Common Variability Language. In this contribution, we propose an SPL process for Self-StarMAS, paying particular attention to agents embedded in sensor motes.

Scrum and Global Delivery: Pitfalls and Lessons Learned

NASA Astrophysics Data System (ADS)

Sadun, Cristiano

Two trends are becoming widespread in software development work—agile development processes and global delivery, both promising sizable benefits in productivity, capacity and so on. Combining the two is a highly attractive possibility, even more so in fast-paced and constrained commercial software engineering projects. However, a degree of conflict exists between the assumptions underlying the two ideas, leading to pitfalls and challenges in agile/distributed projects which are new, both with respect to traditional development and agile or distributed efforts adopted separately. Succeeding in commercial agile/distributed projects implies recognizing these new challenges, proactively planning for them, and actively put in place solutions and methods to overcome them. This chapter illustrates some of the typical challenges that were met during real-world commercial projects, and how they were solved.

Use of GPM Data Products in SERVIR Hydrological Applications

NASA Astrophysics Data System (ADS)

Limaye, A. S.; Mithieu, F.; Gurung, D. R.; Blankenship, C. B.; Crosson, W. L.; Anderson, E. R.; Flores, A.; Delgado, F.; Stanton, K.; Irwin, D.

2015-12-01

Availability of reliable precipitation data is a major challenge for SERVIR, a joint USAID-NASA project aimed at improving the environmental decision-making capacity of developing countries. GPM data products are fulfilling that challenge through frequent, high spatial resolution precipitation products over regional scales. SERVIR is using the products in different ways. First, SERVIR is using those in hydrologic modeling over Eastern Africa and in Hindu Kush Himalaya. SERVIR's distributed hydrologic modeling capability is helping the hydrological and meteorological departments in SERVIR regions, or Hubs, identify local watershed deserving immediate attention - such as recurring floods. Additionally, SERVIR technical implementers in the Hubs are building capacities of the departments and ministries in their member countries to effectively use the GPM products. SERVIR also provides an easy access for efficient integration of GPM products in web map services. This presentation will highlight ongoing collaborations and results generated through collaborative partnership among the water resources and hydrometeorology departments in Kenya, Uganda, Rwanda, Namibia, and Bhutan, SERVIR Hubs, and SERVIR Applied Sciences Team projects

Induced Pluripotent Stem Cell-Derived Red Blood Cells and Platelet Concentrates: From Bench to Bedside.

PubMed

Focosi, Daniele; Amabile, Giovanni

2017-12-27

Red blood cells and platelets are anucleate blood components indispensable for oxygen delivery and hemostasis, respectively. Derivation of these blood elements from induced pluripotent stem (iPS) cells has the potential to develop blood donor-independent and genetic manipulation-prone products to complement or replace current transfusion banking, also minimizing the risk of alloimmunization. While the production of erythrocytes from iPS cells has challenges to overcome, such as differentiation into adult-type phenotype that functions properly after transfusion, platelet products are qualitatively and quantitatively approaching a clinically-applicable level owing to advances in expandable megakaryocyte (MK) lines, platelet-producing bioreactors, and novel reagents. Guidelines that assure the quality of iPS cells-derived blood products for clinical application represent a novel challenge for regulatory agencies. Considering the minimal risk of tumorigenicity and the expected significant demand of such products, ex vivo production of iPS-derived blood components can pave the way for iPS translation into the clinic.

Challenges, uncertainties, and issues facing gas production from gas-hydrate deposits

USGS Publications Warehouse

Moridis, G.J.; Collett, T.S.; Pooladi-Darvish, M.; Hancock, S.; Santamarina, C.; Boswel, R.; Kneafsey, T.; Rutqvist, J.; Kowalsky, M.B.; Reagan, M.T.; Sloan, E.D.; Sum, A.K.; Koh, C.A.

2011-01-01

The current paper complements the Moridis et al. (2009) review of the status of the effort toward commercial gas production from hydrates. We aim to describe the concept of the gas-hydrate (GH) petroleum system; to discuss advances, requirements, and suggested practices in GH prospecting and GH deposit characterization; and to review the associated technical, economic, and environmental challenges and uncertainties, which include the following: accurate assessment of producible fractions of the GH resource; development of methods for identifying suitable production targets; sampling of hydrate-bearing sediments (HBS) and sample analysis; analysis and interpretation of geophysical surveys of GH reservoirs; well-testing methods; interpretation of well-testing results; geomechanical and reservoir/well stability concerns; well design, operation, and installation; field operations and extending production beyond sand-dominated GH reservoirs; monitoring production and geomechanical stability; laboratory investigations; fundamental knowledge of hydrate behavior; the economics of commercial gas production from hydrates; and associated environmental concerns. ?? 2011 Society of Petroleum Engineers.

Maximizing Potential: A School-Based Conception of Psychosocial Development

ERIC Educational Resources Information Center

Cross, Tracy L.; Cross, Jennifer Riedl

2017-01-01

Optimal talent development can only occur when high ability students are willing to take opportunities for growth in a domain and are able to persist when presented with challenges that accompany performance or production at the highest levels. This paper proposes the use of Erikson's theory of psychosocial development to provide a framework…

Challenging/interesting lignin times

DOE PAGES

Ragauskas, Arthur J.

2016-08-31

Anyone who is working in the fuels industry knows that we are living in challenging times. On a personal note, I recall that ~5 years ago, some of my children's friends headed out into the petroleum industry to start their careers and several have now returned because of the retrenching work force. Despite these challenging times, the cellulosic ethanol industry continues to develop commercial operations, but with today's cost structure, biofuels production facilities have certainly slowed their pace of development and roll-out. Furthermore, the biological technology platform for biorefining plant polysaccharides to biofuels has been reported to have an intrinsicmore » advantage, if it can convert its waste lignin stream to value-added components.[1]« less

The National Mechatronic Platform. The basis of the educational programs in the knowledge society

NASA Astrophysics Data System (ADS)

Maties, V.

2016-08-01

The shift from the information society to the knowledge based society caused by the mechatronic revolution, that took place in the 9th decade of the last century, launched a lot of challenges for education and researches activities too. Knowledge production development asks for new educational technologies to stimulate the initiative and creativity as a base to increase the productivity in the knowledge production. The paper presents details related on the innovative potential of mechatronics as educational environment for transdisciplinarity learning and integral education. The basic infrastructure of that environment is based on mechatronic platforms. In order to develop the knowledge production at the national level the specific structures are to be developed. The paper presents details related on the structure of the National Mechatronic Platform as a true knowledge factory. The benefits of the effort to develop the specific infrastructure for knowledge production in the field of mechatronics are outlined too.

An Integrated Assessment of Location-Dependent Scaling for Microalgae Biofuel Production Facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coleman, Andre M.; Abodeely, Jared; Skaggs, Richard

Successful development of a large-scale microalgae-based biofuels industry requires comprehensive analysis and understanding of the feedstock supply chain—from facility siting/design through processing/upgrading of the feedstock to a fuel product. The evolution from pilot-scale production facilities to energy-scale operations presents many multi-disciplinary challenges, including a sustainable supply of water and nutrients, operational and infrastructure logistics, and economic competitiveness with petroleum-based fuels. These challenges are addressed in part by applying the Integrated Assessment Framework (IAF)—an integrated multi-scale modeling, analysis, and data management suite—to address key issues in developing and operating an open-pond facility by analyzing how variability and uncertainty in space andmore » time affect algal feedstock production rates, and determining the site-specific “optimum” facility scale to minimize capital and operational expenses. This approach explicitly and systematically assesses the interdependence of biofuel production potential, associated resource requirements, and production system design trade-offs. The IAF was applied to a set of sites previously identified as having the potential to cumulatively produce 5 billion-gallons/year in the southeastern U.S. and results indicate costs can be reduced by selecting the most effective processing technology pathway and scaling downstream processing capabilities to fit site-specific growing conditions, available resources, and algal strains.« less

Bioengineering Solutions for Manufacturing Challenges in CAR T Cells

PubMed Central

Piscopo, Nicole J.; Mueller, Katherine P.; Das, Amritava; Hematti, Peiman; Murphy, William L.; Palecek, Sean P.; Capitini, Christian M.

2017-01-01

The next generation of therapeutic products to be approved for the clinic is anticipated to be cell therapies, termed “living drugs” for their capacity to dynamically and temporally respond to changes during their production ex vivo and after their administration in vivo. Genetically engineered chimeric antigen receptor (CAR) T cells have rapidly developed into powerful tools to harness the power of immune system manipulation against cancer. Regulatory agencies are beginning to approve CAR T cell therapies due to their striking efficacy in treating some hematological malignancies. However, the engineering and manufacturing of such cells remains a challenge for widespread adoption of this technology. Bioengineering approaches including biomaterials, synthetic biology, metabolic engineering, process control and automation, and in vitro disease modeling could offer promising methods to overcome some of these challenges. Here, we describe the manufacturing process of CAR T cells, highlighting potential roles for bioengineers to partner with biologists and clinicians to advance the manufacture of these complex cellular products under rigorous regulatory and quality control. PMID:28840981

Production of Human Pluripotent Stem Cell Therapeutics Under Defined Xeno-free Conditions: Progress and Challenges

PubMed Central

Fan, Yongjia; Wu, Jincheng; Ashok, Preeti; Hsiung, Michael; Tzanakakis, Emmanuel S.

2014-01-01

Recent advances on human pluripotent stem cells (hPSCs), including human embryonic stem cells (hESCs) and induced pluripotent stem cells (hiPSCs) have brought us closer to the realization of their clinical potential. Nonetheless, tissue engineering and regenerative medicine applications will require the generation of hPSC products well beyond the laboratory scale. This also mandates the production of hPSC therapeutics in fully-defined, xeno-free systems and in a reproducible manner. Toward this goal, we summarize current developments in defined media free of animal-derived components for hPSC culture. Bioinspired and synthetic extracellular matrices for the attachment growth and differentiation of hPSCs are also reviewed. Given that most progress in xeno-free medium and substrate development has been demonstrated in two-dimensional rather than three dimensional culture systems, translation from the former to the latter poses unique difficulties. These challenges are discussed in the context of cultivation platforms of hPSCs as aggregates, on microcarriers or after encapsulation in biocompatible scaffolds. PMID:25077810

Production of human pluripotent stem cell therapeutics under defined xeno-free conditions: progress and challenges.

PubMed

Fan, Yongjia; Wu, Jincheng; Ashok, Preeti; Hsiung, Michael; Tzanakakis, Emmanuel S

2015-02-01

Recent advances on human pluripotent stem cells (hPSCs), including human embryonic stem cells (hESCs) and induced pluripotent stem cells (hiPSCs) have brought us closer to the realization of their clinical potential. Nonetheless, tissue engineering and regenerative medicine applications will require the generation of hPSC products well beyond the laboratory scale. This also mandates the production of hPSC therapeutics in fully-defined, xeno-free systems and in a reproducible manner. Toward this goal, we summarize current developments in defined media free of animal-derived components for hPSC culture. Bioinspired and synthetic extracellular matrices for the attachment, growth and differentiation of hPSCs are also reviewed. Given that most progress in xeno-free medium and substrate development has been demonstrated in two-dimensional rather than three dimensional culture systems, translation from the former to the latter poses unique difficulties. These challenges are discussed in the context of cultivation platforms of hPSCs as aggregates, on microcarriers or after encapsulation in biocompatible scaffolds.

Production of C2-C4 diols from renewable bioresources: new metabolic pathways and metabolic engineering strategies.

PubMed

Zhang, Ye; Liu, Dehua; Chen, Zhen

2017-01-01

C2-C4 diols classically derived from fossil resource are very important bulk chemicals which have been used in a wide range of areas, including solvents, fuels, polymers, cosmetics, and pharmaceuticals. Production of C2-C4 diols from renewable resources has received significant interest in consideration of the reducing fossil resource and the increasing environmental issues. While bioproduction of certain diols like 1,3-propanediol has been commercialized in recent years, biosynthesis of many other important C2-C4 diol isomers is highly challenging due to the lack of natural synthesis pathways. Recent advances in synthetic biology have enabled the de novo design of completely new pathways to non-natural molecules from renewable feedstocks. In this study, we review recent advances in bioproduction of C2-C4 diols, focusing on new metabolic pathways and metabolic engineering strategies being developed. We also discuss the challenges and future trends toward the development of economically competitive processes for bio-based diol production.

Physicochemical Property Guidelines for Modern Agrochemicals.

PubMed

Zhang, Yu; Lorsbach, Beth; Castetter, Scott; Lambert, William T; Kister, Jeremy; Wang, Nick X; Klittich, Carla; Roth, Joshua; Sparks, Thomas C; Loso, Mike R

2018-04-17

The relentless need for the discovery and development of new agrochemicals continues due to driving forces such as loss of existing products through the development of resistance, the necessity for products with more favorable environmental and toxicological profiles, shifting pest spectra, and the changing agricultural needs and practices of the farming community. These new challenges underscore the demand for novel, high quality starting points to accelerate the discovery of new agrochemicals that address market challenges. This article discusses the efforts to identify the optimum ranges of physicochemical properties of agrochemicals through analysis of modern commercial products. Specifically, we reviewed literature studies examining physicochemical property effects and analyzed the properties typical of successful fungicides, herbicides, and insecticides (chewing and sap-feeding pests). From the analysis, a new set of physicochemical property guidelines for each discipline, as well as building block class, are proposed. These new guidelines should significantly aid in the discovery of next generation agrochemicals. This article is protected by copyright. All rights reserved.

Development and testing of a novel subsea production system and control buoy

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1997-04-01

The remoteness of Australia`s northwest shelf presents challenges for the economic viability of offshore resource-development projects. Accordingly, the East Spar development has been designed to minimize capital and life-cycle costs to ensure the long-term viability of this offshore gas field. The offshore facilities are made up of a novel unmanned navigation, communication, and control (NCC) buoy linked to a subsea-production system that includes heat exchangers, insert-retrievable choke valves, multiphase flow-meters, and an on-line pipeline-corrosion monitoring system. The technological building blocks for field development are industry proved. However, the novel arrangement of this proven technology into a remotely controlled, self-contained, minimum-maintenancemore » unmanned facility is unique and has led to many challenges during the design and testing of the NCC buoy and subsea facilities. Among these challenges has been the formulation of an integration test program of the NCC buoy and subsea hardware that proves, as far as reasonably possible, the complete functionality of each equipment item and interface, subject to constraints imposed by schedule, cost, and logistics. Integration testing is particularly important to confirm that the offshore facilities will operate as designed with sufficient reliability and system redundancy to ensure continuous operation throughout the 20-year field life.« less

Challenges in Translational Development of Pharmaceutical Cocrystals.

PubMed

Kale, Dnyaneshwar P; Zode, Sandeep S; Bansal, Arvind K

2017-02-01

The last 2 decades have witnessed increased research in the area of cocrystals resulting in deeper scientific understanding, increase in intellectual property landscape, and evolution in the regulatory environment. Pharmaceutical cocrystals have received significant attention as a new solid form on account of their ability to modulate poor physicochemical properties of drug molecules. However, pharmaceutical development of cocrystals could be challenging, thus limiting their translation into viable drug products. In the present commentary, the role of cocrystals in the modulation of material properties and challenges involved in the pharmaceutical development of cocrystals have been discussed. The major hurdles encountered in the development of cocrystals such as safety of coformers, unpredictable performance during dissolution and solubility in different media, difficulties in establishing in vitro-in vivo correlation, and polymorphism have been extensively discussed. The influence of selecting appropriate formulation and process design on these challenges has been discussed. Finally, a brief outline of cocrystals that are undergoing clinical development has also been presented. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Age-dependent trade-offs between immunity and male, but not female, reproduction.

PubMed

McNamara, Kathryn B; van Lieshout, Emile; Jones, Therésa M; Simmons, Leigh W

2013-01-01

Immune function is costly and must be traded off against other life-history traits, such as gamete production. Studies of immune trade-offs typically focus on adult individuals, yet the juvenile stage can be a highly protracted period when reproductive resources are acquired and immune challenges are ubiquitous. Trade-offs during development are likely to be important, yet no studies have considered changes in adult responses to immune challenges imposed at different stages of juvenile development. By manipulating the timing of a bacterial immune challenge to the larvae of the cotton bollworm moth, we examined potential trade-offs between investment into immunity at different stages of juvenile development (early or late) and subsequent adult reproductive investment into sperm or egg production. Our data reveal an age-dependent trade-off between juvenile immune function and adult male reproductive investment. Activation of the immune response during late development resulted in a reduced allocation of resources to eupyrene (fertilizing) sperm production. Immune activation from the injection procedure itself (irrespective of whether individuals were injected with an immune elicitor or a control solution) also caused reproductive trade-offs; males injected early in development produced fewer apyrene (nonfertilizing) sperm. Contrary to many other studies, our study demonstrates these immune trade-offs under ad libitum nutritional conditions. No trade-offs were observed between female immune activation and adult reproductive investment. We suggest the differences in trade-offs observed between male sperm types and the absence of reproductive trade-offs in females may be the result of ontogenetic differences in gamete production in this species. Our data reveal developmental windows when trade-offs between immune function and gametic investment are made, and highlight the importance of considering multiple developmental periods when making inferences regarding the fundamental trade-offs expected between immune function and reproduction. © 2012 The Authors. Journal of Animal Ecology © 2012 British Ecological Society.

Control and Diagnosis in Integrated Product Development - Observations during the Development of an AGV

NASA Astrophysics Data System (ADS)

Stetter, R.; Simundsson, A.

2015-11-01

This paper is concerned with the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of integrated product development have attracted significant attention during the last decades. Today, it is generally observed that product development processes of complex systems can only be successful if the activities in the different domains are well connected and synchronised and if an ongoing communication is present - an ongoing communication spanning the technical domains and also including functions such as production planning, marketing/distribution, quality assurance, service and project planning. Obviously, numerous approaches to tackle this challenge are present in scientific literature and in industrial practice, as well. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The main source of insight of the presented research is the product development process of an Automated Guided Vehicle (AGV) which is intended to be used on rough terrain. The paper starts with a background describing Integrated Product Development. The second section deals with the product development of the sample product. The third part summarizes some insights and formulates first hypotheses concerning control and diagnosis in Integrated Product Development.

Systems Biology of Industrial Microorganisms

NASA Astrophysics Data System (ADS)

Papini, Marta; Salazar, Margarita; Nielsen, Jens

The field of industrial biotechnology is expanding rapidly as the chemical industry is looking towards more sustainable production of chemicals that can be used as fuels or building blocks for production of solvents and materials. In connection with the development of sustainable bioprocesses, it is a major challenge to design and develop efficient cell factories that can ensure cost efficient conversion of the raw material into the chemical of interest. This is achieved through metabolic engineering, where the metabolism of the cell factory is engineered such that there is an efficient conversion of sugars, the typical raw materials in the fermentation industry, into the desired product. However, engineering of cellular metabolism is often challenging due to the complex regulation that has evolved in connection with adaptation of the different microorganisms to their ecological niches. In order to map these regulatory structures and further de-regulate them, as well as identify ingenious metabolic engineering strategies that full-fill mass balance constraints, tools from systems biology can be applied. This involves both high-throughput analysis tools like transcriptome, proteome and metabolome analysis, as well as the use of mathematical modeling to simulate the phenotypes resulting from the different metabolic engineering strategies. It is in fact expected that systems biology may substantially improve the process of cell factory development, and we therefore propose the term Industrial Systems Biology for how systems biology will enhance the development of industrial biotechnology for sustainable chemical production.

Systems biology of industrial microorganisms.

PubMed

Papini, Marta; Salazar, Margarita; Nielsen, Jens

2010-01-01

The field of industrial biotechnology is expanding rapidly as the chemical industry is looking towards more sustainable production of chemicals that can be used as fuels or building blocks for production of solvents and materials. In connection with the development of sustainable bioprocesses, it is a major challenge to design and develop efficient cell factories that can ensure cost efficient conversion of the raw material into the chemical of interest. This is achieved through metabolic engineering, where the metabolism of the cell factory is engineered such that there is an efficient conversion of sugars, the typical raw materials in the fermentation industry, into the desired product. However, engineering of cellular metabolism is often challenging due to the complex regulation that has evolved in connection with adaptation of the different microorganisms to their ecological niches. In order to map these regulatory structures and further de-regulate them, as well as identify ingenious metabolic engineering strategies that full-fill mass balance constraints, tools from systems biology can be applied. This involves both high-throughput analysis tools like transcriptome, proteome and metabolome analysis, as well as the use of mathematical modeling to simulate the phenotypes resulting from the different metabolic engineering strategies. It is in fact expected that systems biology may substantially improve the process of cell factory development, and we therefore propose the term Industrial Systems Biology for how systems biology will enhance the development of industrial biotechnology for sustainable chemical production.

In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market

PubMed Central

Geris, L.; Guyot, Y.; Schrooten, J.; Papantoniou, I.

2016-01-01

The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design. PMID:27051516

In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

PubMed

Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

2016-04-06

The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.

An industrial perspective on the design and development of medicines for older patients.

PubMed

Page, Sharon; Coupe, Alastair; Barrett, Andrew

2016-10-30

An increasing elderly population is leading to a change in the global demographics. This presents a new challenge to society and the pharmaceutical industry. This demographic shift is providing an opportunity for the pharmaceutical industry to meet the specific needs of the changing patient population. One issue that has been identified is defining what is meant by "an older patient", since this definition cannot be simply limited to chronological age. The fundamental purpose of the design and development process is to create a product that can be used by the patient group in a safe and efficacious manner. In the pharmaceutical industry ICH Q8 is used to guide the design and development of medicines. The process leads to the definition of the Quality Target Product Profile (QTPP) for a specific drug product and patient population. One can imagine a product with various presentations described in the QTPP which suit paediatrics, adults and older patients. It is recognised that designing medicines for smaller population groups will result in multiple presentations that could lead to smaller manufacturing batch sizes. In the short to medium term; dose flexibility, easy-to-swallow formulations, and easier access packaging are all factors under consideration. Dose flexibility could be achieved with various dosage forms such as oral liquids, mini-tablets, or multi-particulates. Whilst patient dosage preferences are beginning to be understood, further investigation is needed to balance the needs of the patient, care giver, prescriber, and payer. There also remain a number of challenges with the engineering solutions and delivery device for mini-tablets and multi-particulates (aside from filled capsules) to accurately and robustly deliver the dose, and issues with handling the device and the packaging for an older patient. It is also recognised that there are numerous challenges, not least of which is the definition of the older patient and a generic QTPP for an older patients' drug product. It is likely that there will be no simple solution or 'one-size-fits-all' approach in drug product development to resolve the complex issues presented by the ageing population. Copyright © 2016 Elsevier B.V. All rights reserved.

Petroleum Prices: Past, Present, and Prospective,

DTIC Science & Technology

1987-01-01

other oil-exporting developing nations such as Mexico and Malaysia ) enjoyed relatively high export revenues and quickly adjusted their spending habits to... challenge Soviet oil production for first place in fuel-equivalent terms. Natural gas currently provides about 95 percent ansmuch energy as oil pro- duction...been expressed without challenge in many recent forecasts. By now, OPEC nations in general, and Persian Gulf producers in particular, appear to have

Lessons Learned during the Development of HumaPen® Memoir™, an Insulin Pen with a Memory Feature

PubMed Central

Breslin, Stuart D.; Ignaut, Debra A.; Boyd, Douglas E.

2010-01-01

Insulin pens are developed to address specific needs of diabetes patients for their pens, such as ease of use, portability, and discreetness. Like many consumer-based products, the development of insulin pens can pose significant challenges to the development team in that they must balance substantial accuracy requirements with aesthetic desires. The HumaPen® Memoir™ team learned valuable lessons throughout the development process that may be worth highlighting. A keen understanding of the unmet needs of the patient population and a skillfully planned product generation map are critical to successful device development. A development team must decide whether to use a Quality Functional Deployment or system engineering-based development plan and, additionally, recognize where proof of concept ends and product development begins to maintain a strict timeline for the project. A proficiency in understanding and managing technical risk is critical to ensure a timely and high-quality product launch to the marketplace. PMID:20513318

The dairy industry: a brief description of production practices, trends, and farm characteristics around the world.

PubMed

Douphrate, David I; Hagevoort, G Robert; Nonnenmann, Matthew W; Lunner Kolstrup, Christina; Reynolds, Stephen J; Jakob, Martina; Kinsel, Mark

2013-01-01

The global dairy industry is composed of a multitude of countries with unique production practices and consumer markets. The global average number of cows per farm is about 1-2 cows; however, as a farm business model transitions from sustenance to market production, the average herd size, and subsequent labor force increases. Dairy production is unique as an agricultural commodity because milk is produced daily, for 365 days per year. With the introduction of new technology such as the milking parlor, the global industry trend is one of increasing farm sizes. The farm sizes are the largest in the United States; however, the European Union produces the most milk compared with other global producers. Dairy production is essential for economic development and sustainable communities in rural areas. However, the required capital investment and availability of local markets and labor are continued challenges. Due to farm expansion, international producers are faced with new challenges related to assuring food safety and a safe working environment for their workforce. These challenges exist in addition to the cultural and language barriers related to an increasing dependence on immigrant labor in many regions of the world. Continued success of the global dairy industry is vital. Therefore, research should continue to address the identification of occupational risk factors associated with injuries and illnesses, as well as develop cost-effective interventions and practices that lead to the minimization or elimination of these injuries and illnesses on a global scale, among our valuable population of dairy producers and workers.

Packaging of silicon photonic devices: from prototypes to production

NASA Astrophysics Data System (ADS)

Morrissey, Padraic E.; Gradkowski, Kamil; Carroll, Lee; O'Brien, Peter

2018-02-01

The challenges associated with the photonic packaging of silicon devices is often underestimated and remains technically challenging. In this paper, we review some key enabling technologies that will allow us to overcome the current bottleneck in silicon photonic packaging; while also describing the recent developments in standardisation, including the establishment of PIXAPP as the worlds first open-access PIC packaging and assembly Pilot Line. These developments will allow the community to move from low volume prototype photonic packaged devices to large scale volume manufacturing, where the full commercialisation of PIC technology can be realised.

Development, characterization, and optimization of a new suspension chicken-induced pluripotent stem cell line for the production of Newcastle disease vaccine

USDA-ARS?s Scientific Manuscript database

Traditionally, substrates for production of vaccines have been embryonated eggs or adherent cell culture. The daunting challenge of scaling up these technologies in the face of an outbreak has been a limitation for industrial applicability. Suspension cell lines are better suited in many ways to e...

Virtual Factory Framework for Supporting Production Planning and Control.

PubMed

Kibira, Deogratias; Shao, Guodong

2017-01-01

Developing optimal production plans for smart manufacturing systems is challenging because shop floor events change dynamically. A virtual factory incorporating engineering tools, simulation, and optimization generates and communicates performance data to guide wise decision making for different control levels. This paper describes such a platform specifically for production planning. We also discuss verification and validation of the constituent models. A case study of a machine shop is used to demonstrate data generation for production planning in a virtual factory.

Membranes for bioelectrochemical systems: challenges and research advances.

PubMed

Dhar, Bipro Ranjan; Lee, Hyung-Sool

2013-01-01

Increasing energy demand has been a big challenge for current society, as the fossil fuel sources are gradually decreasing. Hence, development of renewable and sustainable energy sources for the future is considered one of the top priorities in national strategic plans. Bioenergy can meet future energy requirements - renewability, sustainability, and even carbon-neutrality. Bioenergy production from wastes and wastewaters is especially attractive because of dual benefits of energy generation and contaminant stabilization. There are several bioenergy technologies using wastes and wastewaters as electron donor, which include anaerobic digestion, dark biohydrogen fermentation, biohydrogen production using photosynthetic microorganisms, and bioelectrochemical systems (BESs). Among them BES seems to be very promising as we can produce a variety of value-added products from wastes and wastewaters, such as electric power, hydrogen gas, hydrogen peroxide, acetate, ethanol etc. Most ofthe traditional BES uses a membrane to separate the anode and cathode chamber, which is essential for improving microbial metabolism on the anode and the recovery of value-added products on the cathode. Performance of BES lacking a membrane can be seriously deteriorated, due to oxygen diffusion or substantial loss of synthesized products. For this reason, usage of a membrane seems essential to facilitate BES performance. However, a membrane can bring several technical challenges to BES application compared to membrane-less BES. These challenges include poor proton permeability, substrate loss, oxygen back diffusion, pH gradient, internal resistance, biofouling, etc. This paper aims to review the major technical barriers associated with membranes and future research directions for their application in BESs.

Companies Claim to Fame and their scientific challenges in vaccine development.

PubMed

Boon, Louis

2009-02-21

Although basic scientific immunological knowledge is the foundation for the development of novel vaccination approaches, beyond proof of concept in animal models, translational scientific immunological efforts are obligatory for successful development of a vaccine for use in humans. Translational technology is developed/used by biotechnology companies to generate better, safer or cheaper vaccines. Their proprietary position and/or proprietary technology are the basis of services that they offer to other companies or for products that they develop themselves. Some of the translational challenges are described in this review. In addition, a number of novel technologies developed by several biotechnology companies in The Netherlands are described. This document however, is far from complete and highlights only a small part of it.

Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains.

