Evaluation production index of test well about tight gas reservoir

NASA Astrophysics Data System (ADS)

Huang, Xiaoliang; Yan, Wende; Yuan, Yingzhong; Li, Jiqiang; Li, Xiaoxue

2018-03-01

It is important that the tight gas reservoir is developed with test wells in the first place for the reasonable development, and it is necessary evaluation production index of test well. So, the paper will evaluate gas wells capacity, reasonable production, production decline law and producing reserves. Combining with calculation theory, comparison of adjacent wells and field practice, obtained reasonable production, production decline law and production reserves about test well, and through analysis the adjacent well obtained development experience and lessons about tight gas reservoir. The results show that the gas well development should pay attention to reasonable production and prevent energy falling too fast in tight gas reservoirs, The decline rule of wells with long production time should be analyzed by two stages. Through study, it will provide some reference and guidance for the development of gas wells in tight gas reservoirs.

Product Development and its Comparative Analysis by SLA, SLS and FDM Rapid Prototyping Processes

NASA Astrophysics Data System (ADS)

Choudhari, C. M.; Patil, V. D.

2016-09-01

To grab market and meeting deadlines has increased the scope of new methods in product design and development. Industries continuously strive to optimize the development cycles with high quality and cost efficient products to maintain market competitiveness. Thus the need of Rapid Prototyping Techniques (RPT) has started to play pivotal role in rapid product development cycle for complex product. Dimensional accuracy and surface finish are the corner stone of Rapid Prototyping (RP) especially if they are used for mould development. The paper deals with the development of part made with the help of Selective Laser Sintering (SLS), Stereo-lithography (SLA) and Fused Deposition Modelling (FDM) processes to benchmark and investigate on various parameters like material shrinkage rate, dimensional accuracy, time, cost and surface finish. This helps to conclude which processes can be proved to be effective and efficient in mould development. In this research work the emphasis was also given to the design stage of a product development to obtain an optimum design solution for an existing product.

Use of consumer insight in the new product development process in the meat sector.

PubMed

Grunert, Klaus G; Verbeke, Wim; Kügler, Jens O; Saeed, Faiza; Scholderer, Joachim

2011-11-01

Successful new product development requires input from the market throughout the product development process, from identification of opportunities via screening of ideas, development of concepts, development of physical prototypes and to launch. Drawing on work done in the EU FP6 projects PROSAFEBEEF and Q-PORKCHAINS and a Danish project, all dealing with new product development in the meat sector, it is shown how the use of consumer insight techniques can a) support the identification of market opportunities, b) make sure that technologies applied are acceptable to consumers, c) aid the selection and optimisation of new product concepts and related communication, and d) be used to test product prototypes before final launch. Copyright © 2011 Elsevier Ltd. All rights reserved.

Emerging Issues from New Product Development in Food Manufacturing Industries.

DTIC Science & Technology

1981-08-19

where price competition can be avoided by increasing emphasis on new product development and by experimenting with product characteristics and images...stress price compe- tition rather than emphasize new product devel- opment and further extend the availability of economy-oriented food products ...is based not on costs and price , but on new product development. 33/, 34/ 13 Economic theory predicts that forces that act to concentrate economic

A meta-heuristic approach supported by NSGA-II for the design and plan of supply chain networks considering new product development

NASA Astrophysics Data System (ADS)

Alizadeh Afrouzy, Zahra; Paydar, Mohammad Mahdi; Nasseri, Seyed Hadi; Mahdavi, Iraj

2018-03-01

There are many reasons for the growing interest in developing new product projects for any firm. The most embossed reason is surviving in a highly competitive industry which the customer tastes are changing rapidly. A well-managed supply chain network can provide the most profit for firms due to considering new product development. Along with profit, customer satisfaction and production of new products are goals which lead to a more efficient supply chain. As new products appear in the market, the old products could become obsolete, and then phased out. The most important parameter in a supply chain which considers new and developed products is the time that developed and new products are introduced and old products are phased out. With consideration of the factors noted above, this study proposes to design a tri-objective multi-echelon multi-product multi-period supply chain model, which incorporates product development and new product production and their effects on supply chain configuration. The supply chain under consideration is assumed to consist of suppliers, manufacturers, distributors and customer groups. In terms of overcoming NP-hardness of the proposed model and in order to solve the complicated problem, a non-dominated sorting genetic algorithm is employed. As there is no benchmark available in the literature, the non-dominated ranking genetic algorithm is developed to validate the results obtained and some test problems are provided to show the applicability of the proposed methodology and evaluate the performance of the algorithms.

Science and Technology in Development Environments - Industry and Department of Defense Case Studies

DTIC Science & Technology

2003-11-01

an acronym for Product and Cycle Time Excellence, is designed to manage product development , business development , and business alliance processes...experiments. 3. Test Practicality—Pilot development with limited production. 4. Prove Profitability—Pilot production. 5. Manage Life Cycle —Manufacturing and...compressor, particularly in a turbofan configuration, was developed primarily under a CIP for these two engines. The TF30 and F100 experiences provide

Developing a new production host from a blueprint: Bacillus pumilus as an industrial enzyme producer.

PubMed

Küppers, Tobias; Steffen, Victoria; Hellmuth, Hendrik; O'Connell, Timothy; Bongaerts, Johannes; Maurer, Karl-Heinz; Wiechert, Wolfgang

2014-03-24

Since volatile and rising cost factors such as energy, raw materials and market competitiveness have a significant impact on the economic efficiency of biotechnological bulk productions, industrial processes need to be steadily improved and optimized. Thereby the current production hosts can undergo various limitations. To overcome those limitations and in addition increase the diversity of available production hosts for future applications, we suggest a Production Strain Blueprinting (PSB) strategy to develop new production systems in a reduced time lapse in contrast to a development from scratch.To demonstrate this approach, Bacillus pumilus has been developed as an alternative expression platform for the production of alkaline enzymes in reference to the established industrial production host Bacillus licheniformis. To develop the selected B. pumilus as an alternative production host the suggested PSB strategy was applied proceeding in the following steps (dedicated product titers are scaled to the protease titer of Henkel's industrial production strain B. licheniformis at lab scale): Introduction of a protease production plasmid, adaptation of a protease production process (44%), process optimization (92%) and expression optimization (114%). To further evaluate the production capability of the developed B. pumilus platform, the target protease was substituted by an α-amylase. The expression performance was tested under the previously optimized protease process conditions and under subsequently adapted process conditions resulting in a maximum product titer of 65% in reference to B. licheniformis protease titer. In this contribution the applied PSB strategy performed very well for the development of B. pumilus as an alternative production strain. Thereby the engineered B. pumilus expression platform even exceeded the protease titer of the industrial production host B. licheniformis by 14%. This result exhibits a remarkable potential of B. pumilus to be the basis for a next generation production host, since the strain has still a large potential for further genetic engineering. The final amylase titer of 65% in reference to B. licheniformis protease titer suggests that the developed B. pumilus expression platform is also suitable for an efficient production of non-proteolytic enzymes reaching a final titer of several grams per liter without complex process modifications.

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

Low-Cost Rapid Usability Testing: Its Application in Both Product Development and System Implementation.

PubMed

Kushniruk, Andre; Borycki, Elizabeth

2017-01-01

In recent years there has been considerable discussion around the need for certification and regulation of healthcare information technology (IT). In particular, the usability of the products being developed needs to be evaluated. This has included the application of standards designed to ensure the process of system development is user-centered and takes usability into consideration while a product is being developed. In addition to this, in healthcare, organizations in the United States and Europe have also addressed the need and requirement for product certification. However, despite these efforts there are continued reports of unusable and unsafe implementations. In this paper we discuss the need to not only include (and require) usability testing in the one-time development process of health IT products (such as EHRs), but we also argue for the need to additionally develop specific usability standards and requirements for usability testing during the implementation of vendor products (i.e. post product development) in healthcare settings. It is further argued that health IT products that may have been certified regarding their development process will still require application of usability testing in the process of implementing them in real hospital settings in order to ensure usability and safety. This is needed in order to ensure that the final result of both product development and implementation processes take into account and apply the latest usability principles and methods.

Expanding lean thinking to the product and process design and development within the framework of sustainability

NASA Astrophysics Data System (ADS)

Sorli, M.; Sopelana, A.; Salgado, M.; Pelaez, G.; Ares, E.

2012-04-01

Companies require tools to change towards a new way of developing and producing innovative products to be manufactured considering the economic, social and environmental impact along the product life cycle. Based on translating Lean principles in Product Development (PD) from the design stage and, along the entire product life cycle, it is aimed to address both sustainability and environmental issues. The drivers of sustainable culture within a lean PD have been identified and a baseline for future research on the development of appropriate tools and techniques has been provided. This research provide industry with a framework which balance environmental and sustainable factors with lean principles to be considered and incorporated from the beginning of product design and development covering the entire product lifecycle.

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.

76 FR 19100 - Maria Carmen Palazzo: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... development or approval, including the process for development or approval, of any drug product or otherwise... development or approval, including the process for development or approval, of any drug product or otherwise... approval, including the process for development or approval, of any drug product and otherwise relating to...

Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.

PubMed

Edwards, Eric S; Edwards, Evan T; Simons, F Estelle R; North, Robert

2015-05-01

The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration. A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: 'human factors engineering,' 'human factors,' 'medical products,' 'epinephrine/adrenaline auto-injector,' 'healthcare' and 'patient safety.' This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program. For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.

Developing Socio-Cultural Scaffolding Model to Elicit Learners's Speech Production

ERIC Educational Resources Information Center

Englishtina, Inti

2015-01-01

This study is concerned with developing scaffolding model to elicit bilingual kindergarten children's English speech production. It is aimed at describing what the teachers need in eliciting their students' speech production; how a scaffolding model should be developed to elicit the children's speech production; and how effective is the…

On Adaptive Extended Different Life Cycle of Product Design Strategy

NASA Astrophysics Data System (ADS)

Wenwen, Jiang; Zhibin, Xie

The article uses research ways of following the whole lifespan of product and enterprise's development course to research strategy of company's product design and development. It announces enterprises of different nature, enterprises at different developing stage will adopt different mode strategy. It also announces close causality between development course of company and central technology and product. The result indicated in different developing stages such as company development period, crisis predicament period, lasting steadies period, improving by payback period, issues steadies secondary period, declining go and live period, enterprise should pursue different mode product tactics of research and development such as shrinking strategy, consolidating strategy, innovation keeping forging ahead strategy. Enterprise should break regular management mode to introduce different research and development mode to promote enterprise's competitiveness effectively.

Error-Free Software

NASA Technical Reports Server (NTRS)

1989-01-01

001 is an integrated tool suited for automatically developing ultra reliable models, simulations and software systems. Developed and marketed by Hamilton Technologies, Inc. (HTI), it has been applied in engineering, manufacturing, banking and software tools development. The software provides the ability to simplify the complex. A system developed with 001 can be a prototype or fully developed with production quality code. It is free of interface errors, consistent, logically complete and has no data or control flow errors. Systems can be designed, developed and maintained with maximum productivity. Margaret Hamilton, President of Hamilton Technologies, also directed the research and development of USE.IT, an earlier product which was the first computer aided software engineering product in the industry to concentrate on automatically supporting the development of an ultrareliable system throughout its life cycle. Both products originated in NASA technology developed under a Johnson Space Center contract.

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.

Development of interactive hypermedia software for high school biology: A research and development study

NASA Astrophysics Data System (ADS)

Alturki, Uthman T.

The goal of this research was to research, design, and develop a hypertext program for students who study biology. The Ecology Hypertext Program was developed using Research and Development (R&D) methodology. The purpose of this study was to place the final "product", a CD-ROM for learning biology concepts, in the hands of teachers and students to help them in learning and teaching process. The product was created through a cycle of literature review, needs assessment, development, and a cycle of field tests and revisions. I applied the ten steps of R&D process suggested by Borg and Gall (1989) which, consisted of: (1) Literature review, (2) Needs assessment, (3) Planning, (4) Develop preliminary product, (5) Preliminary field-testing, (6) Preliminary revision, (7) Main field-testing, (8) Main revision, (9) Final field-testing, and (10) Final product revision. The literature review and needs assessment provided a support and foundation for designing the preliminary product---the Ecology Hypertext Program. Participants in the needs assessment joined a focus group discussion. They were a group of graduate students in education who suggested the importance for designing this product. For the preliminary field test, the participants were a group of high school students studying biology. They were the potential user of the product. They reviewed the preliminary product and then filled out a questionnaire. Their feedback and suggestions were used to develop and improve the product in a step called preliminary revision. The second round of field tasting was the main field test in which the participants joined a focus group discussion. They were the same group who participated in needs assessment task. They reviewed the revised product and then provided ideas and suggestions to improve the product. Their feedback were categorized and implemented to develop the product as in the main revision task. Finally, a group of science teachers participated in this study by reviewing the product and then filling out the questionnaire. Their suggestions were used to conduct the final step in R&D methodology, the final product revision. The primary result of this study was the Ecology Hypertext Program. It considered a small attempt to give students an opportunity to learn through an interactive hypertext program. In addition, using the R&D methodology was an ideal procedure for designing and developing new educational products and material.

F-35 Joint Strike Fighter: Continued Oversight Needed as Program Plans to Begin Development of New Capabilities

DTIC Science & Technology

2016-04-01

3Concurrency is broadly defined as the overlap between technology development and product development or between product development and...reported extensively on the F-35 program’s cost, schedule, and performance problems. The program plans to begin increasing production rates over the...internal DOD program analyses. GAO also collected and analyzed production and supply chain performance data, and interviewed DOD, program, and

The product space conditions the development of nations.

PubMed

Hidalgo, C A; Klinger, B; Barabási, A-L; Hausmann, R

2007-07-27

Economies grow by upgrading the products they produce and export. The technology, capital, institutions, and skills needed to make newer products are more easily adapted from some products than from others. Here, we study this network of relatedness between products, or "product space," finding that more-sophisticated products are located in a densely connected core whereas less-sophisticated products occupy a less-connected periphery. Empirically, countries move through the product space by developing goods close to those they currently produce. Most countries can reach the core only by traversing empirically infrequent distances, which may help explain why poor countries have trouble developing more competitive exports and fail to converge to the income levels of rich countries.

The National Heart, Lung, and Blood Institute Small Business Program: A Comprehensive Ecosystem for Biomedical Product Development.

PubMed

Marek, Kurt W

2016-12-01

Small companies working to develop products in the cardiovascular space face numerous challenges, from regulatory, intellectual property, and reimbursement barriers to securing funds to keep the lights on and reach the next development milestone. Most small companies that spin out from universities have the scientific knowledge, but product development expertise and business acumen are also needed to be successful. Other challenges include reduced interest in early stage technologies (Pharma & Biotech 2015 in Review, EP Vantage) and limited deal flow for cardiovascular products (Gormley B., Wall Street Journal, September 15, 2014). The NHLBI small business program is a comprehensive ecosystem designed to address these critical challenges and to provide resources and expertise to assist early stage companies developing cardiovascular and other products within the institute's mission. This article describes steps that NHLBI has taken to enhance our small business program to more effectively translate basic discoveries into commercial products to benefit patients and public health, including enhancing internal expertise and developing non-financial resources to assist small businesses as they develop their products and seek private sector investment and partnership.

Geographic information system development in the CARETS project

USGS Publications Warehouse

Mitchell, William B.; Fegeas, Robin G.; Fitzpatrick, Katherine A.; Hallam, Cheryl A.

1977-01-01

Experience in the development of a geographic information system to support the CARETS project has confirmed the considerable advantages that may accrue by paralleling the system development with a rational and balanced system production effort which permits the integration of the education and training of users with interim deliverable products to them. Those advantages include support for a long-term staff plan that recognizes substantial staff changes through system development and implementation, a fiscal plan that provides continuity in resources necessary for total system development, and a feedback system which allows the user to communicate his experiences in using the system. Thus far balance between system development and system production has not been achieved because of continuing large-scale spatial data processing requirements coupled with strong and insistent demands from users for immediately deliverable products from the system. That imbalance has refocussed staffing and fiscal plans from long-term system development to short- and near-term production requirements, continuously extends total system development time, and increases the possibility that later system development may reduce the usefulness of current interim products.

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.

Model development of production management unit to enhance entrepreneurship attitude of vocational school students from fashion department

NASA Astrophysics Data System (ADS)

Sumaryani, Sri

2018-03-01

The purpose of this study is to develop a model of production management unit to enhance entrepreneurship attitude of vocational school students from fashion department. This study concerns in developing students' entrepreneurship attitude in management which includes planning, organizing, applying and evaluation. The study uses Research and Development (R & D) approach with three main steps; preliminary study, development step, and product validation. Research subject was vocational school teachers from fashion department in Semarang, Salatiga and Demak. This study yields a development model of production management unit that could enhance vocational school students' entrepreneurship attitude in fashion department. The result shows that research subjects have understood about of production management unit in Vocational School (SMK).

China Report, Political, Sociological and Military Affairs PRC State Council Bulletin No. 18, 20 Aug 1984

DTIC Science & Technology

1985-03-14

development of pasteurized milk, yogurt and milk drinks.. We must combine this with the production of all kinds of milk powder (especially that...products, with emphasis on developing beancurd and fermented bean products. We must also develop soybean flour and beanflour products. Fruit and vegetable...Beverage industry: We should develop drinks like fruit juice, vegetable juice, fruit sodapop, soybean milk, fermented soybean milk, mineral water

Annual Growth of Contract Costs for Major Programs in Development and Early Production

DTIC Science & Technology

2016-03-21

changes, we can identify some underlying drivers and rule out others. Development and Early Production Differences BBP-era drops are driven by dropping...Annual Growth of Contract Costs for Major Programs in Development and Early Production Dan Davis and Philip S...Growth of Contract Costs for Major Programs in Development and Early Production Dan Davis and Philip S. Antón March 21, 2016 SUMMARY Cost is

An Assessment of Air Force Development Portfolio Management Practices

DTIC Science & Technology

2002-01-01

of Product Innovation Management , 12, 235–246. Cooper, R. G., & Kleinschmidt, E. J. (1995). Benchmarking the firm’s criti- cal success factors in new...product development. Journal of Product Innovation Management , 12, 374– 391. Cooper, R. G., Edgett, S. J., & Klein- schmidt, E. J. (1998a). Best...Scott, G. M. (2000). Critical technology management issues of new product development in high-tech companies. Journal of Product Innovation Management , 17

30 CFR 203.76 - When might MMS withdraw or reduce the approved size of my relief?

Code of Federal Regulations, 2010 CFR

2010-07-01

... your post-production development report (§ 203.70). Development costs are those expenditures defined in... application (e.g., change from a fixed platform to floating production system, or from an independent development and production system to one with subsea wells tied back to a host production facility, etc.). (b...

From Discovery to Production: Biotechnology of Marine Fungi for the Production of New Antibiotics.

PubMed

Silber, Johanna; Kramer, Annemarie; Labes, Antje; Tasdemir, Deniz

2016-07-21

Filamentous fungi are well known for their capability of producing antibiotic natural products. Recent studies have demonstrated the potential of antimicrobials with vast chemodiversity from marine fungi. Development of such natural products into lead compounds requires sustainable supply. Marine biotechnology can significantly contribute to the production of new antibiotics at various levels of the process chain including discovery, production, downstream processing, and lead development. However, the number of biotechnological processes described for large-scale production from marine fungi is far from the sum of the newly-discovered natural antibiotics. Methods and technologies applied in marine fungal biotechnology largely derive from analogous terrestrial processes and rarely reflect the specific demands of the marine fungi. The current developments in metabolic engineering and marine microbiology are not yet transferred into processes, but offer numerous options for improvement of production processes and establishment of new process chains. This review summarises the current state in biotechnological production of marine fungal antibiotics and points out the enormous potential of biotechnology in all stages of the discovery-to-development pipeline. At the same time, the literature survey reveals that more biotechnology transfer and method developments are needed for a sustainable and innovative production of marine fungal antibiotics.

HEADROOM APPROACH TO DEVICE DEVELOPMENT: CURRENT AND FUTURE DIRECTIONS.

PubMed

Girling, Alan; Lilford, Richard; Cole, Amanda; Young, Terry

2015-01-01

The headroom approach to medical device development relies on the estimation of a value-based price ceiling at different stages of the development cycle. Such price-ceilings delineate the commercial opportunities for new products in many healthcare systems. We apply a simple model to obtain critical business information as the product proceeds along a development pathway, and indicate some future directions for the development of the approach. Health economic modelling in the supply-side development cycle for new products. The headroom can be used: initially as a 'reality check' on the viability of the device in the healthcare market; to support product development decisions using a real options approach; and to contribute to a pricing policy which respects uncertainties in the reimbursement outlook. The headroom provides a unifying thread for business decisions along the development cycle for a new product. Over the course of the cycle attitudes to uncertainty will evolve, based on the timing and manner in which new information accrues. Within this framework the developmental value of new information can justify the costs of clinical trials and other evidence-gathering activities. Headroom can function as a simple shared tool to parties in commercial negotiations around individual products or groups of products. The development of similar approaches in other contexts holds promise for more rational planning of service provision.

Eco-organic tourism as an element of the sustainable development of territories

NASA Astrophysics Data System (ADS)

Ivanov, D. V.; Ziganshin, I. I.

2018-01-01

Organic agricultural production is an ecologically oriented alternative to traditional agriculture and is aimed at ensuring food and environmental safety of the population and territories. The development of ecological tourism on the basis of organic production farms is considered as a promising direction in the development of regional programs for the sustainable development of territories. Studies have shown that, farms engaged in the production of organic products in the Republic of Tatarstan have a significant potential for the development of eco-organic tourism using elements of the nature protection structure.

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.

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

PubMed

Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

2016-11-01

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

Forest productivity: producing goods and services for people

Treesearch

Thomas R. Crow; Daniel C. Dey; Don Riemenschneider

2006-01-01

Presents the progress made by North Central Research Station scientists working in the Forest Productivity Integrated Research and Development Program over the past several years. We discuss policy relevant research on assessing productivity, modeling potential, productivity, and improving productivity within the conceptual framework for research and development in the...

Development of medicine-intended isotope production technologies at Yerevan Physics Institute

NASA Astrophysics Data System (ADS)

Avetisyan, Albert; Avagyan, Robert; Kerobyan, Ivetta; Dallakyan, Ruben; Harutyunyan, Gevorg; Melkonyan, Aleksandr

2015-05-01

Accelerator-based 99mTc and 123I isotopes production technologies were created and developed at A.Alikhanyan National Science Laboratory (former Yerevan Physics Institute - YerPhI). The method involves the irradiation of natural molybdenum (for 99mTc production) and natural xenon (for 123I production) using high-intensity bremsstrahlung photons from the electron beam of the LUE50 linear electron accelerator located at the YerPhI. We have developed and tested the extraction of 99mTc and 123I from the irradiated natural MoO3 and natural Xe, respectively. The production method has been developed and shown to be successful. The current activity is devoted to creation and development of the technology of direct production 99mTc on the 100Mo as target materials using the proton beam from an IBA C18/18 cyclotron. The proton cyclotron C18/18 (producer - IBA, Belgium) was purchased and will be installed nearby AANL (YerPhI) till end 2014. The 18 MeV protons will be used to investigate accelerator-based schemes for the direct production of 99mTc. Main topics of studies will include experimental measurement of 99mTc production yield for different energies of protons, irradiation times, intensities, development of new methods of 99mTc extraction from irradiated materials, development of target preparation technology, development of target material recovery methods for multiple use and others.