PubMed

Verdijk, Pauline; Rots, Nynke Y; Bakker, Wilfried A M

2011-05-01

Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose for the alternative inactivated poliovirus vaccine (IPV) are significantly higher and the current production capacity is not sufficient for worldwide distribution of the vaccine. In order to achieve cost-prize reduction and improve affordability, IPV production processes and dose-sparing strategies should be developed to facilitate local manufacture at a relatively lower cost. The use of attenuated Sabin instead of wild-type polio strains will provide additional safety during vaccine production and permits production in low-cost settings. Sabin-IPV is under development by several manufacturers. This article gives an overview of results from clinical trials with Sabin-IPV and discusses the requirements and challenges in the clinical development of this novel IPV.

Producing Cochrane systematic reviews-a qualitative study of current approaches and opportunities for innovation and improvement.

PubMed

Turner, Tari; Green, Sally; Tovey, David; McDonald, Steve; Soares-Weiser, Karla; Pestridge, Charlotte; Elliott, Julian

2017-08-01

Producing high-quality, relevant systematic reviews and keeping them up to date is challenging. Cochrane is a leading provider of systematic reviews in health. For Cochrane to continue to contribute to improvements in heath, Cochrane Reviews must be rigorous, reliable and up to date. We aimed to explore existing models of Cochrane Review production and emerging opportunities to improve the efficiency and sustainability of these processes. To inform discussions about how to best achieve this, we conducted 26 interviews and an online survey with 106 respondents. Respondents highlighted the importance and challenge of creating reliable, timely systematic reviews. They described the challenges and opportunities presented by current production models, and they shared what they are doing to improve review production. They particularly highlighted significant challenges with increasing complexity of review methods; difficulty keeping authors on board and on track; and the length of time required to complete the process. Strong themes emerged about the roles of authors and Review Groups, the central actors in the review production process. The results suggest that improvements to Cochrane's systematic review production models could come from improving clarity of roles and expectations, ensuring continuity and consistency of input, enabling active management of the review process, centralising some review production steps; breaking reviews into smaller "chunks", and improving approaches to building capacity of and sharing information between authors and Review Groups. Respondents noted the important role new technologies have to play in enabling these improvements. The findings of this study will inform the development of new Cochrane Review production models and may provide valuable data for other systematic review producers as they consider how best to produce rigorous, reliable, up-to-date reviews.

An integrated assessment of location-dependent scaling for microalgae biofuel production facilities

DOE PAGES

Coleman, André M.; Abodeely, Jared M.; Skaggs, Richard L.; ...

2014-06-19

Successful development of a large-scale microalgae-based biofuels industry requires comprehensive analysis and understanding of the feedstock supply chain—from facility siting and design through processing and upgrading of the feedstock to a fuel product. The evolution from pilot-scale production facilities to energy-scale operations presents many multi-disciplinary challenges, including a sustainable supply of water and nutrients, operational and infrastructure logistics, and economic competitiveness with petroleum-based fuels. These challenges are partially addressed by applying the Integrated Assessment Framework (IAF) – an integrated multi-scale modeling, analysis, and data management suite – to address key issues in developing and operating an open-pond microalgae production facility.more » This is done by analyzing how variability and uncertainty over space and through time affect feedstock production rates, and determining the site-specific “optimum” facility scale to minimize capital and operational expenses. This approach explicitly and systematically assesses the interdependence of biofuel production potential, associated resource requirements, and production system design trade-offs. To provide a baseline analysis, the IAF was applied in this paper to a set of sites in the southeastern U.S. with the potential to cumulatively produce 5 billion gallons per year. Finally, the results indicate costs can be reduced by scaling downstream processing capabilities to fit site-specific growing conditions, available and economically viable resources, and specific microalgal strains.« less

Issues and challenges of involving users in medical device development.

PubMed

Bridgelal Ram, Mala; Grocott, Patricia R; Weir, Heather C M

2008-03-01

User engagement has become a central tenet of health-care policy. This paper reports on a case study in progress that highlights user engagement in the research process in relation to medical device development. To work with a specific group of medical device users to uncover unmet needs, translating these into design concepts, novel technologies and products. To validate a knowledge transfer model that may be replicated for a range of medical device applications and user groups. In depth qualitative case study to elicit and analyse user needs. The focus is on identifying design concepts for medical device applications from unmet needs, and validating these in an iterative feedback loop to the users. The case study has highlighted three interrelated challenges: ensuring unmet needs drive new design concepts and technology development; managing user expectations and managing the research process. Despite the challenges, active participation of users is crucial to developing usable and clinically effective devices.

Efficacy of a modified live Flavobacterium columnare vaccine in fish.

PubMed

Shoemaker, Craig A; Klesius, Phillip H; Drennan, John D; Evans, Joyce J

2011-01-01

Flavobacterium columnare is an aquatic bacterium that is responsible for columnaris disease. This aquatic pathogen has a worldwide distribution and is highly infectious to both warm and cold water fish. A modified live F. columnare vaccine was developed by repeated passage of a virulent strain on increasing concentrations of rifampicin that resulted in attenuation. Here we report vaccination/challenge trials to evaluate efficacy and safety. In separate laboratory trials, immersion vaccination of channel catfish (Ictalurus punctatus) fry between 10 to 48 days post hatch (DPH) with experimental vaccine or licensed product resulted in relative percent survival (RPS) between 57-94% following challenge. Similarly, a vaccination/challenge trial using largemouth bass (Micropterus salmoides) fry at 10 DPH was performed using various doses of licensed product under laboratory conditions. Results demonstrated safety of the vaccine and significant protection following challenge with RPS values between 74-94%, depending on vaccine dose. Together, these trials demonstrate the vaccine administered to early life-stage channel catfish and largemouth bass is safe and reduces mortality following challenge with F. columnare. Published by Elsevier Ltd.

Roadmap for a Smart Factory: A Modular, Intelligent Concept for the Production of Specialty Chemicals.

PubMed

Reitze, Arnulf; Jürgensmeyer, Nikolas; Lier, Stefan; Kohnke, Marco; Riese, Julia; Grünewald, Marcus

2018-04-09

Digitalization and increasing the flexibility of production concepts offer the possibility to react to market challenges in the field of specialty chemicals. Shorter product lifetimes, increasing product individualization, and the resulting market volatility impose new requirements on plant operators. Novel concepts such as modular production plants and developments in digitalization (Industry 4.0) are able to assist the implementation of smart factories in specialty chemicals. These essential concepts will be presented in this Minireview. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

The Challenge of Reproducibility and Accuracy in Nutrition Research: Resources and Pitfalls1234

PubMed Central

Kuszak, Adam J; Williamson, John S; Hopp, D Craig; Betz, Joseph M

2016-01-01

Inconsistent and contradictory results from nutrition studies conducted by different investigators continue to emerge, in part because of the inherent variability of natural products, as well as the unknown and therefore uncontrolled variables in study populations and experimental designs. Given these challenges inherent in nutrition research, it is critical for the progress of the field that researchers strive to minimize variability within studies and enhance comparability between studies by optimizing the characterization, control, and reporting of products, reagents, and model systems used, as well as the rigor and reporting of experimental designs, protocols, and data analysis. Here we describe some recent developments relevant to research on plant-derived products used in nutrition research, highlight some resources for optimizing the characterization and reporting of research using these products, and describe some of the pitfalls that may be avoided by adherence to these recommendations. PMID:26980822

Silver Nanoparticles: Technological Advances, Societal Impacts, and Metrological Challenges

PubMed Central

Calderón-Jiménez, Bryan; Johnson, Monique E.; Montoro Bustos, Antonio R.; Murphy, Karen E.; Winchester, Michael R.; Vega Baudrit, José R.

2017-01-01

Silver nanoparticles (AgNPs) show different physical and chemical properties compared to their macroscale analogs. This is primarily due to their small size and, consequently, the exceptional surface area of these materials. Presently, advances in the synthesis, stabilization, and production of AgNPs have fostered a new generation of commercial products and intensified scientific investigation within the nanotechnology field. The use of AgNPs in commercial products is increasing and impacts on the environment and human health are largely unknown. This article discusses advances in AgNP production and presents an overview of the commercial, societal, and environmental impacts of this emerging nanoparticle (NP), and nanomaterials in general. Finally, we examine the challenges associated with AgNP characterization, discuss the importance of the development of NP reference materials (RMs) and explore their role as a metrological mechanism to improve the quality and comparability of NP measurements. PMID:28271059

Silver nanoparticles: technological advances, societal impacts, and metrological challenges

NASA Astrophysics Data System (ADS)

Calderón-Jiménez, Bryan; Johnson, Monique E.; Montoro Bustos, Antonio R.; Murphy, Karen E.; Winchester, Michael R.; Vega Baudrit, José R.

2017-02-01

Silver nanoparticles (AgNPs) show different physical and chemical properties compared to their macroscale analogs. This is primarily due to their small size and, consequently, the exceptional surface area of these materials. Presently, advances in the synthesis, stabilization, and production of AgNPs have fostered a new generation of commercial products and intensified scientific investigation within the nanotechnology field. The use of AgNPs in commercial products is increasing and impacts on the environment and human health are largely unknown. This article discusses advances in AgNP production and presents an overview of the commercial, societal, and environmental impacts of this emerging nanoparticle (NP), and nanomaterials in general. Finally, we examine the challenges associated with AgNP characterization, discuss the importance of the development of NP reference materials (RMs) and explore their role as a metrological mechanism to improve the quality and comparability of NP measurements.

Silver Nanoparticles: Technological Advances, Societal Impacts, and Metrological Challenges.

PubMed

Calderón-Jiménez, Bryan; Johnson, Monique E; Montoro Bustos, Antonio R; Murphy, Karen E; Winchester, Michael R; Vega Baudrit, José R

2017-01-01

Silver nanoparticles (AgNPs) show different physical and chemical properties compared to their macroscale analogs. This is primarily due to their small size and, consequently, the exceptional surface area of these materials. Presently, advances in the synthesis, stabilization, and production of AgNPs have fostered a new generation of commercial products and intensified scientific investigation within the nanotechnology field. The use of AgNPs in commercial products is increasing and impacts on the environment and human health are largely unknown. This article discusses advances in AgNP production and presents an overview of the commercial, societal, and environmental impacts of this emerging nanoparticle (NP), and nanomaterials in general. Finally, we examine the challenges associated with AgNP characterization, discuss the importance of the development of NP reference materials (RMs) and explore their role as a metrological mechanism to improve the quality and comparability of NP measurements.

Early career mentoring for translational researchers: mentee perspectives on challenges and issues.

PubMed

Keller, Thomas E; Collier, Peter J; Blakeslee, Jennifer E; Logan, Kay; McCracken, Karen; Morris, Cynthia

2014-01-01

The education and training of early career biomedical translational researchers often involves formal mentoring by more experienced colleagues. This study investigated the nature of these mentoring relationships from the perspective of mentees. The objective was to understand the challenges and issues encountered by mentees in forming and maintaining productive mentoring relationships. Three focus groups (n=14) were conducted with early career researchers who had mentored career development awards. Thematic analysis identified, categorized, and illustrated the challenges and issues reported by mentees. The range of mentee challenges was reflected in five major categories: (a) network--finding appropriate mentors to meet various needs; (b) access--structuring schedules and opportunities to receive mentoring; (c) expectations--negotiating the mechanics of the mentoring relationship and its purpose; (d) alignment--managing mentor-mentee mismatches regarding interests, priorities, and goals; and (e) skills and supports--developing the institutional supports to be successful. Mentoring relationships created for academic training and career development contend with tasks common to many other relationships, namely, recognizing compatibility, finding time, establishing patterns, agreeing to goals, and achieving aims. Identifying challenges faced by mentees can facilitate the development of appropriate trainings and supports to foster mentoring relationships in academic and career settings.

Sustainable concretes for transportation infrastructure.

DOT National Transportation Integrated Search

2010-07-01

performance in concrete for structural and transportation applications. Based on the challenges associated with coal ash (including SDA) and the economic costs linked to cement production, this research seeks to develop an environmentally friendly an...

Guidelines to design engineering education in the twenty-first century for supporting innovative product development

NASA Astrophysics Data System (ADS)

Violante, Maria Grazia; Vezzetti, Enrico

2017-11-01

In the twenty-first century, meeting our technological challenges demands educational excellence, a skilled populace that is ready for the critical challenges society faces. There is widespread consensus, however, that education systems are failing to adequately prepare all students with the essential twenty-first century knowledge and skills necessary to succeed in life, career, and citizenship. The purpose of this paper is to understand how twenty-first century knowledge and skills can be appropriately embedded in engineering education finalised to innovative product development by using additive manufacturing (AM). The study designs a learning model by which to achieve effective AM education to address the requirements of twenty-first century and to offer students the occasion to experiment with STEM (Science, technology, engineering, and mathematics) concepts. The study is conducted using the quality function deployment (QFD) methodology.

The DOE Bioenergy Research Centers: History, Operations, and Scientific Output

DOE PAGES

Slater, Steven C.; Simmons, Blake A.; Rogers, Tamara S.; ...

2015-08-20

Over the past 7 years, the US Department of Energy's Office of Biological and Environmental Research has funded three Bioenergy Research Centers (BRCs). These centers have developed complementary and collaborative research portfolios that address the key technical and economic challenges in biofuel production from lignocellulosic biomass. All three centers have established a close, productive relationship with DOE's Joint Genome Institute (JGI). This special issue of Bioenergy Research samples the breadth of basic science and engineering work required to underpin a diverse, sustainable, and robust biofuel industry. In this report, which was collaboratively produced by all three BRCs, we discuss themore » BRC contributions over their first 7 years to the development of renewable transportation fuels. In additon, we also highlight the BRC research published in the current issue and discuss technical challenges in light of recent progress.« less

Design and Development of the Blackbird: Challenges and Lessons Learned

NASA Technical Reports Server (NTRS)

Merlin, Peter W.

2009-01-01

The Lockheed Blackbirds hold a unique place in the development of aeronautics. In their day, the A-12, YF-12, M-21, D-21, and SR-71 variants outperformed all other jet airplanes in terms of altitude and speed. Now retired, they remain the only production aircraft capable of sustained Mach 3 cruise and operational altitudes above 80,000 feet. In this paper the author describes the design evolution of the Blackbird from Lockheed's early Archangel studies for the Central Intelligence Agency through Senior Crown, production of the Air Force's SR-71. He describes the construction and materials challenges faced by Lockheed, the Blackbird's performance characteristics and capabilities, and the National Aeronautics and Space Administration's role in using the aircraft as a flying laboratory to collect data on materials, structures, loads, heating, aerodynamics, and performance for high-speed aircraft.

From maturity to value-added innovation: lessons from the pharmaceutical and agro-biotechnology industries.

PubMed

Mittra, James; Tait, Joyce; Wield, David

2011-03-01

The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system. Copyright © 2010 Elsevier Ltd. All rights reserved.

Regulatory Challenges for Cartilage Repair Technologies.

PubMed

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Environmental impacts of beef production: Review of challenges and perspectives for durability.

PubMed

Gerber, Pierre J; Mottet, Anne; Opio, Carolyn I; Falcucci, Alessandra; Teillard, Félix

2015-11-01

Beef makes a substantial contribution to food security, providing protein, energy and also essential micro-nutrients to human populations. Rumination allows cattle - and other ruminant species - to digest fibrous feeds that cannot be directly consumed by humans and thus to make a net positive contribution to food balances. This contribution is of particular importance in marginal areas, where agro-ecological conditions and weak infrastructures do not offer much alternative. It is also valuable where cattle convert crop residues and by-products into edible products and where they contribute to soil fertility through their impact on nutrients and organic matter cycles. At the same time, environmental sustainability issues are acute. They chiefly relate to the low efficiency of beef cattle in converting natural resources into edible products. Water use, land use, biomass appropriation and greenhouse gas emissions are for example typically higher per unit of edible product in beef systems than in any other livestock systems, even when corrected for nutritional quality. This particularly causes environmental pressure when production systems are specialized towards the delivery of edible products, in large volumes. The paper discusses environmental challenges at global level, recognizing the large diversity of systems. Beef production is faced with a range of additional sustainability challenges, such as changing consumer perceptions, resilience to climate change, animal health and inequities in access to land and water resources. Entry-points for environmental sustainability improvement are discussed within this broader development context. Copyright © 2015. Published by Elsevier Ltd.

Biosimilars--global issues, national solutions.

PubMed

Knezevic, Ivana; Griffiths, Elwyn

2011-09-01

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of "biosimilars", to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherapeutic products. Copyright © 2011. Published by Elsevier Ltd.

Human-Centered Design Capability

NASA Technical Reports Server (NTRS)

Fitts, David J.; Howard, Robert

2009-01-01

For NASA, human-centered design (HCD) seeks opportunities to mitigate the challenges of living and working in space in order to enhance human productivity and well-being. Direct design participation during the development stage is difficult, however, during project formulation, a HCD approach can lead to better more cost-effective products. HCD can also help a program enter the development stage with a clear vision for product acquisition. HCD tools for clarifying design intent are listed. To infuse HCD into the spaceflight lifecycle the Space and Life Sciences Directorate developed the Habitability Design Center. The Center has collaborated successfully with program and project design teams and with JSC's Engineering Directorate. This presentation discusses HCD capabilities and depicts the Center's design examples and capabilities.

Data sharing for public health research: A qualitative study of industry and academia.

PubMed

Saunders, Pamela A; Wilhelm, Erin E; Lee, Sinae; Merkhofer, Elizabeth; Shoulson, Ira

2014-01-01

Data sharing is a key biomedical research theme for the 21st century. Biomedical data sharing is the exchange of data among (non)affiliated parties under mutually agreeable terms to promote scientific advancement and the development of safe and effective medical products. Wide sharing of research data is important for scientific discovery, medical product development, and public health. Data sharing enables improvements in development of medical products, more attention to rare diseases, and cost-efficiencies in biomedical research. We interviewed 11 participants about their attitudes and beliefs about data sharing. Using a qualitative, thematic analysis approach, our analysis revealed a number of themes including: experiences, approaches, perceived challenges, and opportunities for sharing data.

EPOS: Integrating seismological Research Infrastructures within Europe

NASA Astrophysics Data System (ADS)

Eck Van, Torild; Clinton, John; Haslinger, Florian; Michelini, Alberto

2013-04-01

Seismological data, products and models are currently produced in Europe within individual countries or research organizations, and with the contribution of coordinating organizations like ORFEUS and EMSC. In spite of these partly scattered resources, significant scientific results are obtained, excellent monitoring and information systems are operational and a huge amount of research quality data is being archived and disseminated. The seismological community, however, realizes that an effective European-scale integration of seismological and related geophysical data, products and models, combined with broad and easy access, is needed to facilitate future top level geoscience, for example, to appropriately harness the technological advancements enabling large scale and near-real time data processing. Here we present the technical concepts and developments within European seismology that will build the next generation of integrated services. Within the EPOS initiative and a number of related projects, where seismology infrastructure and IT developments are merging, in depth discussions are on-going on how to realize an effective integration. Concepts and visions addressing the obviously complex challenges resulting from the current highly distributed facilities and resources in Europe are emerging and are already partly being implemented. We will provide an overview of developments within key EU projects (NERA, VERCE, COOPEUS, EUDAT, REAKT, COMMIT, etc) and demonstrate how these are in coherence with EPOS and other on-going global initiatives. Within seismology current focus is on addressing IT related challenges to a) organize distributed data archives, develop metadata attributes for improved data searching, specifically including quality indicators, and define products from data and/or models, and b) define and create(on-line) monitoring, data access and processing tools. While developments to meet those challenges originate partly from within the community itself, it is important to harvest relevant ideas and tools from other scientific communities dealing with similar issues. We will present a short summary of those developments and how they fit within the proposed visions and concepts. These integration developments address a wide framework of seismological services that include: basic seismological data services (waveform data from velocity and acceleration sensors from land and underwater sites); seismological data products (source mechanism and process estimates, earthquake catalogues, structural and tomography model estimations); seismological models (synthetic waveforms, earth and earthquake source models, hazard models).Our aim is to build significantlyimproved seismological services and valuable products for multidisciplinary earth science research.

[Equity, public health and genomics: the legal, social and biotechnology challenge in México].

PubMed

Oliva-Sánchez, Pablo Francisco; Jafif-Cojab, Marcos; Akkad-Schaffer, Isaac; Waliszewski-Zamorano, Esteban

2013-01-01

Mexico has entered an era where health research is enriched by the study of genetic variants that determinate how the different human populations are differentially susceptible to diseases. The objective is to design new strategies in health care and services based on medical genomics. However, to ensure universal access to these products, we should rethink the legal aspects that facilitate the design of health policies, based on the principle of equity. Intrinsic factors of the Mexican health system as inequity, poverty and low investment in health research, are challenges that add to the development of appropriate distribution strategies for the use of new genomic products for health. This article discusses these challenges and establish the basis to design policies and appropriate use of these new genomic-based health care services.

Challenges and opportunities in synthetic biology for chemical engineers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Luo, YZ; Lee, JK; Zhao, HM

Synthetic biology provides numerous great opportunities for chemical engineers in the development of new processes for large-scale production of biofuels, value-added chemicals, and protein therapeutics. However, challenges across all scales abound. In particular, the modularization and standardization of the components in a biological system, so-called biological parts, remain the biggest obstacle in synthetic biology. In this perspective, we will discuss the main challenges and opportunities in the rapidly growing synthetic biology field and the important roles that chemical engineers can play in its advancement. (C) 2012 Elsevier Ltd. All rights reserved.

Challenges and opportunities in synthetic biology for chemical engineers

PubMed Central

Luo, Yunzi; Lee, Jung-Kul; Zhao, Huimin

2012-01-01

Synthetic biology provides numerous great opportunities for chemical engineers in the development of new processes for large-scale production of biofuels, value-added chemicals, and protein therapeutics. However, challenges across all scales abound. In particular, the modularization and standardization of the components in a biological system, so-called biological parts, remain the biggest obstacle in synthetic biology. In this perspective, we will discuss the main challenges and opportunities in the rapidly growing synthetic biology field and the important roles that chemical engineers can play in its advancement. PMID:24222925

Challenges and opportunities in synthetic biology for chemical engineers.

PubMed

Luo, Yunzi; Lee, Jung-Kul; Zhao, Huimin

2013-11-15

Synthetic biology provides numerous great opportunities for chemical engineers in the development of new processes for large-scale production of biofuels, value-added chemicals, and protein therapeutics. However, challenges across all scales abound. In particular, the modularization and standardization of the components in a biological system, so-called biological parts, remain the biggest obstacle in synthetic biology. In this perspective, we will discuss the main challenges and opportunities in the rapidly growing synthetic biology field and the important roles that chemical engineers can play in its advancement.

Developing smokeless tobacco products for smokers: an examination of tobacco industry documents.

PubMed

Carpenter, C M; Connolly, G N; Ayo-Yusuf, O A; Wayne, G Ferris

2009-02-01

To investigate whether development of smokeless tobacco products (SLT) is intended to target current smokers. This study analysed internal tobacco industry documents to describe research related to the smokeless tobacco market. Relevant documents included those detailing the development and targeting of SLT products with a particular emphasis on moist snuff. Cigarette and SLT manufacturers recognised that shifting demographics of SLT users, as well as indoor smoking restrictions, health concerns and reduced social acceptability of smoking could impact the growth of the SLT market. Manufacturers developed new SLT products to target cigarette smokers promoting dual cigarette and SLT use. Heavy marketing of new SLT products may encourage dual use and result in unknown public health effects. SLT products have been designed to augment cigarette use and offset regulatory strategies such as clean indoor air laws. In the United States, the SLT strategy may provide cigarette companies with a diversified range of products under the prospect of federal regulation. These products may pose significant challenges to efforts by federal agencies to reduce harm caused by tobacco use.

Raising the Bar: Challenging Students in a Capstone Project Course with an Android and Mobile Web Parallel Development Team Project

ERIC Educational Resources Information Center

Wong, Wilson; Pepe, James; Englander, Irv

2017-01-01

Information systems capstone projects aim to prepare students for what they will encounter in the industry after graduation. Corporate application development is often a complex endeavor that requires coordination between related products. For example, software development in the mobile application sector may require a coordinated parallel…

Developing Preservice Elementary Teachers' Knowledge and Practices through Modeling-Centered Scientific Inquiry

ERIC Educational Resources Information Center

Schwarz, Christina

2009-01-01

Preservice elementary teachers face many challenges in learning how to teach science effectively, such as engaging students in science, organizing instruction, and developing a productive learning community. This paper reports on several iterative cycles of design-based research aimed at fostering preservice teachers' principled reasoning around…

Changing human-ecological relationships and drivers using the Quesungual agroforestry system in western Honduras

USDA-ARS?s Scientific Manuscript database

The development of sustainable agricultural production systems in the tropics is challenging in part because the local and external conditions that affect sustainability are constantly in flux. The Quesungual Agroforestry System (QSMAS) was developed in response to these changing conditions. The his...

77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device development--namely, business planning and...

Next-generation biofuels: a new challenge for yeast.

PubMed

Petrovič, Uroš

2015-09-01

Economic growth depends strongly on the availability and price of fuels. There are various reasons in different parts of the world for efforts to decrease the consumption of fossil fuels, but biofuels are one of the main solutions considered towards achieving this aim globally. As the major bioethanol producer, the yeast Saccharomyces cerevisiae has a central position among biofuel-producing organisms. However, unprecedented challenges for yeast biotechnology lie ahead, as future biofuels will have to be produced on a large scale from sustainable feedstocks that do not interfere with food production, and which are generally not the traditional carbon source for S. cerevisiae. Additionally, the current trend in the development of biofuels is to synthesize molecules that can be used as drop-in fuels for existing engines. Their properties should therefore be more similar to those of oil-derived fuels than those of ethanol. Recent developments and challenges lying ahead for cost-effective production of such designed biofuels, using S. cerevisiae-based cell factories, are presented in this review. Copyright © 2015 John Wiley & Sons, Ltd.

Catalytic Organometallic Reactions of Ammonia

PubMed Central

Klinkenberg, Jessica L.

2012-01-01

Until recently, ammonia had rarely succumbed to catalytic transformations with homogeneous catalysts, and the development of such reactions that are selective for the formation of single products under mild conditions has encountered numerous challenges. However, recently developed catalysts have allowed several classes of reactions to create products with nitrogen-containing functional groups from ammonia. These reactions include hydroaminomethylation, reductive amination, alkylation, allylic substitution, hydroamination, and cross-coupling. This Minireview describes examples of these processes and the factors that control catalyst activity and selectivity. PMID:20857466

Addressing China's grand challenge of achieving food security while ensuring environmental sustainability.

PubMed

Lu, Yonglong; Jenkins, Alan; Ferrier, Robert C; Bailey, Mark; Gordon, Iain J; Song, Shuai; Huang, Jikun; Jia, Shaofeng; Zhang, Fusuo; Liu, Xuejun; Feng, Zhaozhong; Zhang, Zhibin

2015-02-01

China's increasingly urbanized and wealthy population is driving a growing and changing demand for food, which might not be met without significant increase in agricultural productivity and sustainable use of natural resources. Given the past relationship between lack of access to affordable food and political instability, food security has to be given a high priority on national political agendas in the context of globalization. The drive for increased food production has had a significant impact on the environment, and the deterioration in ecosystem quality due to historic and current levels of pollution will potentially compromise the food production system in China. We discuss the grand challenges of not only producing more food but also producing it sustainably and without environmental degradation. In addressing these challenges, food production should be considered as part of an environmental system (soil, air, water, and biodiversity) and not independent from it. It is imperative that new ways of meeting the demand for food are developed while safeguarding the natural resources upon which food production is based. We present a holistic approach to both science and policy to ensure future food security while embracing the ambition of achieving environmental sustainability in China. It is a unique opportunity for China to be a role model as a new global player, especially for other emerging economies.

Systems and synthetic metabolic engineering for amino acid production - the heartbeat of industrial strain development.

PubMed

Becker, Judith; Wittmann, Christoph

2012-10-01

With a world market of more than four million tons per year, l-amino acids are among the most important products in industrial biotechnology. The recent years have seen a tremendous progress in the development of tailor-made strains for such products, intensively driven from systems metabolic engineering, which upgrades strain engineering into a concept of optimization on a global scale. This concept seems especially valuable for efficient amino acid production, demanding for a global modification of pathway fluxes - a challenge with regard to the high complexity of the underlying metabolism, superimposed by various layers of metabolic and transcriptional control. Copyright © 2011 Elsevier Ltd. All rights reserved.

Response to MRO's end-to-end data accountability challenges

NASA Technical Reports Server (NTRS)

Lee, Young H.

2005-01-01

(MRO) on August 12, 2005. It carries six science instruments and three engineering payloads. Because MRO will produce an unprecedented number of science products, it will transmit a much higher data volume via high data rate than any other deep space mission to date. Keeping track of MRO products as well as relay products would be a daunting, expensive task without a well-planned data-product tracking strategy. To respond to this challenge, the MRO project developed the End-to- End Data Accountability System by utilizing existing information available from both ground and flight elements. Therefore, a capability to perform first-order problem diagnosis is essential in order for MRO to answer the questions, where is my data? and when will my data be available? This paper details the approaches taken, design and implementation of the tools, procedures and teams that track data products from the time they are predicted until they arrive in the hands of the end users.

Resolving legal, ethical, and human rights challenges in HIV vaccine research.