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

PubMed

Niimi, Shingo

2015-01-01

Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

77 FR 56646 - Wayne E. Spencer: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-13

..., including the process for development or approval, of a drug product under the FD&C Act. Dr. Spencer was..., including the process for development or approval, of a drug product under the FD&C Act. On March 7, 2012... to the development or approval, including the process for development or approval, of a drug product...

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.

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.

The development speed paradox: can increasing development speed reduce R&D productivity?

PubMed

Lendrem, Dennis W; Lendrem, B Clare

2014-03-01

In the 1990s the pharmaceutical industry sought to increase R&D productivity by shifting development tasks into parallel to reduce development cycle times and increase development speed. This paper presents a simple model demonstrating that, when attrition rates are high as in pharmaceutical development, such development speed initiatives can increase the expected time for the first successful molecule to complete development. Increasing the development speed of successful molecules could actually reduce R&D productivity - the development speed paradox. Copyright © 2013 Elsevier Ltd. All rights reserved.

A national research & development strategy for biomass crop feedstocks

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

Wright, L.L.; Cushman, J.H.

Planning was initiated in 1996 with the objective of reevaluating current biomass feedstock research and development strategies to: (1) assure that by 2005, one or more commercial lignocellulosic to ethanol projects will be able to acquire a dependable supply of biomass crop feedstocks; (2) assure that recently initiated demonstrations of crops to electricity will be successful and; (3) assure that the research base needed to support future biomass industry expansion is being developed. Multiple trends and analyses indicate that biomass energy research and development strategies must take into account the fact that competition for land will define the upper limitsmore » of available biomass energy crop supplies and will largely dictate the price of those supplies. Only crop production and utilization strategies which contribute profit to the farmer or landowner and to energy producers will be used commercially for biomass energy production. Strategies for developing biomass {open_quotes}energy{close_quotes} crop supplies must take into consideration all of the methods by which biomass crops will enter biomass energy markets. The lignocellulosic materials derived from crops can be available as primary residues or crop by-products; secondary residues or processing by-products; co-products (at both the crop production and processing stages); or, as dedicated energy crops. Basic research and development (R&D) leading to yield improvement continues to be recommended as a major long-term focus for dedicated energy crops. Many additional near term topics need attention, some of which are also applicable to by-products and co-products. Switchgrass R&D should be expanded and developed with greater collaboration of USDA and state extension groups. Woody crop research should continue with significant cost-share from industries developing the crops for other commercial products. Co-product options need more investigation.« less

Challenges for Product Roadmapping in Inter-company Collaboration

NASA Astrophysics Data System (ADS)

Suomalainen, Tanja; Tihinen, Maarit; Parviainen, Päivi

Product roadmapping is a critical activity in product development, as it provides a link between business aspects and requirements engineering and thus helps to manage a high-level view of the company’s products. Nowadays, inter-company collaboration, such as outsourcing, is a common way of developing software products, as through collaboration, organisations gain advantages, such as flexibility with in-house resources, savings in product development costs and gain a physical presence in important markets. The role of product roadmapping becomes even more critical in collaborative settings, since different companies need to align strategies and work together to create products. In order to support companies in improving their own product roadmapping processes, this paper first gives an overview of product roadmapping and then discusses in detail an empirical study of the current practices in industry. The presented results particularly focus on the most challenging and important activities of product roadmapping in collaboration.

The Creative Learning Group Drug Education Program Developed by the Creative Learning Group. Product Development Report No. 6.

ERIC Educational Resources Information Center

Thompson, Lorna J.; Kratochvil, Daniel W.

This report of the development of a drug-educational product which appears to have potential impact, is based upon published materials, documents in the files of the developing agency, and interviews with staff who were involved in the development of the product. The long-range goal of the drug program is to encourage young people to develop…

A Product Development Decision Model for Cockpit Weather Information System

NASA Technical Reports Server (NTRS)

Sireli, Yesim; Kauffmann, Paul; Gupta, Surabhi; Kachroo, Pushkin; Johnson, Edward J., Jr. (Technical Monitor)

2003-01-01

There is a significant market demand for advanced cockpit weather information products. However, it is unclear how to identify the most promising technological options that provide the desired mix of consumer requirements by employing feasible technical systems at a price that achieves market success. This study develops a unique product development decision model that employs Quality Function Deployment (QFD) and Kano's model of consumer choice. This model is specifically designed for exploration and resolution of this and similar information technology related product development problems.

A Product Development Decision Model for Cockpit Weather Information Systems

NASA Technical Reports Server (NTRS)

Sireli, Yesim; Kauffmann, Paul; Gupta, Surabhi; Kachroo, Pushkin

2003-01-01

There is a significant market demand for advanced cockpit weather information products. However, it is unclear how to identify the most promising technological options that provide the desired mix of consumer requirements by employing feasible technical systems at a price that achieves market success. This study develops a unique product development decision model that employs Quality Function Deployment (QFD) and Kano's model of consumer choice. This model is specifically designed for exploration and resolution of this and similar information technology related product development problems.

DEVELOPMENT OF CONTINUOUS SOLVENT EXTRACTION PROCESSES FOR COAL DERIVED CARBON PRODUCTS

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

Elliot B. Kennel; Stephen P. Carpenter; Dady Dadyburjor

2006-03-27

The purpose of this DOE-funded effort is to develop continuous processes for solvent extraction of coal for the production of carbon products. These carbon products include materials used in metals smelting, especially in the aluminum and steel industries, as well as porous carbon structural material referred to as ''carbon foam'' and carbon fibers. During this reporting period, efforts have focused on the development of continuous processes for hydrogenation as well as continuous production of carbon foam and coke.

Improving product introduction through effective design reviews.

PubMed

Pelnik, Tammy M

2003-01-01

The design review process is a part of the manufacturer's due diligence in developing a safe and effective product. Design review provides early and on-going independent feedback to developers. By adopting a proactive review process, design improvements can be pursued at an optimum time in the product development effort, i.e., when it will cost less to implement changes and when these changes may have the greatest impact. Effective implementation of the design review requirement will lead to better medical products and improved product introduction results.

Clinical development of gene- and cell-based therapies: overview of the European landscape

PubMed Central

de Wilde, Sofieke; Guchelaar, Henk-Jan; Zandvliet, Maarten Laurens; Meij, Pauline

2016-01-01

In the last decade, many clinical trials with gene- and cell-based therapies were performed and increasing interest in the development was established by (national) authorities, academic developers, and commercial companies. However, until now only eight products have received marketing authorization (MA) approval. In this study, a comprehensive overview of the clinical development of gene- and cell-based therapies in Europe is presented, with a strong focus on product-technical aspects. Public data regarding clinical trials with gene- and cell-based therapies, obtained from the European Union (EU) clinical trial database (EudraCT) between 2004 and 2014 were analyzed, including product-technical variables as potential determinants affecting development. 198 unique gene and cell therapy products were identified, which were studied in 278 clinical trials, mostly in phase 1/2 trials and with cell therapies as major group. Furthermore, most products were manufactured from autologous starting material mostly manufactured from stem cells. The majority of the trials were sponsored by academia, whereas phase 3 trials mostly by large companies. Academia dominated early-stage development by mainly using bone marrow derived products and stem cells. Conversely, commercial sponsors were more actively pursuing in vivo gene therapy medicinal product development, and cell therapies derived from differentiated tissue in later-stage development. PMID:27990447

Between Product Development and Mass Production: Tensions as Triggers for Concept-Level Learning

ERIC Educational Resources Information Center

Jalonen, Meri; Ristimäki, Päivi; Toiviainen, Hanna; Pulkkis, Anneli; Lohtander, Mika

2016-01-01

Purpose: This paper aims to analyze learning in organizational transformations by focusing on concept-level tensions faced in two young companies, which were searching for a reorientation of activity with a production network between innovative product development and efficient mass production. Design/methodology/approach: An intervention-based…

The Effects of Development Team Skill on Software Product Quality

NASA Technical Reports Server (NTRS)

Beaver, Justin M.; Schiavone, Guy A.

2006-01-01

This paper provides an analysis of the effect of the skill/experience of the software development team on the quality of the final software product. A method for the assessment of software development team skill and experience is proposed, and was derived from a workforce management tool currently in use by the National Aeronautics and Space Administration. Using data from 26 smallscale software development projects, the team skill measures are correlated to 5 software product quality metrics from the ISO/IEC 9126 Software Engineering Product Quality standard. in the analysis of the results, development team skill is found to be a significant factor in the adequacy of the design and implementation. In addition, the results imply that inexperienced software developers are tasked with responsibilities ill-suited to their skill level, and thus have a significant adverse effect on the quality of the software product. Keywords: software quality, development skill, software metrics

Development of service-oriented products based on the inverse manufacturing concept.

PubMed

Fujimoto, Jun; Umeda, Yasushi; Tamura, Tetsuya; Tomiyama, Tetsuo; Kimura, Fumihiko

2003-12-01

To achieve sustainability, resource consumption and waste generation must be drastically decreased. For societal acceptance, preservation of both quality of life and corporate profits are essential. One promising approach is to shift the source of value from the amount of product sold to the quality of services the product provides. This paper describes the need for redesigning recycling systems from a manufacturing perspective and then discusses the possibility of this "servicification" of products, describing our experience with prototype development. We discuss development of product prototypes and their business, using consumer facsimile machines as an example of "service-oriented products". Traditional thought presumes that only products comprising new materials and components are valuable. Consideration of a service-oriented product can serve as a stimulus to revise this mode of thought and to control delivery and quality of disposed products. This paper also provides a life cycle simulation of the developed service-oriented business. Simulation results indicate that service-oriented business can potentially reduce environmental impact while extending business opportunities from the viewpoint of whole product life cycles.

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.

From Discovery to Production: Biotechnology of Marine Fungi for the Production of New Antibiotics

PubMed Central

Silber, Johanna; Kramer, Annemarie; Labes, Antje; Tasdemir, Deniz

2016-01-01

Filamentous fungi are well known for their capability of producing antibiotic natural products. Recent studies have demonstrated the potential of antimicrobials with vast chemodiversity from marine fungi. Development of such natural products into lead compounds requires sustainable supply. Marine biotechnology can significantly contribute to the production of new antibiotics at various levels of the process chain including discovery, production, downstream processing, and lead development. However, the number of biotechnological processes described for large-scale production from marine fungi is far from the sum of the newly-discovered natural antibiotics. Methods and technologies applied in marine fungal biotechnology largely derive from analogous terrestrial processes and rarely reflect the specific demands of the marine fungi. The current developments in metabolic engineering and marine microbiology are not yet transferred into processes, but offer numerous options for improvement of production processes and establishment of new process chains. This review summarises the current state in biotechnological production of marine fungal antibiotics and points out the enormous potential of biotechnology in all stages of the discovery-to-development pipeline. At the same time, the literature survey reveals that more biotechnology transfer and method developments are needed for a sustainable and innovative production of marine fungal antibiotics. PMID:27455283

The Construction and Development of Indicators of Learning Organization at Higher Educational Institutions Emphasizing Graduate Production and Social Development

ERIC Educational Resources Information Center

Hanrin, Chanwit; Sri-Amphai, Pissamai; Ruangmontri, Karn; Namwan, Tharinthorn

2011-01-01

The Purposes of this research were to construct and develop indicators of learning organization at higher educational institutions emphasize graduate production and social development, and to test the congruence of the structural model of the indicators of learning organization at higher educational institutions emphasizing graduate production and…

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

The impact of the Orphan Drug Act on drug discovery.

PubMed

Haffner, Marlene E; Maher, Paul D

2006-11-01

For nearly a quarter of a century the FDA Office of Orphan Products Development has administered the US Orphan Drug Act, which assists in bringing a wide variety of drug and biological (drug) products to treat rare diseases to market. Enthusiasm for rare disease product development has been sustained, seen throughout a wide spectrum of product types and disease conditions, and has resulted in clinically meaningful medical advances. Development of programmes for rare disease treatment worldwide, coupled with the development of drugs for diseases affecting developing countries, attests to the strength of this legislation. The marketing of almost 300 products in the US for rare diseases also testifies to the depth and intensity of scientific endeavour in this area.

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.

19 CFR 10.173 - Evidence of country of origin.

Code of Federal Regulations, 2010 CFR

2010-04-01

... entry—(1) Merchandise not wholly the growth, product, or manufacture of a beneficiary developing country... growth, product, or manufacture of a single beneficiary developing country, the exporter of the... treatment. (2) Merchandise wholly the growth, product, or manufacture of a beneficiary developing country...

19 CFR 10.173 - Evidence of country of origin.

Code of Federal Regulations, 2011 CFR

2011-04-01

... entry—(1) Merchandise not wholly the growth, product, or manufacture of a beneficiary developing country... growth, product, or manufacture of a single beneficiary developing country, the exporter of the... treatment. (2) Merchandise wholly the growth, product, or manufacture of a beneficiary developing country...

Concept of Operations for the ESC Product Line Approach.

DTIC Science & Technology

1996-08-30

production of the application. Product Line Engineering Center ( PLEC ) defines and evolves product line architectures with the SAG. The PLEC is also tasked... PLEC , SAG, and PLAS and offers scenarios for asset and system development. • Section 4 outlines the ESC Product Line transition strategy. • Section...Line or System Needs User Select PLEC ; Assess PL architecture Product Line Architecture Development ments; architecture selection Architecture

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…

Quality risk management in pharmaceutical development.

PubMed

Charoo, Naseem Ahmad; Ali, Areeg Anwer

2013-07-01

The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by design paradigm, the product performance properties relevant to the patient are predefined in target product profile (TPP). Together with prior knowledge and experience, TPP helps in identification of critical quality attributes (CQA's). Initial risk assessment which identifies risks to these CQA's provides impetus for product development. Product and process are designed to gain knowledge about these risks, devise strategies to eliminate or mitigate these risks and meet objectives set in TPP. By laying more emphasis on high risk events the protection level of patient is increased. The process being scientifically driven improves the transparency and reliability of the manufacturer. The focus on risk to the patient together with flexible development approach saves invaluable resources, increases confidence on quality and reduces compliance risk. The knowledge acquired in analysing risks to CQA's permits construction of meaningful design space. Within the boundaries of the design space, variation in critical material characteristics and process parameters must be managed in order to yield a product having the desired characteristics. Specifications based on product and process understanding are established such that product will meet the specifications if tested. In this way, the product is amenable to real time release, since specifications only confirm quality but they do not serve as a means of effective process control.

A first-generation software product line for data acquisition systems in astronomy

NASA Astrophysics Data System (ADS)

López-Ruiz, J. C.; Heradio, Rubén; Cerrada Somolinos, José Antonio; Coz Fernandez, José Ramón; López Ramos, Pablo

2008-07-01

This article presents a case study on developing a software product line for data acquisition systems in astronomy based on the Exemplar Driven Development methodology and the Exemplar Flexibilization Language tool. The main strategies to build the software product line are based on the domain commonality and variability, the incremental scope and the use of existing artifacts. It consists on a lean methodology with little impact on the organization, suitable for small projects, which reduces product line start-up time. Software Product Lines focuses on creating a family of products instead of individual products. This approach has spectacular benefits on reducing the time to market, maintaining the know-how, reducing the development costs and increasing the quality of new products. The maintenance of the products is also enhanced since all the data acquisition systems share the same product line architecture.

77 FR 22843 - Notice of Product Development

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2012-0020] Notice of Product Development In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR... Administration (FRA) a Notice of Product Development per 49 CFR 236.913(d)(1)(i) for the modification of the...

7 CFR 915.45 - Production research, marketing research and development.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Production research, marketing research and... AGRICULTURE AVOCADOS GROWN IN SOUTH FLORIDA Order Regulating Handling Research and Development § 915.45 Production research, marketing research and development. The committee may, with the approval of the...

7 CFR 915.45 - Production research, marketing research and development.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Production research, marketing research and... AGRICULTURE AVOCADOS GROWN IN SOUTH FLORIDA Order Regulating Handling Research and Development § 915.45 Production research, marketing research and development. The committee may, with the approval of the...

7 CFR 915.45 - Production research, marketing research and development.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false Production research, marketing research and... AGRICULTURE AVOCADOS GROWN IN SOUTH FLORIDA Order Regulating Handling Research and Development § 915.45 Production research, marketing research and development. The committee may, with the approval of the...

7 CFR 915.45 - Production research, marketing research and development.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Production research, marketing research and... AGRICULTURE AVOCADOS GROWN IN SOUTH FLORIDA Order Regulating Handling Research and Development § 915.45 Production research, marketing research and development. The committee may, with the approval of the...

7 CFR 915.45 - Production research, marketing research and development.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Production research, marketing research and... AGRICULTURE AVOCADOS GROWN IN SOUTH FLORIDA Order Regulating Handling Research and Development § 915.45 Production research, marketing research and development. The committee may, with the approval of the...

Disaggregating reserve-to-production ratios: An algorithm for United States oil and gas reserve development

NASA Astrophysics Data System (ADS)

Williams, Charles William

Reserve-to-production ratios for oil and gas development are utilized by oil and gas producing states to monitor oil and gas reserve and production dynamics. These ratios are used to determine production levels for the manipulation of oil and gas prices while maintaining adequate reserves for future development. These aggregate reserve-to-production ratios do not provide information concerning development cost and the best time necessary to develop newly discovered reserves. Oil and gas reserves are a semi-finished inventory because development of the reserves must take place in order to implement production. These reserves are considered semi-finished in that they are not counted unless it is economically profitable to produce them. The development of these reserves is encouraged by profit maximization economic variables which must consider the legal, political, and geological aspects of a project. This development is comprised of a myriad of incremental operational decisions, each of which influences profit maximization. The primary purpose of this study was to provide a model for characterizing a single product multi-period inventory/production optimization problem from an unconstrained quantity of raw material which was produced and stored as inventory reserve. This optimization was determined by evaluating dynamic changes in new additions to reserves and the subsequent depletion of these reserves with the maximization of production. A secondary purpose was to determine an equation for exponential depletion of proved reserves which presented a more comprehensive representation of reserve-to-production ratio values than an inadequate and frequently used aggregate historical method. The final purpose of this study was to determine the most accurate delay time for a proved reserve to achieve maximum production. This calculated time provided a measure of the discounted cost and calculation of net present value for developing new reserves. This study concluded that the theoretical model developed by this research may be used to provide a predictive equation for each major oil and gas state so that a net present value to undiscounted net cash flow ratio might be calculated in order to establish an investment signal for profit maximizers. This equation inferred how production decisions were influenced by exogenous factors, such as price, and how policies performed which lead to recommendations regarding effective policies and prudent planning.

Space and Missile Systems Center Standard: Software Development

DTIC Science & Technology

2015-01-16

maintenance , or any other activity or combination of activities resulting in products . Within this standard, requirements to “develop,” “define...integration, reuse, reengineering, maintenance , or any other activity that results in products ). The term “developer” encompasses all software team...activities that results in software products . Software development includes new development, modification, reuse, reengineering, maintenance , and any other

Importance of Intelligence for Strategic Scenario Building: The Information Section Role in Research and Development

ERIC Educational Resources Information Center

Minamizaki, Noriko

2017-01-01

Product development of Japanese companies has changed greatly from the post-war revival period, when it was promoted mainly to provide low-cost, high-quality products. In recent years, it has become necessary to develop products and services that correspond to social issues. Research and development has shifted from a technological basis to a…

Factors Important to the Prioritization and Development of Successful Topical Microbicides for HIV-1

PubMed Central

Buckheit, Karen W.; Buckheit, Robert W.

2012-01-01

Significant advancements in topical microbicide development have occurred since the prevention strategy was first described as a means to inhibit the sexual transmission of HIV-1. The lack of clinical efficacy of the first generation microbicide products has focused development attention on specific antiretroviral agents, and these agents have proven partially successful in human clinical trials. With greater understanding of vaginal and rectal virus infection, replication, and dissemination, better microbicide products and delivery strategies should result in products with enhanced potency. However, a variety of development gaps exist which relate to product dosing, formulation and delivery, and pharmacokinetics and pharmacodynamics which must be better understood in order to prioritize microbicide products for clinical development. In vitro, ex vivo, and in vivo models must be optimized with regard to these development gaps in order to put the right product at the right place, at the right time, and at the right concentration for effective inhibition of virus transmission. As the microbicide field continues to evolve, we must harness the knowledge gained from unsuccessful and successful clinical trials and development programs to continuously enhance our preclinical development algorithms. PMID:22848826

Engineering Education for Agricultural and Rural Development in Africa

ERIC Educational Resources Information Center

Adewumi, B. A.

2008-01-01

Agricultural Engineering has transformed agricultural practices from subsistence level to medium and large-scale production via mechanisation in the developed nations. This has reduced the labour force requirements in agriculture; increased production levels and efficiency, product shelf life and product quality; and resulted into…

Guidance for Product Category Rule Development: Process, Outcome and Next Steps

EPA Science Inventory

Background The development of Product Category Rules (PCRs) is inconsistent among the program operators using ISO 14025 as the basis. Furthermore, the existence of several other product claim standards and specifications that require PCRs for making product claims, has the potent...

Status of molten carbonate fuel cell technology development

NASA Astrophysics Data System (ADS)

Parsons, E. L., Jr.; Williams, M. C.; George, T. J.

The MCFC technology has been identified by the DOE as a promising product for commercialization. Development of the MCFC technology supports the National Energy Strategy. Review of the status of the MCFC technology indicates that the MCFC technology developers are making rapid and significant progress. Manufacturing facility development and extensive testing is occurring. Improvements in performance (power density), lower costs, improved packaging, and scale up to full height are planned. MCFC developers need to continue to be responsive to end-users in potential markets. It will be market demands for the correct product definition which will ultimately determine the character of MCFC power plants. There is a need for continued MCFC product improvement and multiple product development tests.

Enhanced Traceability for Bulk Processing of Sentinel-Derived Information Products

NASA Astrophysics Data System (ADS)

Lankester, Thomas; Hubbard, Steven; Knowelden, Richard

2016-08-01

The advent of widely available, systematically acquired and advanced Earth observations from the Sentinel platforms is spurring development of a wide range of derived information products. Whilst welcome, this rapid rate of development inevitably leads to some processing instability as algorithms and production steps are required to evolve accordingly. To mitigate this instability, the provenance of EO-derived information products needs to be traceable and transparent.Airbus Defence and Space (Airbus DS) has developed the Airbus Processing Cloud (APC) as a virtualised processing farm for bulk production of EO-derived data and information products. The production control system of the APC transforms internal configuration control information into an INSPIRE metadata file containing a stepwise set of processing steps and data source elements that provide the complete and transparent provenance of each product generated.

Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties.

PubMed

Nijhara, Ruchika; Balakrishnan, Krishna

2006-06-01

Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.

76 FR 9574 - Agency Information Collection Activities; Proposed Collection; Comment Request; Use of Surveys in...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... of Surveys in Developing Improved Labeling for Insect Repellent Products AGENCY: Environmental... of Surveys in Developing Improved Labeling for Insect Repellent Products'' and identified by EPA ICR... insect repellent products. Title: Use of Surveys in Developing Improved Labeling for Insect Repellent...