PubMed

Patterson, D

2000-01-01

In the absence of a cure for AIDS, attention has turned to the possibility of developing a preventive vaccine for HIV infection. Yet many scientific, ethical, legal, and economic obstacles remain. At the current rate, the development and production of an effective vaccine could take 15 to 20 years or longer. If tens of millions more HIV infections and deaths are to be avoided in the coming decades, vaccine research needs to be greatly expedited. Furthermore, it must be undertaken ethically, and the products of this research must benefit people in developing countries. This article, an edited and updated version of a paper presented at "Putting Third First," addresses challenges arising in HIV preventive vaccine research in developing countries. It does not address clinical research in developing countries relating to treatments or therapeutic vaccines. Nor does it address legal and ethical issues relating to HIV vaccine research in industrialized countries, although similar issues arise in both contexts. The article concludes that while ethical codes are silent on the obligation to undertake research and development, international law provides strong legal obligations--particularly with regard to industrialized states--that should be invoked to accelerate HIV vaccine development, and distribution.

Challenges of Human Space Flight

NASA Technical Reports Server (NTRS)

Davis, Jeffrey R.; Charles, John B.

2006-01-01

The presentations will be given during the X-Prize symposium, exploring the multi-faceted dimensions of spaceflight ranging from the technical developments necessary to achieve safe routine flight to and from and through space to the new personal business opportunities and economic benefits that will open in space and here on Earth. The symposium will delve into the technical, regulatory, market and financial needs and challenges that must be met in charting and executing the incremental developments leading to Personal Spaceflight and the opening of a Place Called Space. The presentation covers facets of human space flight including descriptions of life in space, the challenges of delivering medical care in space, and the preparations needed for safe and productive human travel to the moon and Mars.

Analysis of Economic and Environmental Aspects of Microalgae Biorefinery for Biofuels Production: A Review.

PubMed

Chia, Shir Reen; Chew, Kit Wayne; Show, Pau Loke; Yap, Yee Jiun; Ong, Hwai Chyuan; Ling, Tau Chuan; Chang, Jo-Shu

2018-06-01

Microalgae are considered promising feedstock for the production of biofuels and other bioactive compounds, yet there are still challenges on commercial applications of microalgae-based products. This review focuses on the economic analysis, environmental impact, and industrial potential of biofuels production from microalgae. The cost of biofuels production remains higher compared to conventional fuel sources. However, integration of biorefinery pathways with biofuels production for the recovery of value-added products (such as antioxidants, natural dyes, cosmetics, nutritional supplements, polyunsaturated fatty acids, and so forth) could substantially reduce the production costs. It also paves the way for sustainable energy resources by significantly reducing the emissions of CO 2 , NO x , SO x , and heavy metals. Large-scale biofuels production has yet to be successfully commercialized with many roadblocks ahead and heavy competition with conventional fuel feedstock as well as technological aspects. One of the prominent challenges is to develop a cost-effective method to achieve high-density microalgal cultivation on an industrial scale. The biofuels industry should be boosted by Government's support in the form of subsidies and incentives, for addressing the pressing climate change issues, achieving sustainability, and energy security. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Sophisticated Cloning, Fermentation, and Purification Technologies for an Enhanced Therapeutic Protein Production: A Review

PubMed Central

Gupta, Sanjeev K.; Shukla, Pratyoosh

2017-01-01

The protein productions strategies are crucial towards the development of application based research and elucidating the novel purification strategies for industrial production. Currently, there are few innovative avenues are studies for cloning, upstream, and purification through efficient bioprocess development. Such strategies are beneficial for industries as well as proven to be vital for effectual therapeutic protein development. Though, these techniques are well documented, but, there is scope of addition to current knowledge with novel and new approaches and it will pave new avenues in production of recombinant microbial and non-microbial proteins including secondary metabolites. In this review, we have focussed on the recent development in clone selection, various modern fermentation and purification technologies and future directions in these emerging areas. Moreover, we have also highlighted notable perspectives and challenges involved in the bioengineering of such proteins, including quality by design, gene editing and pioneering ideas. The biopharmaceutical industries continue to shift towards more flexible, automated platforms and economical product development, which in turn can help in developing the cost effective processes and affordable drug development for a large community. PMID:28725194

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

PubMed

Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

2018-03-01

Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

Challenges and successes for the grantees and the Technical Advisory Group of WHO's influenza vaccine technology transfer initiative.

PubMed

Grohmann, Gary; Francis, Donald P; Sokhey, Jaspal; Robertson, James

2016-10-26

One of the aims of the WHO Global Action Plan for Influenza Vaccines (GAP) was to transfer influenza vaccine production technology to interested manufacturers and governments in developing countries, to enable greater influenza vaccine manufacturing capacity against any pandemic threat or pandemic. For this objective, the GAP was supported by an independent Technical Advisory Group (TAG) to assist WHO to select vaccine manufacturing proposals for funding and to provide programmatic support for successful grantees. While there were many challenges, for both the TAG and grantees, there were also notable successes with an additional capacity of 338-600 million pandemic vaccine doses being made possible by the programme between 2007 and 2015, and a potential capacity of more than 600 million by 2016/17 with up to one billion doses expected by 2018/19. Seasonal vaccine production was also developed in 4 countries with another 4-5 countries expected to be producing seasonal vaccine by 2018/19. The relatively small WHO investments - in time and funding - made in these companies to develop their own influenza vaccine production facilities have had quite dramatic results. Copyright © 2016 Elsevier Ltd. All rights reserved.

Peer exchange for Southwestern states, May 7-10, 2013.

DOT National Transportation Integrated Search

2013-05-01

The objectives of the peer exchange were the following: : Create networks and open lines of communication. : Develop an understanding of product evaluation programs in other states. : Seek commonalities in research being done and challeng...

Integrating novel data streams to support biosurveillance in commercial livestock production systems in developed countries: challenges and opportunities.

PubMed

Gates, M Carolyn; Holmstrom, Lindsey K; Biggers, Keith E; Beckham, Tammy R

2015-01-01

Reducing the burden of emerging and endemic infectious diseases on commercial livestock production systems will require the development of innovative technology platforms that enable information from diverse animal health resources to be collected, analyzed, and communicated in near real-time. In this paper, we review recent initiatives to leverage data routinely observed by farmers, production managers, veterinary practitioners, diagnostic laboratories, regulatory officials, and slaughterhouse inspectors for disease surveillance purposes. The most commonly identified challenges were (1) the lack of standardized systems for recording essential data elements within and between surveillance data streams, (2) the additional time required to collect data elements that are not routinely recorded by participants, (3) the concern over the sharing and use of business sensitive information with regulatory authorities and other data analysts, (4) the difficulty in developing sustainable incentives to maintain long-term program participation, and (5) the limitations in current methods for analyzing and reporting animal health information in a manner that facilitates actionable response. With the significant recent advances in information science, there are many opportunities to develop more sophisticated systems that meet national disease surveillance objectives, while still providing participants with valuable tools and feedback to manage routine animal health concerns.

Integrating Novel Data Streams to Support Biosurveillance in Commercial Livestock Production Systems in Developed Countries: Challenges and Opportunities

PubMed Central

Gates, M. Carolyn; Holmstrom, Lindsey K.; Biggers, Keith E.; Beckham, Tammy R.

2015-01-01

Reducing the burden of emerging and endemic infectious diseases on commercial livestock production systems will require the development of innovative technology platforms that enable information from diverse animal health resources to be collected, analyzed, and communicated in near real-time. In this paper, we review recent initiatives to leverage data routinely observed by farmers, production managers, veterinary practitioners, diagnostic laboratories, regulatory officials, and slaughterhouse inspectors for disease surveillance purposes. The most commonly identified challenges were (1) the lack of standardized systems for recording essential data elements within and between surveillance data streams, (2) the additional time required to collect data elements that are not routinely recorded by participants, (3) the concern over the sharing and use of business sensitive information with regulatory authorities and other data analysts, (4) the difficulty in developing sustainable incentives to maintain long-term program participation, and (5) the limitations in current methods for analyzing and reporting animal health information in a manner that facilitates actionable response. With the significant recent advances in information science, there are many opportunities to develop more sophisticated systems that meet national disease surveillance objectives, while still providing participants with valuable tools and feedback to manage routine animal health concerns. PMID:25973416

Challenges to develop nitrogen-fixing cereals by direct nif-gene transfer.

PubMed

Curatti, Leonardo; Rubio, Luis M

2014-08-01

Some regions of the developing world suffer low cereal production yields due to low fertilizer inputs, among other factors. Biological N2 fixation, catalyzed by the prokaryotic enzyme nitrogenase, is an alternative to the use of synthetic N fertilizers. The molybdenum nitrogenase is an O2-labile metalloenzyme composed of the NifDK and NifH proteins, which biosyntheses require a number of nif gene products. A challenging strategy to increase cereal crop productivity in a scenario of low N fertilization is the direct transfer of nif genes into cereals. The sensitivity of nitrogenase to O2 and the apparent complexity of nitrogenase biosynthesis are the main barriers identified so far. Expression of active NifH requires the products of nifM, nifH, and possibly nifU and nifS, whereas active NifDK requires the products of nifH, nifD, nifK, nifB, nifE, nifN, and possibly nifU, nifS, nifQ, nifV, nafY, nifW and nifZ. Plastids and mitochondria are potential subcellular locations for nitrogenase. Both could provide the ATP and electrons required for nitrogenase to function but they differ in their internal O2 levels and their ability to incorporate ammonium into amino acids. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Managing large energy and mineral resources (EMR) projects in challenging environments

NASA Astrophysics Data System (ADS)

Chanmeka, Arpamart

The viability of energy mineral resources (EMR) construction projects is contingent upon the state of the world economic climate. Oil sands projects in Alberta, Canada exemplify large EMR projects that are highly sensitive to fluctuations in the world market. Alberta EMR projects are constrained by high fixed production costs and are also widely recognized as one of the most challenging construction projects to successfully deliver due to impacts from extreme weather conditions, remote locations and issues with labor availability amongst others. As indicated in many studies, these hardships strain the industry's ability to execute work efficiently, resulting in declining productivity and mounting cost and schedule overruns. Therefore, to enhance the competitiveness of Alberta EMR projects, project teams are targeting effective management strategies to enhance project performance and productivity by countering the uniquely challenging environment in Alberta. The main purpose of this research is to develop industry wide benchmarking tailored to the specific constraints and challenges of Alberta. Results support quantitative assessments and identify the root causes of project performance and ineffective field productivity problems in the heavy industry sector capital projects. Customized metrics produced from the data collected through a web-based survey instrument were used to quantitatively assess project performance in the following dimensions: cost, schedule, change, rework, safety, engineering and construction productivity and construction practices. The system enables the industry to measure project performance more accurately, get meaningful comparisons, while establishing credible norms specific to Alberta projects. Data analysis to identify the root cause of performance problems was conducted. The analysis of Alberta projects substantiated lessons of previous studies to create an improved awareness of the abilities of Alberta-based companies to manage their unique projects. This investigation also compared Alberta-based projects with U.S. projects to point out the differences in project process and management strategies under different environments. The relative impact of factors affecting construction productivity were identified and validated by the input from industry experts. The findings help improve the work processes used by companies developing projects in Alberta.

The Challenges of Developing Disciplinary Knowledge and Making Links across the Disciplines in Early Years and Primary Humanities

ERIC Educational Resources Information Center

Swift, Diane

2017-01-01

This article argues that an understanding of disciplinary knowledge production helps to underpin a conceptual structure for the humanities curriculum. This is important as a conceptual curriculum more overtly supports knowledge production for both pupils and teachers than one that is solely focused on propositional knowledge. It can mean the…

Identification of single-nucleotide polymorphic loci associated with biomass yield under water deficit in alfalfa (Medicago sativa L.) using genome-wide sequencing and association mapping

USDA-ARS?s Scientific Manuscript database

Alfalfa is a worldwide grown forage crop and is important due to its high biomass production and nutritional value. However, the production of alfalfa is challenged by adverse environmental stress factors such as drought and other stresses. Developing drought resistance alfalfa is an important breed...

Staged Catalytic Partial Oxidation (SCPO) System - The State of Art Integrated Short Contact Time Hydrogen Generator

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ke Liu; Jin Ki Hong; Wei Wei

Research and development on hydrogen and syngas production have great potential in addressing the following challenges in energy arena: (1) produce more clean fuels to meet the increasing demands for clean liquid and gaseous fuels for transportation and electricity generation, (2) increase the efficiency of energy utilization for fuels and electricity production, and (3) eliminate the pollutants and decouple the link between energy utilization and greenhouse gas emissions in end-use systems [Song, 2006, Liu, Song & Subramani 2009]. In this project, GE Global Research (GEGR) collaborated with Argonne National Laboratory (ANL) and the University of Minnesota (UoMn), developed and demonstratedmore » a low cost, compact staged catalytic partial oxidation (SCPO) technology for distributed hydrogen generation. GEGR analyzed different reforming system designs, and developed the SCPO reforming system which is a unique technology staging and integrating 3 different short contact time catalysts in a single, compact reactor: catalytic partial oxidation (CPO), steam methane reforming (SMR) and water-gas shift (WGS). This integration is demonstrated via the fabrication of a prototype scale unit of each key technology. Approaches for key technical challenges of the program includes: · Analyzed different system designs · Designed the SCPO hydrogen production system · Developed highly active and sulfur tolerant CPO catalysts · Designed and built different pilot-scale reactors to demonstrate each key technology · Evaluated different operating conditions · Quantified the efficiency and cost of the system · Developed process design package (PDP) for 1500 kg H2/day distributed H2 production unit. SCPO met the Department of Energy (DOE) and GE’s cost and efficiency targets for distributed hydrogen production.« less

Integrating data mining technique and AHP in market analysis to propose new product development in real estate

NASA Astrophysics Data System (ADS)

Yunita; Galinium, M.; Lukas

2017-01-01

New product development in real estate industry is a challenging process since it is related to long term concept and high cost. A newly proposed product development should meet customer need and their preferences which appropriate with customer buying power and company value. This research use data mining for profiling customer transaction and Analytic Hierarchy Process (AHP) method for product selection in new product development. This research utilizes Weka as data mining open source software to profiling data customers. The analysis correlated product preferences and profiling demography such as city, age, gender and occupation. Demography profiles gives description buying power and product preferences. The products proposed are based on customer profiles and rank of the product by AHP method. The product with the highest score will be proposed as new product development. Case studies of this research are real estate projects in Serang, Makassar, and Balikpapan. Makassar and Balikpapan are the project that already gained success and Serang is new project which new products development will be proposed to launch. Based on profiling and product preference of customer in Balikpapan, Makassar, and prospectus of Serang markets, new products development that will be proposed are house type of 120/200 m2 with price around Rp1.300.000.000 and house type of 71/120 m2 with price around Rp800.000.000. The markets of Serang and Balikpapan have similarities in profiles as urban city so the new products development will adopt the succeed story of Balikpapan project.

Biological hydrogen production by dark fermentation: challenges and prospects towards scaled-up production.

PubMed

RenNanqi; GuoWanqian; LiuBingfeng; CaoGuangli; DingJie

2011-06-01

Among different technologies of hydrogen production, bio-hydrogen production exhibits perhaps the greatest potential to replace fossil fuels. Based on recent research on dark fermentative hydrogen production, this article reviews the following aspects towards scaled-up application of this technology: bioreactor development and parameter optimization, process modeling and simulation, exploitation of cheaper raw materials and combining dark-fermentation with photo-fermentation. Bioreactors are necessary for dark-fermentation hydrogen production, so the design of reactor type and optimization of parameters are essential. Process modeling and simulation can help engineers design and optimize large-scale systems and operations. Use of cheaper raw materials will surely accelerate the pace of scaled-up production of biological hydrogen. And finally, combining dark-fermentation with photo-fermentation holds considerable promise, and has successfully achieved maximum overall hydrogen yield from a single substrate. Future development of bio-hydrogen production will also be discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Embedded systems engineering for products and services design.

PubMed

Ahram, Tareq Z; Karwowski, Waldemar; Soares, Marcelo M

2012-01-01

Systems engineering (SE) professionals strive to develop new techniques to enhance the value of contributions to multidisciplinary smart product design teams. Products and services designers challenge themselves to search beyond the traditional design concept of addressing the physical, social, and cognitive factors. This paper covers the application of embedded user-centered systems engineering design practices into work processes based on the ISO 13407 framework [20] to support smart systems and services design and development. As practitioners collaborate to investigate alternative smart product designs, they concentrate on creating valuable products which will enhance positive interaction. This paper capitalizes on the need to follow a user-centered SE approach to smart products design [4, 22]. Products and systems intelligence should embrace a positive approach to user-centered design while improving our understanding of usable value-adding, experience and extending our knowledge of what inspires others to design enjoyable services and products.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Duval, B.C.; Beuque, J.M.

This exploration and production strategy for gas was first developed in the late 60`s when Indonesia was rightly perceived as being a country with large, geologically promising and almost untouched offshore acreage. First oil, and later gas, discoveries were made in the Mahakam Delta Basin of Kalimantan, and very large gas fields were developed in response to a fast growing market for LNG, especially in Japan and the Far East. Thereafter, a proactive search for opportunities in several countries was started, and this led to a concentration on fields in Thailand and Myanmar that had been already discovered but hadmore » not been developed because of specific technical difficulties and/or marketing uncertainties. The risks and challenges of these projects are discussed, including the replacement of reserves in a mature area (Mahakam), the production of thin, numerous and structurally complicated reservoirs (Bongkot, Thailand), and the resolution of commercial problems (Myonmar). These challenges were successfully dealt with by the application of a combination of modern geoscientific technologies, the integration of separate disciplines and the introduction of cost-reduction measures.« less

Successful Development of Satiety Enhancing Food Products: Towards a Multidisciplinary Agenda of Research Challenges

PubMed Central

Van Kleef, E.; Van Trijp, J.C.M.; Van Den Borne, J.J.G.C.; Zondervan, C.

2012-01-01

In the context of increasing prevalence of overweight and obesity in societies worldwide, enhancing the satiating capacity of foods may help people control their energy intake and weight. This requires an integrated approach between various food-related disciplines. By structuring this approach around the new product development process, this paper aims to present the contours of such an integrative approach by going through the current state of the art around satiety enhancing foods. It portrays actual food choice as the end result of a complex interaction between internal satiety signals, other food benefits, and environmental cues. Three interrelated routes to satiating enhancement are to change the food composition to develop stronger physiological satiation and satiety signals, anticipate and build on smart external stimuli at the moment of purchase and consumption, and improve palatability and acceptance of satiety enhanced foods. Key research challenges in achieving these routes in the field of nutrition, food technology, consumer, marketing, and communication are outlined. PMID:22530713

Successful development of satiety enhancing food products: towards a multidisciplinary agenda of research challenges.

PubMed

Van Kleef, E; Van Trijp, J C M; Van Den Borne, J J G C; Zondervan, C

2012-01-01

In the context of increasing prevalence of overweight and obesity in societies worldwide, enhancing the satiating capacity of foods may help people control their energy intake and weight. This requires an integrated approach between various food-related disciplines. By structuring this approach around the new product development process, this paper aims to present the contours of such an integrative approach by going through the current state of the art around satiety enhancing foods. It portrays actual food choice as the end result of a complex interaction between internal satiety signals, other food benefits, and environmental cues. Three interrelated routes to satiating enhancement are to change the food composition to develop stronger physiological satiation and satiety signals, anticipate and build on smart external stimuli at the moment of purchase and consumption, and improve palatability and acceptance of satiety enhanced foods. Key research challenges in achieving these routes in the field of nutrition, food technology, consumer, marketing, and communication are outlined.

The technical consideration of multi-beam mask writer for production

NASA Astrophysics Data System (ADS)

Lee, Sang Hee; Ahn, Byung-Sup; Choi, Jin; Shin, In Kyun; Tamamushi, Shuichi; Jeon, Chan-Uk

2016-10-01

Multi-beam mask writer is under development to solve the throughput and patterning resolution problems in VSB mask writer. Theoretically, the writing time is appropriate for future design node and the resolution is improved with multi-beam mask writer. Many previous studies show the feasible results of resolution, CD control and registration. Although such technical results of development tool seem to be enough for mass production, there are still many unexpected problems for real mass production. In this report, the technical challenges of multi-beam mask writer are discussed in terms of production and application. The problems and issues are defined based on the performance of current development tool compared with the requirements of mask quality. Using the simulation and experiment, we analyze the specific characteristics of electron beam in multi-beam mask writer scheme. Consequently, we suggest necessary specifications for mass production with multi-beam mask writer in the future.

Limited treatment with beta-1,3/1,6-glucan improves production values of broiler chickens challenged with Escherichia coli.

PubMed

Huff, G R; Huff, W E; Rath, N C; Tellez, G

2006-04-01

The development of antibiotic-resistant bacteria has led to a need for alternatives to antibiotics for growth promotion and disease prevention in poultry production. The helical polysaccharide beta-1,3/1,6-glucan is derived from the cell wall of Saccharomyces cervisiae and has immunomodulating activities. The objective of this study was to determine the ability of 2 supplementation programs with a commercial beta-1,3/1,6-glucan product to protect broiler chicks from experimental respiratory challenge with Escherichia coli. Chicks were housed in battery-brooders from 1 d of age and fed a standard starter diet or the same diet containing 20 g/ton (22 ppm) of purified beta-1,3/1,6-glucan either continuously (BG25d) or for only the first 7 d prior to challenge (BG7d). At d 7 one-half of the birds were inoculated in the thoracic air sac with 800 cfu of a serotype O2, nonmotile strain of E. coli. All surviving birds were necropsied at d 25. Body weight of survivors and feed conversion efficiency were protected from the adverse effects of E. coli challenge by BG7d but not by BG25d. Mortality was nominally decreased from 63% (control) to 53% in BG25d and 47% in BG7d, but these decreases were not significant. The relative weights of the liver and heart were increased, and the bursa of Fabricius relative weights were decreased by E. coli challenge, and these effects were modulated by beta-glucan treatment. Despite positive effects of BG7d in E. coli-challenged birds, the BW of nonchallenged birds was decreased by BG7d and BG25d. These results suggest that supplementation of broiler diets with beta-1,3/1,6-glucan may be valuable for decreasing production losses due to E. coli respiratory disease, but that the immune stimulation provided may also result in decreased production values under experimental battery conditions or for birds raised in an environment with minimal disease challenges.

Exploring barriers and opportunities in adopting crowdsourcing based new product development in manufacturing SMEs

NASA Astrophysics Data System (ADS)

Qin, Shengfeng; Van der Velde, David; Chatzakis, Emmanouil; McStea, Terry; Smith, Neil

2016-10-01

Crowdsourcing is an innovative business practice of obtaining needed services, ideas, or content or even funds by soliciting contributions from a large group of people (the `Crowd'). The potential benefits of utilizing crowdsourcing in product design are well-documented, but little research exists on what are the barriers and opportunities in adopting crowdsourcing in new product development (NPD) of manufacturing SMEs. In order to answer the above questions, a Proof of Market study is carried out on crowdsourcing-based product design under an Innovate UK funded Smart project, which aims at identifying the needs, challenges and future development opportunities associated with adopting crowdsourcing strategies for NPD. The research findings from this study are reported here and can be used to guide future development of crowdsourcing-based collaborative design methods and tools and provide some practical references for industry to adopt this new and emerging collaborative design method in their business.

Regulatory Challenges for Cartilage Repair Technologies

PubMed Central

Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)–approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product’s attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible. PMID:26069647

Opportunities and Challenges in the Design and Analysis of Biomass Supply Chains.

PubMed

Lautala, Pasi T; Hilliard, Michael R; Webb, Erin; Busch, Ingrid; Richard Hess, J; Roni, Mohammad S; Hilbert, Jorge; Handler, Robert M; Bittencourt, Roger; Valente, Amir; Laitinen, Tuuli

2015-12-01

The biomass supply chain is one of the most critical elements of large-scale bioenergy production and in many cases a key barrier for procuring initial funding for new developments on specific energy crops. Most productions rely on complex transforming chains linked to feed and food markets. The term 'supply chain' covers various aspects from cultivation and harvesting of the biomass, to treatment, transportation, and storage. After energy conversion, the product must be delivered to final consumption, whether it is in the form of electricity, heat, or more tangible products, such as pellets and biofuels. Effective supply chains are of utmost importance for bioenergy production, as biomass tends to possess challenging seasonal production cycles and low mass, energy and bulk densities. Additionally, the demand for final products is often also dispersed, further complicating the supply chain. The goal of this paper is to introduce key components of biomass supply chains, examples of related modeling applications, and if/how they address aspects related to environmental metrics and management. The paper will introduce a concept of integrated supply systems for sustainable biomass trade and the factors influencing the bioenergy supply chain landscape, including models that can be used to investigate the factors. The paper will also cover various aspects of transportation logistics, ranging from alternative modal and multi-modal alternatives to introduction of support tools for transportation analysis. Finally gaps and challenges in supply chain research are identified and used to outline research recommendations for the future direction in this area of study.

Opportunities and Challenges in the Design and Analysis of Biomass Supply Chains

NASA Astrophysics Data System (ADS)

Lautala, Pasi T.; Hilliard, Michael R.; Webb, Erin; Busch, Ingrid; Richard Hess, J.; Roni, Mohammad S.; Hilbert, Jorge; Handler, Robert M.; Bittencourt, Roger; Valente, Amir; Laitinen, Tuuli

2015-12-01

The biomass supply chain is one of the most critical elements of large-scale bioenergy production and in many cases a key barrier for procuring initial funding for new developments on specific energy crops. Most productions rely on complex transforming chains linked to feed and food markets. The term `supply chain' covers various aspects from cultivation and harvesting of the biomass, to treatment, transportation, and storage. After energy conversion, the product must be delivered to final consumption, whether it is in the form of electricity, heat, or more tangible products, such as pellets and biofuels. Effective supply chains are of utmost importance for bioenergy production, as biomass tends to possess challenging seasonal production cycles and low mass, energy and bulk densities. Additionally, the demand for final products is often also dispersed, further complicating the supply chain. The goal of this paper is to introduce key components of biomass supply chains, examples of related modeling applications, and if/how they address aspects related to environmental metrics and management. The paper will introduce a concept of integrated supply systems for sustainable biomass trade and the factors influencing the bioenergy supply chain landscape, including models that can be used to investigate the factors. The paper will also cover various aspects of transportation logistics, ranging from alternative modal and multi-modal alternatives to introduction of support tools for transportation analysis. Finally gaps and challenges in supply chain research are identified and used to outline research recommendations for the future direction in this area of study.

Natural product-based amyloid inhibitors.

PubMed

Velander, Paul; Wu, Ling; Henderson, Frances; Zhang, Shijun; Bevan, David R; Xu, Bin

2017-09-01

Many chronic human diseases, including multiple neurodegenerative diseases, are associated with deleterious protein aggregates, also called protein amyloids. One common therapeutic strategy is to develop protein aggregation inhibitors that can slow down, prevent, or remodel toxic amyloids. Natural products are a major class of amyloid inhibitors, and several dozens of natural product-based amyloid inhibitors have been identified and characterized in recent years. These plant- or microorganism-extracted compounds have shown significant therapeutic potential from in vitro studies as well as in vivo animal tests. Despite the technical challenges of intrinsic disordered or partially unfolded amyloid proteins that are less amenable to characterizations by structural biology, a significant amount of research has been performed, yielding biochemical and pharmacological insights into how inhibitors function. This review aims to summarize recent progress in natural product-based amyloid inhibitors and to analyze their mechanisms of inhibition in vitro. Major classes of natural product inhibitors and how they were identified are described. Our analyses comprehensively address the molecular interactions between the inhibitors and relevant amyloidogenic proteins. These interactions are delineated at molecular and atomic levels, which include covalent, non-covalent, and metal-mediated mechanisms. In vivo animal studies and clinical trials have been summarized as an extension. To enhance natural product bioavailability in vivo, emerging work using nanocarriers for delivery has also been described. Finally, issues and challenges as well as future development of such inhibitors are envisioned. Copyright © 2017 Elsevier Inc. All rights reserved.

Natural product-based amyloid inhibitors

PubMed Central

Velander, Paul; Wu, Ling; Henderson, Frances; Zhang, Shijun; Bevan, David R.; Xu, Bin

2018-01-01

Many chronic human diseases, including multiple neurodegenerative diseases, are associated with deleterious protein aggregates, also called protein amyloids. One common therapeutic strategy is to develop protein aggregation inhibitors that can slow down, prevent, or remodel toxic amyloids. Natural products are a major class of amyloid inhibitors, and several dozens of natural product-based amyloid inhibitors have been identified and characterized in recent years. These plant- or microorganism-extracted compounds have shown significant therapeutic potential from in vitro studies as well as in vivo animal tests. Despite the technical challenges of intrinsic disordered or partially unfolded amyloid proteins that are less amenable to characterizations by structural biology, a significant amount of research has been performed, yielding biochemical and pharmacological insights into how inhibitors function. This review aims to summarize recent progress in natural product-based amyloid inhibitors and to analyze their mechanisms of inhibition in vitro. Major classes of natural product inhibitors and how they were identified are described. Our analyses comprehensively address the molecular interactions between the inhibitors and relevant amyloidogenic proteins. These interactions are delineated at molecular and atomic levels, which include covalent, non-covalent, and metal-mediated mechanisms. In vivo animal studies and clinical trials have been summarized as an extension. To enhance natural product bioavailability in vivo, emerging work using nanocarriers for delivery has also been described. Finally, issues and challenges as well as future development of such inhibitors are envisioned. PMID:28390938

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C

PubMed Central

Belle, Steven H; Fried, Michael W; Afdhal, Nezam; Navarro, Victor J; Hawke, Roy L; Wahed, Abdus S; Doo, Edward; Meyers, Catherine M

2012-01-01

Background Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. Purpose We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. Methods This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. Results Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. Potential limitations Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. Conclusions The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products. PMID:22058086

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C.

PubMed

Reddy, K Rajender; Belle, Steven H; Fried, Michael W; Afdhal, Nezam; Navarro, Victor J; Hawke, Roy L; Wahed, Abdus S; Doo, Edward; Meyers, Catherine M

2012-02-01

Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. POTENTIAL LIMITATIONS: Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products.

Future materials requirements for the high-energy-intensity production of aluminum

NASA Astrophysics Data System (ADS)

Welch, B. J.; Hyland, M. M.; James, B. J.

2001-02-01

Like all metallurgical industries, aluminum smelting has been under pressure from two fronts—to give maximum return on investment to the shareholders and to comply with environmental regulations by reducing greenhouse emissions. The smelting process has advanced by improving efficiency and productivity while continuing to seek new ways to extend the cell life. Materials selection (particularly the use of more graphitized cathodic electrodes) has enabled lower energy consumption, while optimization of the process and controlling in a narrow band has enabled increases in productivity and operations at higher current densities. These changes have, in turn, severely stressed the materials used for cell construction, and new problems are emerging that are resulting in a reduction of cell life. The target for aluminum electro-winning has been to develop an oxygen-evolving electrode, rather than one that evolves substantial amounts of carbon dioxide. Such an electrode, when combined with suitable wettable cathode material developments, would reduce operating costs by eliminating the need for frequent electrode change and would enable more productive cell designs and reduce plant size. The materials specifications for developing these are, however, an extreme challenge. Those specifications include minimized corrosion rate of any electrode into the electrolyte, maintaining an electronically conducting oxidized surface that is of low electrical resistance, meeting the metal purity targets, and enabling variable operating current densities. Although the materials specifications can readily be written, the processing and production of the materials is the challenge.

Health management with reduced antibiotic use - the U.S. experience.

PubMed

Baker, Rodney

2006-01-01

Since World War II the use of antimicrobial products associated with food animal production has increased. Antimicrobials along with evolving production practices have significantly increased throughput, animal welfare, and improved health. Concerns surrounding the growing significance of emerging and in some cases rapidly disseminating antibiotic (antimicrobial) resistant bacterial pathogens among human and livestock populations has stimulated a reassessment of this application. The negative publicity has led many consumers and activist groups to believe that protein derived from food animals grown in the absence of those drugs is safer than products derived from the conventionally reared. There is a general fear that antimicrobial usage in agriculture threatens the sustainability of human therapeutic agents and the public wellbeing. The issue has gradually emerged from "fringe group paranoia" to mainstream - finally impacting consumer choices. Antimicrobial resistance concerns have stimulated a significant reaction by the US animal agriculture industry. Numerous pig production entities, large and small, have attempted to create additional pork product value by developing niche marketing opportunities. Thus far most of the subtherapeutic in-feed antimicrobial reduction has been voluntary in the US. Two production areas have developed where reduced usage occurs. First is the growth of antibiotic free production (ABF) and second is an increased use of treatment levels which avoids subtherapeutic criticism. The bulk of this article is directed at new production practices, pig health management, disease elimination, and biosecurity efforts that result from early industry attempts at reduced or excluded antimicrobial pig production. Raising antimicrobial (antibiotic) free (ABF) pork from birth is challenging for a variety of reasons. Some of these challenges can be cost effectively dealt with while others are difficult if not impossible to control in modern production environments. Healthy pig production is essential for sustainable ABF operations.

Cold-water coral carbonate mounds as unique palaeo-archives: the Plio-Pleistocene Challenger Mound record (NE Atlantic)

NASA Astrophysics Data System (ADS)

Thierens, M.; Browning, E.; Pirlet, H.; Loutre, M.-F.; Dorschel, B.; Huvenne, V. A. I.; Titschack, J.; Colin, C.; Foubert, A.; Wheeler, A. J.

2013-08-01

Through the interplay of a stabilising cold-water coral framework and a dynamic sedimentary environment, cold-water coral carbonate mounds create distinctive centres of bio-geological accumulation in often complex (continental margin) settings. The IODP Expedition 307 drilling of the Challenger Mound (eastern Porcupine Seabight; NE Atlantic) not only retrieved the first complete developmental history of a coral carbonate mound, it also exposed a unique, Early-Pleistocene sedimentary sequence of exceptional resolution along the mid-latitudinal NE Atlantic margin. In this study, a comprehensive assessment of the Challenger Mound as an archive of Quaternary palaeo-environmental change and long-term coral carbonate mound development is presented. New and existing environmental proxy records, including clay mineralogy, planktonic foraminifer and calcareous nannofossil biostratigraphy and assemblage counts, planktonic foraminifer oxygen isotopes and siliciclastic particle-size, are thereby discussed within a refined chronostratigraphic and climatic context. Overall, the development of the Challenger Mound shows a strong affinity to the Plio-Pleistocene evolution of the Northern Hemisphere climate system, albeit not being completely in phase with it. The two major oceanographic and climatic transitions of the Plio-Pleistocene - the Late Pliocene/Early Pleistocene intensification of continental ice-sheet development and the mid-Pleistocene transition to the more extremely variable and more extensively glaciated late Quaternary - mark two major thresholds in Challenger Mound development: its Late Pliocene (>2.74 Ma) origin and its Middle-Late Pleistocene to recent decline. Distinct surface-water perturbations (i.e. water-mass/polar front migrations, productivity changes, melt-water pulses) are identified throughout the sequence, which can be linked to the intensity and extent of ice development on the nearby British-Irish Isles since the earliest Pleistocene. Glaciation-induced shifts in surface-water primary productivity are thereby proposed to fundamentally control cold-water coral growth, which in turn influences on-mound sediment accumulation and, hence, coral carbonate mound development throughout the Pleistocene. As local factors, such as proximal ice-sheet dynamics and on-mound changes in cold-water coral density, significantly affected the development of the Challenger Mound, they can potentially explain the nature of its palaeo-record and its offsets with the periodicities of global climate variability. On the other hand, owing to this unique setting, a regionally exceptional, high-resolution palaeo-record of Early Pleistocene (ca 2.6 to 2.1 Ma) environmental change (including early British-Irish ice-sheet development), broadly in phase with the 41 ka-paced global climate system, is preserved in the lower Challenger Mound. All in all, the Challenger Mound record highlights the wider relevance of coral carbonate mound archives and their potential to capture unique records from dynamic (continental margin) environments.

Managing distributed software development in the Virtual Astronomical Observatory

NASA Astrophysics Data System (ADS)

Evans, Janet D.; Plante, Raymond L.; Boneventura, Nina; Busko, Ivo; Cresitello-Dittmar, Mark; D'Abrusco, Raffaele; Doe, Stephen; Ebert, Rick; Laurino, Omar; Pevunova, Olga; Refsdal, Brian; Thomas, Brian

2012-09-01

The U.S. Virtual Astronomical Observatory (VAO) is a product-driven organization that provides new scientific research capabilities to the astronomical community. Software development for the VAO follows a lightweight framework that guides development of science applications and infrastructure. Challenges to be overcome include distributed development teams, part-time efforts, and highly constrained schedules. We describe the process we followed to conquer these challenges while developing Iris, the VAO application for analysis of 1-D astronomical spectral energy distributions (SEDs). Iris was successfully built and released in less than a year with a team distributed across four institutions. The project followed existing International Virtual Observatory Alliance inter-operability standards for spectral data and contributed a SED library as a by-product of the project. We emphasize lessons learned that will be folded into future development efforts. In our experience, a well-defined process that provides guidelines to ensure the project is cohesive and stays on track is key to success. Internal product deliveries with a planned test and feedback loop are critical. Release candidates are measured against use cases established early in the process, and provide the opportunity to assess priorities and make course corrections during development. Also key is the participation of a stakeholder such as a lead scientist who manages the technical questions, advises on priorities, and is actively involved as a lead tester. Finally, frequent scheduled communications (for example a bi-weekly tele-conference) assure issues are resolved quickly and the team is working toward a common vision.

Using Android-Based Educational Game for Learning Colloid Material

NASA Astrophysics Data System (ADS)

Sari, S.; Anjani, R.; Farida, I.; Ramdhani, M. A.

2017-09-01

This research is based on the importance of the development of student’s chemical literacy on Colloid material using Android-based educational game media. Educational game products are developed through research and development design. In the analysis phase, material analysis is performed to generate concept maps, determine chemical literacy indicators, game strategies and set game paths. In the design phase, product packaging is carried out, then validation and feasibility test are performed. Research produces educational game based on Android that has the characteristics that is: Colloid material presented in 12 levels of game in the form of questions and challenges, presents visualization of discourse, images and animation contextually to develop the process of thinking and attitude. Based on the analysis of validation and trial results, the product is considered feasible to use.

Global Entrepreneurship, Creating and Working Across Cultures

NASA Astrophysics Data System (ADS)

Raghu, Surya

2015-04-01

In this presentation we will discuss the opportunities and challenges for those young scientists who would like to take up entrepreneurial careers - particularly for ideas, inventions and products that have potential of global markets. While some ideas can have immediate global ``takers'' - others need to be ``tuned'' in to local contexts. The impact on economic development and sustainability are also associated with global markets - particularly in the developing countries. Involving and learning to work with cross-cultural teams go a long way in identifying such needs and opportunities and developing solutions or products that meet these needs.

Rapid Development and Distribution of Mobile Media-Rich Clinical Practice Guidelines Nationwide in Colombia.

PubMed

Flórez-Arango, José F; Sriram Iyengar, M; Caicedo, Indira T; Escobar, German

2017-01-01

Development and electronic distribution of Clinical Practice Guidelines production is costly and challenging. This poster presents a rapid method to represent existing guidelines in auditable, computer executable multimedia format. We used a technology that enables a small number of clinicians to, in a short period of time, develop a substantial amount of computer executable guidelines without programming.

The Power of One? Conditions Which Challenge Managerial Professional Development Practices

ERIC Educational Resources Information Center

Hardy, Ian

2014-01-01

This paper draws upon Bourdieu's concepts of habitus, capital and field to better understand and appreciate the conditions which encouraged the productive professional development (PD) practices of one very capable teacher working in a secondary school in the British Midlands. Rather than celebrating this teacher's practices and perspective as…

Biochar research activities and their relation to development and environmental quality: A meta-analysis

USDA-ARS?s Scientific Manuscript database

Developing agricultural technologies to double food supply by 2030 and at the same time reducing the emissions of greenhouse gases from agriculture will be challenging, but an imperative issue for the 21st century. The production and application of biochar could contribute to achieving these goals, ...

Extension Professionals' Perspectives on Supporting Feedstock Production for Biofuels: Concerns, Challenges, and Opportunities

ERIC Educational Resources Information Center

Townsend, Patricia A.; Haider, Nora M.; Asah, Stanley T.; Zobrist, Kevin W.

2016-01-01

The development of successful bioenergy programs will depend on informed and prepared Extension professionals who are willing and equipped to provide technical support. A survey of Extension professionals in the Pacific Northwest revealed barriers to program development, including limits on time and knowledge and concerns about economic returns…

Genomic tools for developing markers for postharvest disease resistance in Rosaceae fruit crops

USDA-ARS?s Scientific Manuscript database

A wealth of new plant genomic information and molecular tools have been developed over the past ten years and now the challenge is to learn how to apply this information to address critical production problems, such as disease resistance and abiotic stress tolerance. Malus sieversii, an apple speci...

Burrowing under the Gates: Becoming a Mole in Your Own Institution.

ERIC Educational Resources Information Center

Baker, Edith M.

English or rhetoric and composition faculty must work to collapse disciplinary boundaries in their institutions. The challenge facing English departments is to collapse the "we-they" mentality, to develop productive partnerships with other departments, and to develop a healthy respect for other disciplines. At Yavapai College in Arizona,…

Pedagogy for Addressing the Worldview Challenge in Sustainable Development of Agriculture

ERIC Educational Resources Information Center

Jordan, Nicholas R.; Bawden, Richard J.; Bergmann, Luke

2008-01-01

Agriculture is offering new forms of support to society, as evidenced by rapid development of an agricultural "bio-economy," and increasing emphasis on production of ecological services in farmed landscapes. The advent of these innovations will engage agricultural professionals in critical civic debates about matters that are complex and…

Rural Land Use: A Need for New Priorities.

ERIC Educational Resources Information Center

Fletcher, Wendell; Little, Charles E.

The new demands being placed on the rural land base--for agricultural production, for energy and minerals, as well as for economic development--are considerable, and rural areas today face the difficult challenge of finding ways to accommodate new growth and development, while at the same time ensuring that essential activities and the inherent…

A Software Product Line Process to Develop Agents for the IoT

PubMed Central

Ayala, Inmaculada; Amor, Mercedes; Fuentes, Lidia; Troya, José M.

2015-01-01

One of the most important challenges of this decade is the Internet of Things (IoT), which aims to enable things to be connected anytime, anyplace, with anything and anyone, ideally using any path/network and any service. IoT systems are usually composed of heterogeneous and interconnected lightweight devices that support applications that are subject to change in their external environment and in the functioning of these devices. The management of the variability of these changes, autonomously, is a challenge in the development of these systems. Agents are a good option for developing self-managed IoT systems due to their distributed nature, context-awareness and self-adaptation. Our goal is to enhance the development of IoT applications using agents and software product lines (SPL). Specifically, we propose to use Self-StarMASMAS, multi-agent system) agents and to define an SPL process using the Common Variability Language. In this contribution, we propose an SPL process for Self-StarMAS, paying particular attention to agents embedded in sensor motes. PMID:26140350

Characteristics and consumer acceptance of healthier meat and meat product formulations-a review.

PubMed

Hathwar, Swapna C; Rai, Amit Kumar; Modi, Vinod Kumar; Narayan, Bhaskar

2012-12-01

Awareness of health and nutrition has led to the development of "functional foods" which is a new approach to achieve healthier status thus reducing the risk of diseases. Meat has been highly exploited as a functional ingredient/food in recent years wherein meat has either been modified or incorporated into non meat products. Changing consumer demand has influenced the market for all types of meat. The development and marketing the functional foods can be, however, very challenging compared to the foods that conventionally have a high health image. This review gives the overall perception about importance of using meat/meat products as a functional food.

Perspectives and advances of biological H2 production in microorganisms.

PubMed

Rupprecht, Jens; Hankamer, Ben; Mussgnug, Jan H; Ananyev, Gennady; Dismukes, Charles; Kruse, Olaf

2006-09-01

The rapid development of clean fuels for the future is a critically important global challenge for two main reasons. First, new fuels are needed to supplement and ultimately replace depleting oil reserves. Second, fuels capable of zero CO2 emissions are needed to slow the impact of global warming. This review summarizes the development of solar powered bio-H2 production processes based on the conversion of photosynthetic products by fermentative bacteria, as well as using photoheterotrophic and photoautrophic organisms. The use of advanced bioreactor systems and their potential and limitations in terms of process design, efficiency, and cost are also briefly reviewed.

Reference Materials: Significance, General Requirements, and Demand.

PubMed

Kiełbasa, Anna; Gadzała-Kopciuch, Renata; Buszewski, Bogusław

2016-05-03

Reference materials play an important part in the quality control of measurements. Rapid development of such new scientific disciplines as proteomics, metabolomics, and genomics also necessitates development of new reference materials. This is a great challenge due to the complexity of the production of new reference materials and difficulties associated with achieving their homogeneity and stability. CRMs of tissue are of particular importance. They can be counted among the matrices that are most complex and time consuming in preparation. Tissue is the place of transformation and accumulation of many substances (e.g., metabolites, which are intermediate or end products resulting from metabolic processes). Trace amounts of many substances in tissues must be determined with adequate precision and accuracy. To meet the needs stemming from research and from problems and challenges faced by chemists, analysts, and toxicologists, the number of certified reference materials should be continuously increased.

Towards the effective plastic waste management in Bangladesh: a review.

PubMed

Mourshed, Monjur; Masud, Mahadi Hasan; Rashid, Fazlur; Joardder, Mohammad Uzzal Hossain

2017-12-01

The plastic-derived product, nowadays, becomes an indispensable commodity for different purposes. A huge amount of used plastic causes environmental hazards that turn in danger for marine life, reduces the fertility of soil, and contamination of ground water. Management of this enormous plastic waste is challenging in particular for developing countries like Bangladesh. Lack of facilities, infrastructure development, and insufficient budget for waste management are some of the prime causes of improper plastic management in Bangladesh. In this study, the route of plastic waste production and current plastic waste management system in Bangladesh have been reviewed extensively. It emerges that no technical and improved methods are adapted in the plastic management system. A set of the sustainable plastic management system has been proposed along with the challenges that would emerge during the implementation these strategies. Successful execution of the proposed systems would enhance the quality of plastic waste management in Bangladesh and offers enormous energy from waste.

Anaerobic digestion of microalgal biomass: Challenges, opportunities and research needs.

PubMed

Gonzalez-Fernandez, Cristina; Sialve, Bruno; Molinuevo-Salces, Beatriz

2015-12-01

Integration of anaerobic digestion (AD) with microalgae processes has become a key topic to support economic and environmental development of this resource. Compared with other substrates, microalgae can be produced close to the plant without the need for arable lands and be fully integrated within a biorefinery. As a limiting step, anaerobic hydrolysis appears to be one of the most challenging steps to reach a positive economic balance and to completely exploit the potential of microalgae for biogas and fertilizers production. This review covers recent investigations dealing with microalgae AD and highlights research opportunities and needs to support the development of this resource. Novel approaches to increase hydrolysis rate, the importance of the reactor design and the noteworthiness of the microbial anaerobic community are addressed. Finally, the integration of AD with microalgae processes and the potential of the carboxylate platform for chemicals and biofuels production are reviewed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Application of Artificial Intelligence technology to the analysis and synthesis of reliable software systems

NASA Technical Reports Server (NTRS)

Wild, Christian; Eckhardt, Dave

1987-01-01

The development of a methodology for the production of highly reliable software is one of the greatest challenges facing the computer industry. Meeting this challenge will undoubtably involve the integration of many technologies. This paper describes the use of Artificial Intelligence technologies in the automated analysis of the formal algebraic specifications of abstract data types. These technologies include symbolic execution of specifications using techniques of automated deduction and machine learning through the use of examples. On-going research into the role of knowledge representation and problem solving in the process of developing software is also discussed.

Precision injection molding of freeform optics

NASA Astrophysics Data System (ADS)

Fang, Fengzhou; Zhang, Nan; Zhang, Xiaodong

2016-08-01

Precision injection molding is the most efficient mass production technology for manufacturing plastic optics. Applications of plastic optics in field of imaging, illumination, and concentration demonstrate a variety of complex surface forms, developing from conventional plano and spherical surfaces to aspheric and freeform surfaces. It requires high optical quality with high form accuracy and lower residual stresses, which challenges both optical tool inserts machining and precision injection molding process. The present paper reviews recent progress in mold tool machining and precision injection molding, with more emphasis on precision injection molding. The challenges and future development trend are also discussed.

A review of the promises and challenges of micro-concentrator photovoltaics

NASA Astrophysics Data System (ADS)

Domínguez, César; Jost, Norman; Askins, Steve; Victoria, Marta; Antón, Ignacio

2017-09-01

Micro concentrator photovoltaics (micro-CPV) is an unconventional approach for developing high-efficiency low-cost PV systems. The micrifying of cells and optics brings about an increase of efficiency with respect to classical CPV, at the expense of some fundamental challenges at mass production. The large costs linked to miniaturization under conventional serial-assembly processes raise the need for the development of parallel manufacturing technologies. In return, the tiny sizes involved allows exploring unconventional optical architectures or revisiting conventional concepts that were typically discarded because of large material consumption or high bulk absorption at classical CPV sizes.

Commercialising genetically engineered animal biomedical products.

PubMed

Sullivan, Eddie J; Pommer, Jerry; Robl, James M

2008-01-01

Research over the past two decades has increased the quality and quantity of tools available to produce genetically engineered animals. The number of potentially viable biomedical products from genetically engineered animals is increasing. However, moving from cutting-edge research to development and commercialisation of a biomedical product that is useful and wanted by the public has significant challenges. Even early stage development of genetically engineered animal applications requires consideration of many steps, including quality assurance and quality control, risk management, gap analysis, founder animal establishment, cell banking, sourcing of animals and animal-derived material, animal facilities, product collection facilities and processing facilities. These steps are complicated and expensive. Biomedical applications of genetically engineered animals have had some recent successes and many applications are well into development. As researchers consider applications for their findings, having a realistic understanding of the steps involved in the development and commercialisation of a product, produced in genetically engineered animals, is useful in determining the risk of genetic modification to the animal nu. the potential public benefit of the application.

IN31A-1734 Development and Evaluation of a Gridded CrIS/ATMS Visualization for Operational Forecasting

NASA Technical Reports Server (NTRS)

Zavodsky, Bradley; Smith, Nadia; Dostalek, Jack; Stevens, Eric; Nelson, Kristine; Weisz, Elisabeth; Berndt, Emily; Line, Bill; Barnet, Chris; Gambacorta, Antonia;

Ionic liquid-based green processes for energy production.

PubMed

Zhang, Suojiang; Sun, Jian; Zhang, Xiaochun; Xin, Jiayu; Miao, Qingqing; Wang, Jianji

2014-11-21

To mitigate the growing pressure on resource depletion and environment degradation, the development of green processes for the production of renewable energy is highly required. As a class of novel and promising media, ionic liquids (ILs) have shown infusive potential applications in energy production. Aiming to offer a critical overview regarding the new challenges and opportunities of ILs for developing green processes of renewable energy, this article emphasises the role of ILs as catalysts, solvents, or electrolytes in three broadly interesting energy production processes from renewable resources, such as CO2 conversion to fuels and fuel additives, biomass pretreatment and conversion to biofuels, as well as solar energy and energy storage. It is expected that this article will stimulate a generation of new ideas and new technologies in IL-based renewable energy production.

Breaking the silence: new strategies for discovering novel natural products.

PubMed

Ren, Hengqian; Wang, Bin; Zhao, Huimin

2017-12-01

Natural products have been a prolific source of antibacterial and anticancer drugs for decades. One of the major challenges in natural product discovery is that the vast majority of natural product biosynthetic gene clusters (BGCs) have not been characterized, partially due to the fact that they are either transcriptionally silent or expressed at very low levels under standard laboratory conditions. Here we describe the strategies developed in recent years (mostly between 2014-2016) for activating silent BGCs. These strategies can be broadly divided into two categories: approaches in native hosts and approaches in heterologous hosts. In addition, we briefly discuss recent advances in developing new computational tools for identification and characterization of BGCs and high-throughput methods for detection of natural products. Copyright © 2017 Elsevier Ltd. All rights reserved.

From Zero to Integration in Eight Months, the Dawn Ground Data System Engineering Challenge

NASA Technical Reports Server (NTRS)

Dubon, Lydia P.

2006-01-01

The Dawn GDS Team met the SC Sim integration challenge in eight months. The GDS System Engineering approach in response to the SC Simintegration challenge, focused on a set of key practices: decomposition of project request into manageable requirements; integration of multiple ground disciplines and experts into a focused team effort; risk management thru management of expectations; and aggregation of intermediate products into a final product. By maintaining a a system-level focus, the overall systems engineering process unified team GDS Team members with a common goal: the success of the ground system as a whole and not just the success of their individual expert contributions. Incorporation of Agile-type development efforts were aligned with a risk strategy based on team-oriented principles and expectations management, thus achieving a more stable baseline solution without compromising the integrity of the GDS design.

A Brief Literature Overview of Various Routes to Biorenewable Fuels from Lipids for the National Alliance for Advanced Biofuels and Bio-products (NAABB) Consortium

DOE Office of Scientific and Technical Information (OSTI.GOV)

Albrecht, Karl O.; Hallen, Richard T.

2011-03-29

Renewable methods of producing transportation fuels are currently the focus of numerous large research efforts across the globe. Renewable fuel produced from algal lipids is one aspect of this research that could have profound implications on future transportation fuel requirements. However, technical challenges remain in several areas of algal-lipid-based fuels. These challenges include the identification and development of robust and productive algal species as well as extraction methods to recover the produced lipids. Not the least of these technical challenges is the conversion of the algae lipids to fungible fuels. This brief literature review focuses primarily on state-of-the-art “downstream” applicationsmore » of producing fuel from fats and lipids, which can be applied to ongoing research with algae-derived lipids.« less

Challenges in Liquid-Phase Exfoliation, Processing, and Assembly of Pristine Graphene.

PubMed

Parviz, Dorsa; Irin, Fahmida; Shah, Smit A; Das, Sriya; Sweeney, Charles B; Green, Micah J

2016-10-01

Recent developments in the exfoliation, dispersion, and processing of pristine graphene (i.e., non-oxidized graphene) are described. General metrics are outlined that can be used to assess the quality and processability of various "graphene" products, as well as metrics that determine the potential for industrial scale-up. The pristine graphene production process is categorized from a chemical engineering point of view with three key steps: i) pretreatment, ii) exfoliation, and iii) separation. How pristine graphene colloidal stability is distinct from the exfoliation step and is dependent upon graphene interactions with solvents and dispersants are extensively reviewed. Finally, the challenges and opportunities of using pristine graphene as nanofillers in polymer composites, as well as as building blocks for macrostructure assemblies are summarized in the context of large-scale production. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Progress in development of an integrated dietary supplement ingredient database at the NIH Office of Dietary Supplements

PubMed Central

Dwyer, Johanna T.; Picciano, Mary Frances; Betz, Joseph M.; Fisher, Kenneth D.; Saldanha, Leila G.; Yetley, Elizabeth A.; Coates, Paul M.; Radimer, Kathy; Bindewald, Bernadette; Sharpless, Katherine E.; Holden, Joanne; Andrews, Karen; Zhao, Cuiwei; Harnly, James; Wolf, Wayne R.; Perry, Charles R.

2013-01-01

Several activities of the Office of Dietary Supplements (ODS) at the National Institutes of Health involve enhancement of dietary supplement databases. These include an initiative with US Department of Agriculture to develop an analytically substantiated dietary supplement ingredient database (DSID) and collaboration with the National Center for Health Statistics to enhance the dietary supplement label database in the National Health and Nutrition Examination Survey (NHANES). The many challenges that must be dealt with in developing an analytically supported DSID include categorizing product types in the database, identifying nutrients, and other components of public health interest in these products and prioritizing which will be entered in the database first. Additional tasks include developing methods and reference materials for quantifying the constituents, finding qualified laboratories to measure the constituents, developing appropriate sample handling procedures, and finally developing representative sampling plans. Developing the NHANES dietary supplement label database has other challenges such as collecting information on dietary supplement use from NHANES respondents, constant updating and refining of information obtained, developing default values that can be used if the respondent cannot supply the exact supplement or strength that was consumed, and developing a publicly available label database. Federal partners and the research community are assisting in making an analytically supported dietary supplement database a reality. PMID:25309034

Trade-offs and Opportunities in the Nexus of Energy and Water-for-Food

NASA Astrophysics Data System (ADS)

Rosegrant, M. W.

2015-12-01

The world economy is under pressure for greater, more efficient and more sustainable use of natural resources to meet complementary and competing objectives in the energy, water, and food sectors. Increasing national, regional, and seasonal water scarcities in much of the world pose severe challenges for national governments, the international development community, and ultimately, for individual water users. This presentation assesses the nexus between energy and water, with an emphasis on the interactions and trade-offs between energy and water for food production. It examines the impact of biofuel production on water quantity and quality, and the potential for hydropower potential to meet energy challenges while expanding irrigation water supplies and food production potential, thereby enhancing global food security. Biofuel production affects both water quantity and quality. Expanding production of biofuels—through either crop-based production systems or direct biomass production—can significantly increase demand for water as more acreage is planted or the crop mix begins to favor thirstier crops; water demand for bio-refineries creates additional competition with agricultural water use. Water quality can also be adversely affected by increased acreage for fertilizer-intensive crops, such as maize or sugarcane, which can result in increased nitrate run-off and soil erosion. Hydropower has become a relatively forgotten part of the energy-water security picture that deserves renewed attention. Unlike biofuels, hydropower does not normally compete with agricultural water. Instead, development of hydropower could complement food production by developing dam structures and power that also provide irrigation water and support its distribution for growing food crops. But balanced hydropower policies require consideration of potential trade-offs with environmental and social impacts.

Center for Advanced Biofuel Systems (CABS) Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kutchan, Toni M.

2015-12-02

One of the great challenges facing current and future generations is how to meet growing energy demands in an environmentally sustainable manner. Renewable energy sources, including wind, geothermal, solar, hydroelectric, and biofuel energy systems, are rapidly being developed as sustainable alternatives to fossil fuels. Biofuels are particularly attractive to the U.S., given its vast agricultural resources. The first generation of biofuel systems was based on fermentation of sugars to produce ethanol, typically from food crops. Subsequent generations of biofuel systems, including those included in the CABS project, will build upon the experiences learned from those early research results and willmore » have improved production efficiencies, reduced environmental impacts and decreased reliance on food crops. Thermodynamic models predict that the next generations of biofuel systems will yield three- to five-fold more recoverable energy products. To address the technological challenges necessary to develop enhanced biofuel systems, greater understanding of the non-equilibrium processes involved in solar energy conversion and the channeling of reduced carbon into biofuel products must be developed. The objective of the proposed Center for Advanced Biofuel Systems (CABS) was to increase the thermodynamic and kinetic efficiency of select plant- and algal-based fuel production systems using rational metabolic engineering approaches grounded in modern systems biology. The overall strategy was to increase the efficiency of solar energy conversion into oils and other specialty biofuel components by channeling metabolic flux toward products using advanced catalysts and sensible design:1) employing novel protein catalysts that increase the thermodynamic and kinetic efficiencies of photosynthesis and oil biosynthesis; 2) engineering metabolic networks to enhance acetyl-CoA production and its channeling towards lipid synthesis; and 3) engineering new metabolic networks for the production of hydrocarbons required to meet commercial fuel standards.« less

Hybrid photocathodes for solar fuel production: coupling molecular fuel-production catalysts with solid-state light harvesting and conversion technologies.