7 CFR 925.45 - Production research and market research and development.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Production research and market research and... AGRICULTURE GRAPES GROWN IN A DESIGNATED AREA OF SOUTHEASTERN CALIFORNIA Research and Market Development § 925.45 Production research and market research and development. The committee, with the approval of the...

7 CFR 917.39 - Production research, market research and development.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Production research, market research and development... AGRICULTURE FRESH PEARS AND PEACHES GROWN IN CALIFORNIA Order Regulating Handling Research § 917.39 Production research, market research and development. The committees, with the approval of the Secretary, may...

7 CFR 925.45 - Production research and market research and development.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Production research and market research and... AGRICULTURE GRAPES GROWN IN A DESIGNATED AREA OF SOUTHEASTERN CALIFORNIA Research and Market Development § 925.45 Production research and market research and development. The committee, with the approval of the...

7 CFR 917.39 - Production research, market research and development.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Production research, market research and development... AGRICULTURE FRESH PEARS AND PEACHES GROWN IN CALIFORNIA Order Regulating Handling Research § 917.39 Production research, market research and development. The committees, with the approval of the Secretary, may...

7 CFR 925.45 - Production research and market research and development.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Production research and market research and... AGRICULTURE GRAPES GROWN IN A DESIGNATED AREA OF SOUTHEASTERN CALIFORNIA Research and Market Development § 925.45 Production research and market research and development. The committee, with the approval of the...

7 CFR 925.45 - Production research and market research and development.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Production research and market research and... AGRICULTURE GRAPES GROWN IN A DESIGNATED AREA OF SOUTHEASTERN CALIFORNIA Research and Market Development § 925.45 Production research and market research and development. The committee, with the approval of the...

7 CFR 917.39 - Production research, market research and development.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false Production research, market research and development... AGRICULTURE FRESH PEARS AND PEACHES GROWN IN CALIFORNIA Order Regulating Handling Research § 917.39 Production research, market research and development. The committees, with the approval of the Secretary, may...

7 CFR 925.45 - Production research and market research and development.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false Production research and market research and... AGRICULTURE GRAPES GROWN IN A DESIGNATED AREA OF SOUTHEASTERN CALIFORNIA Research and Market Development § 925.45 Production research and market research and development. The committee, with the approval of the...

7 CFR 917.39 - Production research, market research and development.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Production research, market research and development... AGRICULTURE FRESH PEARS AND PEACHES GROWN IN CALIFORNIA Order Regulating Handling Research § 917.39 Production research, market research and development. The committees, with the approval of the Secretary, may...

7 CFR 917.39 - Production research, market research and development.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Production research, market research and development... AGRICULTURE FRESH PEARS AND PEACHES GROWN IN CALIFORNIA Order Regulating Handling Research § 917.39 Production research, market research and development. The committees, with the approval of the Secretary, may...

A Conceptual Framework for Measuring R&D Product Impact.

ERIC Educational Resources Information Center

Hull, William L.; And Others

A framework to aid in estimating the impact from educational research and development (R&D) products was developed at the National Center for Research in Vocational Education at the Ohio State University. The dimensions of the framework (product development, distribution, implementation, utilization and effects) are explained in detail. The…

Technological Development and Its Implications for Educational Planning.

ERIC Educational Resources Information Center

Sanyal, Bikas C.

The phenomenon of technological development has assumed great importance in the contemporary world. It is reflected in unprecedented growth in productivity with accompanying labor saving, in improvement of quality of products, in the launching of new products and services, and in the development of new branches of activity. This document reports…

Cybersecurity and the Medical Device Product Development Lifecycle.

PubMed

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

Optimization of Primary Drying in Lyophilization during Early Phase Drug Development using a Definitive Screening Design with Formulation and Process Factors.

PubMed

Goldman, Johnathan M; More, Haresh T; Yee, Olga; Borgeson, Elizabeth; Remy, Brenda; Rowe, Jasmine; Sadineni, Vikram

2018-06-08

Development of optimal drug product lyophilization cycles is typically accomplished via multiple engineering runs to determine appropriate process parameters. These runs require significant time and product investments, which are especially costly during early phase development when the drug product formulation and lyophilization process are often defined simultaneously. Even small changes in the formulation may require a new set of engineering runs to define lyophilization process parameters. In order to overcome these development difficulties, an eight factor definitive screening design (DSD), including both formulation and process parameters, was executed on a fully human monoclonal antibody (mAb) drug product. The DSD enables evaluation of several interdependent factors to define critical parameters that affect primary drying time and product temperature. From these parameters, a lyophilization development model is defined where near optimal process parameters can be derived for many different drug product formulations. This concept is demonstrated on a mAb drug product where statistically predicted cycle responses agree well with those measured experimentally. This design of experiments (DoE) approach for early phase lyophilization cycle development offers a workflow that significantly decreases the development time of clinically and potentially commercially viable lyophilization cycles for a platform formulation that still has variable range of compositions. Copyright © 2018. Published by Elsevier Inc.

The analysis of market knowledge competence effect and research & development (R&D) toward the policy making of new product development

NASA Astrophysics Data System (ADS)

Purwanggono, Bambang; Sesuko, Agung; Budiawan, Wiwik

2017-11-01

The increasing mobility of people without adequate provision of mass transportation infrastructures makes people choose private transportation like motorcycles. Such circumstances lead the motorcycle manufacturers in Indonesia competing to develop their products to meet the needs of customers. In addition, the new regulation of Central Bank of Indonesia dealing with the credit advances has raised the intense competition of motorcycles industries in Indonesia. One of the ways to win the competition is by developing new and improved products. In developing and improving the products, companies need to consider resource utilization. In this research, researcher utilizes the resources that exist both inside and outside the enterprise such as customer demands, intensity of competition, perception of the importance of market knowledge, importance of market competence, and internal R&D as well as external R&D is expected to develop new products that are superior. The study involved 150 employees as respondents. The method used in the study is Structural Equation Modeling (SEM) with AMOS 20.0 statistical software. The result shows that the demands of the customers and the intensity of competition lead to a positive effect on market knowledge competence, while the perception of the market knowledge importance does not influence the development of new products, and market knowledge competence, internal R&D and external R&D have positive effect on the development of new products.

Spatial rainfall data in open source environment

NASA Astrophysics Data System (ADS)

Schuurmans, Hanneke; Maarten Verbree, Jan; Leijnse, Hidde; van Heeringen, Klaas-Jan; Uijlenhoet, Remko; Bierkens, Marc; van de Giesen, Nick; Gooijer, Jan; van den Houten, Gert

2013-04-01

Since January 2013 The Netherlands have access to innovative high-quality rainfall data that is used for watermanagers. This product is innovative because of the following reasons. (i) The product is developed in a 'golden triangle' construction - corporation between government, business and research. (ii) Second the rainfall products are developed according to the open-source GPL license. The initiative comes from a group of water boards in the Netherlands that joined their forces to fund the development of a new rainfall product. Not only data from Dutch radar stations (as is currently done by the Dutch meteorological organization KNMI) is used but also data from radars in Germany and Belgium. After a radarcomposite is made, it is adjusted according to data from raingauges (ground truth). This results in 9 different rainfall products that give for each moment the best rainfall data. Specific knowledge is necessary to develop these kind of data. Therefore a pool of experts (KNMI, Deltares and 3 universities) participated in the development. The philosophy of the developers (being corporations) is that products like this should be developed in open source. This way knowledge is shared and the whole community is able to make suggestions for improvement. In our opinion this is the only way to make real progress in product development. Furthermore the financial resources of government organizations are optimized. More info (in Dutch): www.nationaleregenradar.nl

New irradiation facilities for development of production methods of medical radionuclides at cyclotrons at Forschungszentrum Jülich

NASA Astrophysics Data System (ADS)

Spellerberg, S.; Scholten, B.; Spahn, I.; Felden, O.; Gebel, R.; Qaim, S. M.; Bai, M.; Neumaier, B.

2017-05-01

An essential basis for research and development work on radiopharmaceuticals is the efficient production of radionuclides of high quality. In this process research-oriented studies aiming for elucidation of biochemical processes require novel products. The radionuclide development at INM-5 entails basic research, e.g. the determination of nuclear reaction data, as well as technical aspects of practical production, such as high-current targetry, chemical separation, formulation and quality control. In this work developments, adaptation and optimization of irradiation facilities at the BC 1710, JULIC as Injector of COSY and COSY itself are summarized, which shall allow the extension of radionuclide production possibilities, aiming at innovations in medical applications.

Regulatory structures for gene therapy medicinal products in the European Union.

PubMed

Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

2012-01-01

Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

Toward a unified account of comprehension and production in language development.

PubMed

McCauley, Stewart M; Christiansen, Morten H

2013-08-01

Although Pickering & Garrod (P&G) argue convincingly for a unified system for language comprehension and production, they fail to explain how such a system might develop. Using a recent computational model of language acquisition as an example, we sketch a developmental perspective on the integration of comprehension and production. We conclude that only through development can we fully understand the intertwined nature of comprehension and production in adult processing.

Equipment for nuclear medical centers, production capabilities of Rosatom enterprises

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

Gavrish, Yu. N., E-mail: gavrish@luts.niiefa.spb.su; Koloskov, S. A.; Smirnov, V. P.

2015-12-15

Analysis of the capabilities of the State Corporation Rosatom enterprises on the development and production of diagnostic and therapeutic equipment for nuclear medicine centers is presented. Prospects of the development of accelerator equipment for the production of a wide range of radioisotope products are shown, and the trends of its development are determined. A comparative analysis of the technical parameters of domestic tomographs and devices for brachytherapy with foreign counterparts is given.

Concept Engineering: An Investigation Of TIME versus Market Orientation in Product Concept Development

DTIC Science & Technology

1993-06-01

Designers and Champions of Innovation. Journal of Product Innovation Management . Vol. 8,91-103 Barabba, V. P., & Zaltman, G. (1991). Hearing the Voice of...Kleinschmidt, E. K. (1986). An Investigation into the New Product Process: Steps, Deficiencies, and Impact. Journal of Product Innovation Management . Vol...Product and Process Development. Journal of Product Innovation Management . Vol. 4,81-88 Goodman, M. (1974). Study Notes in System Dynamics. Cambridge, MA

Human Resource Development: Allies or Opponents?

ERIC Educational Resources Information Center

Nadler, Leonard

Human resource development (HRD) and productivity are allies; they are synergistic. Productivity can be defined as an increase of output with no increase in input. An increase in productivity can be accomplished in the workplace through speed-up or capital investment. When productivity improvements are introduced, the philosophy of the…

A Model for the Evaluation of Educational Products.

ERIC Educational Resources Information Center

Bertram, Charles L.

A model for the evaluation of educational products based on experience with development of three such products is described. The purpose of the evaluation model is to indicate the flow of evaluation activity as products undergo development. Evaluation is given Stufflebeam's definition as the process of delineating, obtaining, and providing useful…

Peering into the Secrets of Food and Agricultural Co-products

USDA-ARS?s Scientific Manuscript database

Scanning electron microscopy is a useful tool for directing product development and is equally important for developing products from food crops and co-products from the agricultural waste after harvest. The current trend in food research is to produce foods that are fast to prepare and/or ready to ...

15 CFR 996.12 - Development of standards compliance tests for a hydrographic product or class.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality Assurance Program for Hydrographic Products § 996.12 Development of standards compliance tests for...

78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-31

...] Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment... support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It... Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' published in...

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

Software Development Standard for Mission Critical Systems

DTIC Science & Technology

2014-03-17

new development, modification, reuse, reengineering, maintenance , or any other activity or combination of activities resulting in products . Within...develops” includes new development, modification, integration, reuse, reengineering, maintenance , or any other activity that results in products ... Maintenance organization. The organization that is responsible for modifying and otherwise sustaining the software and other software products and

New Food Product Development Assistance for Rural Food Enterprises.

ERIC Educational Resources Information Center

Stoll, William F.

1988-01-01

This article describes examples of new food product development activities engaged in at the University of Minnesota Technical College with local industry, showing how they have been used as teaching models in the classroom. These activities have led to a program of New Product Development Assistance for small food companies in southeastern…

76 FR 72423 - Bridging the Idea Development Evaluation Assessment and Long-Term Initiative and Total Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0780] Bridging the Idea Development Evaluation Assessment and Long-Term Initiative and Total Product Life Cycle... Idea Development Evaluation Assessment and Long-Term Initiative and Total Product Life Cycle Approaches...

Creating a High Impact Learning Environment for Engineering Technology Students

ERIC Educational Resources Information Center

Zhan, Wei; Wang, Jyhwen; Vanajakumari, Manoj; Johnson, Michael D.

2018-01-01

This paper discusses an initiative called Product Innovation and Development (PID) that was launched at Texas A&M University. The goal of PID is to create a high impact learning environment that focuses on innovative product development. Undergraduate students are hired to develop innovative new products. The student teams generate ideas for…

78 FR 30928 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

...; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products... Investigators on the Research and Development of Tobacco Products'' has been approved by the Office of... Meetings With Industry and Investigators on the Research and Development of Tobacco Products'' to OMB for...

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

The National Heart, Lung, and Blood Institute Small Business Program

PubMed Central

Marek, Kurt W.

2016-01-01

SUMMARY Small companies working to develop products in the cardiovascular space face numerous challenges, from regulatory, intellectual property, and reimbursement barriers to securing funds to keep the lights on and reach the next development milestone. Most small companies that spin out from universities have the scientific knowledge, but product development expertise and business acumen are also needed to be successful. Other challenges include reduced interest in early stage technologies (Pharma & Biotech 2015 in Review, EP Vantage) and limited deal flow for cardiovascular products (Gormley B., Wall Street Journal, September 15, 2014). The NHLBI small business program is a comprehensive ecosystem designed to address these critical challenges and to provide resources and expertise to assist early stage companies developing cardiovascular and other products within the institute’s mission. This article describes steps that NHLBI has taken to enhance our small business program to more effectively translate basic discoveries into commercial products to benefit patients and public health, including enhancing internal expertise and developing non-financial resources to assist small businesses as they develop their products and seek private sector investment and partnership. PMID:28580435

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

Waterpipe industry products and marketing strategies: analysis of an industry trade exhibition

PubMed Central

Jawad, Mohammed; Nakkash, Rima T; Hawkins, Ben; Akl, Elie A

2016-01-01

Introduction Understanding product development and marketing strategies of transnational tobacco companies (TTCs) has been of vital importance in developing effective tobacco control policy. However, comparatively little is known of the waterpipe tobacco industry, which TTCs have recently entered. This study aimed to gain an understanding of waterpipe tobacco products and marketing strategies by visiting a waterpipe trade exhibition. Methods In April 2014 the first author attended an international waterpipe trade exhibition, recording descriptions of products and collecting all marketing items available. We described the purpose and function of all products, and performed a thematic analysis of messages in marketing material. Results We classified the waterpipe products into seven categories and noted product variation within categories. Electronic waterpipe products (which mimic electronic cigarettes) rarely appeared on waterpipe tobacco marketing material, but were displayed just as widely. Claims of reduced harm, safety and quality were paramount on marketing materials, regardless of whether they were promoting waterpipe tobacco, waterpipe tobacco-substitutes, electronic waterpipes or charcoal. Conclusions Waterpipe products are diverse in nature and are marketed as healthy and safe products. Furthermore, the development of electronic waterpipe products appear to be closely connected with the electronic cigarette industry, rather than the waterpipe tobacco manufacturers. Tobacco control policy must evolve to take account of the vast and expanding array of waterpipe products, and potentially also charcoal products developed for waterpipe smokers. We recommend tobacco-substitutes be classified as tobacco products. Continued surveillance of the waterpipe industry is warranted. PMID:26149455

User Experience Evaluation Methods in Product Development (UXEM'09)

NASA Astrophysics Data System (ADS)

Roto, Virpi; Väänänen-Vainio-Mattila, Kaisa; Law, Effie; Vermeeren, Arnold

High quality user experience (UX) has become a central competitive factor of product development in mature consumer markets [1]. Although the term UX originated from industry and is a widely used term also in academia, the tools for managing UX in product development are still inadequate. A prerequisite for designing delightful UX in an industrial setting is to understand both the requirements tied to the pragmatic level of functionality and interaction and the requirements pertaining to the hedonic level of personal human needs, which motivate product use [2]. Understanding these requirements helps managers set UX targets for product development. The next phase in a good user-centered design process is to iteratively design and evaluate prototypes [3]. Evaluation is critical for systematically improving UX. In many approaches to UX, evaluation basically needs to be postponed until the product is fully or at least almost fully functional. However, in an industrial setting, it is very expensive to find the UX failures only at this phase of product development. Thus, product development managers and developers have a strong need to conduct UX evaluation as early as possible, well before all the parts affecting the holistic experience are available. Different types of products require evaluation on different granularity and maturity levels of a prototype. For example, due to its multi-user characteristic, a community service or an enterprise resource planning system requires a broader scope of UX evaluation than a microwave oven or a word processor that is meant for a single user at a time. Before systematic UX evaluation can be taken into practice, practical, lightweight UX evaluation methods suitable for different types of products and different phases of product readiness are needed. A considerable amount of UX research is still about the conceptual frameworks and models for user experience [4]. Besides, applying existing usability evaluation methods (UEMs) without adaptation to evaluate UX may lead to some scoping issues. Consequently, there is a strong need to put UX evaluation from research into practice.

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.

Improved milk production performance of smallholder farms in West Java (Indonesia).

PubMed

Sembada, Pria; Duteurtre, Guillaume; Purwanto, Bagus Priyo; Suryahadi

2016-04-01

In Indonesia, because of the rapidly growing demand for dairy products, the development of milk production in rural communities can play a strong role in reducing poverty. However, the development of smallholder dairy production requires adequate support from the government, development organizations, and private firms. To assess the needs and situations of poor dairy farmers, we conducted a study in Ciater sub-district in West Java Province to compare the current situation with the situation that prevailed 4 years ago, i.e., before the implementation of a dairy development project. Data were collected from 61 farms in June 2014. The average number of cows on the farms surveyed was three to four, and each relied on cultivating an average of 0.4 ha of forage. Results showed that thanks to the project activities, milk productivity per cow and net income from milk production increased by 25% between 2010 and 2014. These results underline the importance of providing training and technical support for the development of the livelihoods of dairy smallholders.

Variables influencing food perception reviewed for consumer-oriented product development.

PubMed

Sijtsema, Siet; Linnemann, Anita; van Gaasbeek, Ton; Dagevos, Hans; Jongen, Wim

2002-01-01

Consumer wishes have to be translated into product characteristics to implement consumer-oriented product development. Before this step can be made, insight in food-related behavior and perception of consumers is necessary to make the right, useful, and successful translation. Food choice behavior and consumers' perception are studied in many disciplines. Models of food behavior and preferences therefore were studied from a multidisciplinary perspective. Nearly all models structure the determinants related to the person, the food, and the environment. Consequently, the overview of models was used as a basis to structure the variables influencing food perception into a model for consumer-oriented product development. To this new model, referred to as food perception model, other variables like time and place as part of consumption moment were added. These are important variables influencing consumers' perception, and therefore of increasing importance to consumer-oriented product development nowadays. In further research, the presented food perception model is used as a tool to implement successful consumer-oriented product development.

Natural products for chronic cough: Text mining the East Asian historical literature for future therapeutics.

PubMed

Shergis, Johannah Linda; Wu, Lei; May, Brian H; Zhang, Anthony Lin; Guo, Xinfeng; Lu, Chuanjian; Xue, Charlie Changli

2015-08-01

Chronic cough is a significant health burden. Patients experience variable benefits from over the counter and prescribed products, but there is an unmet need to provide more effective treatments. Natural products have been used to treat cough and some plant compounds such as pseudoephedrine from ephedra and codeine from opium poppy have been developed into drugs. Text mining historical literature may offer new insight for future therapeutic development. We identified natural products used in the East Asian historical literature to treat chronic cough. Evaluation of the historical literature revealed 331 natural products used to treat chronic cough. Products included plants, minerals and animal substances. These natural products were found in 75 different books published between AD 363 and 1911. Of the 331 products, the 10 most frequently and continually used products were examined, taking into consideration findings from contemporary experimental studies. The natural products identified are promising and offer new directions in therapeutic development for treating chronic cough. © The Author(s) 2015.

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.

Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.

PubMed

Pariser, Anne R; Slack, Daniel J; Bauer, Larry J; Warner, Catherine A; Tracy, LaRee A

2012-08-01

New drug and biologic product marketing applications submitted to FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2010 were analyzed to identify rare disease application characteristics associated with higher approval rates. The results show that approval rates were similar for rare and common disease applications. Larger company size, prior regulatory experience and priority review designation were associated with higher approval rates. The study findings show that rare disease product development is feasible, and increased interactions between product developers and FDA in early investigational phases can facilitate product development. Published by Elsevier Ltd.

Beneficial Effects of Marine Algal Compounds in Cosmeceuticals

PubMed Central

Thomas, Noel Vinay; Kim, Se-Kwon

2013-01-01

The name “cosmeceuticals” is derived from “cosmetics and pharmaceuticals”, indicating that a specific product contains active ingredients. Marine algae have gained much importance in cosmeceutical product development due to their rich bioactive compounds. In the present review, marine algal compounds (phlorotannins, sulfated polysaccharides and tyrosinase inhibitors) have been discussed toward cosmeceutical application. In addition, atopic dermatitis and the possible role of matrix metalloproteinase (MMP) in skin-related diseases have been explored extensively for cosmeceutical products. The proper development of marine algae compounds will be helpful in cosmeceutical product development and in the development of the cosmeceutical industry. PMID:23344156

[Contribution of microbiologists of Kirov City to development of penicillin and streptomycin production processes (70 years since development of technology for submerged production of first domestic antibiotics)].

PubMed

Bakulin, M K; Tumanov, A S; Bakulin, V M; Kalininskiĭ, V B

2014-01-01

The publication is concerned with development of the technological processes for submered production of the first domestic antibiotics 70 years age. The literature data on the contribution of the microbiologists of the Kirov City and mainly the workers of the Red Army Research Institute of Epidemiology and Hygiene (nowadays Central Research Institute No. 48 of the Ministry of Defense of the Russian Federation, Kirov), to development of the manufacture processes for production of penicillin and streptomycin are reviewed.

The Development of the Market of the Production of Solar Energy in Poland and Selected EU Countries in the Years 2009-2014 - Comparative Analysis

NASA Astrophysics Data System (ADS)

Dorozińska, Weronika; Gawron, Maciej; Stańko, Paulina; Stępień, Natalia; Świstak, Patrycja; Ji, Han Yeon

2016-03-01

The paper discusses issues related to the development of solar energy production in Poland and selected EU countries in the years 2009-2014. The analysis of data concerning the production of solar energy in Poland and selected EU countries is presented as well as the strategic goals of the Union in respect the development of the `solar energy industry'. The article discusses the benefits and costs of the transformation of energy engineering and development of the production of solar energy, which is one of the most widespread and popular technologies of the production of energy from renewable resources in view of environment protection or reduction of the costs of energy consumption.

Innovative development path of ethnomedicines: a case study.

PubMed

Zhu, Zhaoyun; Gui, Yali; Wang, Li; Wang, Ting; Yang, Yang; Niu, Yunzhuang; Fu, Dehuan; Wang, Jingkun; Cui, Tao

2017-06-01

Innovative development extends the vitality of ethnomedicines. Developing ethnomedicines is not only beneficial to the public but also to the related industry and transforms economic growth, driving local social and economic development further. Its economic benefit can be used to optimize and promote the hardware and software of the platform, as well as support the sustainable development of ethnomedicines. Apart from research and discussion on the innovative development of ethnomedicines on the basis of theory and regulations, this series of articles also summarizes cases that are conducive to the overall understanding of the necessity and feasibility of the innovative development. In terms of industrial development, large enterprises and products, such as Yunnan Baiyao, Guizhou Miao ethnomedicines, Cheezheng Tibetan Medicine, products developed from Dengzhanhua (Erigeron breviscapus), the Gold series of Yi ethnomedicines, and products developed from Sanqi (Panax notoginseng), in China are introduced and summarized, focusing on resource superiority, sustainable innovation, standard research and development, and production, as well as intellectual property protection.

77 FR 8284 - Western Digital Technologies, Inc., Hard Drive Development Engineering Group Irvine (Formerly at...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

...'s facilities in Asia for engineering positions involving production, design, and development work... that appear to relate to production and design work and one position advertised by Western Digital in... performed new product design and their duties extend to sustaining production. AR 152, 212- 218, 228-231...

Production Systems and Rural Development in Canada.

ERIC Educational Resources Information Center

Sinclair, Peter R.

The paper examines the social structure of Canada's agricultural production. It argues that "the official development strategy is typical of state involvement in maturing capitalist economies and that, in so far as these policies are successful, they bring to an end small scale production of primary products by absorbing rural people into an…

Modeling Sustainability in Product Development and Commercialization

ERIC Educational Resources Information Center

Carlson, Robert C.; Rafinejad, Dariush

2008-01-01

In this article, the authors present the framework of a model that integrates strategic product development decisions with the product's impact on future conditions of resources and the environment. The impact of a product on stocks of nonrenewable sources and sinks is linked in a feedback loop to the cost of manufacturing and using the product…

What is the health care product?

PubMed

France, K R; Grover, R

1992-06-01

Because of the current competitive environment, health care providers (hospitals, HMOs, physicians, and others) are constantly searching for better products and better means for delivering them. The health care product is often loosely defined as a service. The authors develop a more precise definition of the health care product, product line, and product mix. A bundle-of-elements concept is presented for the health care product. These conceptualizations help to address how health care providers can segment their market and position, promote, and price their products. Though the authors focus on hospitals, the concepts and procedures developed are applicable to other health care organizations.

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.

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.

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

Successful development of recombinant DNA-derived pharmaceuticals.

PubMed

Werner, R G; Pommer, C H

1990-11-01

Successful development of recombinant DNA-derived pharmaceuticals, a new class of therapeutic agents, is determined by a variety of factors affecting the selection and positioning of the compound under development. For an efficient development it is of utmost importance that the mechanism of action of the compound selected be understood on a molecular level. The compound's potential therapeutical profile and a strong patent position are key positioning considerations, as well as vital elements in shortening the development phase and protecting innovation. Installation of an interdisciplinary project management team, along with a clear definition of team members' responsibilities, is required to avoid delays and improve communication during development. Selection of the organism to be used in production must take into consideration both the structure of the protein and the quality and safety of the final product. New technologies require a considerable investment in new manufacturing facilities and equipment. Often, the decision for such an investment must be made early and with a high degree of uncertainty. Desired product yield, expected dosage, and estimated market potential are the most important considerations in this decision. Following public disclosure of the plan to develop recombinant DNA-derived products, approval of the production plant and expansion or adaptation to the new process and technology may be delayed. For this reason, they should be considered as a critical step in the overall development phase. Recruitment of qualified staff is a time-consuming and critical element of the production process. Its impact on the product timeline should not be underestimated, especially if such technologies are new to the company. The entire production process must be validated in respect to identity, purity, and safety of the product to guarantee constant product quality, as well as for safety aspects in the environment. Adequate in-process and final product controls have to be established and specifications determined for release or rejection of batches for preclinical and clinical studies as well as for marketing. Preclinical testing is limited because recombinant DNA-derived proteins cannot be differentiated from naturally occurring human proteins, and because some proteins are species-specific.

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.

[Status of libraries and databases for natural products at abroad].

PubMed

Zhao, Li-Mei; Tan, Ning-Hua

2015-01-01

For natural products are one of the important sources for drug discovery, libraries and databases of natural products are significant for the development and research of natural products. At present, most of compound libraries at abroad are synthetic or combinatorial synthetic molecules, resulting to access natural products difficult; for information of natural products are scattered with different standards, it is difficult to construct convenient, comprehensive and large-scale databases for natural products. This paper reviewed the status of current accessing libraries and databases for natural products at abroad and provided some important information for the development of libraries and database for natural products.

Isolation and Purification of Biotechnological Products

NASA Astrophysics Data System (ADS)

Hubbuch, Jürgen; Kula, Maria-Regina

2007-05-01

The production of modern pharma proteins is one of the most rapid growing fields in biotechnology. The overall development and production is a complex task ranging from strain development and cultivation to the purification and formulation of the drug. Downstream processing, however, still accounts for the major part of production costs. This is mainly due to the high demands on purity and thus safety of the final product and results in processes with a sequence of typically more than 10 unit operations. Consequently, even if each process step would operate at near optimal yield, a very significant amount of product would be lost. The majority of unit operations applied in downstream processing have a long history in the field of chemical and process engineering; nevertheless, mathematical descriptions of the respective processes and the economical large-scale production of modern pharmaceutical products are hampered by the complexity of the biological feedstock, especially the high molecular weight and limited stability of proteins. In order to develop new operational steps as well as a successful overall process, it is thus a necessary prerequisite to develop a deeper understanding of the thermodynamics and physics behind the applied processes as well as the implications for the product.

[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

PubMed

Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

2014-01-01

Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

17 CFR 229.1205 - (Item 1205) Drilling and other exploratory and development activities.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., disclose: (1) The number of net productive and dry exploratory wells drilled; and (2) The number of net productive and dry development wells drilled. (b) Definitions. For purposes of this Item 1205, the following... an oil or gas well. (2) A productive well is an exploratory, development, or extension well that is...

Application of Pharmacokinetics and Pharmacodynamics in Product Life Cycle Management. A Case Study with a Carbidopa-Levodopa Extended-Release Formulation.

PubMed

Modi, Nishit B

2017-05-01

Increasing costs in discovering and developing new molecular entities and the continuing debate on limited company pipelines mean that pharmaceutical companies are under significant pressure to maximize the value of approved products. Life cycle management in the context of drug development comprises activities to maximize the effective life of a product. Life cycle approaches can involve new formulations, new routes of delivery, new indications or expansion of the population for whom the product is indicated, or development of combination products. Life cycle management may provide an opportunity to improve upon the current product through enhanced efficacy or reduced side effects and could expand the therapeutic market for the product. Successful life cycle management may include the potential for superior efficacy, improved tolerability, or a better prescriber or patient acceptance. Unlike generic products where bioequivalence to an innovator product may be sufficient for drug approval, life cycle management typically requires a series of studies to characterize the value of the product. This review summarizes key considerations in identifying product candidates that may be suitable for life cycle management and discusses the application of pharmacokinetics and pharmacodynamics in developing new products using a life cycle management approach. Examples and a case study to illustrate how pharmacokinetics and pharmacodynamics contributed to the selection of dosing regimens, demonstration of an improved therapeutic effect, or regulatory approval of an improved product label are presented.

Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition.

PubMed

Evens, Ronald P

2016-01-01

The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recombinant human insulin in 1982, originating from the Genentech company. The pharma industry in the early years of 1970s and 1980s engaged with biotechnology companies only to a small extent with their in-licensing of a few recombinant molecules, led by Roche, Eli Lilly, and Johnson and Johnson. However, subsequently and dramatically over the last 25 years, biotechnology has become a primary driver of product and technology innovation and has become a cornerstone in new product development by all biopharma companies. This review demonstrates these evolutionary changes regarding approved products, product pipelines, novelty of the products, FDA approval rates, product sales, financial R&D investments in biotechnology, partnerships, mergers and acquisitions, and patent issues. We now have about 300 biotechnology products approved in USA covering 16 medical disciplines and about 250 indications, with the engagement of 25 pharma companies, along with their biotechnology company innovators and partners. The biotechnology pipeline involves over 1000 molecules in clinical trials, including over 300 molecules associated with the top 10 pharma companies. Product approval rates by the FDA for biotechnology products are over double the rate for drugs. Yes, the R&D paradigm has changed with biotechnology now as one of the major focuses for new product development with novel molecules by the whole biopharma industry.

Development and status of Arkansas' primary forest products industry

Treesearch

Dennis M. May

1990-01-01

The development of Arkansas' primary forest products industry is presented by following the changes in numbers and types of mills operating through time as well as the State's production of roundwood to supply the changing industry.

[Chemistry for sustainable construction: 20 years of progress].

PubMed

Leoni, R

2012-01-01

Sustainable development is based on three pillars, economic, social and environmental development. Sustainable products can be developed only by companies that grow on these pillars, but in building sustainability is often identified only with the reduction of dangerous synthetic substances. From this point of view, the efforts of the construction chemicals industry have focused on reducing emissions, dust and volatile organic compounds (VOCs), replacing, if technically possible, the most dangerous components, such as formaldehyde, phthalates, and chlorinated or aromatic solvents, and developing water-borne products with very low VOC emissions. Differences in the definition of VOC and in the methods of measurement of emissions, however, make it difficult to choose the safest product and grows in the construction industry the need to reference trusted standards and product certifications to guarantee users. At present, products labeled "bio", "eco" or "solvent free" do not necessarily mean safe products.

From electronic consumer products to e-wastes: Global outlook, waste quantities, recycling challenges.

PubMed

Tansel, Berrin

2017-01-01

Advancements in technology, materials development, and manufacturing processes have changed the consumer products and composition of municipal solid waste (MSW) since 1960s. Increasing quantities of discarded consumer products remain a major challenge for recycling efforts, especially for discarded electronic products (also referred as e-waste). The growing demand for high tech products has increased the e-waste quantities and its cross boundary transport globally. This paper reviews the challenges associated with increasing e-waste quantities. The increasing need for raw materials (especially for rare earth and minor elements) and unregulated e-waste recycling operations in developing and underdeveloped counties contribute to the growing concerns for e-waste management. Although the markets for recycled materials are increasing; there are major challenges for development of the necessary infrastructure for e-waste management and accountability as well as development of effective materials recovery technologies and product design. Copyright © 2016 Elsevier Ltd. All rights reserved.

Success rates for product development strategies in new drug development.

PubMed

Dahlin, E; Nelson, G M; Haynes, M; Sargeant, F

2016-04-01

While research has examined the likelihood that drugs progress across phases of clinical trials, no research to date has examined the types of product development strategies that are the most likely to be successful in clinical trials. This research seeks to identify the strategies that are most likely to reach the market-those generated using a novel product development strategy or strategies that combine a company's expertise with both drugs and indications, which we call combined experience strategies. We evaluate the success of product development strategies in the drug development process for a sample of 2562 clinical trials completed by 406 US pharmaceutical companies. To identify product development strategies, we coded each clinical trial according to whether it consisted of an indication or a drug that was new to the firm. Accordingly, a clinical trial that consists of both an indication and a drug that were both new to the firm represents a novel product development strategy; indication experience is a product development strategy that consists of an indication that a firm had tested previously in a clinical trial, but with a drug that was new to the firm; drug experience is a product development strategy that consists of a drug that the firm had prior experience testing in clinical trials, but with an indication that was new to the firm; combined experience consists of both a drug and an indication that the firm had experience testing in clinical trials. Success rates for product development strategies across clinical phases were calculated for the clinical trials in our sample. Combined experience strategies had the highest success rate. More than three and a half percent (0·036) of the trials that combined experience with drugs and indications eventually reached the market. The next most successful strategy is drug experience (0·025) with novel strategies trailing closely (0·024). Indication experience strategies are the least successful (0·008). These differences are statistically significant. The primary contribution of this study is that product development strategies combining experience with drugs and indications strategies are the most likely to reach the market, even though they are least common strategy. Therefore, combined experience strategies remain underutilized. The findings also suggest a promising path for pursuing combined experience strategies: gaining expertise with drugs is likely to be a more effective path to gaining the expertise necessary for developing subsequent recombination strategies. © 2016 John Wiley & Sons Ltd.

Design for Production Manual. Volume 3. The Application of Production Engineering

DTIC Science & Technology

1985-12-01

3.1.1.1 Product Development The main objective of a product development strategy is to develop desiqns which are both highly marketable and which-allow the...responsibility between stages. Control is exercised by workers and foremen at each stage. 3-1 /104 3.1.1.2 Marketing and sales As a result of a well defined...to become even more competitive by achieving greater overlap, even for a mix of ships being constructed simultaneously. Their goal is to achieve

Recirculation: A New Concept to Drive Innovation in Sustainable Product Design for Bio-Based Products.

PubMed

Sherwood, James; Clark, James H; Farmer, Thomas J; Herrero-Davila, Lorenzo; Moity, Laurianne

2016-12-29

Bio-based products are made from renewable materials, offering a promising basis for the production of sustainable chemicals, materials, and more complex articles. However, biomass is not a limitless resource or one without environmental and social impacts. Therefore, while it is important to use biomass and grow a bio-based economy, displacing the unsustainable petroleum basis of energy and chemical production, any resource must be used effectively to reduce waste. Standards have been developed to support the bio-based product market in order to achieve this aim. However, the design of bio-based products has not received the same level of attention. Reported here are the first steps towards the development of a framework of understanding which connects product design to resource efficiency. Research and development scientists and engineers are encouraged to think beyond simple functionality and associate value to the potential of materials in their primary use and beyond.

A novel heuristic for optimization aggregate production problem: Evidence from flat panel display in Malaysia

NASA Astrophysics Data System (ADS)

Al-Kuhali, K.; Hussain M., I.; Zain Z., M.; Mullenix, P.

2015-05-01

Aim: This paper contribute to the flat panel display industry it terms of aggregate production planning. Methodology: For the minimization cost of total production of LCD manufacturing, a linear programming was applied. The decision variables are general production costs, additional cost incurred for overtime production, additional cost incurred for subcontracting, inventory carrying cost, backorder costs and adjustments for changes incurred within labour levels. Model has been developed considering a manufacturer having several product types, which the maximum types are N, along a total time period of T. Results: Industrial case study based on Malaysia is presented to test and to validate the developed linear programming model for aggregate production planning. Conclusion: The model development is fit under stable environment conditions. Overall it can be recommended to adapt the proven linear programming model to production planning of Malaysian flat panel display industry.

Importance And Role Of Competence In Professional Career Of Product Develop Engineers

NASA Astrophysics Data System (ADS)

Miltenović, Aleksandar; Banić, Milan; Miltenović, Vojislav

2015-07-01

Product development is a creative task where is systematically created a new product, which makes possible to firms to offer attractive, innovative and market oriented products. In conditions of fierce competition and saturated markets, companies that do not innovate are stagnating and disappear from the market. Innovation is therefore every intervention which can reduce production costs, enables optimum utilization of available human, energy and material resources, improve product quality, improve the placement, which leads to an increase in competitiveness. A prerequisite for fulfillment of the above-mentioned tasks is that the companies have engineers with the appropriate competencies, which are able to, through creativity, innovation and fascinating technique of creating new or improving existing products and lunch it on the market. The paper discusses the role and importance of the competences that are necessary for a successful professional career of product development engineers.

A roadmap for cost-of-goods planning to guide economic production of cell therapy products.

PubMed

Lipsitz, Yonatan Y; Milligan, William D; Fitzpatrick, Ian; Stalmeijer, Evelien; Farid, Suzanne S; Tan, Kah Yong; Smith, David; Perry, Robert; Carmen, Jessica; Chen, Allen; Mooney, Charles; Fink, John

2017-12-01

Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long-term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Protein and starch digestibilities and mineral availability of products developed from potato, soy and corn flour.

PubMed

Gahlawat, P; Sehgal, S

1998-01-01

A technique for development of potato flour was standardized. Five products viz. cake, biscuit, weaning food, panjiri and ladoo were prepared incorporating potato flour, defatted soy flour and corn flour. Baking and roasting were the major processing techniques employed for the development of these products. Protein, ash and fat contents of potato flour were almost similar to those of raw potatoes. Significant differences in protein, ash and fat contents of all the products were observed. Protein and starch digestibility of potato flour was significantly higher than that of raw potatoes. Protein digestibility increased by 12 to 17 percent on baking or roasting of products. Processed products had significantly higher starch digestibility and mineral availability compared to raw products. Thus, it can be concluded that roasting and baking are effective means of improving starch and protein digestibility and mineral availability of products.

Selection of an Alternative Production Part Approval Process to Improve Weapon Systems Production Readiness

DTIC Science & Technology

2017-09-01

production outcomes: 1) knowledge gaps in technology, 2) design instability and 3) manufacturing knowledge gaps. Only manufacturing knowledge gaps...ability to produce at a desired production rate. Each item produced under this manufacturing development is to meet that item’s design requirements. The...represented with respect to assessing manufacturing design and development with a verification and demonstration. DOD acquisition waits to assess production

Glycosylation and Activities of Natural Products.

PubMed

Huang, Gangliang; Lv, Meijiao; Hu, Jinchuan; Huang, Kunlin; Xu, Hong

2016-01-01

Natural products are widely found in nature, their number and variety are numerous, the structures are complex and diverse. These natural products have many physiological and pharmacological activities. Glycosylation can increase the diversity of structure and function of natural product, it has become the focus of drug research and development. The impacts of glycosylation of natural products to water solubility, pharmacological activities, bioavailability, or others were described in this review, which provides a reference for the development and application of glycosylated natural products.

Preparing the Production of a New Product in Small and Medium-Sized Enterprises by Using the Method of Projects Management

NASA Astrophysics Data System (ADS)

Bijańska, Jolanta; Wodarski, Krzysztof; Wójcik, Janusz

2016-06-01

Efficient and effective preparation the production of new products is important requirement for a functioning and development of small and medium-sized enterprises. One of the methods, which support the fulfilment of this condition is project management. This publication presents the results of considerations, which are aimed at developing a project management model of preparation the production of a new product, adopted to specificity of small and medium-sized enterprises.

Developing a 30-m grassland productivity estimation map for central Nebraska using 250-m MODIS and 30-m Landsat-8 observations

USGS Publications Warehouse

Gu, Yingxin; Wylie, Bruce K.

2015-01-01

Accurately estimating aboveground vegetation biomass productivity is essential for local ecosystem assessment and best land management practice. Satellite-derived growing season time-integrated Normalized Difference Vegetation Index (GSN) has been used as a proxy for vegetation biomass productivity. A 250-m grassland biomass productivity map for the Greater Platte River Basin had been developed based on the relationship between Moderate Resolution Imaging Spectroradiometer (MODIS) GSN and Soil Survey Geographic (SSURGO) annual grassland productivity. However, the 250-m MODIS grassland biomass productivity map does not capture detailed ecological features (or patterns) and may result in only generalized estimation of the regional total productivity. Developing a high or moderate spatial resolution (e.g., 30-m) productivity map to better understand the regional detailed vegetation condition and ecosystem services is preferred. The 30-m Landsat data provide spatial detail for characterizing human-scale processes and have been successfully used for land cover and land change studies. The main goal of this study is to develop a 30-m grassland biomass productivity estimation map for central Nebraska, leveraging 250-m MODIS GSN and 30-m Landsat data. A rule-based piecewise regression GSN model based on MODIS and Landsat (r = 0.91) was developed, and a 30-m MODIS equivalent GSN map was generated. Finally, a 30-m grassland biomass productivity estimation map, which provides spatially detailed ecological features and conditions for central Nebraska, was produced. The resulting 30-m grassland productivity map was generally supported by the SSURGO biomass production map and will be useful for regional ecosystem study and local land management practices.

Review of the cultivation program within the National Alliance for Advanced Biofuels and Bioproducts

DOE PAGES

Lammers, Peter J.; Huesemann, Michael; Boeing, Wiebke; ...

2016-12-12

The cultivation efforts within the National Alliance for Advanced Biofuels and Bioproducts (NAABB) were developed to provide four major goals for the consortium, which included biomass production for downstream experimentation, development of new assessment tools for cultivation, development of new cultivation reactor technologies, and development of methods for robust cultivation. The NAABB consortium testbeds produced over 1500 kg of biomass for downstream processing. The biomass production included a number of model production strains, but also took into production some of the more promising strains found through the prospecting efforts of the consortium. Cultivation efforts at large scale are intensive andmore » costly, therefore the consortium developed tools and models to assess the productivity of strains under various environmental conditions, at lab scale, and validated these against scaled outdoor production systems. Two new pond-based bioreactor designs were tested for their ability to minimize energy consumption while maintaining, and even exceeding, the productivity of algae cultivation compared to traditional systems. Also, molecular markers were developed for quality control and to facilitate detection of bacterial communities associated with cultivated algal species, including the Chlorella spp. pathogen, Vampirovibrio chlorellavorus, which was identified in at least two test site locations in Arizona and New Mexico. Finally, the consortium worked on understanding methods to utilize compromised municipal wastewater streams for cultivation. In conclusion, this review provides an overview of the cultivation methods and tools developed by the NAABB consortium to produce algae biomass, in robust low energy systems, for biofuel production.« less

Waterpipe industry products and marketing strategies: analysis of an industry trade exhibition.

PubMed

Jawad, Mohammed; Nakkash, Rima T; Hawkins, Ben; Akl, Elie A

2015-12-01

Understanding product development and marketing strategies of transnational tobacco companies (TTCs) has been of vital importance in developing an effective tobacco control policy. However, comparatively little is known of the waterpipe tobacco industry, which TTCs have recently entered. This study aimed to gain an understanding of waterpipe tobacco products and marketing strategies by visiting a waterpipe trade exhibition. In April 2014, the first author attended an international waterpipe trade exhibition, recording descriptions of products and collecting all available marketing items. We described the purpose and function of all products, and performed a thematic analysis of messages in marketing material. We classified waterpipe products into four categories and noted product variation within categories. Electronic waterpipe products (which mimic electronic cigarettes) rarely appeared on waterpipe tobacco marketing material, but were displayed just as widely. Claims of reduced harm, safety and quality were paramount on marketing materials, regardless of whether they were promoting consumption products (tobacco, tobacco substitutes), electronic waterpipes or accessories. Waterpipe products are diverse in nature and are marketed as healthy and safe products. Furthermore, the development of electronic waterpipe products appears to be closely connected with the electronic cigarette industry, rather than the waterpipe tobacco manufacturers. Tobacco control policy must evolve to take account of the vast and expanding array of waterpipe products, and potentially also charcoal products developed for waterpipe smokers. We recommend that tobacco substitutes be classified as tobacco products. Continued surveillance of the waterpipe industry is warranted. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The effects assessment of firm environmental strategy and customer environmental conscious on green product development.