PubMed

Cedeno, Diana; Krawicz, Alexandra; Moore, Gary F

2015-06-06

Artificial photosynthesis is described as the great scientific and moral challenge of our time. We imagine a future where a significant portion of our energy is supplied by such technologies. However, many scientific, engineering and policy challenges must be addressed for this realization. Scientific challenges include the development of effective strategies to couple light absorption, electron transfer and catalysis for efficient conversion of light energy to chemical energy as well as the construction and study of structurally diverse assemblies to carry out these processes. In this article, we review recent efforts from our own research to develop a modular approach to interfacing molecular fuel-production catalysts to visible-light-absorbing semiconductors and discuss the role of the interfacing material as a protection layer for the catalysts as well as the underpinning semiconductor. In concluding, we briefly discuss the potential benefits of a globally coordinated project on artificial photosynthesis that interfaces teams of scientists, engineers and policymakers. Further, we offer cautions that such a large interconnected organization should consider. This article is inspired by, and draws largely from, an invited presentation given by the corresponding author at the Royal Society at Chicheley Hall, home of the Kavli Royal Society International Centre, Buckinghamshire on the themed meeting topic: 'Do we need a global project on artificial photosynthesis?'

Ready-to-use foods for management of moderate acute malnutrition: considerations for scaling up production and use in programs.

PubMed

Osendarp, Saskia; Rogers, Beatrice; Ryan, Kelsey; Manary, Mark; Akomo, Peter; Bahwere, Paluku; Belete, Hilina; Zeilani, Mamane; Islam, Munirul; Dibari, Filippo; De Pee, Saskia

2015-03-01

Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are processed in a safe, reliable, and financially sustainable local production facility; and the effective use of these products in large-scale community-based programs. Linear programming tools can be used successfully to design local compositions that are in line with international guidelines, low in cost, and acceptable, and the efficacy of these local formulations in the treatment of MAM was recently demonstrated in Malawi. The production of local formulations for programs at scale relies on the existence of a reliable and efficient local production facility. Technical assistance may be required in the development of sustainable business models at an early stage in the process, taking into account the stringent product quality and safety criteria and the required investments. The use of ready-to-use products, as of any food supplement, in programs at scale will be affected by the practice of household sharing and diversion of these products for other uses. Additional measures can be considered to account for sharing. These products designed for the treatment and prevention of MAM are to be used in community-based programs and should therefore be used in conjunction with other interventions and designed so that they do not replace the intake of other foods and breastmilk. Remaining challenges and implications for the (operations) research agenda are discussed.

Linking research to global health equity: the contribution of product development partnerships to access to medicines and research capacity building.

PubMed

Pratt, Bridget; Loff, Bebe

2013-11-01

Certain product development partnerships (PDPs) recognize that to promote the reduction of global health disparities they must create access to their products and strengthen research capacity in developing countries. We evaluated the contribution of 3 PDPs--Medicines for Malaria Venture, Drugs for Neglected Diseases Initiative, and Institute for One World Health--according to Frost and Reich's access framework. We also evaluated PDPs' capacity building in low- and middle-income countries at the individual, institutional, and system levels. We found that these PDPs advance public health by ensuring their products' registration, distribution, and adoption into national treatment policies in disease-endemic countries. Nonetheless, ensuring broad, equitable access for these populations--high distribution coverage; affordability, particularly for the poor; and adoption at provider and end-user levels--remains a challenge.

A nicotine delivery device without the nicotine? Tobacco industry development of low nicotine cigarettes.

PubMed

Dunsby, J; Bero, L

2004-12-01

Defining harm reduction and regulating potentially reduced exposure products (PREPs), including low nicotine products, are key issues in tobacco control policy. The US Congress has been considering legislation authorising the Food and Drug Administration (FDA) to regulate tobacco products. To investigate tobacco industry perceptions, interests, motivations, and knowledge regarding the marketability of low nicotine tobacco products. Qualitative analysis of internal tobacco industry documents identified in the Legacy Tobacco Documents Library between February 2002 and June 2004. Search terms included low-, no-, reduced-nicotine; denicotinization; low-, reduced- alkaloids; Next; de-nic; and key names of people, organisations, projects, and their common abbreviations and acronyms. The tobacco industry has made repeated efforts to develop low nicotine cigarettes. Reasons for doing so include consumer appeal and economic importance in a highly competitive cigarette market for "healthier" products. The industry considered the development of a new "denic" market segment a critical challenge. The tobacco industry exploits consumer misunderstanding of the health effects of nicotine in development and marketing efforts. The industry has risked the development of a less addictive product to expand the market reach of tobacco products based on perceived health benefits and appeal to quitters.

Chapter 10: Research and Deployment of Renewable Bioenergy Production from Microalgae

DOE Office of Scientific and Technical Information (OSTI.GOV)

Laurens, Lieve M; Glasser, Melodie

Recent progress towards the implementation of renewable bioenergy production has included microalgae, which have potential to significantly contribute to a viable future bioeconomy. In a current challenging energy landscape, where an increased demand for renewable fuels is projected and accompanied by plummeting fossil fuels' prices, economical production of algae-based fuels becomes more challenging. However, in the context of mitigating carbon emissions with the potential of algae to assimilate large quantities of CO2, there is a route to drive carbon sequestration and utilization to support a sustainable and secure global energy future. This chapter places international energy policy in the contextmore » of the current and projected energy landscape. The contribution that algae can make, is summarized as both a conceptual contribution as well as an overview of the commercial infrastructure installed globally. Some of the major recent developments and crucial technology innovations are the results of global government support for the development of algae-based bioenergy, biofuels and bioproduct applications, which have been awarded as public private partnerships and are summarized in this chapter.« less

Creating and testing the concept of an academic NGO for enhancing health equity: a new mode of knowledge production?

PubMed

Robinson, Vivian; Tugwell, Peter; Walker, Peter; Ter Kuile, Aleida A; Neufeld, Vic; Hatcher-Roberts, Janet; Amaratunga, Carol; Andersson, Neil; Doull, Marion; Labonte, Ron; Muckle, Wendy; Murangira, Felicite; Nyamai, Caroline; Ralph-Robinson, Dawn; Simpson, Don; Sitthi-Amorn, Chitr; Turnbull, Jeff; Walker, Joelle; Wood, Chris

2007-08-01

Collaborative action is required to address persistent and systematic health inequities which exist for most diseases in most countries of the world. The Academic NGO initiative (ACANGO) described in this paper was set up as a focused network giving priority to twinned partnerships between Academic research centres and community-based NGOs. ACANGO aims to capture the strengths of both in order to build consensus among stakeholders, engage the community, focus on leadership training, shared management and resource development and deployment. A conceptual model was developed through a series of community consultations. This model was tested with four academic-community challenge projects based in Kenya, Canada, Thailand and Rwanda and an online forum and coordinating hub based at the University of Ottawa. Between February 2005 and February 2007, each of the four challenge projects was able to show specific outputs, outcomes and impacts related to enhancing health equity through the relevant production and application of knowledge. The ACANGO initiative model and network has demonstrated success in enhancing the production and use of knowledge in program design and implementation for vulnerable populations.

Regulation of stem cell-based therapies in Canada: current issues and concerns.

PubMed

von Tigerstrom, Barbara; Nguyen, Thu Minh; Knoppers, Bartha Maria

2012-09-01

Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and conditions. Despite the excitement over such advances, regulators are faced with the challenge of determining criteria to ensure stem cells and their products are safe and effective for human use. However, stem cell-based products and therapies present unique regulatory challenges because standard drug development models do not wholly apply given the complexity and diversity of these products and therapies. As a result, regulatory requirements are often unclear and ambiguous creating unnecessary barriers for research. In order to better understand the barriers that might affect Canadian stem cell researchers, we sought feedback from stakeholders regarding areas of uncertainty or concern about existing regulatory oversight of cell therapies. A selection of Canadian researchers and clinicians working in the area of stem cell research were interviewed to assess certain key questions: 1) whether current regulatory requirements are easily accessible and well understood; 2) whether regulatory requirements create important challenges or barriers; and 3) whether there is a need for further guidance on the issue. The results of this survey are summarized and compared to issues and concerns experienced in other countries, as reported in the literature, to identify challenges which may be on the horizon and to provide possible solutions for regulatory reform.

Surmounting the unique challenges in health disparities education: a multi-institution qualitative study.

PubMed

Carter-Pokras, Olivia; Bereknyei, Sylvia; Lie, Desiree; Braddock, Clarence H

2010-05-01

The National Consortium for Multicultural Education for Health Professionals (Consortium) comprises educators representing 18 US medical schools, funded by the National Institutes of Health. Collective lessons learned from curriculum implementation by principal investigators (PIs) have the potential to guide similar educational endeavors. Describe Consortium PI's self-reported challenges with curricular development, solutions and their new curricular products. Information was collected from PIs over 2 months using a 53-question structured three-part questionnaire. The questionnaire addressed PI demographics, curriculum implementation challenges and solutions, and newly created curricular products. Study participants were 18 Consortium PIs. Descriptive analysis was used for quantitative data. Narrative responses were analyzed and interpreted using qualitative thematic coding. Response rate was 100%. Common barriers and challenges identified by PIs were: finding administrative and leadership support, sustaining the momentum, continued funding, finding curricular space, accessing and engaging communities, and lack of education research methodology skills. Solutions identified included engaging stakeholders, project-sharing across schools, advocacy and active participation in committees and community, and seeking sustainable funding. All Consortium PIs reported new curricular products and extensive dissemination efforts outside their own institutions. The Consortium model has added benefits for curricular innovation and dissemination for cultural competence education to address health disparities. Lessons learned may be applicable to other educational innovation efforts.

Probiotics, prebiotics, and microencapsulation: A review.

PubMed

Sarao, Loveleen Kaur; Arora, M

2017-01-22

The development of a suitable technology for the production of probiotics is a key research for industrial production, which should take into account the viability and the stability of the organisms involved. Microbial criteria, stress tolerance during processing, and storage of the product constitute the basis for the production of probiotics. Generally, the bacteria belonging to the genera Lactobacillus and Bifidobacterium have been used as probiotics. Based on their positive qualities, probiotic bacteria are widely used in the production of food. Interest in the incorporation of the probiotic bacteria into other products apart from dairy products has been increasing and represents a great challenge. The recognition of dose delivery systems for probiotic bacteria has also resulted in research efforts aimed at developing probiotic food outside the dairy sector. Producing probiotic juices has been considered more in the recent years, due to an increased concern in personal health of consumers. This review focuses on probiotics, prebiotics, and the microencapsulation of living cells.

Liposomal Drug Product Development and Quality: Current US Experience and Perspective.

PubMed

Kapoor, Mamta; Lee, Sau L; Tyner, Katherine M

2017-05-01

Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency has received over 400 liposomal drug product submissions (excluding combination therapies), and there are currently eight approved liposomal drug products on the US market. In order to identify the pain points in development and manufacturing of liposomal drug products, a retrospective analysis was performed from a quality perspective on submissions for new and generic liposomal drug products. General analysis on liposomal drug product submissions was also performed. Results indicated that 96% of the submissions were Investigational New Drug (IND) applications, 3% were New Drug Applications (NDAs), and the remaining 1% was Abbreviated New Drug Applications (ANDAs). Doxorubicin hydrochloride was the most commonly used drug substance incorporated into the liposomes (31%). The majority of the liposomal products were administered via intravenous route (84%) with cancer (various types) being the most common indication (63%). From a quality perspective, major challenges during the development of liposomal drug products included identification and (appropriate) characterization of critical quality attributes of liposomal drug products and suitable control strategies during product development. By focusing on these areas, a faster and more efficient development of liposomal drug products may be achieved. Additionally, in this way, the drug review process for such products can be streamlined.

Opportunities and challenges for the export of U.S. value-added wood products to China

Treesearch

Scott Bowe; Matt Bumgardner; Terry Mace

2008-01-01

This report explores some of the opportunities for, and challenges associated with, exporting wood products to China. Five topics are examined: an overview of trends in forestry and forest products in China, export opportunities and challenges for U.S. primary wood producers (Study 1), export opportunities and challenges for U.S. secondary wood producers (Study 2),...

Exploring Challenges and Opportunities of Coproduction: USDA Climate Hub Efforts to Integrate Coproduction with Applied Research and Decision Support Tool Development in the Northwest

NASA Astrophysics Data System (ADS)

Roesch-McNally, G.; Prendeville, H. R.

2017-12-01

A lack of coproduction, the joint production of new technologies or knowledge among technical experts and other groups, is arguably one of the reasons why much scientific information and resulting decision support systems are not very usable. Increasingly, public agencies and academic institutions are emphasizing the importance of coproduction of scientific knowledge and decision support systems in order to facilitate greater engagement between the scientific community and key stakeholder groups. Coproduction has been embraced as a way for the scientific community to develop actionable scientific information that will assist end users in solving real-world problems. Increasing the level of engagement and stakeholder buy-in to the scientific process is increasingly necessary, particularly in the context of growing politicization of science and the scientific process. Coproduction can be an effective way to build trust and can build-on and integrate local and traditional knowledge. Employing coproduction strategies may enable the development of more relevant and useful information and decision support tools that address stakeholder challenges at relevant scales. The USDA Northwest Climate Hub has increasingly sought ways to integrate coproduction in the development of both applied research projects and the development of decision support systems. Integrating coproduction, however, within existing institutions is not always simple, given that coproduction is often more focused on process than products and products are, for better or worse, often the primary focus of applied research and tool development projects. The USDA Northwest Climate Hub sought to integrate coproduction into our FY2017 call for proposal process. As a result we have a set of proposals and fledgling projects that fall along the engagement continuum (see Figure 1- attached). We will share the challenges and opportunities that emerged from this purposeful integration of coproduction into the work that we prioritized for funding. This effort highlights strategies for how federal agencies might consider how and whether to codify coproduction tenets into their collaborations and agenda setting.

Challenges in Catalytic Manufacture of Renewable Pyrrolidinones from Fermentation Derived Succinate

DOE Office of Scientific and Technical Information (OSTI.GOV)

White, James F.; Holladay, Johnathan E.; Zacher, Alan H.

2014-09-05

Fermentation derived succinic acid ammonium salt is an ideal precursor for manufacture of renewable N-methyl pyrrolidinone (NMP) or 2-pyrrolidinone (2P) via heterogeneous catalysis. However, there are many challenges to making this a practical reality. Chief among the challenges is avoiding catalyst poisoning by fermentation by- and co-products. Battelle / Pacific Northwest National Laboratory (PNNL) have developed an economically effective technology strategy for this purpose. The technology is a combination of purely thermal processing, followed by simple catalytic hydrogenation that together avoids catalyst poisoning from fermentation impurities and provides high selectivity and yields of NMP or 2P.

Miniature rotary actuator

NASA Technical Reports Server (NTRS)

Fink, R. A.; Ellis, R. C.

1996-01-01

The trend toward smaller satellites has challenged component manufacturers to reduce the size, weight, and cost of their products while maintaining high performance. Both a new stepper motor and a new harmonic drive were developed to meet this need. The resulting actuator embodies small angle stepper technology usually reserved for larger units and incorporates an integral approach to harmonic drive design. By product simplifications, costs were significantly reduced over prior designs.

Early Career Mentoring for Translational Researchers: Mentee Perspectives on Challenges and Issues

PubMed Central

Keller, Thomas E.; Collier, Peter J.; Blakeslee, Jennifer E.; Logan, Kay; McCracken, Karen; Morris, Cynthia

2014-01-01

Background and purposes The education and training of early career biomedical translational researchers often involves formal mentoring by more experienced colleagues. This study investigated the nature of these mentoring relationships from the perspective of mentees. The objective was to understand the challenges and issues encountered by mentees in forming and maintaining productive mentoring relationships. Method Three focus groups (n=14) were conducted with early career researchers who had mentored career development awards. Thematic analysis identified, categorized, and illustrated the challenges and issues reported by mentees. Results The range of mentee challenges was reflected in five major categories: 1) network—finding appropriate mentors to meet various needs; 2) access—structuring schedules and opportunities to receive mentoring; 3) expectations—negotiating the mechanics of the mentoring relationship and its purpose; 4) alignment—managing mentor-mentee mismatches regarding interests, priorities, and goals; and 5) skills and supports—developing the institutional supports to be successful. Conclusions Mentoring relationships created for academic training and career development contend with tasks common to many other relationships, namely recognizing compatibility, finding time, establishing patterns, agreeing to goals, and achieving aims. Identifying challenges faced by mentees can facilitate the development of appropriate trainings and supports to foster mentoring relationships in academic and career settings. PMID:25010230

The big challenges in modeling human and environmental well-being.

PubMed

Tuljapurkar, Shripad

2016-01-01

This article is a selective review of quantitative research, historical and prospective, that is needed to inform sustainable development policy. I start with a simple framework to highlight how demography and productivity shape human well-being. I use that to discuss three sets of issues and corresponding challenges to modeling: first, population prehistory and early human development and their implications for the future; second, the multiple distinct dimensions of human and environmental well-being and the meaning of sustainability; and, third, inequality as a phenomenon triggered by development and models to examine changing inequality and its consequences. I conclude with a few words about other important factors: political, institutional, and cultural.

Tapping the Vast Potential of the Data Deluge in Small-scale Food-Animal Production Businesses: Challenges to Near Real-time Data Analysis and Interpretation.

PubMed

Vial, Flavie; Tedder, Andrew

2017-01-01

Food-animal production businesses are part of a data-driven ecosystem shaped by stringent requirements for traceability along the value chain and the expanding capabilities of connected products. Within this sector, the generation of animal health intelligence, in particular, in terms of antimicrobial usage, is hindered by the lack of a centralized framework for data storage and usage. In this Perspective, we delimit the 11 processes required for evidence-based decisions and explore processes 3 (digital data acquisition) to 10 (communication to decision-makers) in more depth. We argue that small agribusinesses disproportionally face challenges related to economies of scale given the high price of equipment and services. There are two main areas of concern regarding the collection and usage of digital farm data. First, recording platforms must be developed with the needs and constraints of small businesses in mind and move away from local data storage, which hinders data accessibility and interoperability. Second, such data are unstructured and exhibit properties that can prove challenging to its near real-time preprocessing and analysis in a sector that is largely lagging behind others in terms of computing infrastructure and buying into digital technologies. To complete the digital transformation of this sector, investment in rural digital infrastructure is required alongside the development of new business models to empower small businesses to commit to near real-time data capture. This approach will deliver critical information to fill gaps in our understanding of emerging diseases and antimicrobial resistance in production animals, eventually leading to effective evidence-based policies.

Optimization of insect cell based protein production processes - online monitoring, expression systems, scale up.

PubMed

Druzinec, Damir; Salzig, Denise; Brix, Alexander; Kraume, Matthias; Vilcinskas, Andreas; Kollewe, Christian; Czermak, Peter

2013-01-01

Due to the increasing use of insect cell based expression systems in research and industrial recombinant protein production, the development of efficient and reproducible production processes remains a challenging task. In this context, the application of online monitoring techniques is intended to ensure high and reproducible product qualities already during the early phases of process development. In the following chapter, the most common transient and stable insect cell based expression systems are briefly introduced. Novel applications of insect cell based expression systems for the production of insect derived antimicrobial peptides/proteins (AMPs) are discussed using the example of G. mellonella derived gloverin. Suitable in situ sensor techniques for insect cell culture monitoring in disposable and common bioreactor systems are outlined with respect to optical and capacitive sensor concepts. Since scale up of production processes is one of the most critical steps in process development, a conclusive overview is given about scale up aspects for industrial insect cell culture processes.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Behnke, Craig

DOE Award # EE0000393 was awarded to fund research into the development of beneficial uses of surplus algal biomass and the byproducts of biofuel production. At the time of award, Sapphire’s intended fuel production pathway was a fairly conventional extraction of lipids from biomass, resulting in a defatted residue which could be processed using anaerobic digestion. Over the lifetime of the award, we conducted extensive development work and arrived at the conclusion that anaerobic digestion presented significant technical challenges for this high-nitrogen, high-ash, and low carbon material. Over the same timeframe, Sapphire’s fuel production efforts came to focus on hydrothermalmore » liquefaction. As a result of this technology focus, the residue from fuel production became unsuitable for either anaerobic digestion (or animal feed uses). Finally, we came to appreciate the economic opportunity that the defatted biomass could represent in the animal feed space, as well as understanding the impact of seasonal production on a biofuels extraction plant, and sought to develop uses for surplus biomass produced in excess of the fuel production unit’s capacity.« less

Identification of a leadership competency model for use in the development, recruitment & retention of intermodal transportation workers.

DOT National Transportation Integrated Search

2010-12-01

Transportation, like most industries, faces critical leadership challenges. Attracting, retaining, : and training high potential candidates are essential to safe and productive organizational : performance. Indeed, as the reliance on efficient public...

Influences on Researchers' Commitment.

ERIC Educational Resources Information Center

Bailey, Jeffrey G.

1994-01-01

A study in a new university investigated the relative importance of six factors (job security/promotion, availability of research resources, contribution to university mission, personal stimulation/challenge, colleague relationship, and professional recognition/development) on research commitment and productivity. Discipline, rank, and gender were…

Biofuels and Fisheries: Risks and Opportunities .

EPA Science Inventory

A rapidly developing biofuels industry in the U.S. and around the globe poses novel environmental challenges and opportunities, with implications for teh health and sustainability of fisheries. Changes in land uses and agricultural practices for production of biofuel feedstocks ...

Managing design for manufacture and assembly in the development of MEMS-based products

NASA Astrophysics Data System (ADS)

Hsu, Hung-Yao; Narasimhan, Nachchinarkkinian; Hariz, Alex J.

2006-12-01

Design for manufacturability, assembly and reliability of MEMS products is being applied to a multitude of novel MEMS products to make up for the lack of "Standard Process for MEMS" concept. The latter has proved a major handicap in commercialization of MEMS devices when compared to integrated circuits products. Furthermore, an examination of recent engineering literature seems to suggest convergence towards the development of the design for manufacturability and reliability of MEMS products. This paper will highlight the advantages and disadvantages of conventional techniques that have been pursued up to this point to achieve commercialization of MEMS products, identify some of the problems slowing down development, and explore measures that could be taken to try to address those problems. Successful commercialization critically depends on packaging and assembly, manufacturability, and reliability for micro scale products. However, a methodology that appropriately shadows next generation knowledge management will undoubtedly address most of the critical problems that are hampering development of MEMS industries. Finally this paper will also identify contemporary issues that are challenging the industry in regards to product commercialization and will recommend appropriate measures based on knowledge flow to address those shortcomings and lay out plans to expedient and successful paths to market.

NASA/SPoRT's GOES-R Activities in Support of Product Development, Management, and Training

NASA Technical Reports Server (NTRS)

Fuell, Kevin K.; Jedlovec, Gary; Molthan, Andrew L.; Stano, Geoffrey T.

2012-01-01

The NASA Short-term Prediction Research and Transition (SPoRT) Center supports many activities within the GOES-R Proving Grounds (PG). These include the development of imagery from existing instrumentation as a proxy to future Advanced Baseline Imager (ABI) capabilities on GOES-R. The Moderate Resolution Imaging Spectroradiometer (MODIS) and the Visible/Infrared Imager/Radiometer Suite (VIIRS) instruments are used to provide a glimpse of the multi-spectral capabilities that will become the norm as the number of channels and data rate dramatically increase with GOES-R. The NOAA/NWS has plans to provide operational users with all ABI channels at the highest resolution. Data fusion of individual channels into composite red, green, and blue imagery products will assist the end user with this future wave of information. While increasing the efficiency in the operational use of ABI channels, these composites provide only qualitative information. Within the GOES-R PG, SPoRT and other partners are exploring ways to include quantitative information as part of the composite imagery. However, limitations in local hardware processing and/or data bandwidth for users of the GOES-R data stream are challenges to overcome. This presentation will discuss the creation of these composite images as well as possible solutions to address these processing challenges. In a similar manner the Geostationary Lightning Mapper (GLM) to be launched on GOES-R presents several data management challenges. The GLM is a pioneering instrument to quantify total lightning from a geostationary platform. The expected data frequency from the GLM is to be at a sub-minute interval. Users of such a data set may have little experience in handling such a rapid update of information. To assist users, SPoRT is working with the NWS to develop tools within the user fs decision support system to allow tracking and analysis of total lightning from a storm-based perspective. This presentation will discuss the challenges and progress of this tool development work. With new data and products comes the need for user Training. Within the GOES-R PG SPoRT is supporting the demonstration of these future products by providing various training materials to end users. A summary of training provided to operational users will be discussed.

NASA/SPoRT's GOES-R Activities in Support of Product Development, Management, and Training

NASA Astrophysics Data System (ADS)

Fuell, K. K.; Jedlovec, G.; Molthan, A.; Stano, G. T.

2012-12-01

The NASA Short-term Prediction Research and Transition (SPoRT) Center supports many activities within the GOES-R Proving Grounds (PG). These include the development of imagery from existing instrumentation as a proxy to future Advanced Baseline Imager (ABI) capabilities on GOES-R. The Moderate Resolution Imaging Spectroradiometer (MODIS) and the Visible/Infrared Imager/Radiometer Suite (VIIRS) instruments are used to provide a glimpse of the multi-spectral capabilities that will become the norm as the number of channels and data rate dramatically increase with GOES-R. The NOAA/NWS has plans to provide operational users with all ABI channels at the highest resolution. Data fusion of individual channels into composite red, green, and blue imagery products will assist the end user with this future wave of information. While increasing the efficiency in the operational use of ABI channels, these composites provide only qualitative information. Within the GOES-R PG, SPoRT and other partners are exploring ways to include quantitative information as part of the composite imagery. However, limitations in local hardware processing and/or data bandwidth for users of the GOES-R data stream are challenges to overcome. This presentation will discuss the creation of these composite images as well as possible solutions to address these processing challenges. In a similar manner the Geostationary Lightning Mapper (GLM) to be launched on GOES-R presents several data management challenges. The GLM is a pioneering instrument to quantify total lightning from a geostationary platform. The expected data frequency from the GLM is to be at a sub-minute interval. Users of such a data set may have little experience in handling such a rapid update of information. To assist users, SPoRT is working with the NWS to develop tools within the user's decision support system to allow tracking and analysis of total lightning from a storm-based perspective. This presentation will discuss the challenges and progress of this tool development work. With new data and products comes the need for user Training. Within the GOES-R PG SPoRT is supporting the demonstration of these future products by providing various training materials to end users. A summary of training provided to operational users will be discussed.

Life in the dark: Roots and how they regulate plant-soil interactions

NASA Astrophysics Data System (ADS)

Wu, Y.; Chou, C.; Peruzzo, L.; Riley, W. J.; Hao, Z.; Petrov, P.; Newman, G. A.; Versteeg, R.; Blancaflor, E.; Ma, X.; Dafflon, B.; Brodie, E.; Hubbard, S. S.

2017-12-01

Roots play a key role in regulating interactions between soil and plants, an important biosphere process critical for soil development and health, global food security, carbon sequestration, and the cycling of elements (water, carbon, nutrients, and environmental contaminants). However, their underground location has hindered studies of plant roots and the role they play in regulating plant-soil interactions. Technological limitations for root phenotyping and the lack of an integrated approach capable of linking root development, its environmental adaptation/modification with subsequent impact on plant health and productivity are major challenges faced by scientists as they seek to understand the plant's hidden half. To overcome these challenges, we combine novel experimental methods with numerical simulations, and conduct controlled studies to explore the dynamic growth of crop roots. We ask how roots adapt to and change the soil environment and their subsequent impacts on plant health and productivity. Specifically, our efforts are focused on (1) developing novel geophysical approaches for non-invasive plant root and rhizosphere characterization; (2) correlating root developments with key canopy traits indicative of plant health and productivity; (3) developing numerical algorithms for novel geophysical root signal processing; (4) establishing plant growth models to explore root-soil interactions and above and below ground traits co-variabilities; and (5) exploring how root development modifies rhizosphere physical, hydrological, and geochemical environments for adaptation and survival. Our preliminary results highlight the potential of using electro-geophysical methods to quantifying key rhizosphere traits, the capability of the ecosys model for mechanistic plant growth simulation and traits correlation exploration, and the combination of multi-physics and numerical approach for a systematic understanding of root growth dynamics, impacts on soil physicochemical environments, and plant health and productivity.