PubMed

Tsai, Ming-Tien; Chuang, Li-Min; Chao, Shu-Tsung; Chang, Hsiao-Ping

2012-07-01

The purpose of this study is to examine why both parties (industry and consumer market) have mutual interests in protecting the environment but they still are hesitant to act green. The study used two-stage sampling from consumer market to depict ideal green product characteristics and reliable toy companies, and visit these companies for the second sample collection to examine whether the organizational eco-innovation strategy with customer value has a positive effect on green product development. In other words, the customer's benefit is an important factor for new product development strategy for green toys. This research shows that the willingness to buy green toys increases if most people in society buy green toys. This represents that customers are environmentally conscious and care about protecting the environment, or buying green toys is the result of a new economic trend and childhood education. The willingness to buy green toys increases if customers think that green products implies an enhancement on new product development to toy manufacturers. Further, if manufacturers are able to manage the difficulty of cooperation with all parties in the supply chain and difficulties related to production, they are willing to adopt customers' perceived value on green toys for their new product development strategy. It is rare to find academic research discussing the perspectives of both consumers and manufacturers in the same study because the research topic is very broad and many conditions must be considered. This research aims to find the effect of consumer-perceived value and company eco-innovation on green product development.

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.

22 CFR 125.4 - Exemptions of general applicability.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., except detailed design, development, production or manufacturing information; (7) Technical data..., production, or manufacture of any defense article; (4) Copies of technical data, including classified..., development, production, or manufacture of any defense article; (9) Technical data, including classified...

A Planning Guide for Small and Medium Size Wood Products Companies

Treesearch

Jeff Howe; Stephen Bratkovich

2005-01-01

At the beginning of the 21st century, North American wood products companies are facing competitive pressure from numerous sources. Traditional products are being manufactured in new regions (e.g., China and the developing nations), and substitute products are being developed by competing industries (e.g., plastics and composites). The bottom line is strained by...

Ecological Modernisation and Discourses on Rural Non-Wood Bioenergy Production in Finland from 1980 to 2005

ERIC Educational Resources Information Center

Huttunen, Suvi

2009-01-01

Rural bioenergy production is currently a much debated question worldwide. It is closely connected to questions of environmental protection and rural development in both developing and industrial world. In Finland, rural bioenergy production has traditionally meant the production of wood fuels for heating purposes. The utilisation of forest…

Development and quality characteristics of shelf-stable soy-agushie: a residual by-product of soymilk production.

PubMed

Nti, Christina A; Plahar, Wisdom A; Annan, Nana T

2016-03-01

A process was developed for the production of a high-protein food ingredient, soy-agushie, from the residual by-product of soymilk production. The product, with a moisture content of about 6%, was evaluated for its quality characteristics and performance in traditional dishes. The protein content was about 26% with similar amino acids content as that of the whole soybean. Lysine remained high in the dehydrated product (6.57 g/16 g N). While over 60% of the original B vitamins content in the beans was extracted with the milk, high proportions of the minerals were found to be retained in the residual by-product. The process adequately reduced the trypsin inhibitor levels in the beans from 25 to 1.5 mg/g. High sensory scores were obtained for recipes developed with soy-agushie in traditional dishes. The scope of utilization of the soy-agushie could be widened to include several traditional foods and bakery products for maximum nutritional benefits.

[Diagnosis of the productive capacity of the IMSS regarding health technologies].

PubMed

Figueroa-Lara, Alejandro; López-Fernández, Fátima Itzel; López-Domínguez, Adriana; Fajardo-Dolci, German

To quantify the production capacity and performance in research and technological developments of the Mexican Social Security Institute (IMSS). We identified and analyzed information of the legislation, human and financial resources, and infrastructure addressed for research and technological development of IMSS. We analyzed whether the information on the legal framework contained key features to boost research and technological development. Information on the human, financial, and infrastructure resources were obtained from official sources. The research productivity was identified by a bibliometric analysis in 2014; productivity in technological developments was identified by intellectual products. The legal framework of the IMSS has several areas for improvement to boost research and technological development, especially the guidelines for technology transfer. The IMSS has 438 researchers, 39 research units, and a budget of US$ 37.4 million for research and technological development. The rate of articles published per 10 researchers was 4.8; while rate patients was 1.8. The IMSS has a great potential to translate research into technological developments, it is only necessary to make some changes to the legal framework.

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

Auditory Perception, Suprasegmental Speech Processing, and Vocabulary Development in Chinese Preschoolers.

PubMed

Wang, Hsiao-Lan S; Chen, I-Chen; Chiang, Chun-Han; Lai, Ying-Hui; Tsao, Yu

2016-10-01

The current study examined the associations between basic auditory perception, speech prosodic processing, and vocabulary development in Chinese kindergartners, specifically, whether early basic auditory perception may be related to linguistic prosodic processing in Chinese Mandarin vocabulary acquisition. A series of language, auditory, and linguistic prosodic tests were given to 100 preschool children who had not yet learned how to read Chinese characters. The results suggested that lexical tone sensitivity and intonation production were significantly correlated with children's general vocabulary abilities. In particular, tone awareness was associated with comprehensive language development, whereas intonation production was associated with both comprehensive and expressive language development. Regression analyses revealed that tone sensitivity accounted for 36% of the unique variance in vocabulary development, whereas intonation production accounted for 6% of the variance in vocabulary development. Moreover, auditory frequency discrimination was significantly correlated with lexical tone sensitivity, syllable duration discrimination, and intonation production in Mandarin Chinese. Also it provided significant contributions to tone sensitivity and intonation production. Auditory frequency discrimination may indirectly affect early vocabulary development through Chinese speech prosody. © The Author(s) 2016.

The global capacity for manufacturing vaccines. Prospects for competition and collaboration among producers in the next decade.

PubMed

Robbins, A; Arita, I

1994-01-01

Can the world respond to the demands of the Children's Vaccine Initiative (CVI) to produce large quantities of affordable vaccines that have never been manufactured previously? Vaccines for the world's birth cohort of 150 million will continue to be produced in the countries that use the greatest part of the global vaccine supply. Thus, the CVI will rely on increased self sufficiency in vaccine production in the developing world and "shared development" of new and improved vaccines. The CVI's goal is to direct product development to meet the needs of immunization programs, but it must not neglect production. Thus, from the start, investment at the front end of the development and production sequence requires attention to the ultimate production capacity.

Technical Requirements for the Development of Marine Steel in China

NASA Astrophysics Data System (ADS)

Su, Hang; Pan, Tao; Chai, Feng; Yang, Caifu

China now experiences a fast development in shipbuilding and marine steel, the self-developed steel could meet the needs among 95% domestic clients. But in the items of some special high-end products, there are still certain gaps with advanced foreign countries, and these are mainly high-quality and strong-capacity products, large-size products, low-temperature products, and anti-corrosion, anti-fatigue and high-level failure arrest products. In the present paper, some domestic research and development (R& D) results in industry have been introduced, also, it points out that to eliminate these gaps, should rely on both the tech-progress in iron and steel industry, shipbuilding, and marine steel industry, and the establishment and improvement of the R& D system in researching, manufacturing, testing, producing and application.

Regulation of immunotherapeutic products for cancer and FDA’s role in product development and clinical evaluation

PubMed Central

2013-01-01

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials of both active and passive immunotherapeutic products that have the potential to convert life-ending diseases into chronic but manageable conditions. Clinical trials investigating immunotherapeutics are ongoing with some trials at advanced stages of development. However, as with many products involving novel mechanisms of action, major regulatory and scientific issues arising with clinical use of immunotherapeutic products remain to be addressed. In this review, we address issues related to different immunotherapeutics and provide recommendations for the characterization and evaluation of these products during various stages of product and clinical development. PMID:24764535

A Proposal of Product Development Collaboration Method Using User Support Information and its Experimental Evaluation

NASA Astrophysics Data System (ADS)

Tanaka, Mitsuru; Kataoka, Masatoshi; Koizumi, Hisao

As the market changes more rapidly and new products continue to get more complex and multifunctional, product development collaboration with competent partners and leading users is getting more important to come up with new products that are successful in the market in a timely manner. ECM (engineering chain management) and SCM (supply chain management) are supply-side approaches toward this collaboration. In this paper, we propose a demand-side approach toward product development collaboration with users based on the information gathered through user support interactions. The approach and methodology proposed here was applied to a real data set, and its effectiveness was verified.

Cross-country disparity in agricultural productivity: quantifying the role of modern seed adoption.

PubMed

O'Gorman, Melanie; Pandey, Manish

2010-01-01

Inequality of agricultural labour productivity across the developing world has increased substantially over the past 40 years. This article asks: to what extent did the diffusion of Green Revolution seed varieties contribute to increasing agricultural labour productivity disparity across the developing countries? We find that 22 per cent of cross-country variation in agricultural labour productivity can be attributed to the diffusion of high-yielding seed varieties across countries, and that the impact of such diffusion differed significantly across regions. We discuss the implications of these findings for policy directed at increasing agricultural labour productivity in the developing world.

East Europe Report

DTIC Science & Technology

1986-01-29

fulfillment of planned parameters, and must see to it that the programs for research and technological development will be fully imple- mented. The...productivity by developing and introducing new technology and raising the technological level, and the quality of products; -- developing cooperation in...production, :science, and technology , with -a view to accelerating scientific-technical pro.,res:s, this bei.ng a basic contlition for an intensive

Developing regulatory strategy for microbicides.

PubMed

Nardi, Ronald; Arterburn, Linda; Carlton, Lisa

2014-01-01

Ever since the discovery that a virus was responsible for AIDS, prevention of HIV infection has been a drug/vaccine development target in therapeutic research. Microbicide products are a viable, globally applicable option; however, to date, no product has been approved anywhere in the world. Development of such a product will need to account for the changing disease landscape and will need to leverage available regulatory pathways to gain approvals in the developed world and emerging markets. In countries where the regulatory pathway is not clear which is the case in several emerging markets, sponsors will need to employ a flexible approach to gather and meet local regulatory requirements and ultimately gain product approvals.

New Product Development (NPD) Process - An Example of Industrial Sector

NASA Astrophysics Data System (ADS)

Kazimierska, Marianna; Grębosz-Krawczyk, Magdalena

2017-12-01

This aim of this article is to present the process of new product introduction on example of industrial sector in context of new product development (NPD) concept. In the article, the concept of new product development is discussed and the different stages of the process of new electric motor development are analysed taking into account its objectives, implemented procedures, functions and responsibilities division. In the article, information from secondary sources and the results of empirical research - conducted in an international manufacturing company - are used. The research results show the significance of project leader and regular cooperation with final client in the NPD process.

Systematic development of technical textiles

NASA Astrophysics Data System (ADS)

Beer, M.; Schrank, V.; Gloy, Y.-S.; Gries, T.

2016-07-01

Technical textiles are used in various fields of applications, ranging from small scale (e.g. medical applications) to large scale products (e.g. aerospace applications). The development of new products is often complex and time consuming, due to multiple interacting parameters. These interacting parameters are production process related and also a result of the textile structure and used material. A huge number of iteration steps are necessary to adjust the process parameter to finalize the new fabric structure. A design method is developed to support the systematic development of technical textiles and to reduce iteration steps. The design method is subdivided into six steps, starting from the identification of the requirements. The fabric characteristics vary depending on the field of application. If possible, benchmarks are tested. A suitable fabric production technology needs to be selected. The aim of the method is to support a development team within the technology selection without restricting the textile developer. After a suitable technology is selected, the transformation and correlation between input and output parameters follows. This generates the information for the production of the structure. Afterwards, the first prototype can be produced and tested. The resulting characteristics are compared with the initial product requirements.

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.

Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies

PubMed Central

Xu, Wei; Boehm, Garth; Zheng, Qiang

2015-01-01

Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically available.This is justified as the article is only concerned with inherent product quality risks. After establishing a link between Chinese essential medicines and those available in the US, we examine US recall data to separate product specific recalls. We conclude that, in addition to existing manufacturing based risks, there are two other product specific risks that stand out from all others, degradation and dissolution failure. Methodology for relative product risk for degradation is needed to be developed and further work is required to better understand dissolution failures which largely occur with modified-release solid oral products. We conclude that a product specific quality risk profile would be enhanced by including a risk assessment for degradation for all products, and in the case of solid oral products, dissolution. PMID:26904402

Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies.

PubMed

Xu, Wei; Boehm, Garth; Zheng, Qiang

2016-01-01

Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically available.This is justified as the article is only concerned with inherent product quality risks. After establishing a link between Chinese essential medicines and those available in the US, we examine US recall data to separate product specific recalls. We conclude that, in addition to existing manufacturing based risks, there are two other product specific risks that stand out from all others, degradation and dissolution failure. Methodology for relative product risk for degradation is needed to be developed and further work is required to better understand dissolution failures which largely occur with modified-release solid oral products. We conclude that a product specific quality risk profile would be enhanced by including a risk assessment for degradation for all products, and in the case of solid oral products, dissolution.

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

50 CFR 18.126 - What does a Letter of Authorization allow?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Oil and Gas Exploration, Development, and Production Activities in the Beaufort Sea and Adjacent...) Developing oil fields and associated activities; (4) Drilling production wells and performing production support operations; (5) Conducting environmental monitoring activities associated with exploration...

50 CFR 18.126 - What does a Letter of Authorization allow?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Oil and Gas Exploration, Development, and Production Activities in the Beaufort Sea and Adjacent...) Developing oil fields and associated activities; (4) Drilling production wells and performing production support operations; (5) Conducting environmental monitoring activities associated with exploration...

50 CFR 18.126 - What does a Letter of Authorization allow?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Oil and Gas Exploration, Development, and Production Activities in the Beaufort Sea and Adjacent...) Developing oil fields and associated activities; (4) Drilling production wells and performing production support operations; (5) Conducting environmental monitoring activities associated with exploration...

Predicting Software Suitability Using a Bayesian Belief Network

NASA Technical Reports Server (NTRS)

Beaver, Justin M.; Schiavone, Guy A.; Berrios, Joseph S.

2005-01-01

The ability to reliably predict the end quality of software under development presents a significant advantage for a development team. It provides an opportunity to address high risk components earlier in the development life cycle, when their impact is minimized. This research proposes a model that captures the evolution of the quality of a software product, and provides reliable forecasts of the end quality of the software being developed in terms of product suitability. Development team skill, software process maturity, and software problem complexity are hypothesized as driving factors of software product quality. The cause-effect relationships between these factors and the elements of software suitability are modeled using Bayesian Belief Networks, a machine learning method. This research presents a Bayesian Network for software quality, and the techniques used to quantify the factors that influence and represent software quality. The developed model is found to be effective in predicting the end product quality of small-scale software development efforts.

Report Briefs: Publications of the Energy Division, Oak Ridge National Laboratory, 1999

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

Moser, C.I.

The Bureau of Labor Statistics (BLS) is responsible for collecting data to estimate price indices such as the Consumer Price Index (CPI). BLS accomplishes this task by sending field staff to places of business to price actual products. The field staff are given product checklists to help them determine whether the products found are comparable to products priced the previous month. Prices for noncomparable products are not included in the current month's price index calculations. A serious problem facing BLS is developing product checklists for dynamic product areas, new industries, and the service sector. It is difficult to keep checklistsmore » up to date and quite often simply to develop checklists for service industry products. Some people estimate that more than 50% of U.S. economic activity is not accounted for in the CPI. The objective it to provide the results of tests on a method for helping BLS staff build new product checklists quickly and efficiently. The domain chosen for studying the method was the telecommunications industry. The method developed by ORNL is based on behavioral science and knowledge-engineering principles. The method has ten steps, which include developing a sample of domain experts, asking experts to list products in the domain, culling the list of products to a manageable number, asking experts to group the remaining products, identifying product clusters using multidimensional scaling and cluster analysis, asking experts to compare pairs of products within clusters, and, finally, developing checklists with the comparison data. The method performed as expected. Several prototype checklists for products in the telecommunications domain were developed, including checklists for paging services, digital cell phones, web browsers, routers, and LAN modems. It was particularly difficult, however, to find experts to participate in the project. Attending a professional meeting and contacting experts from the conference's mailing list proved to be the best approach for this domain. The method has performed well in two domains: the telecommunications industry, as demonstrated in this project, and the PC software industry, as demonstrated in a previous project. It is recommended that the method be further tested in additional service industries, such as the nursing home industry. In addition, further attention needs to be devoted to developing procedures for the method to improve its cost and time efficiency. For example, if automated methods were used to collect information from the experts and if the experts could be assembled at one time, it could be possible to create prototype checklists in one day.« less

Natural Products as a Foundation for Drug Discovery

PubMed Central

Beutler, John A.

2009-01-01

Natural products have contributed to the development of many drugs for diverse indications. While most U.S. pharmaceutical companies have reduced or eliminated their in-house natural product groups, new paradigms and new enterprises have evolved to carry on a role for natural products in the pharmaceutical industry. Many of the reasons for the decline in popularity of natural products are being addressed by the development of new techniques for screening and production. This overview aims to inform pharmacologists of current strategies and techniques that make natural products a viable strategic choice for inclusion in drug discovery programs. PMID:20161632

The Auburn Engineering Technical Assistance Program investigation of polyvinyl alcohol film developments pertaining to radioactive particle decontamination and industrial waste minimization

NASA Astrophysics Data System (ADS)

Mole, Tracey Lawrence

In this work, an effective and systematic model is devised to synthesize the optimal formulation for an explicit engineering application in the nuclear industry, i.e. radioactive decontamination and waste reduction. Identification of an optimal formulation that is suitable for the desired system requires integration of all the interlacing behaviors of the product constituents. This work is unique not only in product design, but also in these design techniques. The common practice of new product development is to design the optimized product for a particular industrial niche and then subsequent research for the production process is conducted, developed and optimized separately from the product formulation. In this proposed optimization design technique, the development process, disposal technique and product formulation is optimized simultaneously to improve production profit, product behavior and disposal emissions. This "cradle to grave" optimization approach allowed a complex product formulation development process to be drastically simplified. The utilization of these modeling techniques took an industrial idea to full scale testing and production in under 18 months by reducing the number of subsequent laboratory trials required to optimize the formula, production and waste treatment aspects of the product simultaneously. This particular development material involves the use of a polymer matrix that is applied to surfaces as part of a decontamination system. The polymer coating serves to initially "fix" the contaminants in place for detection and ultimate elimination. Upon mechanical entrapment and removal, the polymer coating containing the radioactive isotopes can be dissolved in a solvent processor, where separation of the radioactive metallic particles can take place. Ultimately, only the collection of divided solids should be disposed of as nuclear waste. This creates an attractive alternative to direct land filling or incineration. This philosophy also provides waste generators a way to significantly reduce waste and associated costs, and help meet regulatory, safety and environmental requirements. In order for the polymeric film exhibit the desired performance, a combination of discrete constraints must be fulfilled. These interacting characteristics include the choice of polymer used for construction, drying time, storage constraints, decontamination ability, removal behavior, application process, coating strength and dissolvability processes. Identification of an optimized formulation that is suitable for this entire decontamination system requires integration of all the interlacing characteristics of the coating composition that affect the film behavior. A novel systematic method for developing quantitative values for theses qualitative characteristics is being developed in order to simultaneously optimize the design formulation subject to the discrete product specifications. This synthesis procedure encompasses intrinsic characteristics vital to successful product development, which allows for implementation of the derived model optimizations to operate independent of the polymer film application. This contribution illustrates the optimized synthesis example by which a large range of polymeric compounds and mixtures can be completed. (Abstract shortened by UMI.)

Development and testing of the Rho Sigma Incorporated microprocessor control subsystem

NASA Technical Reports Server (NTRS)

Hankins, J. D.

1979-01-01

Product development and performance tests of three programmable microprocessor controllers for use with solar heating and cooling systems are presented. The products were developed to be marketable for public use.

Developing an inventor support service which performs early stage market and manufacturing evaluations. Final report

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

Not Available

1991-10-01

American businesses are learning the difficult high cost lesson of ignoring production and market factors (producibility, unit product cost (UPC), marketability, etc) during the engineering design phase of product development. Studies have shown that the Japanese spend three times as long as Americans in the design feasibility and decision process of new product introductions and one third the amount of time in the implementation of those products. There is a 20 to 1 cost benefit on effort applied in the design phase versus the production phase of the product life cycle. The number one goal of this project was tomore » establish an organization that has, as one of its purposes, the providing of services responsive to the needs of independent inventors. The number two goal was to demonstrate the value of providing marketing and manufacturing counsel at an early stage in the product development process. The first study goal was met by providing the materials and information necessary to establish an evaluation team and an organization to handle such evaluations. The second study goal was met by demonstrating the impact of early market analysis and manufacturing considerations on product design and therefore on the description of the invention for four different inventions. These inventions were selected at various stages of development. Regardless of stage of development, the marketing and manufacturing reviews resulted in significant changes in design and/or market positioning.« less

Developing an inventor support service which performs early stage market and manufacturing evaluations. [Final Report

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

Not Available

1991-10-01

American businesses are learning the difficult high cost lesson of ignoring production and market factors (producibility, unit product cost (UPC), marketability, etc) during the engineering design phase of product development. Studies have shown that the Japanese spend three times as long as Americans in the design feasibility and decision process of new product introductions and one third the amount of time in the implementation of those products. There is a 20 to 1 cost benefit on effort applied in the design phase versus the production phase of the product life cycle. The number one goal of this project was tomore » establish an organization that has, as one of its purposes, the providing of services responsive to the needs of independent inventors. The number two goal was to demonstrate the value of providing marketing and manufacturing counsel at an early stage in the product development process. The first study goal was met by providing the materials and information necessary to establish an evaluation team and an organization to handle such evaluations. The second study goal was met by demonstrating the impact of early market analysis and manufacturing considerations on product design and therefore on the description of the invention for four different inventions. These inventions were selected at various stages of development. Regardless of stage of development, the marketing and manufacturing reviews resulted in significant changes in design and/or market positioning.« less

Recent advances and state-of-the-art strategies in strain and process engineering for biobutanol production by Clostridium acetobutylicum.

PubMed

Xue, Chuang; Zhao, Jingbo; Chen, Lijie; Yang, Shang-Tian; Bai, Fengwu

Butanol as an advanced biofuel has gained great attention due to its environmental benefits and superior properties compared to ethanol. However, the cost of biobutanol production via conventional acetone-butanol-ethanol (ABE) fermentation by Clostridium acetobutylicum is not economically competitive, which has hampered its industrial application. The strain performance and downstream process greatly impact the economics of biobutanol production. Although various engineered strains with carefully orchestrated metabolic and sporulation-specific pathways have been developed, none of them is ideal for industrial biobutanol production. For further strain improvement, it is necessary to develop advanced genome editing tools and a deep understanding of cellular functioning of genes in metabolic and regulatory pathways. Processes with integrated product recovery can increase fermentation productivity by continuously removing inhibitory products while generating butanol (ABE) in a concentrated solution. In this review, we provide an overview of recent advances in C. acetobutylicum strain engineering and process development focusing on in situ product recovery. With deep understanding of systematic cellular bioinformatics, the exploration of state-of-the-art genome editing tools such as CRISPR-Cas for targeted gene knock-out and knock-in would play a vital role in Clostridium cell engineering for biobutanol production. Developing advanced hybrid separation processes for in situ butanol recovery, which will be discussed with a detailed comparison of advantages and disadvantages of various recovery techniques, is also imperative to the economical development of biobutanol. Copyright © 2017 Elsevier Inc. All rights reserved.

Results of SEI Independent Research and Development Projects

DTIC Science & Technology

2008-12-01

contained there. When laptops with a dual-core processor came out, ITunes fails crashed. ITunes was designed as multi-threaded application, but until...involving product portfolio, in-bound technical marketing, research and development, product engineering, supply chain, and out-bound sales and marketing...of quality and process improvement professionals to the marketing, product engineering, supply chain, product test and sales professionals. 3

Measuring Net Investment and Productivity in Timber Production

Treesearch

David N. Wear

1994-01-01

An index number approach is developed for measuring changes in inputs, outputs, and total factor productivity in a timber-producing sector. These methods are applied to timber production in the U.S. South for the period 1952 to 1985. Results suggest that development of the sector may be described by an adjustment phase between 1952 and 1962 and a growth phase between...

A Product Analysis Method and Its Staging to Develop Redesign Competences

ERIC Educational Resources Information Center

Hansen, Claus Thorp; Lenau, Torben Anker

2013-01-01

Most product development work in industrial practice is incremental, i.e., the company has had a product in production and on the market for some time, and now time has come to design an upgraded variant. This type of redesign project requires that the engineering designers have competences to carry through an analysis of the existing product…

Creativity Enhancement in a Product Development Course through Entrepreneurship Learning and Intellectual Property Awareness

ERIC Educational Resources Information Center

Silva, Arlindo; Henriques, Elsa; Carvalho, Aldina

2009-01-01

Product development is the set of activities starting with the perception of a market need and ending in the production and sale of a new product satisfying that need. Broadly speaking, it is a process that should follow a structured methodology, if a certain level of effectiveness and efficacy is envisaged. In the Portuguese industrial…

From prototype to production system: lessons learned from the evolution of the SignOut System at Mount Sinai Medical Center.

PubMed

Kushniruk, Andre; Karson, Tom; Moore, Carlton; Kannry, Joseph

2003-01-01

Approaches to the development of information systems in large health care institutions range from prototyping to conventional development of large scale production systems. This paper discusses the development of the SignOut System at Mount Sinai Medical Center, which was designed in 1997 to capture vital resident information. Local need quickly outstripped proposed delays for building a production system and a prototype system quickly became a production system. By the end of 2002 the New SignOut System was built to create an integrated application that was a true production system. In this paper we discuss the design and implementation issues in moving from a prototype to a production system. The production system had a number of advantages, including increased organizational visibility, integration into enterprise resource planning and full time staff for support. However, the prototype allowed for more rapid design and subsequent changes, less training, and equal to or superior help desk support. It is argued that healthcare IT systems may need characteristics of both prototype and production system development to rapidly meet the changing and different needs of healthcare user populations.

Design for Health and Well Being: Knitted Products for Diabetics

NASA Astrophysics Data System (ADS)

Gault, A.

2016-07-01

This paper will discuss the design development, manufacturing and testing of knitted products maximizing the use of new innovations in Nano- technology and the integration of Phase Changing Materials specifically for diabetics. The project identified key aspects requiring design solutions to bring improvement to the circulatory problems with specific reference to the diabetic condition. Diabetics have particular difficulty in regulating their body temperature and this can result in the condition worsening, and resulting in loss of digits or limbs. The design of products to prevent the deterioration of the diabetic condition and to help those with limb loss was developed in collaboration with a Northern Ireland diabetic consultant, a product engineer and a knitwear designer. The fusion of ideas between the stakeholders resulted in the development and manufacture of a range of products that have been successfully tested at the yarn and fabric development stage and have been proven to maintain body temperature by either cooling or warming and therefore bring improvement to health and well-being. Whilst the product has a performance element the design ideas created desirable products that not only provided solutions to the brief but also resulted in products that had further market applications.

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.

Updates on Managing Type 2 Diabetes Mellitus with Natural Products: Towards Antidiabetic Drug Development.

PubMed

Alam, Fahmida; Islam, Md Asiful; Kamal, M A; Gan, Siew Hua

2016-08-13

Over the years, natural products have shown success as antidiabetics in vitro, in vivo and in clinical trials. Because natural product-derived drugs are more affordable and effective with fewer side-effects compared to conventional therapies, pharmaceutical research is increasingly leaning towards the discovery of new antidiabetic drugs from natural products targeting pathways or components associated with type 2 diabetes mellitus (T2DM) pathophysiology. However, the drug discovery process is very lengthy and costly with significant challenges. Therefore, various techniques are currently being developed for the preclinical research phase of drug discovery with the aim of drug development with less time and efforts from natural products. In this review, we have provided an update on natural products including fruits, vegetables, spices, nuts, beverages and mushrooms with potential antidiabetic activities from in vivo, in vitro and clinical studies. Synergistic interactions between natural products and antidiabetic drugs; and potential antidiabetic active compounds from natural products are also documented to pave the way for combination treatment and new drug discovery, respectively. Additionally, a brief idea of the drug discovery process along with the challenges that arise during drug development from natural products and the methods to conquer those challenges are discussed to create a more convenient future drug discovery process.

A new chapter in pharmaceutical manufacturing: 3D-printed drug products.

PubMed

Norman, James; Madurawe, Rapti D; Moore, Christine M V; Khan, Mansoor A; Khairuzzaman, Akm

2017-01-01

FDA recently approved a 3D-printed drug product in August 2015, which is indicative of a new chapter for pharmaceutical manufacturing. This review article summarizes progress with 3D printed drug products and discusses process development for solid oral dosage forms. 3D printing is a layer-by-layer process capable of producing 3D drug products from digital designs. Traditional pharmaceutical processes, such as tablet compression, have been used for decades with established regulatory pathways. These processes are well understood, but antiquated in terms of process capability and manufacturing flexibility. 3D printing, as a platform technology, has competitive advantages for complex products, personalized products, and products made on-demand. These advantages create opportunities for improving the safety, efficacy, and accessibility of medicines. Although 3D printing differs from traditional manufacturing processes for solid oral dosage forms, risk-based process development is feasible. This review highlights how product and process understanding can facilitate the development of a control strategy for different 3D printing methods. Overall, the authors believe that the recent approval of a 3D printed drug product will stimulate continual innovation in pharmaceutical manufacturing technology. FDA encourages the development of advanced manufacturing technologies, including 3D-printing, using science- and risk-based approaches. Published by Elsevier B.V.

TESTING INDOOR AIR PRODUCTS: ONE APPROACH TO DEVELOPING WIDELY ACCEPTED PROTOCOLS

EPA Science Inventory

The paper describes an approach to developing widely acce ted products for testing indoor air products. [NOTE: Research Triangle Institute (RTI) is a partner in the U.S. Environmental Protection Agency's (EPA's) Environmental Technology Verification (ETV) Program with responsibil...

Natural products as a foundation for drug discovery.

PubMed

Beutler, John A

2009-09-01

Natural products have provided chemical leads for the development of many drugs for diverse indications. While most U.S. pharmaceutical firms have reduced or eliminated their in-house natural product groups, there is a renewed interest in this source of new chemical entities. Many of the reasons for the past decline in popularity of natural products are being addressed by the development of new techniques for screening and production. The aim of this unit is to review current strategies and techniques that increase the value of natural products as a source for novel drug candidates.

Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs.

PubMed

Le, Tran T

2017-01-01

Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products. Since its enactment in 1983, the ODA has been credited for bringing more than 590 orphan drugs to the market, inspiring the implementation of orphan legislation globally, and enabling the creation of other programs that extend existing knowledge of the natural history of rare diseases and stimulate the development of medical devices for children and patients with rare diseases. This chapter provides a brief overview of the main features and successes of 5 of the orphan incentive programs administered by the US Food and Drug Administration (FDA): the Orphan Drug Designation Program, the Humanitarian Use Device (HUD) Designation Program, the Orphan Products Clinical Trials Grants Program, the Pediatric Device Consortia (PDC) Grant Program, and the Orphan Products Natural History Grants Program.

Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

PubMed

Park, Glen D; Mitchel, Jules T

2016-06-01

While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product. © 2016 New York Academy of Sciences.

Characterization of lipids and antioxidant capacity of novel nutraceutical egg products developed with omega-3-rich oils.

PubMed

Kassis, Nissan M; Gigliotti, Joseph C; Beamer, Sarah K; Tou, Janet C; Jaczynski, Jacek

2012-01-15

Cardiovascular disease has had an unquestioned status of the number one cause of death in the US since 1921. Omega-3 polyunsaturated fatty acids (ω-3 PUFAs) have cardio-protective benefits. However, egg is typically a poor source of ω-3 PUFAs and, in general, the American diet is low in these cardio-protective fatty acids. Novel, nutritionally enhanced egg products were developed by substituting yolk with ω-3 PUFA-rich flaxseed, menhaden, algae, or krill oil. Experimental egg products matched composition of hen egg (whole egg). The experimental egg products, mixed whole egg, and a liquid egg product (Egg Beaters) were microwave-cooked and compared. Although fat, protein, and moisture contents of experimental egg products matched (P > 0.05) mixed whole egg, experimental egg products had more (P < 0.05) ω-3 PUFAs, lower (P < 0.05) ω-6/ω-3 ratio, and depending on oil added, a higher (P < 0.05) unsaturated/saturated fatty acids ratio compared to mixed whole egg. Triglycerides were the main lipid class in all experimental egg products except those developed with krill oil, which had even more phospholipids than mixed whole egg. Analysis of thiobarbituric acid reactive substances showed that lipid oxidation of experimental egg products was lower (P < 0.05) or similar (P > 0.05) to mixed whole egg, except for experimental egg products with krill oil. However, peroxide value showed that all egg samples had minimal oxidation. Experimental egg products developed with menhaden or flaxseed oil had the highest (P < 0.05) concentration of the antioxidant, ethyoxquin compared to all other egg samples. However, experimental egg products with krill oil likely contained a natural antioxidant, astaxanthin. This study demonstrated an alternative approach to developing novel, nutraceutical egg products. Instead of dietary modification of chicken feed, yolk substitution with ω-3 PUFAs oils resulted in enhancement of ω-3 PUFAs beyond levels possible to achieve by modifying chicken feed. Copyright © 2011 Society of Chemical Industry.

Commercialization of veterinary viral vaccines.

PubMed

Flore, P H

2004-12-01

If vaccines are to reliably prevent disease, they must be developed, produced and quality-controlled according to very strict regulations and procedures. Veterinary viral vaccine registrations are governed by different rules in different countries, but these rules all emphasize that the quality of the raw materials--the cells, eggs, animals or plants that are used in production--need to be carefully controlled. The veterinary vaccine business is also very cost-conscious. Emphasis over the last 5-10 years has therefore been to develop culture systems that minimize labor and sterility problems and thus provide for reliable and cost-effective production. Implementing these often more complex systems in a production environment takes considerable effort, first in scale-up trials and further down the line in convincing production personnel to change their familiar system for something new and possibly untried. To complete scale-up trials successfully, it is absolutely necessary to understand the biochemistry of the cells and the influence of the virus on the cells under scale-up and later production conditions. Once a viral product can be produced on a large scale, it is imperative that the quality of the end-product is controlled in an intelligent way. One needs to know whether the end-product performs in the animal as was intended during its conception in the research and development department. The development of the appropriate tests to demonstrate this plays an important role in the successful development of a vaccine.

US Army Medical Research and Development Report.

DTIC Science & Technology

1979-10-01

RI) US ARMY MEDICAL RESEARCH AND DEVELOPMENT REPORT. Colonel/John Jr DTIC JUL 1 5 1980; A USL &MY MEDICAL BIOENGINEERING RESEARCH AND DEVELOPMENT...pollutants in water or soil . Pollutant by-products and breakdown products in water, air or soil will be isolated, characterized, and quantified. Where...determination of selected low-level pollutants io soil and water. Degradation products and secondary pollutants arising from munitions manufacture or pest

Lexical development of noun and predicate comprehension and production in isiZulu

PubMed Central

Ahmed, Saaliha

2016-01-01

This study seeks to investigate the development of noun and predicate comprehension and production in isiZulu-speaking children between the ages of 25 and 36 months. It compares lexical comprehension and production in isiZulu, using an Italian developed and validated vocabulary assessment tool: The Picture Naming Game (PiNG) developed by Bello, Giannantoni, Pettenati, Stefanini and Caselli (2012). The PiNG tool includes four subtests, one each for subnoun comprehension (NC), noun production (NP), predicate comprehension (PC), and predicate production (PP). Children are shown these lexical items and then asked to show comprehension and produce certain lexical items. After adaptation into the South African context, the adapted version of PiNG was used to directly assess the lexical development of isiZulu with the three main objectives to (1) test the efficiency of the adaptation of a vocabulary tool to measure isiZulu comprehension and production development, (2) test previous findings done in many cross-linguistic comparisons that have found that both comprehension and production performance increase with age for a lesser-studied language, and (3) present our findings around the comprehension and production of the linguistic categories of nouns and predicates. An analysis of the results reported in this study show an age effect throughout the entire sample. Across all the age groups, the comprehension of the noun and predicate subtests was better performed than the production of noun and predicate subtests. With regard to lexical items, the responses of children showed an influence of various factors, including the late acquisition of items, possible problems with stimuli presented to them, and the possible input received by the children from their home environment. PMID:27542416

Lexical development of noun and predicate comprehension and production in isiZulu.

PubMed

Nicolas, Ramona Kunene; Ahmed, Saaliha

2016-07-28

This study seeks to investigate the development of noun and predicate comprehension and production in isiZulu-speaking children between the ages of 25 and 36 months. It compares lexical comprehension and production in isiZulu, using an Italian developed and validated vocabulary assessment tool: The Picture Naming Game (PiNG) developed by Bello, Giannantoni, Pettenati, Stefanini and Caselli (2012). The PiNG tool includes four subtests, one each for subnoun comprehension (NC), noun production (NP), predicate comprehension (PC), and predicate production (PP). Children are shown these lexical items and then asked to show comprehension and produce certain lexical items. After adaptation into the South African context, the adapted version of PiNG was used to directly assess the lexical development of isiZulu with the three main objectives to (1) test the efficiency of the adaptation of a vocabulary tool to measure isiZulu comprehension and production development, (2) test previous findings done in many cross-linguistic comparisons that have found that both comprehension and production performance increase with age for a lesser-studied language, and (3) present our findings around the comprehension and production of the linguistic categories of nouns and predicates. An analysis of the results reported in this study show an age effect throughout the entire sample. Across all the age groups, the comprehension of the noun and predicate subtests was better performed than the production of noun and predicate subtests. With regard to lexical items, the responses of children showed an influence of various factors, including the late acquisition of items, possible problems with stimuli presented to them, and the possible input received by the children from their home environment.

Ovation Pharmaceuticals, Inc.

PubMed

Deutsch, Barry

2002-11-01

Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceutical company in August 2002.

Beneficial uses of space

NASA Technical Reports Server (NTRS)

Bloom, H. L.

1977-01-01

The study elicited over 100 ideas for Space Processing. Of the elicited ideas, more than 20% involved processing of biologicals, or related medical and life sciences applications. Among these were High Purity Separation of Isoenzymes, and Development of Biorhythms applications data. Program planning for four products is outlined. Experimentation and testing resulted in definition of nearly 70 series of tests in ground-based laboratories, sounding rockets, etc., and space shuttle. Development schedules established timing and interrelationships of decisions involved in carrying these products to the point of production. The potential profitability of the four products is determined. Resources needed to achieve full scale production included use of shuttle for transportation, for which cost apportionment model was developed. R and D resources for the four products totalled $46,000,000 with Isoenzymes requiring the smallest expenditure, $4,000,000. A computerized profitability model (INVEST) was used to determine the measures of profitability of each product. Results build confidence that there will be a payoff.

Toward exascale production of recombinant adeno-associated virus for gene transfer applications.

PubMed

Cecchini, S; Negrete, A; Kotin, R M

2008-06-01

To gain acceptance as a medical treatment, adeno-associated virus (AAV) vectors require a scalable and economical production method. Recent developments indicate that recombinant AAV (rAAV) production in insect cells is compatible with current good manufacturing practice production on an industrial scale. This platform can fully support development of rAAV therapeutics from tissue culture to small animal models, to large animal models, to toxicology studies, to Phase I clinical trials and beyond. Efforts to characterize, optimize and develop insect cell-based rAAV production have culminated in successful bioreactor-scale production of rAAV, with total yields potentially capable of approaching the exa-(10(18)) scale. These advances in large-scale AAV production will allow us to address specific catastrophic, intractable human diseases such as Duchenne muscular dystrophy, for which large amounts of recombinant vector are essential for successful outcome.

Price competition in the Chinese pharmaceutical market.

PubMed

Wang, Y Richard

2006-06-01

We study price competition between high-quality global products and low-quality local products in a developing country, i.e., China, Nearly all previous studies on pharmaceutical price competition focused on developed countries with bioequivalent generics. In China, local generic products are not bioequivalent and are deemed of lower quality, while global products in the same class are considered similar in quality and better substitutes. We hypothesize that local generic competition drives down local product price but not global product price. In addition, we hypothesize that therapeutic competition among similar global products lowers global product price. Our empirical results support both hypotheses. Number of local generic competitors has a significantly negative effect on local product price but no effect on global product price, while number of global therapeutic competitors has a significantly negative effect on global product price. Policy changes that encourage bioequivalent local products and accelerate global product approvals will enhance price competition in China.

Drug Development Process

MedlinePlus

... Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Patients Home For Patients Learn About Drug and Device Approvals The Drug Development Process The Drug Development Process Share Tweet Linkedin Pin ...

Students Develop New Foods for School Lunch

ERIC Educational Resources Information Center

Lindquist, Michele

2004-01-01

In partnership with their food service staff, the author of this paper developed the "Food Innovations" course, which fulfills the Minnesota graduation requirements for Inquiry: New Product Development. In this course, students first demonstrate an understanding of nutrition, food safety, product development, marketing strategies, and…

Drug-device combination products: regulatory landscape and market growth.

PubMed

Bayarri, L

2015-08-01

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products.

PubMed

Arcidiacono, Judith A; Bauer, Steven R; Kaplan, David S; Allocca, Clare M; Sarkar, Sumona; Lin-Gibson, Sheng

2018-06-01

The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development. Published by Elsevier Inc.

A quality-based cost model for new electronic systems and products

NASA Astrophysics Data System (ADS)

Shina, Sammy G.; Saigal, Anil

1998-04-01

This article outlines a method for developing a quality-based cost model for the design of new electronic systems and products. The model incorporates a methodology for determining a cost-effective design margin allocation for electronic products and systems and its impact on manufacturing quality and cost. A spreadsheet-based cost estimating tool was developed to help implement this methodology in order for the system design engineers to quickly estimate the effect of design decisions and tradeoffs on the quality and cost of new products. The tool was developed with automatic spreadsheet connectivity to current process capability and with provisions to consider the impact of capital equipment and tooling purchases to reduce the product cost.

Development and evaluation of magnesium oxide-based ceramics for chamber parts in mass-production plasma etching equipment

NASA Astrophysics Data System (ADS)

Kasashima, Yuji; Tsutsumi, Kota; Mitomi, Shinzo; Uesugi, Fumihiko

2017-06-01

In mass-production plasma etching equipment, the corrosion of ceramic chamber parts reduces the production yield of LSI and overall equipment effectiveness (OEE) owing to contamination, short useful life, and particle generation. Novel ceramics that can improve the production yield and OEE are highly required. We develop magnesium oxide (MgO)-based ceramics and evaluate them under mass-production plasma etching conditions. The results of this study indicate that the developed MgO-based ceramics with high mechanical properties and low electric resistivity have a higher resistance to corrosion in plasma etching using CF4 gas than Si and conventional ceramic materials such as aluminum oxide and yttrium oxide.

Advancing Models and Data for Characterizing Exposures to Chemicals in Consumer Products

EPA Science Inventory

EPA’s Office of Research and Development (ORD) is leading several efforts to develop data and methods for estimating population chemical exposures related to the use of consumer products. New curated chemical, ingredient, and product use information are being collected fro...

Process and utility water requirements for cellulosic ethanol production processes via fermentation pathway

EPA Science Inventory

The increasing need of additional water resources for energy production is a growing concern for future economic development. In technology development for ethanol production from cellulosic feedstocks, a detailed assessment of the quantity and quality of water required, and the ...

Price trend analysis and its implications for the development of new medical technologies.

PubMed

Brown, Alan; Meenan, Brian J; Young, Terry P

2007-01-01

It is assumed that a company will only develop a new medical technology if it has evidence that it will provide returns that are greater than the investment required to develop that technology and bring it to the market. The price that can be commanded for the new products and the volumes of the products that are sold determine, in large measure, the returns that will be made on the initial investment. Estimating the sales volumes and prices of products are critical factors in decision making during product development. Once in the market prices are not static. Rather they are affected by a range of factors. This paper considers the effect that market experience, represented by cumulative volume of sales, has on prices. How quickly the price declines in response to experience is dependent on a number of factors. How price trends from products already in the market can be used to inform investment decisions of new products and technologies is described.

Usability in product design--the importance and need for systematic assessment models in product development--Usa-Design Model (U-D) ©.

PubMed

Merino, Giselle Schmidt Alves Díaz; Teixeira, Clarissa Stefani; Schoenardie, Rodrigo Petry; Merino, Eugenio Andrés Diáz; Gontijo, Leila Amaral

2012-01-01

In product design, human factors are considered as an element of differentiation given that today's consumer demands are increasing. Safety, wellbeing, satisfaction, health, effectiveness, efficiency, and other aspects must be effectively incorporated into the product development process. This work proposes a usability assessment model that can be incorporated as an assessment tool. The methodological approach is settled in two stages. First a literature review focus specifically on usability and developing user-centred products. After this, a model of usability named Usa-Design (U-D©) is presented. Consisted of four phases: understanding the use context, pre-preliminary usability assessment (efficiency/effectiveness/satisfaction); assessment of usability principles and results, U-D© features are modular and flexible, allowing principles used in Phase 3 to be changed according to the needs and scenario of each situation. With qualitative/quantitative measurement scales of easy understanding and application, the model results are viable and applicable throughout all the product development process.

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.

Biosynthesis of indigo using recombinant E. coli: Development of a biological system for the cost-effective production of a large volume chemical

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

Berry, A.; Battist, S.; Chotani, G.

1995-11-01

Cost-effective production of any large-volume chemical by fermentation requires extensive manipulation of both the production organism and the fermentation and recovery processes. We have developed a recombinant E. coli system for the production of tryptophan and several other products derived from the aromatic amino acid pathway. By linking our technology for low-cost production of tryptophan from glucose with the enzyme naphthalene dioxygenase (NDO), we have achieved an overall process for the production of indigo dye from glucose. To successfully join these two technologies, both the tryptophan pathway and NDO were extensively modified via genetic engineering. In addition, systems were developedmore » to remove deleterious by-products generated during the chemical oxidations leading to indigo formation. Low-cost fermentation processes were developed that utilized minimal-salts media containing glucose as the sole carbon source. Finally, economical recovery processes were used that preserved the environmental friendliness of the biosynthetic route to indigo.« less

Pharmacy-based distribution system for enteral nutrition products.