Future Food Production System Development Pulling From Space Biology Crop Growth Testing in Veggie

NASA Technical Reports Server (NTRS)

Massa, Gioia; Romeyn, Matt; Fritsche, Ralph

2017-01-01

Preliminary crop testing using Veggie indicates the environmental conditions provided by the ISS are generally suitable for food crop production. When plant samples were returned to Earth for analysis, their levels of nutrients were comparable to Earth-grown ground controls. Veggie-grown produce food safety microbiology analysis indicated that space-grown crops are safe to consume. Produce sanitizing wipes were used on-orbit to further reduce risk of foodborne illness. Validation growth tests indicated abiotic challenges of insufficient or excess fluid delivery, potentially reduced air flow leading to excess water, elevated CO2 leading to physiological responses, and microorganisms that became opportunistic pathogens. As NASA works to develop future space food production, several areas of research to define these systems pull from the Veggie technology validation tests. Research into effective, reusable water delivery and water recovery methods for future food production systems arises from abiotic challenges observed. Additionally, impacts of elevated CO2 and refinement of fertilizer and light recipes for crops needs to be assessed. Biotic pulls include methods or technologies to effectively sanitize produce with few consumables and low inputs; work to understand the phytomicrobiome and potentially use it to protect crops or enhance growth; selection of crops with high harvest index and desirable flavors for supplemental nutrition; crops that provide psychosocial benefits, and custom space crop development. Planning for future food production in a deep space gateway or a deep space transit vehicle requires methods of handling and storing seeds, and ensuring space seeds are free of contaminants and long-lived. Space food production systems may require mechanization and autonomous operation, with preliminary testing initiated to identify operations and capabilities that are candidates for automation. Food production design is also pulling from Veggie logistics lessons, as we learn about growing at different scales and move toward developing systems that require less launch mass. Veggie will be used as a test bed for novel food production technologies. Veggie is a relatively simple precursor food production system but the knowledge gained from space biology validation tests in Veggie will have far reaching repercussions on future exploration food production. This work is supported by NASA.

Future Food Production System Development Pulling from Space Biology Crop Growth Testing in Veggie

NASA Technical Reports Server (NTRS)

Massa, G. D.; Romeyn, M. W.; Fritsche, R. F.

2017-01-01

Preliminary crop testing using Veggie indicates the environmental conditions provided by the ISS are generally suitable for food crop production. When plant samples were returned to Earth for analysis, their levels of nutrients were comparable to Earth-grown ground controls. Veggie-grown produce food safety microbiology analysis indicated that space-grown crops are safe to consume. Produce sanitizing wipes were used on-orbit to further reduce risk of foodborne illness. Validation growth tests indicated abiotic challenges of insufficient or excess fluid delivery, potentially reduced air flow leading to excess water, elevated CO2 leading to physiological responses, and microorganisms that became opportunistic pathogens. As NASA works to develop future space food production, several areas of research to define these systems pull from the Veggie technology validation tests. Research into effective, reusable water delivery and water recovery methods for future food production systems arises from abiotic challenges observed. Additionally, impacts of elevated CO2 and refinement of fertilizer and light recipes for crops needs to be assessed. Biotic pulls include methods or technologies to effectively sanitize produce with few consumables and low inputs; work to understand the phytomicrobiome and potentially use it to protect crops or enhance growth; selection of crops with high harvest index and desirable flavors for supplemental nutrition; crops that provide psychosocial benefits, and custom space crop development. Planning for future food production in a deep space gateway or a deep space transit vehicle requires methods of handling and storing seeds, and ensuring space seeds are free of contaminants and long-lived. Space food production systems may require mechanization and autonomous operation, with preliminary testing initiated to identify operations and capabilities that are candidates for automation. Food production design is also pulling from Veggie logistics lessons, as we learn about growing at different scales and move toward developing systems that require less launch mass. Veggie will be used as a test bed for novel food production technologies. Veggie is a relatively simple precursor food production system but the knowledge gained from space biology validation tests in Veggie will have far reaching repercussions on future exploration food production.

Oxygen Sensing for Industrial Safety — Evolution and New Approaches

PubMed Central

Willett, Martin

2014-01-01

The requirement for the detection of oxygen in industrial safety applications has historically been met by electrochemical technologies based on the consumption of metal anodes. Products using this approach have been technically and commercially successful for more than three decades. However, a combination of new requirements is driving the development of alternative approaches offering fresh opportunities and challenges. This paper reviews some key aspects in the evolution of consumable anode products and highlights recent developments in alternative technologies aimed at meeting current and anticipated future needs in this important application. PMID:24681673

Oxygen sensing for industrial safety - evolution and new approaches.

PubMed

Willett, Martin

2014-03-27

The requirement for the detection of oxygen in industrial safety applications has historically been met by electrochemical technologies based on the consumption of metal anodes. Products using this approach have been technically and commercially successful for more than three decades. However, a combination of new requirements is driving the development of alternative approaches offering fresh opportunities and challenges. This paper reviews some key aspects in the evolution of consumable anode products and highlights recent developments in alternative technologies aimed at meeting current and anticipated future needs in this important application.

Metabolic Engineering of Microalgal Based Biofuel Production: Prospects and Challenges.

PubMed

Banerjee, Chiranjib; Dubey, Kashyap K; Shukla, Pratyoosh

2016-01-01

The current scenario in renewable energy is focused on development of alternate and sustainable energy sources, amongst which microalgae stands as one of the promising feedstock for biofuel production. It is well known that microalgae generate much larger amounts of biofuels in a shorter time than other sources based on plant seeds. However, the greatest challenge in a transition to algae-based biofuel production is the various other complications involved in microalgal cultivation, its harvesting, concentration, drying and lipid extraction. Several green microalgae accumulate lipids, especially triacylglycerols (TAGs), which are main precursors in the production of lipid. The various aspects on metabolic pathway analysis of an oleaginous microalgae i.e., Chlamydomonas reinhardtii have elucidated some novel metabolically important genes and this enhances the lipid production in this microalgae. Adding to it, various other aspects in metabolic engineering using OptFlux and effectual bioprocess design also gives an interactive snapshot of enhancing lipid production which ultimately improvises the oil yield. This article reviews the current status of microalgal based technologies for biofuel production, bioreactor process design, flux analysis and it also provides various strategies to increase lipids accumulation via metabolic engineering.

Proteins for breaking barriers in lignocellulosic bioethanol production.

PubMed

Ulaganathan, Kandasamy; Goud, Burragoni S; Reddy, Mettu M; Kumar, Vanaparthi P; Balsingh, Jatoth; Radhakrishna, Surabhi

2015-01-01

Reduction in fossil fuel consumption by using alternate sources of energy is a major challenge facing mankind in the coming decades. Bioethanol production using lignocellulosic biomass is the most viable option for addressing this challenge. Industrial bioconversion of lignocellulosic biomass, though possible now, is not economically viable due to presence of barriers that escalate the cost of production. As cellulose and hemicellulose are the major constituents of terrestrial biomass, which is available in massive quantities, hydrolysis of cellulose and hemicellulose by the microorganisms are the most prominent biochemical processes happening in the earth. Microorganisms possess different categories of proteins associated with different stages of bioethanol production and a number of them are already found and characterized. Many more of these proteins need to be identified which suit the specificities needed for the bioethanol production process. Discovery of proteins with novel specificities and application of genetic engineering technologies to harvest the synergies existing between them with the aim to develop consolidated bioprocess is the major direction of research in the future. In this review, we discuss the different categories of proteins used for bioethanol production in the context of breaking the barriers existing for the economically feasible lignocellulosic bioethanol production.

Achievements, challenges and unmet needs for haemophilia patients with inhibitors

PubMed Central

DARGAUD, Y.; PAVLOVA, A.; LACROIX-DESMAZES, S.; FISCHER, K.; SOUCIE, M.; CLAEYSSENS, S.; SCOTT, D.W.; d’OIRON, R.; LAVIGNE-LISSALDE, G.; KENET, G.; ETTINGSHAUSEN, C. ESCURIOLA; BOREL-DERLON, A.; LAMBERT, T.; PASTA, G.; NÉGRIER, C.

2016-01-01

Summary Over the past 20 years, there have been many advances in haemophilia treatment that have allowed patients to take greater control of their disease. However, the development of factor VIII (FVIII) inhibitors is the greatest complication of the disease and a challenge in the treatment of haemophilia making management of bleeding episodes difficult and surgical procedures very challenging. A meeting to discuss the unmet needs of haemophilia patients with inhibitors was held in Paris on 20 November 2014. Topics discussed were genetic and non-genetic risk factors for the development of inhibitors, immunological aspects of inhibitor development, FVIII products and inhibitor development, generation and functional properties of engineered antigen-specific T regulatory cells, suppression of immune responses to FVIII, prophylaxis in haemophilia patients with inhibitors, epitope mapping of FVIII inhibitors, current controversies in immune tolerance induction therapy, surgery in haemophilia patients with inhibitors and future perspectives for the treatment of haemophilia patients with inhibitors. A summary of the key points discussed is presented in this paper. PMID:26728503

Gelatin controversies in food, pharmaceuticals, and personal care products: Authentication methods, current status, and future challenges.

PubMed

Ali, Eaqub; Sultana, Sharmin; Hamid, Sharifah Bee Abd; Hossain, Motalib; Yehya, Wageeh A; Kader, Abdul; Bhargava, Suresh K

2018-06-13

Gelatin is a highly purified animal protein of pig, cow, and fish origins and is extensively used in food, pharmaceuticals, and personal care products. However, the acceptability of gelatin products greatly depends on the animal sources of the gelatin. Porcine and bovine gelatins have attractive features but limited acceptance because of religious prohibitions and potential zoonotic threats, whereas fish gelatin is welcomed in all religions and cultures. Thus, source authentication is a must for gelatin products but it is greatly challenging due to the breakdown of both protein and DNA biomarkers in processed gelatins. Therefore, several methods have been proposed for gelatin identification, but a comprehensive and systematic document that includes all of the techniques does not exist. This up-to-date review addresses this research gap and presents, in an accessible format, the major gelatin source authentication techniques, which are primarily nucleic acid and protein based. Instead of presenting these methods in paragraph form which needs much attention in reading, the major methods are schematically depicted, and their comparative features are tabulated. Future technologies are forecasted, and challenges are outlined. Overall, this review paper has the merit to serve as a reference guide for the production and application of gelatin in academia and industry and will act as a platform for the development of improved methods for gelatin authentication.

Analysis of pastoralists' perception on challenges and opportunities for sheep and goat production in Northern Kenya.

PubMed

Abdilatif, Mohamed Haji; Onono, Joshua Orungo; Mutua, Florence Kanini

2018-05-16

Small ruminants' production contributes to livelihood of pastoral communities, but this faces myriad constraints. This study aimed at identifying challenges facing producers of small ruminants, prioritizing diseases and their control measures and documenting opportunities for improvement. Sixteen focus group discussions with livestock owners and 13 key informant interviews were done in selected areas in Mandera County, Northern Kenya, and both quantitative and qualitative data collected using a questionnaire guide. Occurrences of diseases (27.4%) and drought (25%) were consistently ranked high in all groups. Other production challenges included increased predation of livestock, inadequate delivery of veterinary services, and increased livestock mortalities. Peste des Petit ruminants was ranked high with a median rank of 21.5%, while contagious caprine pleuropneumonia and sheep and goat pox were ranked second and third, respectively. Other diseases included tick-borne diseases, helminthosis, and pneumonia. Vaccination was ranked as the most effective control strategy for infectious diseases. Other control measures included recitation of Quran and cauterization. However, several opportunities exist for support of small ruminants' production: increased budgetary allocation for disease control by government, initiation of projects that enhance livestock production in the region by government and its development partners. These findings are useful for policy makers for disease control and organizations that are working on projects that focuses on enhancement of pastoralists' resilience, while future research could also identify appropriate technologies that reduces these impacts.

Plastid biotechnology for crop production: present status and future perspectives

PubMed Central

Daniell, Henry

2012-01-01

The world population is expected to reach an estimated 9.2 billion by 2050. Therefore, food production globally has to increase by 70% in order to feed the world, while total arable land, which has reached its maximal utilization, may even decrease. Moreover, climate change adds yet another challenge to global food security. In order to feed the world in 2050, biotechnological advances in modern agriculture are essential. Plant genetic engineering, which has created a new wave of global crop production after the first green revolution, will continue to play an important role in modern agriculture to meet these challenges. Plastid genetic engineering, with several unique advantages including transgene containment, has made significant progress in the last two decades in various biotechnology applications including development of crops with high levels of resistance to insects, bacterial, fungal and viral diseases, different types of herbicides, drought, salt and cold tolerance, cytoplasmic male sterility, metabolic engineering, phytoremediation of toxic metals and production of many vaccine antigens, biopharmaceuticals and biofuels. However, useful traits should be engineered via chloroplast genomes of several major crops. This review provides insight into the current state of the art of plastid engineering in relation to agricultural production, especially for engineering agronomic traits. Understanding the bottleneck of this technology and challenges for improvement of major crops in a changing climate are discussed. PMID:21437683

Addressing China’s grand challenge of achieving food security while ensuring environmental sustainability

PubMed Central

Lu, Yonglong; Jenkins, Alan; Ferrier, Robert C.; Bailey, Mark; Gordon, Iain J.; Song, Shuai; Huang, Jikun; Jia, Shaofeng; Zhang, Fusuo; Liu, Xuejun; Feng, Zhaozhong; Zhang, Zhibin

2015-01-01

China’s increasingly urbanized and wealthy population is driving a growing and changing demand for food, which might not be met without significant increase in agricultural productivity and sustainable use of natural resources. Given the past relationship between lack of access to affordable food and political instability, food security has to be given a high priority on national political agendas in the context of globalization. The drive for increased food production has had a significant impact on the environment, and the deterioration in ecosystem quality due to historic and current levels of pollution will potentially compromise the food production system in China. We discuss the grand challenges of not only producing more food but also producing it sustainably and without environmental degradation. In addressing these challenges, food production should be considered as part of an environmental system (soil, air, water, and biodiversity) and not independent from it. It is imperative that new ways of meeting the demand for food are developed while safeguarding the natural resources upon which food production is based. We present a holistic approach to both science and policy to ensure future food security while embracing the ambition of achieving environmental sustainability in China. It is a unique opportunity for China to be a role model as a new global player, especially for other emerging economies. PMID:26601127

The challenge of electronic waste (e-waste) management in developing countries.

PubMed

Osibanjo, O; Nnorom, I C

2007-12-01

Information and telecommunications technology (ICT) and computer Internet networking has penetrated nearly every aspect of modern life, and is positively affecting human life even in the most remote areas of the developing countries. The rapid growth in ICT has led to an improvement in the capacity of computers but simultaneously to a decrease in the products lifetime as a result of which increasingly large quantities of waste electrical and electronic equipment (e-waste) are generated annually. ICT development in most developing countries, particularly in Africa, depends more on secondhand or refurbished EEEs most of which are imported without confirmatory testing for functionality. As a result large quantities of e-waste are presently being managed in these countries. The challenges facing the developing countries in e-waste management include: an absence of infrastructure for appropriate waste management, an absence of legislation dealing specifically with e-waste, an absence of any framework for end-of-life (EoL) product take-back or implementation of extended producer responsibility (EPR). This study examines these issues as they relate to practices in developing countries with emphasis on the prevailing situation in Nigeria. Effective management of e-waste in the developing countries demands the implementation of EPR, the establishment of product reuse through remanufacturing and the introduction of efficient recycling facilities. The implementation of a global system for the standardization and certification/labelling of secondhand appliances intended for export to developing countries will be required to control the export of electronic recyclables (e-scarp) in the name of secondhand appliances.

Anthropogenic wetlands due to over-irrigation of desert areas; A challenging hydrogeological investigation with extensive geophysical input

NASA Astrophysics Data System (ADS)

Behroozmand, A. A.; Teatini, P.; Pedersen, J. B. B.; Auken, E.; Tosatto, O.; Christiansen, A. V.

2015-12-01

During the last century, many large irrigation projects have been initiated in arid lands worldwide. Despite a tremendous increase in food production, a common problem when characterizing these zones is land degradation in form of waterlogging. As results, large volumes of water are lost due to surplus irrigation in regions where water availability is extremely challenging for both population survival and economic development. The Nubariya depression, Western Desert (Egypt), is a clear example of this mechanism. Following the reclamation of desert lands for agricultural production, an artificial brackish and contaminated lake developed in the area in the late 1990s and presently extends for about 2.5 km2. Available data provide evidence of a simultaneous general deterioration of the groundwater system. With the main objectives of understanding the hydrological evolution of the area, characterizing the hydrogeological setting and developing scenarios for artificial aquifer remediation and recharge, an extensive hydrogeophysical investigation was carried out in this challenging environment using Magnetic Resonance Sounding (MRS, also called surface NMR) and ground-based Transient EM (TEM). The integrated interpretation of the geophysical surveys, properly calibrated with a number of boreholes, provides a clear hydrogeological picture of the upper 100 m sedimentary structure, in terms of both lithology and groundwater quality. The information is then used to set up a regional groundwater flow and a local density-dependent flow and transport numerical model to reproduce the past evolution of the aquifer system and develop a few scenarios for artificial aquifer recharge using the treated waters provided by a nearby waste-water treatment plant. The research outcomes point the hydrological challenges that emerge for an effective management of water resources in reclaimed desert areas and highlight the effectiveness of integrating advanced geophysical and modeling methodologies.

From Policy to Compliance: Federal Energy Efficient Product Procurement

DOE Office of Scientific and Technical Information (OSTI.GOV)

DeMates, Laurèn; Scodel, Anna

Federal buyers are required to purchase energy-efficient products in an effort to minimize energy use in the federal sector, save the federal government money, and spur market development of efficient products. The Federal Energy Management Program (FEMP)’s Energy Efficient Product Procurement (EEPP) Program helps federal agencies comply with the requirement to purchase energy-efficient products by providing technical assistance and guidance and setting efficiency requirements for certain product categories. Past studies have estimated the savings potential of purchasing energy-efficient products at over $500 million per year in energy costs across federal agencies.1 Despite the strong policy support for EEPP and resourcesmore » available, energy-efficient product purchasing operates within complex decision-making processes and operational structures; implementation challenges exist that may hinder agencies’ ability to comply with purchasing requirements. The shift to purchasing green products, including energy-efficient products, relies on “buy in” from a variety of potential actors throughout different purchasing pathways. Challenges may be especially high for EEPP relative to other sustainable acquisition programs given that efficient products frequently have a higher first cost than non-efficient ones, which may be perceived as a conflict with fiscal responsibility, or more simply problematic for agency personnel trying to stretch limited budgets. Federal buyers may also face challenges in determining whether a given product is subject to EEPP requirements. Previous analysis on agency compliance with EEPP, conducted by the Alliance to Save Energy (ASE), shows that federal agencies are getting better at purchasing energy-efficient products. ASE conducted two reviews of relevant solicitations for product and service contracts listed on Federal Business Opportunities (FBO), the centralized website where federal agencies are required to post procurements greater than $25,000. In 2010, ASE estimated a compliance rate of 46% in 2010, up from an estimate of 12% in 2008. Our work updates and expands on ASE’s 2010 analysis to gauge agency compliance with EEPP requirements.« less

Why do some wood-adhesive bonds respond poorly to accelerated moisture-resistant tests?

Treesearch

Charles R. Frihart; James M. Wescott

2008-01-01

The most challenging part of developing acceptable adhesives for wood bonding often is to create a bond that will withstand exposure to wet conditions or wet/dry cycles. Products that pass these tests have been developed empirically, but the aspects that make it difficult for adhesives to pass these tests and systematically ways to develop more durable adhesive bonds...

Corrosion Prevention and Control Planning Guidebook Spiral 3

DTIC Science & Technology

2007-09-01

programs. 5. Develop and recommend corrective and preventive procedures based on reliability and maintainability analyses of field data on similar in...One of the many challenges facing the Program/Acquisition Managers is the ability to develop a meaningful Corrosion Prevention and Control Plan...designated program manager of all activities associated with the acquisition, development , production, fielding , sustainment, and disposal of a DoD weapon

Effect of whole yeast cell product supplementation (CitriStim®) on immune responses and cecal microflora species in pullet and layer chickens during an experimental coccidial challenge.

PubMed

Markazi, Ashley D; Perez, Victor; Sifri, Mamduh; Shanmugasundaram, Revathi; Selvaraj, Ramesh K

2017-07-01

Three separate experiments were conducted to study the effects of whole yeast cell product supplementation in pullets and layer hens. Body weight gain, fecal and intestinal coccidial oocyst counts, cecal microflora species, cytokine mRNA amounts, and CD4+ and CD8+ T-cell populations in the cecal tonsils were analyzed following an experimental coccidial infection. In Experiment I, day-old Leghorn layer chicks were fed 3 experimental diets with 0, 0.1, or 0.2% whole yeast cell product (CitriStim®, ADM, Decatur, IL). At 21 d of age, birds were challenged with 1 × 105 live coccidial oocysts. Supplementation with whole yeast cell product decreased the fecal coccidial oocyst count at 7 (P = 0.05) and 8 (P < 0.01) d post-challenge. In Experiment II, 27-week old Leghorn layer hens were fed 3 experimental diets with 0, 0.05 or 0.1% whole yeast cell product and challenged with 1 × 105 live coccidial oocysts on d 25 of whole yeast cell product feeding. Supplementation with whole yeast cell product decreased the coccidial oocyst count in the intestinal content (P < 0.01) at 5, 13, and 38 d post-coccidial challenge. Supplementation with whole yeast cell product increased relative proportion of Lactobacillus (P < 0.01) in the cecal tonsils 13 d post-coccidial challenge. Supplementation with whole yeast cell product decreased CD8+ T cell percentages (P < 0.05) in the cecal tonsils at 5 d post-coccidial challenge. In Experiment III, 32-week-old Leghorn layer hens were fed 3 experimental diets with 0, 0.1, or 0.2% whole yeast cell product and challenged with 1 × 105 live coccidial oocysts on d 66 of whole yeast cell product feeding. At 5 d post-coccidial challenge, whole yeast cell product supplementation down-regulated (P = 0.01) IL-10 mRNA amount. It could be concluded that supplementing whole yeast cell product can help minimize coccidial infection in both growing pullets and layer chickens. © 2017 Poultry Science Association Inc.

The Role of Latin America’s Land and Water Resources for Global Food Security: Environmental Trade-Offs of Future Food Production Pathways

PubMed Central

Flachsbarth, Insa; Willaarts, Bárbara; Xie, Hua; Pitois, Gauthier; Mueller, Nathaniel D.; Ringler, Claudia; Garrido, Alberto

2015-01-01

One of humanity’s major challenges of the 21st century will be meeting future food demands on an increasingly resource constrained-planet. Global food production will have to rise by 70 percent between 2000 and 2050 to meet effective demand which poses major challenges to food production systems. Doing so without compromising environmental integrity is an even greater challenge. This study looks at the interdependencies between land and water resources, agricultural production and environmental outcomes in Latin America and the Caribbean (LAC), an area of growing importance in international agricultural markets. Special emphasis is given to the role of LAC’s agriculture for (a) global food security and (b) environmental sustainability. We use the International Model for Policy Analysis of Agricultural Commodities and Trade (IMPACT)—a global dynamic partial equilibrium model of the agricultural sector—to run different future production scenarios, and agricultural trade regimes out to 2050, and assess changes in related environmental indicators. Results indicate that further trade liberalization is crucial for improving food security globally, but that it would also lead to more environmental pressures in some regions across Latin America. Contrasting land expansion versus more intensified agriculture shows that productivity improvements are generally superior to agricultural land expansion, from an economic and environmental point of view. Finally, our analysis shows that there are trade-offs between environmental and food security goals for all agricultural development paths. PMID:25617621

The role of Latin America's land and water resources for global food security: environmental trade-offs of future food production pathways.

PubMed

Flachsbarth, Insa; Willaarts, Bárbara; Xie, Hua; Pitois, Gauthier; Mueller, Nathaniel D; Ringler, Claudia; Garrido, Alberto

2015-01-01

One of humanity's major challenges of the 21st century will be meeting future food demands on an increasingly resource constrained-planet. Global food production will have to rise by 70 percent between 2000 and 2050 to meet effective demand which poses major challenges to food production systems. Doing so without compromising environmental integrity is an even greater challenge. This study looks at the interdependencies between land and water resources, agricultural production and environmental outcomes in Latin America and the Caribbean (LAC), an area of growing importance in international agricultural markets. Special emphasis is given to the role of LAC's agriculture for (a) global food security and (b) environmental sustainability. We use the International Model for Policy Analysis of Agricultural Commodities and Trade (IMPACT)-a global dynamic partial equilibrium model of the agricultural sector-to run different future production scenarios, and agricultural trade regimes out to 2050, and assess changes in related environmental indicators. Results indicate that further trade liberalization is crucial for improving food security globally, but that it would also lead to more environmental pressures in some regions across Latin America. Contrasting land expansion versus more intensified agriculture shows that productivity improvements are generally superior to agricultural land expansion, from an economic and environmental point of view. Finally, our analysis shows that there are trade-offs between environmental and food security goals for all agricultural development paths.

Strategies for improving the performance and stability of Ni-based catalysts for reforming reactions.

PubMed

Li, Shuirong; Gong, Jinlong

2014-11-07

Owing to the considerable publicity that has been given to petroleum related economic, environmental, and political problems, renewed attention has been focused on the development of highly efficient and stable catalytic materials for the production of chemical/fuel from renewable resources. Supported nickel nanoclusters are widely used for catalytic reforming reactions, which are key processes for generating synthetic gas and/or hydrogen. New challenges were brought out by the extension of feedstock from hydrocarbons to oxygenates derivable from biomass, which could minimize the environmental impact of carbonaceous fuels and allow a smooth transition from fossil fuels to a sustainable energy economy. This tutorial review describes the recent efforts made toward the development of nickel-based catalysts for the production of hydrogen from oxygenated hydrocarbons via steam reforming reactions. In general, three challenges facing the design of Ni catalysts should be addressed. Nickel nanoclusters are apt to sinter under catalytic reforming conditions of high temperatures and in the presence of steam. Severe carbon deposition could also be observed on the catalyst if the surface carbon species adsorbed on metal surface are not removed in time. Additionally, the production of hydrogen rich gas with a low concentration of CO is a challenge using nickel catalysts, which are not so active in the water gas shift reaction. Accordingly, three strategies were presented to address these challenges. First, the methodologies for the preparation of highly dispersed nickel catalysts with strong metal-support interaction were discussed. A second approach-the promotion in the mobility of the surface oxygen-is favored for the yield of desired products while promoting the removal of surface carbon deposition. Finally, the process intensification via the in situ absorption of CO2 could produce a hydrogen rich gas with low CO concentration. These approaches could also guide the design of other types of heterogeneous base-metal catalysts for high temperature processes including methanation, dry reforming, and hydrocarbon combustion.

Critical product features' identification using an opinion analyzer.

PubMed

Shamim, Azra; Balakrishnan, Vimala; Tahir, Muhammad; Shiraz, Muhammad

2014-01-01

The increasing use and ubiquity of the Internet facilitate dissemination of word-of-mouth through blogs, online forums, newsgroups, and consumer's reviews. Online consumer's reviews present tremendous opportunities and challenges for consumers and marketers. One of the challenges is to develop interactive marketing practices for making connections with target consumers that capitalize consumer-to-consumer communications for generating product adoption. Opinion mining is employed in marketing to help consumers and enterprises in the analysis of online consumers' reviews by highlighting the strengths and weaknesses of the products. This paper describes an opinion mining system based on novel review and feature ranking methods to empower consumers and enterprises for identifying critical product features from enormous consumers' reviews. Consumers and business analysts are the main target group for the proposed system who want to explore consumers' feedback for determining purchase decisions and enterprise strategies. We evaluate the proposed system on real dataset. Results show that integration of review and feature-ranking methods improves the decision making processes significantly.

Critical Product Features' Identification Using an Opinion Analyzer

PubMed Central

Shamim, Azra; Balakrishnan, Vimala

2014-01-01

The increasing use and ubiquity of the Internet facilitate dissemination of word-of-mouth through blogs, online forums, newsgroups, and consumer's reviews. Online consumer's reviews present tremendous opportunities and challenges for consumers and marketers. One of the challenges is to develop interactive marketing practices for making connections with target consumers that capitalize consumer-to-consumer communications for generating product adoption. Opinion mining is employed in marketing to help consumers and enterprises in the analysis of online consumers' reviews by highlighting the strengths and weaknesses of the products. This paper describes an opinion mining system based on novel review and feature ranking methods to empower consumers and enterprises for identifying critical product features from enormous consumers' reviews. Consumers and business analysts are the main target group for the proposed system who want to explore consumers' feedback for determining purchase decisions and enterprise strategies. We evaluate the proposed system on real dataset. Results show that integration of review and feature-ranking methods improves the decision making processes significantly. PMID:25506612

Review of Potential Characterization Techniques in Approaching Energy and Sustainability

DOE PAGES

LePoire, David

2014-03-20

Societal prosperity is linked to sustainable energy and a healthy environment. But, tough global challenges include increased demand for fossil fuels, while approaching peak oil production and uncertainty in the environmental impacts of energy generation. Recently, energy use was identified as a major component of economic productivity, along with capital and labor. Furthermore, other environmental resources and impacts may be nearing environmental thresholds as indicated by nine planetary environmental boundaries, many of which are linked to energy production and use. Foresight techniques could be applied to guide future actions which include emphasis on (1) energy efficiency to bridge the transitionmore » to a renewable energy economy, (2) continued research, development, and assessment of new technologies, (3) improved understanding of environment impacts including natural capital use and degradation, (4) exploration of GDP alternative measures that include both economic production and environmental impacts, and (5) international cooperation and awareness of longer-term opportunities and their associated potential scenarios. Examples from the U.S. and the international community illustrate challenges and potential.« less

Non-dairy probiotic food products: An emerging group of functional foods.

PubMed

Min, Min; Bunt, Craig R; Mason, Susan L; Hussain, Malik A

2018-04-09

The functional food sector has shown tremendous growth in recent years with the application of probiotic bacteria as "food additives". The utilization of probiotic bacteria in food presents many challenges related to their growth, survival, viability, stability and functionality in food processing, storage and consumption as well as changes of sensory characteristics of probiotic foods. Although dairy foods are currently the most common food carrier to deliver probiotics, an increasing number of non-dairy food matrices exhibit potential for delivery of probiotics. This review provides more recent insight into the emergence of non-dairy probiotics products, the interactions between probiotics and different food matrices and the challenges in developing such products. Some of the technical issues are also reviewed and discussed. These issues include the efficacy of probiotic bacteria in non-chilled, low pH or high water activity foods; the potential loss of bacterial viability, additionally unwanted fermentation and changes of the sensory characteristics of food products which may result in poor microbiological quality and low acceptability to consumers.

Lessons learned for composite structures

NASA Technical Reports Server (NTRS)

Whitehead, R. S.

1991-01-01

Lessons learned for composite structures are presented in three technology areas: materials, manufacturing, and design. In addition, future challenges for composite structures are presented. Composite materials have long gestation periods from the developmental stage to fully matured production status. Many examples exist of unsuccessful attempts to accelerate this gestation period. Experience has shown that technology transition of a new material system to fully matured production status is time consuming, involves risk, is expensive and should not be undertaken lightly. The future challenges for composite materials require an intensification of the science based approach to material development, extension of the vendor/customer interaction process to include all engineering disciplines of the end user, reduced material costs because they are a significant factor in overall part cost, and improved batch-to-batch pre-preg physical property control. Historical manufacturing lessons learned are presented using current in-service production structure as examples. Most producibility problems for these structures can be traced to their sequential engineering design. This caused an excessive emphasis on design-to-weight and schedule at the expense of design-to-cost. This resulted in expensive performance originated designs, which required costly tooling and led to non-producible parts. Historically these problems have been allowed to persist throughout the production run. The current/future approach for the production of affordable composite structures mandates concurrent engineering design where equal emphasis is placed on product and process design. Design for simplified assembly is also emphasized, since assembly costs account for a major portion of total airframe costs. The future challenge for composite manufacturing is, therefore, to utilize concurrent engineering in conjunction with automated manufacturing techniques to build affordable composite structures. Composite design experience has shown that significant weight savings have been achieved, outstanding fatigue and corrosion resistance have been demonstrated, and in-service performance has been very successful. Currently no structural design show stoppers exist for composite structures. A major lesson learned is that the full scale static test is the key test for composites, since it is the primary structural 'hot spot' indicator. The major durability issue is supportability of thin skinned structure. Impact damage has been identified as the most significant issue for the damage tolerance control of composite structures. However, delaminations induced during assembly operations have demonstrated a significant nuisance value. The future challenges for composite structures are threefold. Firstly, composite airframe weight fraction should increase to 60 percent. At the same time, the cost of composite structures must be reduced by 50 percent to attain the goal of affordability. To support these challenges it is essential to develop lower cost materials and processes.

Co-management of Water, Energy, and Food Systems: Where Are We and What Does it Take for Implementation?

NASA Astrophysics Data System (ADS)

Akhbari, M.

2015-12-01

Water, energy, and food are closely bound in consumption and production patterns. To increase resource efficiency and productivity in a sustainable fashion, co-management of water, energy, and food resources is becoming inevitable. These co-management schemes require implementation of nexus-based approaches, which takes the interconnections of water, energy, and food systems into account and considers that development in one area may have major effects on others. While society, economy and environment are the action areas to implement a nexus approach, finance, governance, infrastructure and technology can create solutions. Existing obstacles in the action areas and challenges associated with creating solutions increase the complexities to develop nexus-based approaches and complicate their implementation. This study, identifies existing social, economic, and environmental obstacles, financial demands and constraints, shortcomings in governance, and infrastructure problems in the United States as the main challenges that need to be overcome. Then, it will be discussed how advanced technology could be employed to facilitate implementation of nexus-based approaches, followed by providing some recommendations to enable institutions to employ new technology, overcome existing obstacles, and address challenges in order to implement nexus-based management approaches.

Budget Issues: Accrual Budgeting Useful in Certain Areas but Does Not Provide Sufficient Information for Reporting on Our Nation’s Longer-Term Fiscal Challenge

DTIC Science & Technology

2007-12-01

Government Auditing Standards GDP gross domestic product IPSAS International Public Sector Accounting Standards OBEGAL Operating Balance...aligned with the international public sector accounting standards ( IPSAS ), but there were some deviations from IPSAS for constitutional reasons such...which is required under IPSAS . Besides developing the accounting standards to be used in the budget, a key challenge when switching to accrual

Organizing Physics Teacher Professional Education around Productive Habit Development: A Way to Meet Reform Challenges

ERIC Educational Resources Information Center

Etkina, Eugenia; Gregorcic, Bor; Vokos, Stamatis

2017-01-01

Extant literature on teacher preparation suggests that preservice teachers learn best when they are immersed in a community that allows them to develop dispositions, knowledge, and practical skills and share with the community a strong vision of what good teaching entails. However, even if the requisite dispositions, knowledge, and skills in…

Can a Small Minority Institution of Higher Education Develop a Business Oriented Broadcast Management Curriculum?

ERIC Educational Resources Information Center

Mancuso, Louis C.

Broadcast stations throughout the nation are being challenged by the Federal Communications Commission and by private organizations to hire blacks to fill job openings in production and management. Therefore, Xavier University of Louisiana decided to embark on a program to develop a broadcast management program under the auspices of the marketing…

The Impact of Cultural Competence on the Moral Development of Student Affairs Professionals

ERIC Educational Resources Information Center

Cuyjet, Michael J.; Duncan, Angela D.

2013-01-01

As student affairs professionals, we are expected to meet students where they are developmentally and challenge and support them as they learn, develop, and grow into productive citizens. Since our institutions, and society as a whole, are becoming increasingly diverse, it is imperative that we acknowledge the numerous ways cultural background…

The UN Decade of Education for Sustainable Development: Business as Usual in the End

ERIC Educational Resources Information Center

Huckle, John; Wals, Arjen E. J.

2015-01-01

An analysis of the literature supporting the UN Decade of Education for Sustainable Development and a sample of its key products suggests that it failed to acknowledge or challenge neoliberalism as a hegemonic force blocking transitions towards genuine sustainability. The authors argue that the rationale for the Decade was idealistic and that…

Gender-based motivations of non-residential birdwatchers in New York state: a qualitative study

Treesearch

Mary Joyce G. Sali; Diane M. Kuehn

2007-01-01

Birdwatching is the fastest growing outdoor recreation activity in the United States, and birdwatchers are an important economic development force in many rural communities. Wildlife management agencies are being challenged to develop products and programs for non-consumptive natural resource users such as birdwatchers. For effective planning and management of these...

Current frontiers and future directions of telecoupling research

NASA Astrophysics Data System (ADS)

Liu, J.

2016-12-01

The world has been increasingly interconnected over long distances though processes such as international trade, migration, telecommunication, and disease spread. However, previous studies often focused on socioeconomic or environmental issues of distant processes. While these studies have generated useful information for individual disciplines, integrating socioeconomic and environmental information is essential for holistic understanding of complex global challenges and unbiased decision making to address the challenges. To advance integrated research, the framework of telecoupling (socioeconomic and environmental interactions over distances) has been developed to explicitly address both socioeconomic and environmental issues simultaneously. Although the framework is relatively new, it has already been applied to tackle a variety of globally important issues, such as food security, water resources, energy sustainability, land use, international trade (e.g., food, forest products, energy, wildlife, industrial products), species invasion, investment, ecosystem services, conservation, information dissemination, and tourism. These applications have identified many important research gaps (e.g. spillover systems) and hidden linkages (e.g. feedbacks) among distant areas of the world with profound implications for sustainable development, ecosystem health, and human well-being. While working with telecoupling presents more challenges than focusing only on disciplinary issues, support from funding agencies has helped accelerate research on telecoupling and more efforts are being aimed at framework quantification and operationalization. The presenter will provide an overview of the current frontiers, discuss future research directions, and highlight emerging opportunities and challenges in telecoupling research and governance.

Capturing Biological Activity in Natural Product Fragments by Chemical Synthesis

PubMed Central

Crane, Erika A.

2016-01-01

Abstract Natural products have had an immense influence on science and have directly led to the introduction of many drugs. Organic chemistry, and its unique ability to tailor natural products through synthesis, provides an extraordinary approach to unlock the full potential of natural products. In this Review, an approach based on natural product derived fragments is presented that can successfully address some of the current challenges in drug discovery. These fragments often display significantly reduced molecular weights, reduced structural complexity, a reduced number of synthetic steps, while retaining or even improving key biological parameters such as potency or selectivity. Examples from various stages of the drug development process up to the clinic are presented. In addition, this process can be leveraged by recent developments such as genome mining, antibody–drug conjugates, and computational approaches. All these concepts have the potential to identify the next generation of drug candidates inspired by natural products. PMID:26833854

Opportunities and Challenges in the Design and Analysis of Biomass Supply Chains

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lautala, Pasi T.; Hilliard, Michael R.; Webb, Erin

The biomass supply chain is one of the most critical elements of large-scale bioenergy production and in many cases a key barrier for procuring initial funding for new developments on specific energy crops. Most productions rely on complex transforming chains linked to feed and food markets. The term 'supply chain' covers various aspects from cultivation and harvesting of the biomass, to treatment, transportation, and storage. After energy conversion, the product must be delivered to final consumption, whether it is in the form of electricity, heat, or more tangible products, such as pellets and biofuels. Effective supply chains are of utmostmore » importance for bioenergy production, as biomass tends to possess challenging seasonal production cycles and low mass, energy and bulk densities. Additionally, the demand for final products is often also dispersed, further complicating the supply chain. The goal of this paper is to introduce key components of biomass supply chains, examples of related modeling applications, and if/how they address aspects related to environmental metrics and management. The paper will introduce a concept of integrated supply systems for sustainable biomass trade and the factors influencing the bioenergy supply chain landscape, including models that can be used to investigate the factors. Our paper will also cover various aspects of transportation logistics, ranging from alternative modal and multi-modal alternatives to introduction of support tools for transportation analysis. Lastly, gaps and challenges in supply chain research are identified and used to outline research recommendations for the future direction in this area of study.« less

Opportunities and Challenges in the Design and Analysis of Biomass Supply Chains

DOE PAGES

Lautala, Pasi T.; Hilliard, Michael R.; Webb, Erin; ...

2015-06-30

The biomass supply chain is one of the most critical elements of large-scale bioenergy production and in many cases a key barrier for procuring initial funding for new developments on specific energy crops. Most productions rely on complex transforming chains linked to feed and food markets. The term 'supply chain' covers various aspects from cultivation and harvesting of the biomass, to treatment, transportation, and storage. After energy conversion, the product must be delivered to final consumption, whether it is in the form of electricity, heat, or more tangible products, such as pellets and biofuels. Effective supply chains are of utmostmore » importance for bioenergy production, as biomass tends to possess challenging seasonal production cycles and low mass, energy and bulk densities. Additionally, the demand for final products is often also dispersed, further complicating the supply chain. The goal of this paper is to introduce key components of biomass supply chains, examples of related modeling applications, and if/how they address aspects related to environmental metrics and management. The paper will introduce a concept of integrated supply systems for sustainable biomass trade and the factors influencing the bioenergy supply chain landscape, including models that can be used to investigate the factors. Our paper will also cover various aspects of transportation logistics, ranging from alternative modal and multi-modal alternatives to introduction of support tools for transportation analysis. Lastly, gaps and challenges in supply chain research are identified and used to outline research recommendations for the future direction in this area of study.« less

A living foundry for Synthetic Biological Materials: A synthetic biology roadmap to new advanced materials.

PubMed

Le Feuvre, Rosalind A; Scrutton, Nigel S

2018-06-01

Society is on the cusp of harnessing recent advances in synthetic biology to discover new bio-based products and routes to their affordable and sustainable manufacture. This is no more evident than in the discovery and manufacture of Synthetic Biological Materials , where synthetic biology has the capacity to usher in a new Materials from Biology era that will revolutionise the discovery and manufacture of innovative synthetic biological materials. These will encompass novel, smart, functionalised and hybrid materials for diverse applications whose discovery and routes to bio-production will be stimulated by the fusion of new technologies positioned across physical, digital and biological spheres. This article, which developed from an international workshop held in Manchester, United Kingdom, in 2017 [1], sets out to identify opportunities in the new materials from biology era. It considers requirements, early understanding and foresight of the challenges faced in delivering a Discovery to Manufacturing Pipeline for synthetic biological materials using synthetic biology approaches. This challenge spans the complete production cycle from intelligent and predictive design, fabrication, evaluation and production of synthetic biological materials to new ways of bringing these products to market. Pathway opportunities are identified that will help foster expertise sharing and infrastructure development to accelerate the delivery of a new generation of synthetic biological materials and the leveraging of existing investments in synthetic biology and advanced materials research to achieve this goal.

Additive Layer Manufacturing for Launcher's Applications

NASA Astrophysics Data System (ADS)

Vilanova, J.; Romera, P.; Lasagni, F.; Zorrilla, A.; Perinan, A.

2014-06-01

In the next years the European space industry has the challenge of maintaining its competitiveness in launch vehicles (LV) production, due to the growth of competition worldwide. It has to assure its position developing new applied technologies. In this field the effort is focussed on the production of short series of customized products, like payloads, flight components or launcher parts. ALM (Additive Layer Manufacturing) could be a powerful tool that offers new competitiveness factors for this industry, comprising a set of emerging technologies that are becoming a competitor to forming, casting and machining as well as being utilised directly as a complementary alternative.Originally used for prototypes and models, now ALM becomes a very useful technology capable to fabricate functional parts for the space industrial sector. Its demands on rapid technologies are different to "earth" industries, and they aren't so easily satisfied because space is a field with different requirements depending on its application: launchers, reusable vehicles, satellites, probes, low gravity researches, manned spacecraft, or even moon and planetary exploration.This paper reports on the ALM potential applications, under ESA requirements, exploring the challenges and possibilities for its use in the launchers market, trying to answer two basic questions: the first one, whether ALM is a mature technology to be ready for its use as flight hardware; and the second one, if it can be used to reduce the product cycle, and consequently, the development, production and operational costs.

Midwest vision for sustainable fuel production

USDA-ARS?s Scientific Manuscript database

Meeting the challenge of providing 30% of the transportation fuels used in the USA from those developed from biomass will require significant improvements in technology across the supply chain, significant commercial investment in infrastructure, and, because of the unique characteristics of biomass...

Nanotechnology and nanomedicine for healthcare: challenges in translating innovations from bench to bedside.

PubMed

Bellare, Jayesh R

2011-02-01

Nanobioengineering has led to development of human health care products of diagnostic as well as therapeutic nature. Safety and regulatory issues require extensive in vitro and in vivo trials for human applications in near future.

TOXICOLOGY OF MONO- AND DI-ALKYLTIN CHLORIDES

EPA Science Inventory

Mono- and di-alkyltin chlorides are reactive compounds used in the production of stabilizers for polyvinyl chloride (PVC) plastics, primarily used for water distribution pipes. Health effects data were compiled or developed by the manufacturers for the EPA's HPV Challenge progra...

TOXICOLOGY OF MONO- AND DI-ALKYLTIN CHLORIDES.

EPA Science Inventory

Mono- and di-alkyltin chlorides are reactive compounds used in the production of stabilizers for polyvinyl chloride (PVC) plastics, primarily used for water distribution pipes. Health effects data were compiled or developed by the manufacturers for the EPA's HPV Challenge progra...

Lettuce and spinach breeding

USDA-ARS?s Scientific Manuscript database

Lettuce and spinach production is beset by numerous biotic an abiotic challenges, thus the leafy-vegetable industry of California requires continued development of improved, adapted cultivars to meet new disease and insect problems, changes in the market, and changes in growing procedures. The lettu...

Engineering industrial yeast for renewable advanced biofuels applications

USDA-ARS?s Scientific Manuscript database

The industrial yeast Saccharomyces cerevisiae is a candidate for the next-generation biocatalyst development due to its unique genomic background and robust performance in fermentation-based production. In order to meet challenges of renewable and sustainable advanced biofuels conversion including ...

Microbial electrolysis cells turning to be versatile technology: recent advances and future challenges.

PubMed

Zhang, Yifeng; Angelidaki, Irini

2014-06-01

Microbial electrolysis cells (MECs) are an electricity-mediated microbial bioelectrochemical technology, which is originally developed for high-efficiency biological hydrogen production from waste streams. Compared to traditional biological technologies, MECs can overcome thermodynamic limitations and achieve high-yield hydrogen production from wide range of organic matters at relatively mild conditions. This approach greatly reduces the electric energy cost for hydrogen production in contrast to direct water electrolysis. In addition to hydrogen production, MECs may also support several energetically unfavorable biological/chemical reactions. This unique advantage of MECs has led to several alternative applications such as chemicals synthesis, recalcitrant pollutants removal, resources recovery, bioelectrochemical research platform and biosensors, which have greatly broaden the application scopes of MECs. MECs are becoming a versatile platform technology and offer a new solution for emerging environmental issues related to waste streams treatment and energy and resource recovery. Different from previous reviews that mainly focus on hydrogen production, this paper provides an up-to-date review of all the new applications of MECs and their resulting performance, current challenges and prospects of future. Copyright © 2014 Elsevier Ltd. All rights reserved.

Toward a Digital Thread and Data Package for Metals-Additive Manufacturing.

PubMed

Kim, D B; Witherell, P; Lu, Y; Feng, S

2017-01-01

Additive manufacturing (AM) has been envisioned by many as a driving factor of the next industrial revolution. Potential benefits of AM adoption include the production of low-volume, customized, complicated parts/products, supply chain efficiencies, shortened time-to-market, and environmental sustainability. Work remains, however, for AM to reach the status of a full production-ready technology. Whereas the ability to create unique 3D geometries has been generally proven, production challenges remain, including lack of (1) data manageability through information management systems, (2) traceability to promote product producibility, process repeatability, and part-to-part reproducibility, and (3) accountability through mature certification and qualification methodologies. To address these challenges in part, this paper discusses the building of data models to support the development of validation and conformance methodologies in AM. We present an AM information map that leverages informatics to facilitate part producibility, process repeatability, and part-to-part reproducibility in an AM process. We present three separate case studies to demonstrate the importance of establishing baseline data structures and part provenance through an AM digital thread.

Toward a Digital Thread and Data Package for Metals-Additive Manufacturing

PubMed Central

Kim, D. B.; Witherell, P.; Lu, Y.; Feng, S.

2017-01-01

Additive manufacturing (AM) has been envisioned by many as a driving factor of the next industrial revolution. Potential benefits of AM adoption include the production of low-volume, customized, complicated parts/products, supply chain efficiencies, shortened time-to-market, and environmental sustainability. Work remains, however, for AM to reach the status of a full production-ready technology. Whereas the ability to create unique 3D geometries has been generally proven, production challenges remain, including lack of (1) data manageability through information management systems, (2) traceability to promote product producibility, process repeatability, and part-to-part reproducibility, and (3) accountability through mature certification and qualification methodologies. To address these challenges in part, this paper discusses the building of data models to support the development of validation and conformance methodologies in AM. We present an AM information map that leverages informatics to facilitate part producibility, process repeatability, and part-to-part reproducibility in an AM process. We present three separate case studies to demonstrate the importance of establishing baseline data structures and part provenance through an AM digital thread. PMID:28691115

Rectal Pre-Exposure Prophylaxis (PrEP)

PubMed Central

Yang, Haitao; Wang, Lin

2014-01-01

Rectal pre-exposure prophylaxis (PrEP) will be a critical component of HIV prevention products due to the prevalence of unprotected receptive anal intercourse among men who have sex with men and heterosexual couples. Given the biological considerations of this compartment and the complexity of HIV infection, design of a successful rectal microbicide product faces a number of challenges. Important information is being compiled to begin to address deficits in knowledge toward design of rectal PrEP products for men and women. Aspects of formulation development and preclinical and clinical evaluation of rectal products studied to date are summarized in this review. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21–22, 2013. It forms part of a special supplement to Antiviral Research. PMID:24188705

An Overview of NASA SPoRT GOES-R JPSS Proving Ground Testbed Activities

NASA Technical Reports Server (NTRS)

Berndt, Emily; Stano, Geoffrey; Fuell, Kevin; Leroy, Anita; Mcgrath, Kevin; Molthan, Andrew; Schultz, Lori; Smith, Matthew; White, Kris; Schultz, Christopher;

Carbon Monitoring System Applications Framework: Lessons Learned from Stakeholder Engagement Activities

NASA Astrophysics Data System (ADS)

Sepulveda Carlo, E.; Escobar, V. M.; Delgado Arias, S.; Forgotson, C.

2017-12-01

The NASA Carbon Monitoring System initiated by U.S. Congress in 2010 is developing products that characterize and quantify carbon sources and sinks in the United States and the global tropics. In 2013, an applications effort was selected to engage potential end users and gather feedback about their data needs. For the past four years the CMS applications efforts has expanded and implemented a number of strategies to connect carbon scientists to decision-makers, contributing to the societal benefits of CMS data products. The applications efforts use crowd sourcing to collects feedback from stakeholders on challenges and lessons learned in the use of CMS data products. Some of the most common data needs from engaged organizations include above and below-ground biomass and fluxes in forestlands and wetlands, and greenhouse gas (GHG) emissions across all land use/cover and land use changes. Stakeholder organizations' needs for CMS data products support national GHG inventories following the Paris Agreement, carbon markets, and sub-national natural resources management and policies. The lessons learned report presents stakeholder specific applications, challenges, and successes from using CMS data products. To date, the most common uses of CMS products include: conservation efforts, emissions inventory, forestry and land cover applications, and carbon offset projects. The most common challenges include: the need for familiar and consistent products over time, budget constraints, and concern with uncertainty of modeled results. Recurrent recommendations from stakeholder indicate that CMS should provide high resolution (30m) and frequent data products updates (annually). The applications efforts have also helped identified success stories from different CMS projects, including the development of the GHG emissions inventory from Providence, RI, the improvement of the U.S. GHG Inventory though the use of satellite data, and the use of high resolution canopy cover maps for forestry, conservation, and ecosystem services applications in the tristate area of Maryland, Delaware and Pennsylvania. The presentation will discuss the applications framework methodology and strategy, as well as highlight some of the results and lessons learned from these applications efforts.

Urban ecosystem services for resilience planning and management in New York City.

PubMed

McPhearson, Timon; Hamstead, Zoé A; Kremer, Peleg

2014-05-01

We review the current state of knowledge about urban ecosystem services in New York City (NYC) and how these services are regulated, planned for, and managed. Focusing on ecosystem services that have presented challenges in NYC-including stormwater quality enhancement and flood control, drinking water quality, food provisioning and recreation-we find that mismatches between the scale of production and scale of management occur where service provision is insufficient. Adequate production of locally produced services and services which are more accessible when produced locally is challenging in the context of dense urban development that is characteristic of NYC. Management approaches are needed to address scale mismatches in the production and consumption of ecosystem services. By coordinating along multiple scales of management and promoting best management practices, urban leaders have an opportunity to ensure that nature and ecosystem processes are protected in cities to support the delivery of fundamental urban ecosystem services.

Acceptance of wearable technology by people with Alzheimer's disease: issues and accommodations.

PubMed

Mahoney, Edward L; Mahoney, Diane F

2010-09-01

The increasing number of cognitively impaired older adults who exhibit wandering tendencies raises safety concerns. The purpose of the current study was to research the State-of the-Art in Wearable Technologies for persons with Alzheimer's Disease and identify challenges unique to this population and lessons learned. Inclusion criteria specified systems/devices that completed laboratory testing and were commercially available for usage by community-based Alzheimer's family caregivers. Methods included a series of Internet product searches and telephone interviews with related corporate representatives and participant's referrals. Results indicated many products in development or academic research use but only a limited number were available that met the study criteria. The interviews with key informants revealed features necessary to consider when making products to be worn by persons with cognitive impairment. In conclusion, there is no ideal solution and opportunities remain for marketplace innovations and for addressing the challenges associated with balancing safety and security.

Innovations in vaccine development: can regulatory authorities keep up?

PubMed

Cox, Manon M J; Onraedt, Annelies

2012-10-01

Vaccine Production Summit San Francisco, CA, USA, 4-6 June 2012 IBC's 3rd Vaccine Production Summit featured 28 presentations discussing regulatory challenges in vaccine development, including the use of adjuvants, vaccine manufacturing and technology transfer, process development for vaccines and the role of quality by design, how to address vaccine stability, and how vaccine development timelines can be improved. The conference was run in parallel with the single-use applications for Biopharmaceutical Manufacturing conference. Approximately 250 attendees from large pharmaceutical companies, large and small biotech companies, vendors and a more limited number from academia were allowed to access sessions of either conference, including one shared session. This article summarizes the recurring themes across various presentations.

Titanium Aluminide Casting Technology Development

NASA Astrophysics Data System (ADS)

Bünck, Matthias; Stoyanov, Todor; Schievenbusch, Jan; Michels, Heiner; Gußfeld, Alexander

2017-12-01

Titanium aluminide alloys have been successfully introduced into civil aircraft engine technology in recent years, and a significant order volume increase is expected in the near future. Due to its beneficial buy-to-fly ratio, investment casting bears the highest potential for cost reduction of all competing production technologies for TiAl-LPTB. However, highest mechanical properties can be achieved by TiAl forging. In view of this, Access e.V. has developed technologies for the production of TiAl investment cast parts and TiAl die cast billets for forging purposes. While these parts meet the highest requirements, establishing series production and further optimizing resource and economic efficiency are present challenges. In order to meet these goals, Access has recently been certified according to aircraft standards, aiming at qualifying parts for production on technology readiness level 6. The present work gives an overview of the phases of development and certification.

The potential role of the osteoblast in the development of periprosthetic osteolysis: review of in vitro osteoblast responses to wear debris, corrosion products, and cytokines and growth factors.

PubMed

Vermes, C; Glant, T T; Hallab, N J; Fritz, E A; Roebuck, K A; Jacobs, J J

2001-12-01

Limited information is available on the responses of osteoblasts to wear debris, corrosion products, and cytokines and on the roles of altered osteoblast functions in the development of periprosthetic bone loss. Wear debris-challenged osteoblasts exhibit altered functions resulting in the loss of their capacity to produce bone matrix and to replace the resorbed bone. Also, osteoblasts may secrete cytokines, which act in a paracrine fashion to recruit inflammatory cells into the periprosthetic space and to stimulate osteoclastic bone resorption. These effects may be mediated in part by ionic metal dissolution products. We review the mechanisms by which altered osteoblast functions, in response to particulate wear debris, corrosion products, and cytokines and growth factors, may contribute to the development and the progression of periprosthetic osteolysis.

Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.

PubMed

Davis, Gregory C; Beals, John M; Johnson, Craig; Mayer, Mark H; Meiklejohn, Bruce I; Mitlak, Bruce H; Roth, Jody L; Towns, John K; Veenhuizen, Melissa

2009-07-01

Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will likely involve more complexity than comparability assessments of process changes made by the same manufacturer. The history of industry-regulator comparability discussions helps explain why the same degree of testing and flexibility now applied to change-control within a manufacturer's own process, at this time, cannot be extrapolated to the observed and possibly unknown differences between two manufacturing processes that are independently developed by different (non-collaborating) parties. This commentary provides recommendations on the technical aspects that should be considered in the creation of an approval pathway for FOB products. In the authors' view, analytical methodology in its current state cannot alone provide full assurance that the FOB is sufficiently similar to the innovator product. Moreover, the FOB manufacturer will not have access to the extensive knowledge accumulated by the innovator manufacturer from early development through marketing. Thus, extensive clinical evaluation will likely be necessary to provide assurance that the FOB is safe and efficacious. If such testing demonstrates the FOB is safe and efficacious per existing regulatory standards, the product should receive marketing approval as a 'similar' product. Since 'similarity' is a fundamentally different determination than establishing interchangeability between the two products, an interchangeability determination must be based on additional testing and market experience to ensure patient safety. Post-marketing surveillance of the FOB should be conducted to ensure that the approved molecule has similar clinical safety and efficacy as the innovator product, prior to any consideration of interchangeability.

High-throughput screening for bioactive components from traditional Chinese medicine.

PubMed

Zhu, Yanhui; Zhang, Zhiyun; Zhang, Meng; Mais, Dale E; Wang, Ming-Wei

2010-12-01

Throughout the centuries, traditional Chinese medicine has been a rich resource in the development of new drugs. Modern drug discovery, which relies increasingly on automated high throughput screening and quick hit-to-lead development, however, is confronted with the challenges of the chemical complexity associated with natural products. New technologies for biological screening as well as library building are in great demand in order to meet the requirements. Here we review the developments in these techniques under the perspective of their applicability in natural product drug discovery. Methods in library building, component characterizing, biological evaluation, and other screening methods including NMR and X-ray diffraction are discussed.

Innovation management based on proactive engagement of customers: A case study on LEGO Group. Part II: Challenge of engaging the digital customer

NASA Astrophysics Data System (ADS)

Avasilcăi, S.; Rusu, G.