PubMed

Craig, S A; Paulson, M F

1985-12-01

A hospital pharmacy department's implementation of enteral nutrition product distribution and its proposal for an enteral nutrition product admixture service are described. Responsibility for the distribution of enteral nutrition formulations was transferred from the central distribution department to the pharmacy after problems with inventory control, billing procedures, and inappropriate administration of enteral nutrition products were recognized by personnel from the central-distribution area and nutrition services. After additional problems were identified using a multi-disciplinary approach, the pharmacy department implemented an enteral nutrition product distribution system and developed an enteral nutrition product formulary. A proposal was developed for a pharmacy-based enteral nutrition admixture service, but implementation of this service was deferred because data from a cost-effectiveness evaluation and random bacteriologic monitoring did not justify adding the service. Pharmacy-based distribution and formulary control of enteral nutrition products alleviated problems with inaccurate patient charges and accumulation of stock on the nursing units. Pharmacists at this hospital hope to develop an enteral nutrition product admixture program that will result in cost savings for the institution.

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

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

Aerospace Engineering Systems

NASA Technical Reports Server (NTRS)

VanDalsem, William R.; Livingston, Mary E.; Melton, John E.; Torres, Francisco J.; Stremel, Paul M.

1999-01-01

Continuous improvement of aerospace product development processes is a driving requirement across much of the aerospace community. As up to 90% of the cost of an aerospace product is committed during the first 10% of the development cycle, there is a strong emphasis on capturing, creating, and communicating better information (both requirements and performance) early in the product development process. The community has responded by pursuing the development of computer-based systems designed to enhance the decision-making capabilities of product development individuals and teams. Recently, the historical foci on sharing the geometrical representation and on configuration management are being augmented: Physics-based analysis tools for filling the design space database; Distributed computational resources to reduce response time and cost; Web-based technologies to relieve machine-dependence; and Artificial intelligence technologies to accelerate processes and reduce process variability. Activities such as the Advanced Design Technologies Testbed (ADTT) project at NASA Ames Research Center study the strengths and weaknesses of the technologies supporting each of these trends, as well as the overall impact of the combination of these trends on a product development event. Lessons learned and recommendations for future activities will be reported.

Measuring the impact of computer resource quality on the software development process and product

NASA Technical Reports Server (NTRS)

Mcgarry, Frank; Valett, Jon; Hall, Dana

1985-01-01

The availability and quality of computer resources during the software development process was speculated to have measurable, significant impact on the efficiency of the development process and the quality of the resulting product. Environment components such as the types of tools, machine responsiveness, and quantity of direct access storage may play a major role in the effort to produce the product and in its subsequent quality as measured by factors such as reliability and ease of maintenance. During the past six years, the NASA Goddard Space Flight Center has conducted experiments with software projects in an attempt to better understand the impact of software development methodologies, environments, and general technologies on the software process and product. Data was extracted and examined from nearly 50 software development projects. All were related to support of satellite flight dynamics ground-based computations. The relationship between computer resources and the software development process and product as exemplified by the subject NASA data was examined. Based upon the results, a number of computer resource-related implications are provided.

Optimization of Deep Drilling Performance - Development and Benchmark Testing of Advanced Diamond Product Drill Bits & HP/HT Fluids to Significantly Improve Rates of Penetration

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

Alan Black; Arnis Judzis

2005-09-30

This document details the progress to date on the OPTIMIZATION OF DEEP DRILLING PERFORMANCE--DEVELOPMENT AND BENCHMARK TESTING OF ADVANCED DIAMOND PRODUCT DRILL BITS AND HP/HT FLUIDS TO SIGNIFICANTLY IMPROVE RATES OF PENETRATION contract for the year starting October 2004 through September 2005. The industry cost shared program aims to benchmark drilling rates of penetration in selected simulated deep formations and to significantly improve ROP through a team development of aggressive diamond product drill bit--fluid system technologies. Overall the objectives are as follows: Phase 1--Benchmark ''best in class'' diamond and other product drilling bits and fluids and develop concepts for amore » next level of deep drilling performance; Phase 2--Develop advanced smart bit-fluid prototypes and test at large scale; and Phase 3--Field trial smart bit--fluid concepts, modify as necessary and commercialize products. As of report date, TerraTek has concluded all Phase 1 testing and is planning Phase 2 development.« less

Managing Tipping Point Dynamics in Single Development Projects

DTIC Science & Technology

2006-04-30

Journal of Product Innovation Management , 22(2005), 177-192. Lyneis, F., Cooper, K., & Els, S. (2001). Strategic management of complex projects: A case...new product development. Journal of Product Innovation Management ,18(2001), 265-300. Richardson, G.P., & Pugh, A.L. (1981). Introduction to... Product Innovation Management , 17(2000), 128- 142. United States General Accounting Office (USGAO). (1996). Department of Energy: Opportunity to improve

Summary of strategies for planning Productivity Improvement and Quality Enhancement (PIQE)

NASA Technical Reports Server (NTRS)

1986-01-01

The Summary of NASA Strategies for Productivity Improvement and Quality Enhancement respond to NASA's eighth top goal: Establish NASA as a leader in the development and application of advanced technology and management practices which contribute to significant increases in both Agency and national productivity. The Strategies provide the framework for development of the agency-wide Productivity Improvement and Quality Enhancement (PIQE) Plans.

Developing Molecular Genetic Tools to Facilitate Economic Production in Green Algae

DTIC Science & Technology

2012-09-10

Economic Production in Green Algae FA9550-10-1-0052 Georgianna, David, R Gimpel, Javier Hannon, Michael, J Mayfield, Stephen, P Prof. Stephen...Final Performance Report Project Title: Developing Molecular Genetic Tools to Facilitate Economic Production in Green Algae Award Number... ECONOMIC PRODUCTION IN GREEN ALGAE ABSTRACT It is now accepted that algae have enormous potential to generate economically viable and

Biomedical applications of tissue engineering technology: regulatory issues.

PubMed

Hellman, K B

1995-01-01

Novel emerging technologies such as tissue engineering, which utilize the approaches of molecular and cell biology, biotechnology, as well as materials science and engineering, are being used in the development of a wide range of biomedical products developed by industries regulated by the U.S. Food and Drug Administration (FDA). The FDA's mission is to promote and protect the public health by ensuring the safety and effectiveness of pharmaceuticals and medical devices, including those manufactured by novel technology, as assessed by scientific principles and methods. Regulatory review is conducted on a product-by-product basis. To accomplish its mission over the wide range of products in its regulatory purview, the FDA has six centers, each staffed with the scientific and regulatory expertise to evaluate the products in the center's jurisdiction. Recent legislative and regulatory changes are designed to simplify and facilitate the administrative process for evaluating novel combination products emanating from such interdisciplinary technology as tissue engineering and to resolve questions of product regulatory jurisdiction. Under the new procedures, the FDA may designate a lead FDA center for product review based on the primary mode of action of the combination product, with additional center(s) designated to assist in the evaluation in a collaborative or consultative capacity. In addition, FDA centers have increased their cooperation and information sharing with regard to evolving interdisciplinary technology. The FDA InterCenter Tissue Engineering Initiative was established to develop information on intercenter efforts in the evaluation of tissue engineering applications and to identify areas for further consideration. The FDA InterCenter Tissue Engineering Working Group, comprised of staff from the Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.

Insecticide discovery: an evaluation and analysis.

PubMed

Sparks, Thomas C

2013-09-01

There is an on-going need for the discovery and development of new insecticides due to the loss of existing products through the development of resistance, the desire for products with more favorable environmental and toxicological profiles, shifting pest spectrums, and changing agricultural practices. Since 1960, the number of research-based companies in the US and Europe involved in the discovery of new insecticidal chemistries has been declining. In part this is a reflection of the increasing costs of the discovery and development of new pesticides. Likewise, the number of compounds that need to be screened for every product developed has, until recently, been climbing. In the past two decades the agrochemical industry has been able to develop a range of new products that have more favorable mammalian vs. insect selectivity. This review provides an analysis of the time required for the discovery, or more correctly the building process, for a wide range of insecticides developed during the last 60 years. An examination of the data around the time requirements for the discovery of products based on external patents, prior internal products, or entirely new chemistry provides some unexpected observations. In light of the increasing costs of discovery and development, coupled with fewer companies willing or able to make the investment, insecticide resistance management takes on greater importance as a means to preserve existing and new insecticides. Copyright © 2013 Elsevier Inc. All rights reserved.

Community Evaluation for Economic Development. Small Town Strategy.

ERIC Educational Resources Information Center

Gault, George H.; Coppedge, Robert O.

Many communities have economic development efforts, which are generally undertaken in an attempt to create productive employment opportunities and to strengthen the local tax base. Unfortunatley, the economic development efforts of many communities, especially rural communities, are not productive ones. Many rural development efforts fail because…

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.

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

PubMed

Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

2011-08-01

Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

FuzzyCLIPS from research to product

NASA Technical Reports Server (NTRS)

Bochsler, Dan; Dohmann, Edgar

1994-01-01

This paper describes the commercial productization of FuzzyCLIPS which was developed under a NASA Phase 2 SBIR contract. The intent of this paper is to provide a general roadmap of the processes that are required to make a viable, marketable product once its concept and development are complete.

76 FR 37774 - Announcement of Value-Added Producer Grant Application Deadlines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

...-Based Business Ventures develop strategies to create marketing opportunities and to help develop Business Plans for viable marketing opportunities regarding production of bio-based products from... Capital Grants directly related to the processing and/or marketing of value-added products. In order to...

7 CFR 63.200 - NSIIC establishment and purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... production and marketing of sheep or goat products in the United States; (2) Optimize the use of available human capital and resources within the sheep or goat industries; (3) Provide assistance to meet the needs of the sheep or goat industry for infrastructure development, business development, production...

Development of dryland oilseed production systems in northwestern region of the USA

USDA-ARS?s Scientific Manuscript database

This report addresses the development of dryland oilseed crops to provide feedstock for production of biofuels in semiarid portions of the northwestern United States. Bioenergy feedstocks derived from Brassica oilseed crops have been considered for production of hydrotreated renewable jet fuel, but...

Pipeline for Contraceptive Development

PubMed Central

Blithe, Diana L.

2016-01-01

The high rates of unplanned pregnancy reflect unmet need for effective contraceptive methods for women, especially for individuals with health risks such as obesity, diabetes, hypertension, and other conditions that may contraindicate use of an estrogen-containing product. Improvements in safety, user convenience, acceptability and availability of products remain important goals of the contraceptive development program. Another important goal is to minimize the impact of the products on the environment. Development of new methods for male contraception has the potential to address many of these issues with regard to safety for women who have contraindications to effective contraceptive methods but want to protect against pregnancy. It also will address a huge unmet need for men who want to control their fertility. Products under development for men would not introduce eco-toxic hormones in the waste water. Investment in contraceptive research to identify new products for women has been limited in the pharmaceutical industry relative to investment in drug development for other indications. Pharmaceutical R&D for male contraception was active in the 1990’s but was abandoned over a decade ago. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has supported a contraceptive development program since 1969. Through a variety of programs including research grants and contracts, NICHD has developed a pipeline of new targets/products for male and female contraception. A number of lead candidates are under evaluation in the NICHD Contraceptive Clinical Trials Network (CCTN) (1–3). PMID:27523300

New advances in the integrated management of food processing by-products in Europe: sustainable exploitation of fruit and cereal processing by-products with the production of new food products (NAMASTE EU).

PubMed

Fava, Fabio; Zanaroli, Giulio; Vannini, Lucia; Guerzoni, Elisabetta; Bordoni, Alessandra; Viaggi, Davide; Robertson, Jim; Waldron, Keith; Bald, Carlos; Esturo, Aintzane; Talens, Clara; Tueros, Itziar; Cebrián, Marta; Sebők, András; Kuti, Tunde; Broeze, Jan; Macias, Marta; Brendle, Hans-Georg

2013-09-25

By-products generated every year by the European fruit and cereal processing industry currently exceed several million tons. They are disposed of mainly through landfills and thus are largely unexploited sources of several valuable biobased compounds potentially profitable in the formulation of novel food products. The opportunity to design novel strategies to turn them into added value products and food ingredients via novel and sustainable processes is the main target of recently EC-funded FP7 project NAMASTE-EU. NAMASTE-EU aims at developing new laboratory-scale protocols and processes for the exploitation of citrus processing by-products and wheat bran surpluses via the production of ingredients useful for the formulation of new beverage and food products. Among the main results achieved in the first two years of the project, there are the development and assessment of procedures for the selection, stabilization and the physical/biological treatment of citrus and wheat processing by-products, the obtainment and recovery of some bioactive molecules and ingredients and the development of procedures for assessing the quality of the obtained ingredients and for their exploitation in the preparation of new food products. Copyright © 2013 Elsevier B.V. All rights reserved.

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.

A Premiere example of the illusion of harm reduction cigarettes in the 1990s.

PubMed

Pollay, R W; Dewhirst, T

2003-09-01

To use the product launch of Player's Premiere as a case study for understanding the new cigarette product development process during the 1990s. We determine the (in)validity of industry claims that: (1) development of the physical product preceded the promotional promise of "less irritation"; (2) "less irritation" was actually realised; (3) advertising informed consumers; and (4) advertising regulations caused the product's failure in the marketplace. Court proceedings assessing the constitutionality of Canada's Tobacco Act, which substantially restricts cigarette advertising. The 2002 Quebec Superior Court trial yielded a new collection of internal documents from Imperial Tobacco Ltd (ITL), including several about the development and marketing of Player's Premiere. Trial testimony and corporate documents were reviewed to determine the validity of the industry representations about the new cigarette product development process, focusing on the case history of Player's Premiere. In direct contradiction to industry testimony, the documentary evidence demonstrates that (1) communications for Player's Premiere, which claimed less irritation, were developed long before finding a product that could deliver on the promise; (2) ITL did not sell a "less irritating" product that matched its promotional promise; (3) the advertising and other communications for Player's Premiere were extensive, relying on the hi-tech appearances ("tangible credibility") of a "unique" filter, yet were uninformative and vague; and (4) Player's Premiere failed in the marketplace, despite extensive advertising and retail support, because it was an inferior product that did not live up to its promotional promise, not because of regulation of commercial speech. New product development entails extensive consumer research to craft all communications tools in fine detail. In the case of Player's Premiere, this crafting created a false and misleading impression of technological advances producing a "less irritating" cigarette. This product was solely a massive marketing ploy with neither consumer benefits, nor public health benefits. The industry attempted to deceive both consumers and the court.

A Premiere example of the illusion of harm reduction cigarettes in the 1990s

PubMed Central

Pollay, R; Dewhirst, T

2003-01-01

Objective: To use the product launch of Player's Premiere as a case study for understanding the new cigarette product development process during the 1990s. We determine the (in)validity of industry claims that: (1) development of the physical product preceded the promotional promise of "less irritation"; (2) "less irritation" was actually realised; (3) advertising informed consumers; and (4) advertising regulations caused the product's failure in the marketplace. Setting: Court proceedings assessing the constitutionality of Canada's Tobacco Act, which substantially restricts cigarette advertising. The 2002 Quebec Superior Court trial yielded a new collection of internal documents from Imperial Tobacco Ltd (ITL), including several about the development and marketing of Player's Premiere. Method: Trial testimony and corporate documents were reviewed to determine the validity of the industry representations about the new cigarette product development process, focusing on the case history of Player's Premiere. Results: In direct contradiction to industry testimony, the documentary evidence demonstrates that (1) communications for Player's Premiere, which claimed less irritation, were developed long before finding a product that could deliver on the promise; (2) ITL did not sell a "less irritating" product that matched its promotional promise; (3) the advertising and other communications for Player's Premiere were extensive, relying on the hi-tech appearances ("tangible credibility") of a "unique" filter, yet were uninformative and vague; and (4) Player's Premiere failed in the marketplace, despite extensive advertising and retail support, because it was an inferior product that did not live up to its promotional promise, not because of regulation of commercial speech. Conclusions: New product development entails extensive consumer research to craft all communications tools in fine detail. In the case of Player's Premiere, this crafting created a false and misleading impression of technological advances producing a "less irritating" cigarette. This product was solely a massive marketing ploy with neither consumer benefits, nor public health benefits. The industry attempted to deceive both consumers and the court. PMID:12958396

Exploiting mAb structure characteristics for a directed QbD implementation in early process development.

PubMed

Karlberg, Micael; von Stosch, Moritz; Glassey, Jarka

2018-03-07

In today's biopharmaceutical industries, the lead time to develop and produce a new monoclonal antibody takes years before it can be launched commercially. The reasons lie in the complexity of the monoclonal antibodies and the need for high product quality to ensure clinical safety which has a significant impact on the process development time. Frameworks such as quality by design are becoming widely used by the pharmaceutical industries as they introduce a systematic approach for building quality into the product. However, full implementation of quality by design has still not been achieved due to attrition mainly from limited risk assessment of product properties as well as the large number of process factors affecting product quality that needs to be investigated during the process development. This has introduced a need for better methods and tools that can be used for early risk assessment and predictions of critical product properties and process factors to enhance process development and reduce costs. In this review, we investigate how the quantitative structure-activity relationships framework can be applied to an existing process development framework such as quality by design in order to increase product understanding based on the protein structure of monoclonal antibodies. Compared to quality by design, where the effect of process parameters on the drug product are explored, quantitative structure-activity relationships gives a reversed perspective which investigates how the protein structure can affect the performance in different unit operations. This provides valuable information that can be used during the early process development of new drug products where limited process understanding is available. Thus, quantitative structure-activity relationships methodology is explored and explained in detail and we investigate the means of directly linking the structural properties of monoclonal antibodies to process data. The resulting information as a decision tool can help to enhance the risk assessment to better aid process development and thereby overcome some of the limitations and challenges present in QbD implementation today.

Usability in product development practice; an exploratory case study comparing four markets.

PubMed

van Kuijk, Jasper; van Driel, Liesbeth; van Eijk, Daan

2015-03-01

This study explored how usability was dealt with in four product development organizations active in different sectors: high-end automotive, professional printers and copiers, office coffee makers and fast moving consumer goods. The primary differentiators of the selected cases were whether they were targeting businesses or consumers and the degree of product complexity. Interviews with 19 product development practitioners were conducted, focussing on three topics: 1) the product development process and the integration of user involvement, 2) multidisciplinary teamwork, and 3) organizational attitude towards usability. Based on the interviews, context descriptions of the companies were created and barriers and enablers for usability were identified. To verify the findings and to discuss remaining issues a feedback workshop was held in which the primary contact from each company participated. The results indicate that differences in product-market combination lead to differences in organizational attitude towards usability. The prioritization of usability in an organization seems to be influenced by the degree of product complexity (complex products are more prone to suffer from usability issues) and whether developers think that usability is a purchase consideration for their clients. The product-market combination a company targets also affects the methods for user-centred design that a company can apply and that are relevant. What methods for user-centred design are used also seems to be influenced by the attitude towards usability: if usability is considered more important, methods that require more resources can be applied. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Quality assurance after process changes of the production of a therapeutic antibody.

PubMed

Brass, J M; Krummen, K; Moll-Kaufmann, C

1996-12-01

Process development for the production of a therapeutic humanised antibody is a very complex operation. It involves recombinant genetics, verification of a strong expression system, gene amplification, characterisation of a stable host cell expression system, optimisation and design of the mammalian cell culture fermentation system and development of an efficient recovery process resulting in high yields and product quality. Rapid progress in the field and the wish of some pharmaceutical companies for outsourcing their production are the driving forces for process changes relatively late in the development phase. This literature survey is aimed at identifying the limits of acceptable process changes in up scaling of the fermentation and down stream processing of biopharmaceuticals and defining the demand in production validation to prove product equivalency and identity of the isolated, purified therapeutic antibody.

Process and product development in the manufacturing of molecular therapeutics.

PubMed

Atkinson, E M; Christensen, J R

1999-08-01

In the development of molecular therapies, a great deal of attention has focused on tissue targets, gene delivery vectors, and expression cassettes. In order to become an approved therapy, however, a molecular therapeutic has to pass down the same product registration pathway as any other biological product. Moving from research into industrial production requires careful attention to regulatory, manufacturing and quality concerns. Early work on developing and characterizing robust and scaleable manufacturing processes will ultimately be rewarded by ease of implementation as the product is successful in clinical trials. Regulatory agencies require solid process and product characterization studies to demonstrate control and understanding of the molecular therapeutic. As the gene therapy industry matures, standards will continue to rise, creating an industry that is capable of producing safe, high-quality and effective therapies for many of the world's most difficult disease targets.

Let's Scrum! Learning Digital Media Collaboratively

ERIC Educational Resources Information Center

Wilson, Daniel G.; Brown, Joshua; Burke, Adam A.

2013-01-01

The changing landscape of digital media and software development has immense impact on society, not only through consumer use of the products, but also in the way these technologies are developed. Modern software and media-development companies are using collaborative methods to develop innovative and useful products. Technology and engineering…

43 CFR 3483.5 - Crediting of production toward diligent development.

Code of Federal Regulations, 2011 CFR

2011-10-01

... development. (a) For Federal coal leases issued after August 4, 1976, all production after the effective date of the Federal lease shall be credited toward diligent development. (b) For Federal coal leases... after August 4, 1976, shall be credited toward diligent development. (c) For Federal coal leases issued...

43 CFR 3483.5 - Crediting of production toward diligent development.

Code of Federal Regulations, 2013 CFR

2013-10-01

... development. (a) For Federal coal leases issued after August 4, 1976, all production after the effective date of the Federal lease shall be credited toward diligent development. (b) For Federal coal leases... after August 4, 1976, shall be credited toward diligent development. (c) For Federal coal leases issued...

43 CFR 3483.5 - Crediting of production toward diligent development.

Code of Federal Regulations, 2014 CFR

2014-10-01

... development. (a) For Federal coal leases issued after August 4, 1976, all production after the effective date of the Federal lease shall be credited toward diligent development. (b) For Federal coal leases... after August 4, 1976, shall be credited toward diligent development. (c) For Federal coal leases issued...

43 CFR 3483.5 - Crediting of production toward diligent development.

Code of Federal Regulations, 2012 CFR

2012-10-01

... development. (a) For Federal coal leases issued after August 4, 1976, all production after the effective date of the Federal lease shall be credited toward diligent development. (b) For Federal coal leases... after August 4, 1976, shall be credited toward diligent development. (c) For Federal coal leases issued...

[Consumptions of Meat and Dairy Products, Zinc Intake and Pubertal Development in Adolescents in Chengdu].

PubMed

Luo, Jiao; Yang, Ming-zhe; Duan, Ruo-nan; Tian, Guo; Bao, Yu-xin; Chen, Yan-rong; Xue, Hong-mei; Liu, Yan; Cheng, Guo

2015-09-01

To determine the associations between meat, dairy and zinc intake and pubertal development in adolescents in Chengdu. A total of 1320 children and adolescents aged 9-15 years in Chengdu were recruited using a stratified cluster sampling strategy. Dietary intake was assessed by the food frequency questionnaire (FFQ) and 3-day 24-hour dietary recall. Pubertal development was evaluated through physical examinations. Consumptions of meat and dairy, and zinc intake were compared between groups with different levels of pubertal development according to the Tanner criteria. The median age of spermarche was 13. 00 years. The boys who had had spermarche consumed more meat (including red meat) and dairy products than those who had not yet (P<0. 05). Daily consumption of total meat was positively correlated with the level of pubertal development (P<0. 05). The median age of menarche was 12. 11 years. The girls who had had menarche consumed more meat and less diiry products than those who had not yet (P<0. 05). Daily consumption of dairy products was negatively associated with breast development and the level of pubertal development (P < 0. 05). Consumptions of meat, red meat and dairy products are associated with pubertal development in adolescents in Chengdu. However, the differences between boys and girls warrant further studies.