2015-11-01

To foster the development of innovative products and new technologies, nowadays companies use an open innovation system, encouraging stakeholders to contribute, using the companies’ online platforms for open innovation or social media, bringing and sharing creative solutions and ideas in order to respond to challenging needs the company directly expresses. Accordingly, the current research continues the analysis of the LEGO Group innovation efforts, aiming to provide a case study approach based on describing the most important projects and online instruments company uses to interact with customers and other external stakeholders. Thus, by analysing the experience of the company in developing projects of involving stakeholders in the innovation processes, the article emphasizes the objective of these past projects developed by LEGO Group, outlining their objectives regarding the focus on the product or process innovation, the team management and stakeholders involved in the innovation actions and the results they obtained. Moreover, the case study highlights the features of the most important online instruments LEGO Group uses at the moment for engaging LEGO fans, children, parents, and other external stakeholders in developing new LEGO sets. Thus, LEGO online instruments provide the opportunity for customers to be creative and to respond to LEGO management team challenges. Accordingly, LEGO involve customers in bringing innovative ideas for LEGO sets through LEGO Ideas instrument, which aims to engage customers in submitting projects, voting and supporting ideas and also sharing them on social media. Also, the research emphasizes the role of supporting the open dialogue and interaction with customers and other external stakeholders through LEGO.com Create & Share Galleries instrument, using their creativity to upload innovative models in the public galleries. The continuous challenges LEGO launches for their fans create a long-term connection between company and its customers, supporting the value co-creation process, as the submitted ideas can materialize in new LEGO products which can be found on the market. As a consequence, customers’ engagement in the co-creation process facilitated by the multiple online instruments provided by LEGO, resulted in positive outcomes for the company regarding new product development for the sets launched on the market to satisfy changing needs of their customers. The results provided by this case study approach can be useful for the business environment and academia as well in order to understand the role of engaging customers in the open innovation process, creating a competitive advantage on the market for companies.

Commercialization of cellulose nanofibril (CNF) and cellulose nanocrystal (CNC): pathway and challenges

Treesearch

Alan Rudie

2017-01-01

The status of pilot-scale production methods for cellulose nanorods or nanocrystals and the 2,2,6,6-tetramethyl-4-hydroxypiperidine-1-0xyl (TEMPO) grade of cellu— lose nanofibrils are discussed. Both products appear to be poised for scale-up when markets develop, but there are a number of issues that need to be addressed. This chapter outlines concepts for conversion...

Developing microbe-plant interactions for applications in plant-growth promotion and disease control, production of useful compounds, remediation, and carbon sequestration

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wu, C.H.; Bernard, S.; Andersen, G.L.

2009-03-01

Interactions between plants and microbes are an integral part of our terrestrial ecosystem. Microbe-plant interactions are being applied in many areas. In this review, we present recent reports of applications in the areas of plant-growth promotion, biocontrol, bioactive compound and biomaterial production, remediation and carbon sequestration. Challenges, limitations and future outlook for each field are discussed.

The regulator's perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?

PubMed

Crommelin, Daan Ja; Broich, Karl; Holloway, Chris; Meesen, Bianca; Lizrova Preiningerova, Jana; Prugnaud, Jean-Louis; Silva-Lima, Beatriz

2016-08-01

Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients. © The Author(s), 2016.

Concept for Sustained Plant Production on ISS Using VEGGIE Capillary Mat Rooting System

NASA Technical Reports Server (NTRS)

Stutte, Gary W.; Newsham, Gerard; Morrow, Robert M.; Wheeler, Raymond M.

2011-01-01

Plant growth in microgravity presents unique challenges associated with maintaining appropriate conditions for seed germination, seedling establishment, maturation and harvest. They include maintaining appropriate soil moisture content, nutrient balance, atmospheric mixing and containment. Sustained production imposes additional challenges of harvesting, replanting, and safety. The VEGGIE is a deployable (collapsible) plant growth chamber developed as part of a NASA SBIR Phase II by Orbitec, Madison, WI. The intent of VEGGIE is to provide a low-resource system to produce fresh vegetables for the crew on long duration missions. The VEGGIE uses and LED array for lighting, an expandable bellows for containment, and a capillary matting system for nutrient and water delivery. The project evaluated a number of approaches to achieve sustained production, and repeated plantings, using the capillary rooting system. A number of different root media, seed containment, and nutrient delivery systems were evaluated and effects on seed germination and growth were evaluated. A number of issues limiting sustained production, such as accumulation of nutrients, uniform water, elevated vapor pressure deficit, and media containment were identified. A concept using pre-planted rooting packs shown to effectively address a number of those issues and is a promising approach for future development as a planting system for microgravity conditions.

Translating cell-based regenerative medicines from research to successful products: challenges and solutions.

PubMed

Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Egloff, Matthieu; Snykers, Sarah; Salinas, Gabriella Franco; Thomas, Robert; Girling, Alan; Lilford, Richard; Clermont, Gaelle; Kemp, Paul

2014-08-01

The Tissue Engineering & Regenerative Medicine International Society-Europe (TERMIS-EU) Industry Committee as well as its TERMIS-Americas (AM) counterpart intend to address the specific challenges and needs facing the industry in translating academic research into commercial products. Over the last 3 years, the TERMIS-EU Industry Committee has worked with commercial bodies to deliver programs that encourage academics to liaise with industry in proactive collaborations. The TERMIS-EU 2013 Industry Symposium aimed to build on this commercial agenda by focusing on two topics: Operations Management (How to move a process into the good manufacturing practice [GMP] environment) and Clinical Translation (Moving a GMP process into robust trials). These topics were introduced by providing the synergistic business perspective of partnering between the multiple regenerative medicine stakeholders, throughout the life cycle of product development. Seven industry leaders were invited to share their experience, expertise, and strategies. Due to the complex nature of regenerative medicine products, partnering for their successful commercial development seems inevitable to overcome all obstacles by sharing experiences and expertise of all stakeholders. When ideally implemented, the "innovation quotient" of a virtual team resulting from the combination of internal and external project teams can be maximized through maximizing the three main dimensions: core competences, technology portfolio, and alliance management.

Low-cost uncooled VOx infrared camera development

NASA Astrophysics Data System (ADS)

Li, Chuan; Han, C. J.; Skidmore, George D.; Cook, Grady; Kubala, Kenny; Bates, Robert; Temple, Dorota; Lannon, John; Hilton, Allan; Glukh, Konstantin; Hardy, Busbee

2013-06-01

The DRS Tamarisk® 320 camera, introduced in 2011, is a low cost commercial camera based on the 17 µm pixel pitch 320×240 VOx microbolometer technology. A higher resolution 17 µm pixel pitch 640×480 Tamarisk®640 has also been developed and is now in production serving the commercial markets. Recently, under the DARPA sponsored Low Cost Thermal Imager-Manufacturing (LCTI-M) program and internal project, DRS is leading a team of industrial experts from FiveFocal, RTI International and MEMSCAP to develop a small form factor uncooled infrared camera for the military and commercial markets. The objective of the DARPA LCTI-M program is to develop a low SWaP camera (<3.5 cm3 in volume and <500 mW in power consumption) that costs less than US $500 based on a 10,000 units per month production rate. To meet this challenge, DRS is developing several innovative technologies including a small pixel pitch 640×512 VOx uncooled detector, an advanced digital ROIC and low power miniature camera electronics. In addition, DRS and its partners are developing innovative manufacturing processes to reduce production cycle time and costs including wafer scale optic and vacuum packaging manufacturing and a 3-dimensional integrated camera assembly. This paper provides an overview of the DRS Tamarisk® project and LCTI-M related uncooled technology development activities. Highlights of recent progress and challenges will also be discussed. It should be noted that BAE Systems and Raytheon Vision Systems are also participants of the DARPA LCTI-M program.

Large-scale production of diesel-like biofuels - process design as an inherent part of microorganism development.

PubMed

Cuellar, Maria C; Heijnen, Joseph J; van der Wielen, Luuk A M

2013-06-01

Industrial biotechnology is playing an important role in the transition to a bio-based economy. Currently, however, industrial implementation is still modest, despite the advances made in microorganism development. Given that the fuels and commodity chemicals sectors are characterized by tight economic margins, we propose to address overall process design and efficiency at the start of bioprocess development. While current microorganism development is targeted at product formation and product yield, addressing process design at the start of bioprocess development means that microorganism selection can also be extended to other critical targets for process technology and process scale implementation, such as enhancing cell separation or increasing cell robustness at operating conditions that favor the overall process. In this paper we follow this approach for the microbial production of diesel-like biofuels. We review current microbial routes with both oleaginous and engineered microorganisms. For the routes leading to extracellular production, we identify the process conditions for large scale operation. The process conditions identified are finally translated to microorganism development targets. We show that microorganism development should be directed at anaerobic production, increasing robustness at extreme process conditions and tailoring cell surface properties. All the same time, novel process configurations integrating fermentation and product recovery, cell reuse and low-cost technologies for product separation are mandatory. This review provides a state-of-the-art summary of the latest challenges in large-scale production of diesel-like biofuels. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Test Driven Development of Scientific Models

NASA Technical Reports Server (NTRS)

Clune, Thomas L.

2014-01-01

Test-Driven Development (TDD), a software development process that promises many advantages for developer productivity and software reliability, has become widely accepted among professional software engineers. As the name suggests, TDD practitioners alternate between writing short automated tests and producing code that passes those tests. Although this overly simplified description will undoubtedly sound prohibitively burdensome to many uninitiated developers, the advent of powerful unit-testing frameworks greatly reduces the effort required to produce and routinely execute suites of tests. By testimony, many developers find TDD to be addicting after only a few days of exposure, and find it unthinkable to return to previous practices.After a brief overview of the TDD process and my experience in applying the methodology for development activities at Goddard, I will delve more deeply into some of the challenges that are posed by numerical and scientific software as well as tools and implementation approaches that should address those challenges.

Ophthalmic Start-Up Chief Executive Officers' Perceptions of Development Hurdles.

PubMed

Stewart, William C; Nelson, Lindsay A; Kruft, Bonnie; Stewart, Jeanette A

2018-01-01

To identify current challenges facing ophthalmic pharmaceutical start-ups in developing new products. Surveys were distributed to the chief executive officer (CEO) or president of ophthalmic start-ups. The survey attracted 24 responses from 78 surveys distributed (31%). The CEOs stated that a lack of financial capital (n = 18, 75%), FDA regulations (n = 6, 25%), and failure to meet clinical endpoints (n = 6, 25%) were their greatest development hurdles. Risk aversion to medicines in early development (n = 18, 75%), mergers and acquisitions reducing corporate choice for licensing agreements (n = 7, 29%), the emergence of large pharmaceutical-based venture capital funding groups (n = 12, 50%), and the failure of many large pharmaceutical companies to develop their own medicines (n = 10, 42%) were noted as recent prominent trends affecting fundraising. The study suggests that development funding, regulatory burden, and meeting clinical endpoints are the greatest development challenges faced by ophthalmic start-up CEOs. © 2017 S. Karger AG, Basel.

New challenges and opportunities for industrial biotechnology.

PubMed

Chen, Guo-Qiang

2012-08-20

Industrial biotechnology has not developed as fast as expected due to some challenges including the emergences of alternative energy sources, especially shale gas, natural gas hydrate (or gas hydrate) and sand oil et al. The weaknesses of microbial or enzymatic processes compared with the chemical processing also make industrial biotech products less competitive with the chemical ones. However, many opportunities are still there if industrial biotech processes can be as similar as the chemical ones. Taking advantages of the molecular biology and synthetic biology methods as well as changing process patterns, we can develop bioprocesses as competitive as chemical ones, these including the minimized cells, open and continuous fermentation processes et al.

Mask manufacturing improvement through capability definition and bottleneck line management

NASA Astrophysics Data System (ADS)

Strott, Al

1994-02-01

In 1989, Intel's internal mask operation limited itself to research and development activities and re-inspection and pellicle application of externally manufactured masks. Recognizing the rising capital cost of mask manufacturing at the leading edge, Intel's Mask Operation management decided to offset some of these costs by manufacturing more masks internally. This was the beginning of the challenge they set to manufacture at least 50% of Intel's mask volume internally, at world class performance levels. The first step in responding to this challenge was the completion of a comprehensive operation capability analysis. A series of bottleneck improvements by focus teams resulted in an average cycle time improvement to less than five days on all product and less than two days on critical products.

Facility for orbital material processing

NASA Astrophysics Data System (ADS)

Starodubov, D.; McCormick, K.; Dellosa, M.; Erdelyi, E.; Volfson, L.

2018-05-01

The sustainable orbital manufacturing with commercially viable and profitable operation has tremendous potential for driving the space exploration industry and human expansion into outer space. This highly challenging task has never been accomplished before. The current relatively high delivery cost of materials represents the business challenge of value proposition for making products in space. FOMS Inc. team identified an opportunity of fluoride optical fiber manufacturing in space that can lead to the first commercial production on orbit. To address continued cost effective International Space Station (ISS) operations FOMS Inc. has developed and demonstrated for the first time a fully operational space facility for orbital remote manufacturing with up to 50 km fiber fabrication capability and strong commercial potential for manufacturing operations on board the ISS.

From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology--part 2: coverage.

PubMed

Raab, G Gregory; Parr, David H

2006-10-01

This paper, the second of 3 that discuss the reimbursement challenges facing new medical device technology in various issues of this journal, explains the key aspects of coverage that affect the adoption of medical devices. The process Medicare uses to make coverage determinations has become more timely and open over the past several years, but it still lacks the predictability that product innovators prefer. The continued uncertainty surrounding evidence requirements undermines the predictability needed for optimal product planning and innovation. Recent steps taken by the Centers for Medicare and Medicaid Services to provide coverage in return for evidence development should provide patients with access to promising new technologies and procedures while generating important evidence concerning their effectiveness.

Low carbon transition and sustainable development path of tourism industry

NASA Astrophysics Data System (ADS)

Zhu, Hongbing; Zhang, Jing; Zhao, Lei; Jin, Shenglang

2017-05-01

The low carbon transition is as much a transformative technology shift as it represents a response to global environment challenges. The low carbon paradigm presents a new direction of change for tourism industry. However, the lack of theoretical frameworks on low carbon transformation in tourism industry context provides a significant knowledge gap. This paper firstly investigates the relationships between low carbon and sustainable development, followed by exploring the existing challenges of tourism sustainable development. At last, this paper presents a sustainable development path framework for low carbon transition of tourism industry, which include accelerating deployment of renewable energy, energy-saving green building construction, improving green growth investment, and adopting a sustainable consumption and production system, in order to promote energy and water efficiency, waste management, GHG emissions mitigation and eventually enhance its sustainability.

Creation of next generation U.S. Geological Survey topographic maps

USGS Publications Warehouse

Craun, Kari J.

2010-01-01

The U.S. Geological Survey (USGS) is 2 years into a 3-year cycle to create new digital topographic map products for the conterminous United States from data acquired and maintained as part of The National Map databases. These products are in the traditional, USGS topographic quadrangle, 7.5-minute (latitude and longitude) cell format. The 3-year cycle was conceived to follow the acquisition of National Aerial Imagery Program (NAIP) orthorectified imagery, a key layer in the new product. In fiscal year (FY) 2009 (ending September 30, 2009), the first year of the 3-year cycle, the USGS produced 13,200 products. These initial products of the “Digital MapBeta” series had limited feature content, including only the NAIP image, some roads, geographic names, and grid and collar information. The products were created in layered georegistered Portable Document Format (PDF) files, allowing users with freely available Adobe® Reader® software to view, print, and perform simple Geographic Information System-like functions. In FY 2010 (ending September 30, 2010), the USGS produced 20,380 products. These products of the “US Topo” series added hydrography (surface water features), contours, and some boundaries. In FY 2011 (ending September 30, 2011), the USGS will complete the initial coverage with US Topo products and will add additional feature content to the maps. The design, development, and production associated with the US Topo products provide management and technical challenges for the USGS and its public and private sector partners. One challenge is the acquisition and maintenance of nationally consistent base map data from multiple sources. Another is the use of these data to create a consistent, current series of cartographic products that can be used by the broad spectrum of traditional topographic map users. Although the USGS and its partners have overcome many of these challenges, many, such as establishing and funding a sustainable base data-maintenance program, remain to be resolved for the long term.

Physiological Importance and Mechanisms of Protein Hydrolysate Absorption

NASA Astrophysics Data System (ADS)

Zhanghi, Brian M.; Matthews, James C.

Understanding opportunities to maximize the efficient digestion and assimilation by production animals of plant- and animal-derived protein products is critical for farmers, nutritionists, and feed manufacturers to sustain and expand the affordable production of high quality animal products for human consumption. The challenge to nutritionists is to match gastrointestinal tract load to existing or ­inducible digestive and absorptive capacities. The challenge to feed manufacturers is to develop products that are efficient substrates for digestion, absorption, and/or both events. Ultimately, the efficient absorption of digesta proteins depends on the mediated passage (transport) of protein hydrosylate products as dipeptides and unbound amino acids across the lumen- and blood-facing membranes of intestinal absorptive cells. Data testing the relative efficiency of supplying protein as hydrolysates or specific dipeptides versus as free amino acids, and the response of animals in several physiological states to feeding of protein hydrolysates, are presented and reviewed in this chapter. Next, data describing the transport mechanisms responsible for absorbing protein hydrolysate digestion products, and the known and putative regulation of these mechanisms by their substrates (small peptides) and hormones are presented and reviewed. Several conclusions are drawn regarding the efficient use of protein hydrolysate-based diets for particular physiological states, the economically-practical application of which likely will depend on technological advances in the manufacture of protein hydrolysate products.

Contribution of economic evaluation to decision making in early phases of product development: a methodological and empirical review.

PubMed

Hartz, Susanne; John, Jürgen

2008-01-01

Economic evaluation as an integral part of health technology assessment is today mostly applied to established technologies. Evaluating healthcare innovations in their early states of development has recently attracted attention. Although it offers several benefits, it also holds methodological challenges. The aim of our study was to investigate the possible contributions of economic evaluation to industry's decision making early in product development and to confront the results with the actual use of early data in economic assessments. We conducted a literature research to detect methodological contributions as well as economic evaluations that used data from early phases of product development. Economic analysis can be beneficially used in early phases of product development for various purposes including early market assessment, R&D portfolio management, and first estimations of pricing and reimbursement scenarios. Analytical tools available for these purposes have been identified. Numerous empirical works were detected, but most do not disclose any concrete decision context and could not be directly matched with the suggested applications. Industry can benefit from starting economic evaluation early in product development in several ways. Empirical evidence suggests that there is still potential left unused.

A ten-step process to develop case management plans.

PubMed

Tahan, Hussein A

2002-01-01

The use of case management plans has contained cost and improved quality of care successfully. However, the process of developing these plans remains a great challenge for healthcare executives, in this article, the author presents the answer to this challenge by discussing a 10-step formal process that administrators of patient care services and case managers can adapt to their institutions. It also can be used by interdisciplinary team members as a practical guide to develop a specific case management plan. This process is applicable to any care setting (acute, ambulatory, long term, and home care), diagnosis, or procedure. It is particularly important for those organizations that currently do not have a deliberate and systematic process to develop case management plans and are struggling with how to improve the efficiency and productivity of interdisciplinary teams charged with developing case management plans.

Functionality of alternative protein in gluten-free product development.

PubMed

Deora, Navneet Singh; Deswal, Aastha; Mishra, Hari Niwas

2015-07-01

Celiac disease is an immune-mediated disease triggered in genetically susceptible individuals by ingested gluten from wheat, rye, barley, and other closely related cereal grains. The current treatment for celiac disease is life-long adherence to a strict gluten-exclusion diet. The replacement of gluten presents a significant technological challenge, as it is an essential structure-building protein, which is necessary for formulating high-quality baked goods. A major limitation in the production of gluten-free products is the lack of protein functionality in non-wheat cereals. Additionally, commercial gluten-free mixes usually contain only carbohydrates, which may significantly limit the amount of protein in the diet. In the recent past, various approaches are attempted to incorporate protein-based ingredients and to modify the functional properties for gluten-free product development. This review aims to the highlight functionality of the alternative protein-based ingredients, which can be utilized for gluten-free product development both functionally as well as nutritionally. © The Author(s) 2014.

Interfacial sciences in unconventional petroleum production: from fundamentals to applications.

PubMed

He, Lin; Lin, Feng; Li, Xingang; Sui, Hong; Xu, Zhenghe

2015-08-07

With the ever increasing demand for energy to meet the needs of growth in population and improvement in the living standards in particular in developing countries, the abundant unconventional oil reserves (about 70% of total world oil), such as heavy oil, oil/tar sands and shale oil, are playing an increasingly important role in securing global energy supply. Compared with the conventional reserves unconventional oil reserves are characterized by extremely high viscosity and density, combined with complex chemistry. As a result, petroleum production from unconventional oil reserves is much more difficult and costly with more serious environmental impacts. As a key underpinning science, understanding the interfacial phenomena involved in unconventional petroleum production, such as oil liberation from host rocks, oil-water emulsions and demulsification, is critical for developing novel processes to improve oil production while reducing GHG emission and other environmental impacts at a lower operating cost. In the past decade, significant efforts and advances have been made in applying the principles of interfacial sciences to better understand complex unconventional oil-systems, while many environmental and production challenges remain. In this critical review, the recent research findings and progress in the interfacial sciences related to unconventional petroleum production are critically reviewed. In particular, the chemistry of unconventional oils, liberation mechanisms of oil from host rocks and mechanisms of emulsion stability and destabilization in unconventional oil production systems are discussed in detail. This review also seeks to summarize the current state-of-the-art characterization techniques and brings forward the challenges and opportunities for future research in this important field of physical chemistry and petroleum.

[Territory, intersectoriality and stages: requirements for the effectiveness of the sustainable development goals].

PubMed

Gallo, Edmundo; Setti, Andréia Faraoni Freitas

2014-11-01

The post-2015 development agenda highlights the incorporation of sustainability in approaches developed and/or applied to distinct fields of knowledge and action and the demonstration of the effectiveness of experiences of sustainable and healthy territories. This process results from the confrontation of different viewpoints which seek to address social production vis-à-vis their project, with the possibility of updating the hegemonic mode of production and consumption or the emergence of counter-hegemonic rationales. Health, as one of the SDGs, has the challenge of imposing an intersectorial agenda that addresses its social determinants, in a process of participative governance able to build a hierarchy of priorities based on the needs of the territory and build techno-political solutions based on the ecology of knowledge, constituting a strategic-situational and communicative management process. The consistency in formulation of the agenda and potential challenges to its implementation are analyzed, considering its intersectoriality, its strategic governance and management, and especially an assessment of its effectiveness. Moreover, it tests the evaluative tools used and their ability to analyze the consistency in the formulation of the agenda.

Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products.

PubMed

Nicolette, C A; Healey, D; Tcherepanova, I; Whelton, P; Monesmith, T; Coombs, L; Finke, L H; Whiteside, T; Miesowicz, F

2007-09-27

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.

Tissue engineering strategies in spinal arthrodesis: the clinical imperative and challenges to clinical translation.

PubMed

Evans, Nick R; Davies, Evan M; Dare, Chris J; Oreffo, Richard Oc

2013-01-01

Skeletal disorders requiring the regeneration or de novo production of bone present considerable reconstructive challenges and are one of the main driving forces for the development of skeletal tissue engineering strategies. The skeletal or mesenchymal stem cell is a fundamental requirement for osteogenesis and plays a pivotal role in the design and application of these strategies. Research activity has focused on incorporating the biological role of the mesenchymal stem cell with the developing fields of material science and gene therapy in order to create a construct that is not only capable of inducing host osteoblasts to produce bone, but is also osteogenic in its own right. This review explores the clinical need for reparative approaches in spinal arthrodesis, identifying recent tissue engineering strategies employed to promote spinal fusion, and considers the ongoing challenges to successful clinical translation.

Challenging the Myth of Disability.

ERIC Educational Resources Information Center

Brightman, Alan

1989-01-01

Discussion of the rhetoric of disability, including physical, hearing, and visual impairments, highlights possible benefits that computer technology can provide. Designing for disabled individuals is discussed, and product development efforts by Apple Computer to increase microcomputer access to disabled children and adults are described. (LRW)

Affective Dimensions of Reading Instruction

ERIC Educational Resources Information Center

Biberstine, Richard D.

1977-01-01

The challenge to reading instructors is to develop in their pupils not only good reading skills, but also the means to understand their own feelings and emotions through reading, and to build positive feelings and emotions related to the process and products of reading. (MB)

R and D Productivity: New Challenges for the US Space Program

NASA Technical Reports Server (NTRS)

Baskin, O. W. (Editor); Sullivan, L. J. (Editor)

1985-01-01

Various topics related to research and development activities applicable to their U.S. space program are discussed. Project management, automatic control technology, human resources, management information systems, computer aided design, systems engineering, and personnel management were among the topics covered.

Preparing Twice Exceptional Students for Adult Lives: A Critical Need.

ERIC Educational Resources Information Center

Hua, C. Bruce; Coleman, Mary Ruth

2002-01-01

Six necessary program components to prepare gifted students with disabilities for productive adult lives are identified: provide challenging educational experiences along with supports, facilitate passion learning through enrichment activities, empower students through student-centered planning, develop self-advocacy, enhance positive social…

Automated Laser Ultrasonic Testing (ALUT) of Hybrid Arc Welds for Pipeline Construction, #272

DOT National Transportation Integrated Search

2009-12-22

One challenge in developing new gas reserves is the high cost of pipeline construction. Welding costs are a major component of overall construction costs. Industry continues to seek advanced pipeline welding technologies to improve productivity and s...

Women and agricultural productivity: Reframing the Issues.

PubMed

Doss, Cheryl R

2018-01-01

Should agricultural development programmes target women in order to increase productivity? This article analyzes the challenges in distinguishing women's agricultural productivity from that of men. Most of the literature compares productivity on plots managed by women with those managed by men, ignoring the majority of agricultural households in which men and women are both involved in management and production. The empirical studies which have been carried out provide scant evidence for where the returns to projects may be highest, in terms of who to target. Yet, programmes that do not consider gendered responsibilities, resources and constraints, are unlikely to succeed, either in terms of increasing productivity or benefitting men and women smallholder farmers.

Improved process robustness by using closed loop control in deep drawing applications

NASA Astrophysics Data System (ADS)

Barthau, M.; Liewald, M.; Christian, Held

2017-09-01

The production of irregular shaped deep-drawing parts with high quality requirements, which are common in today’s automotive production, permanently challenges production processes. High requirements on lightweight construction of passenger car bodies following European regulations until 2020 have been massively increasing the use of high strength steels substantially for years and are also leading to bigger challenges in sheet metal part production. Of course, the more and more complex shapes of today’s car body shells also intensify the issue due to modern and future design criteria. The metal forming technology tries to meet these challenges by developing a highly sophisticated layout of deep drawing dies that consider part quality requirements, process robustness and controlled material flow during the deep or stretch drawing process phase. A new method for controlling material flow using a closed loop system was developed at the IFU Stuttgart. In contrast to previous approaches, this new method allows a control intervention during the deep-drawing stroke. The blank holder force around the outline of the drawn part is used as control variable. The closed loop is designed as trajectory follow up with feed forward control. The used command variable is the part-wall stress that is measured with a piezo-electric measuring pin. In this paper the used control loop will be described in detail. The experimental tool that was built for testing the new control approach is explained here with its features. A method for gaining the follow up trajectories from simulation will also be presented. Furthermore, experimental results considering the robustness of the deep drawing process and the gain in process performance with developed control loop will be shown. Finally, a new procedure for the industrial application of the new control method of deep drawing will be presented by using a new kind of active element to influence the local blank holder pressure onto part flange.

Professional Master's degree in Nursing: knowledge production and challenges

PubMed Central

Munari, Denize Bouttelet; Parada, Cristina Maria Garcia de Lima; Gelbcke, Francine de Lima; Silvino, Zenith Rosa; Ribeiro, Luana Cássia Miranda; Scochi, Carmen Gracinda Silvan

2014-01-01

Objective to analyze the production of knowledge resulting from the professional master's degree programs in Nursing and to reflect about their perspectives for the area. Method descriptive and analytical study. Data collected from the dissertations of three educational institutions that graduated students in programs of professional master's degree in Nursing between 2006 and 2012 were included. Results most of the 127 course completion studies analyzed were developed within hospital contexts; there was a focus on the organizational and healthcare areas, in the research fields care process and management, and predominance of qualitative studies. There are various products resulting from the course completion studies: evaluation of services/healthcare programs and development of processes, care or educational protocols. Conclusion the programs of professional master's degree in Nursing, which are undergoing a consolidation stage, have recent production under development and there is a gap in the creation of hard technologies and innovation. They are essential for the development of innovative professional practices that articulate the healthcare and educational areas. PMID:26107826

Review—Practical Challenges Hindering the Development of Solid State Li Ion Batteries

DOE PAGES

Kerman, Kian; Luntz, Alan; Viswanathan, Venkatasubramanian; ...

2017-06-09

Solid state electrolyte systems boasting Li+ conductivity of >10 mS cm -1 at room temperature have opened the potential for developing a solid state battery with power and energy densities that are competitive with conventional liquid electrolyte systems. The primary focus of this review is twofold. First, differences in Li penetration resistance in solid state systems are discussed, and kinetic limitations of the solid state interface are highlighted. Second, technological challenges associated with processing such systems in relevant form factors are elucidated, and architectures needed for cell level devices in the context of product development are reviewed. Specific research vectorsmore » that provide high value to advancing solid state batteries are outlined and discussed.« less