Principles of biorefineries.

PubMed

Kamm, B; Kamm, M

2004-04-01

Sustainable economic growth requires safe, sustainable resources for industrial production. For the future re-arrangement of a substantial economy to biological raw materials, completely new approaches in research and development, production and economy are necessary. Biorefineries combine the necessary technologies between biological raw materials and industrial intermediates and final products. The principal goal in the development of biorefineries is defined by the following: (biomass) feedstock-mix + process-mix --> product-mix. Here, particularly the combination between biotechnological and chemical conversion of substances will play an important role. Currently the "whole-crop biorefinery", "green biorefinery" and "lignocellulose-feedstock biorefinery" systems are favored in research and development.

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.

The Evolvement of Automobile Steering System Based on TRIZ

NASA Astrophysics Data System (ADS)

Zhao, Xinjun; Zhang, Shuang

Products and techniques pass through a process of birth, growth, maturity, death and quit the stage like biological evolution process. The developments of products and techniques conform to some evolvement rules. If people know and hold these rules, they can design new kind of products and forecast the develop trends of the products. Thereby, enterprises can grasp the future technique directions of products, and make product and technique innovation. Below, based on TRIZ theory, the mechanism evolvement, the function evolvement and the appearance evolvement of automobile steering system had been analyzed and put forward some new ideas about future automobile steering system.

Development of Learning Models Based on Problem Solving and Meaningful Learning Standards by Expert Validity for Animal Development Course

NASA Astrophysics Data System (ADS)

Lufri, L.; Fitri, R.; Yogica, R.

2018-04-01

The purpose of this study is to produce a learning model based on problem solving and meaningful learning standards by expert assessment or validation for the course of Animal Development. This research is a development research that produce the product in the form of learning model, which consist of sub product, namely: the syntax of learning model and student worksheets. All of these products are standardized through expert validation. The research data is the level of validity of all sub products obtained using questionnaire, filled by validators from various field of expertise (field of study, learning strategy, Bahasa). Data were analysed using descriptive statistics. The result of the research shows that the problem solving and meaningful learning model has been produced. Sub products declared appropriate by expert include the syntax of learning model and student worksheet.

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.

Development of a Dynamic Web Mapping Service for Vegetation Productivity Using Earth Observation and in situ Sensors in a Sensor Web Based Approach

PubMed Central

Kooistra, Lammert; Bergsma, Aldo; Chuma, Beatus; de Bruin, Sytze

2009-01-01

This paper describes the development of a sensor web based approach which combines earth observation and in situ sensor data to derive typical information offered by a dynamic web mapping service (WMS). A prototype has been developed which provides daily maps of vegetation productivity for the Netherlands with a spatial resolution of 250 m. Daily available MODIS surface reflectance products and meteorological parameters obtained through a Sensor Observation Service (SOS) were used as input for a vegetation productivity model. This paper presents the vegetation productivity model, the sensor data sources and the implementation of the automated processing facility. Finally, an evaluation is made of the opportunities and limitations of sensor web based approaches for the development of web services which combine both satellite and in situ sensor sources. PMID:22574019

Developing the science product algorithm testbed for Chinese next-generation geostationary meteorological satellites: Fengyun-4 series

NASA Astrophysics Data System (ADS)

Min, Min; Wu, Chunqiang; Li, Chuan; Liu, Hui; Xu, Na; Wu, Xiao; Chen, Lin; Wang, Fu; Sun, Fenglin; Qin, Danyu; Wang, Xi; Li, Bo; Zheng, Zhaojun; Cao, Guangzhen; Dong, Lixin

2017-08-01

Fengyun-4A (FY-4A), the first of the Chinese next-generation geostationary meteorological satellites, launched in 2016, offers several advances over the FY-2: more spectral bands, faster imaging, and infrared hyperspectral measurements. To support the major objective of developing the prototypes of FY-4 science algorithms, two science product algorithm testbeds for imagers and sounders have been developed by the scientists in the FY-4 Algorithm Working Group (AWG). Both testbeds, written in FORTRAN and C programming languages for Linux or UNIX systems, have been tested successfully by using Intel/g compilers. Some important FY-4 science products, including cloud mask, cloud properties, and temperature profiles, have been retrieved successfully through using a proxy imager, Himawari-8/Advanced Himawari Imager (AHI), and sounder data, obtained from the Atmospheric InfraRed Sounder, thus demonstrating their robustness. In addition, in early 2016, the FY-4 AWG was developed based on the imager testbed—a near real-time processing system for Himawari-8/AHI data for use by Chinese weather forecasters. Consequently, robust and flexible science product algorithm testbeds have provided essential and productive tools for popularizing FY-4 data and developing substantial improvements in FY-4 products.

Mathematical model for dynamic cell formation in fast fashion apparel manufacturing stage

NASA Astrophysics Data System (ADS)

Perera, Gayathri; Ratnayake, Vijitha

2018-05-01

This paper presents a mathematical programming model for dynamic cell formation to minimize changeover-related costs (i.e., machine relocation costs and machine setup cost) and inter-cell material handling cost to cope with the volatile production environments in apparel manufacturing industry. The model is formulated through findings of a comprehensive literature review. Developed model is validated based on data collected from three different factories in apparel industry, manufacturing fast fashion products. A program code is developed using Lingo 16.0 software package to generate optimal cells for developed model and to determine the possible cost-saving percentage when the existing layouts used in three factories are replaced by generated optimal cells. The optimal cells generated by developed mathematical model result in significant cost saving when compared with existing product layouts used in production/assembly department of selected factories in apparel industry. The developed model can be considered as effective in minimizing the considered cost terms in dynamic production environment of fast fashion apparel manufacturing industry. Findings of this paper can be used for further researches on minimizing the changeover-related costs in fast fashion apparel production stage.

Advances in identification and validation of protein targets of natural products without chemical modification.

PubMed

Chang, J; Kim, Y; Kwon, H J

2016-05-04

Covering: up to February 2016Identification of the target proteins of natural products is pivotal to understanding the mechanisms of action to develop natural products for use as molecular probes and potential therapeutic drugs. Affinity chromatography of immobilized natural products has been conventionally used to identify target proteins, and has yielded good results. However, this method has limitations, in that labeling or tagging for immobilization and affinity purification often result in reduced or altered activity of the natural product. New strategies have recently been developed and applied to identify the target proteins of natural products and synthetic small molecules without chemical modification of the natural product. These direct and indirect methods for target identification of label-free natural products include drug affinity responsive target stability (DARTS), stability of proteins from rates of oxidation (SPROX), cellular thermal shift assay (CETSA), thermal proteome profiling (TPP), and bioinformatics-based analysis of connectivity. This review focuses on and reports case studies of the latest advances in target protein identification methods for label-free natural products. The integration of newly developed technologies will provide new insights and highlight the value of natural products for use as biological probes and new drug candidates.

Livestock production: recent trends, future prospects

PubMed Central

Thornton, Philip K.

2010-01-01

The livestock sector globally is highly dynamic. In developing countries, it is evolving in response to rapidly increasing demand for livestock products. In developed countries, demand for livestock products is stagnating, while many production systems are increasing their efficiency and environmental sustainability. Historical changes in the demand for livestock products have been largely driven by human population growth, income growth and urbanization and the production response in different livestock systems has been associated with science and technology as well as increases in animal numbers. In the future, production will increasingly be affected by competition for natural resources, particularly land and water, competition between food and feed and by the need to operate in a carbon-constrained economy. Developments in breeding, nutrition and animal health will continue to contribute to increasing potential production and further efficiency and genetic gains. Livestock production is likely to be increasingly affected by carbon constraints and environmental and animal welfare legislation. Demand for livestock products in the future could be heavily moderated by socio-economic factors such as human health concerns and changing socio-cultural values. There is considerable uncertainty as to how these factors will play out in different regions of the world in the coming decades. PMID:20713389

Current Status of Japanese Global Precipitation Measurement (GPM) Research Project

NASA Astrophysics Data System (ADS)

Kachi, Misako; Oki, Riko; Kubota, Takuji; Masaki, Takeshi; Kida, Satoshi; Iguchi, Toshio; Nakamura, Kenji; Takayabu, Yukari N.

2013-04-01

The Global Precipitation Measurement (GPM) mission is a mission led by the Japan Aerospace Exploration Agency (JAXA) and the National Aeronautics and Space Administration (NASA) under collaboration with many international partners, who will provide constellation of satellites carrying microwave radiometer instruments. The GPM Core Observatory, which carries the Dual-frequency Precipitation Radar (DPR) developed by JAXA and the National Institute of Information and Communications Technology (NICT), and the GPM Microwave Imager (GMI) developed by NASA. The GPM Core Observatory is scheduled to be launched in early 2014. JAXA also provides the Global Change Observation Mission (GCOM) 1st - Water (GCOM-W1) named "SHIZUKU," as one of constellation satellites. The SHIZUKU satellite was launched in 18 May, 2012 from JAXA's Tanegashima Space Center, and public data release of the Advanced Microwave Scanning Radiometer 2 (AMSR2) on board the SHIZUKU satellite was planned that Level 1 products in January 2013, and Level 2 products including precipitation in May 2013. The Japanese GPM research project conducts scientific activities on algorithm development, ground validation, application research including production of research products. In addition, we promote collaboration studies in Japan and Asian countries, and public relations activities to extend potential users of satellite precipitation products. In pre-launch phase, most of our activities are focused on the algorithm development and the ground validation related to the algorithm development. As the GPM standard products, JAXA develops the DPR Level 1 algorithm, and the NASA-JAXA Joint Algorithm Team develops the DPR Level 2 and the DPR-GMI combined Level2 algorithms. JAXA also develops the Global Rainfall Map product as national product to distribute hourly and 0.1-degree horizontal resolution rainfall map. All standard algorithms including Japan-US joint algorithm will be reviewed by the Japan-US Joint Precipitation Measuring Mission (PMM) Science Team (JPST) before the release. DPR Level 2 algorithm has been developing by the DPR Algorithm Team led by Japan, which is under the NASA-JAXA Joint Algorithm Team. The Level-2 algorithms will provide KuPR only products, KaPR only products, and Dual-frequency Precipitation products, with estimated precipitation rate, radar reflectivity, and precipitation information such as drop size distribution and bright band height. At-launch code was developed in December 2012. In addition, JAXA and NASA have provided synthetic DPR L1 data and tests have been performed using them. Japanese Global Rainfall Map algorithm for the GPM mission has been developed by the Global Rainfall Map Algorithm Development Team in Japan. The algorithm succeeded heritages of the Global Satellite Mapping for Precipitation (GSMaP) project, which was sponsored by the Japan Science and Technology Agency (JST) under the Core Research for Evolutional Science and Technology (CREST) framework between 2002 and 2007. The GSMaP near-real-time version and reanalysis version have been in operation at JAXA, and browse images and binary data available at the GSMaP web site (http://sharaku.eorc.jaxa.jp/GSMaP/). The GSMaP algorithm for GPM is developed in collaboration with AMSR2 standard algorithm for precipitation product, and their validation studies are closely related. As JAXA GPM product, we will provide 0.1-degree grid and hourly product for standard and near-realtime processing. Outputs will include hourly rainfall, gauge-calibrated hourly rainfall, and several quality information (satellite information flag, time information flag, and gauge quality information) over global areas from 60°S to 60°N. At-launch code of GSMaP for GPM is under development, and will be delivered to JAXA GPM Mission Operation System by April 2013. At-launch code will include several updates of microwave imager and sounder algorithms and databases, and introduction of rain-gauge correction.

Characteristics of Successful and Unsuccessful Organizational Development

DTIC Science & Technology

1975-03-01

aluminum, automobiles, glass, and household products . The development efforts in these organizations varied from organization to organization...Insurance 1 10 11 Automoti e 4 1 5 Petrochew cal 2 0 2 Censurer Household Products 1 1 2 Forrest Products 3 1 4 Conversion 0 1 1 15 the number of

Natural products as inspiration for the development of new synthetic methods.

PubMed

Ma, Zhiqiang; Chen, Chuo

2018-01-01

Natural products have played an important role in shaping modern synthetic organic chemistry. In particular, their complex molecular skeletons have stimulated the development of many new synthetic methods. We highlight in this article some recent examples of synthetic design inspired by the biosynthesis of natural products.

24 CFR 200.948 - Building product standards and certification program for carpet cushion.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Minimum Property Standards § 200.948 Building product standards and certification program for carpet... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Building product standards and certification program for carpet cushion. 200.948 Section 200.948 Housing and Urban Development Regulations...

24 CFR 3282.360 - PIA acceptance of product certification programs or listings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ENFORCEMENT REGULATIONS Primary Inspection Agencies § 3282.360 PIA acceptance of product certification... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false PIA acceptance of product certification programs or listings. 3282.360 Section 3282.360 Housing and Urban Development Regulations Relating...

76 FR 49773 - International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

...] International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product... availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development... development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics...

[Historical and Hygienic Aspects on Roles of Quality Requirements for Antibiotic Products in Japan: Part 1--Development of Antibiotic Products].

PubMed

Yagisawa, Morimasa; Foster, Patrick J; Kurokawa, Tatsuo

2015-01-01

Antibiotic products have contributed greatly to keep Japanese people healthy by controlling lethal infections. In the early days, antibiotics such as penicillin and streptomycin were produced using microbial fermentation processes. Therefore, the component ratio of the active element and related substances varied lot by lot. For the purpose of efficacy and assuring safety, minimum requirements for penicillin and streptomycin products were enacted. Both variations and the number of clinically available antibiotic products have increased due to the pharmaceutical development of novel natural antibiotics. In addition, semi-synthetic derivatives of various antibiotics have been developed for the purpose of enhancing antimicrobial activity or improving pharmacological properties. As a result, 202 entities of antibiotic products have been approved and used clinically as of 2012. We conducted a detailed investigation of the progress made in the field of antibiotic products, and analyzed the characteristics of those belonging to each class of antibiotics by means of setting up a system of classification that reflects clinical applications. This report is intended to serve as an introduction to our series of investigations into the role and influence of quality requirements on development of antibacterial antibiotic products in Japan. As described here, the general view of antibacterial antibiotic products spanning a time frame of 67 years in Japan might serve as an ideal reference for future reports.

Variability extraction and modeling for product variants.

PubMed

Linsbauer, Lukas; Lopez-Herrejon, Roberto Erick; Egyed, Alexander

2017-01-01

Fast-changing hardware and software technologies in addition to larger and more specialized customer bases demand software tailored to meet very diverse requirements. Software development approaches that aim at capturing this diversity on a single consolidated platform often require large upfront investments, e.g., time or budget. Alternatively, companies resort to developing one variant of a software product at a time by reusing as much as possible from already-existing product variants. However, identifying and extracting the parts to reuse is an error-prone and inefficient task compounded by the typically large number of product variants. Hence, more disciplined and systematic approaches are needed to cope with the complexity of developing and maintaining sets of product variants. Such approaches require detailed information about the product variants, the features they provide and their relations. In this paper, we present an approach to extract such variability information from product variants. It identifies traces from features and feature interactions to their implementation artifacts, and computes their dependencies. This work can be useful in many scenarios ranging from ad hoc development approaches such as clone-and-own to systematic reuse approaches such as software product lines. We applied our variability extraction approach to six case studies and provide a detailed evaluation. The results show that the extracted variability information is consistent with the variability in our six case study systems given by their variability models and available product variants.

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.

STAR Algorithm Integration Team - Facilitating operational algorithm development

NASA Astrophysics Data System (ADS)

Mikles, V. J.

2015-12-01

The NOAA/NESDIS Center for Satellite Research and Applications (STAR) provides technical support of the Joint Polar Satellite System (JPSS) algorithm development and integration tasks. Utilizing data from the S-NPP satellite, JPSS generates over thirty Environmental Data Records (EDRs) and Intermediate Products (IPs) spanning atmospheric, ocean, cryosphere, and land weather disciplines. The Algorithm Integration Team (AIT) brings technical expertise and support to product algorithms, specifically in testing and validating science algorithms in a pre-operational environment. The AIT verifies that new and updated algorithms function in the development environment, enforces established software development standards, and ensures that delivered packages are functional and complete. AIT facilitates the development of new JPSS-1 algorithms by implementing a review approach based on the Enterprise Product Lifecycle (EPL) process. Building on relationships established during the S-NPP algorithm development process and coordinating directly with science algorithm developers, the AIT has implemented structured reviews with self-contained document suites. The process has supported algorithm improvements for products such as ozone, active fire, vegetation index, and temperature and moisture profiles.

The Structure and Infrastructure of the Finnish Research Literature

DTIC Science & Technology

2006-02-06

business context, and reflected the collective learning and coordination skills underlying a firm’s product lines. According to the original proposers...core competencies are the source of competitive advantage and enable the firm to introduce an array of new products and services. They lead to the...development of core products , which are then used to develop a larger number of end user products . Since the original core competence article, many

Process Metallurgy an Enabler of Resource Efficiency: Linking Product Design to Metallurgy in Product Centric Recycling

NASA Astrophysics Data System (ADS)

Reuter, Markus; van Schaik, Antoinette

In this paper the link between process metallurgy, classical minerals processing, product centric recycling and urban/landfill mining is discussed. The depth that has to be achieved in urban mining and recycling must glean from the wealth of theoretical knowledge and insight that have been developed in the past in minerals and metallurgical processing. This background learns that recycling demands a product centric approach, which considers simultaneously the multi-material interactions in man-made complex `minerals'. Fast innovation in recycling and urban mining can be achieved by further evolving from this well developed basis, evolving the techniques and tools that have been developed over the years. This basis has already been used for many years to design, operate and control industrial plants for metal production. This has been the basis for Design for Recycling rules for End-of-Life products. Using, among others, the UNEP Metal Recycling report as a basis (authors are respectively Lead and Main authors of report), it is demonstrated that a common theoretical basis as developed in metallurgy and minerals processing can help much to level the playing field between primary processing, secondary processing, recycling, and urban/landfill mining and product design hence enhancing resource efficiency. Thus various scales of detail link product design with metallurgical process design and its fundamentals.

Ricor's anniversary of 50 innovative years in cryogenic technology

NASA Astrophysics Data System (ADS)

Filis, Avishai; Segal, Victor; Pundak, Nachman; Bar Haim, Zvi; Danziger, Menachem

2017-05-01

Ricor cryogenics was founded in 1967 and since then it has focused on innovative technologies in the cryogenic field. The paper reviews the initial research and development efforts invested in various technologies that have yielded products such as Cryostats for Mossbauer Effect measurement, Liquid gas Dewar containers, Liquid helium vacuum transfer tubes, Cryosurgery and other innovative products. The major registered patents that matured to products such as a magnetic vacuum valve operator, pumped out safety valve and other innovations are reviewed here. As a result of continuous R and D investment, over the years a new generation of innovative Stirling cryogenic products has developed. This development began with massive split slip-on coolers and has progressed as far as miniature IDDCA coolers mainly for IR applications. The accumulated experience in Stirling technology is used also as a platform for developing self-contained water vapor pumps known as MicroStar and NanoStar. These products are also used in collaboration with a research institute in the field of High Temperature Superconductors. The continuous growth in the cryogenic products range and the need to meet market demands have motivated the expansion, of Ricor's manufacturing facility enabling it to become a world leader in the cryocooler field. To date Ricor has manufactured more than 120,000 cryocoolers. The actual cryogenic development efforts and challenges are also reviewed, mainly in the field of long life cryocoolers, ruggedized products, miniaturization and products for space applications.

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.

Case for real-time systems development - Quo vadis?

NASA Technical Reports Server (NTRS)

Erb, Dona M.

1991-01-01

The paper focuses on the distinctive issues of computer-aided software engineering (CASE) products for the development of real-time systems. CASE technologies and associated standardization efforts are evolving from sets of conflicting interests. The majority of case products are intended for use in the development of management information systems. CASE products to support the development of large, complex real-time systems must provide additional capabilities. Generic concerns include the quality of the implementation of the required method for the phase of the system's development and whether the vendor is stable and committed to evolving the products in parallel with nonproprietary standards. The CASE market is undergoing considerable consolidation. The paper describes the major forces, cooperating entities, and remaining uncertainties that need to be weighed in near-term CASE procurements to limit risk of loss of investment in project time, trianing, and money.

The proliferation of aerospace weapons technology: Ballistic missiles and the case of Brazil

NASA Astrophysics Data System (ADS)

Vossen, Terrence John

1993-04-01

The rationale behind the development of ballistic missile production in Brazil is examined by exploring the political, military, and economic determinants of ballistic missile demand in that country. To ascertain how Brazil developed missile production capabilities, the contributions of aerospace industries in industrialized states, the Brazilian space program, trade between less-developed countries, and illicit trade in missile technology are assessed. It is argued that missile development increasingly became a function of economic as opposed to security considerations, and that technologies transferred from developed country aerospace firms and Brazil's space program were primarily responsible for the creation of production capabilities. It is also contended that the proliferation of missile technology to Brazil was consistent with the workings of a system evident in the aerospace weapons technology market that sustains the horizontal spread of weapons production capabilities.

Development of newly enriched bread with quinoa flour and whey

NASA Astrophysics Data System (ADS)

Salazar, D. M.; Naranjo, M.; Pérez, L. V.; Valencia, A. F.; Acurio, L. P.; Gallegos, L. M.; Alvarez, F. C.; Amancha, P. I.; Valencia, M. P.; Rodriguez, C. A.; Arancibia, M. Y.

2017-07-01

Ecuador, Bolivia, and Peru are countries with the highest amount of quinoa production in the world due to the proximity to the Andes. Further, Ecuador has a high production of dairy products, particularly fresh cheese of which production gives a high volume of whey, without further use, with the consequent loss of their nutritional value. The present study was performed to develop a new fortified bread through the incorporation of quinoa flour and whey at three different concentrations. The use of quinoa and whey improved the texture, shelf life and sensory characteristics of bread, compared to those prepared with wheat flour. This study shows the potential of quinoa flour and whey as ingredients in the development of baked products.

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

MODIS Snow and Sea Ice Products

NASA Technical Reports Server (NTRS)

Hall, Dorothy K.; Riggs, George A.; Salomonson, Vincent V.

2004-01-01

In this chapter, we describe the suite of Earth Observing System (EOS) Moderate-Resolution Imaging Spectroradiometer (MODIS) Terra and Aqua snow and sea ice products. Global, daily products, developed at Goddard Space Flight Center, are archived and distributed through the National Snow and Ice Data Center at various resolutions and on different grids useful for different communities Snow products include binary snow cover, snow albedo, and in the near future, fraction of snow in a 5OO-m pixel. Sea ice products include ice extent determined with two different algorithms, and sea ice surface temperature. The algorithms used to develop these products are described. Both the snow and sea ice products, available since February 24,2000, are useful for modelers. Validation of the products is also discussed.

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.

Systematic Approach to the Development, Evolution, and Effectiveness of Integrated Product Development Teams (IPDTs)

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

Margie Jeffs; R. Douglas Hamelin

Integrated Product Development Teams (IPDT) are a key component of any systems engineering (SE) application, but since they are formed primarily from technical considerations, many IPDTs are far less productive than they otherwise could be. By recognizing specific personality types and skill sets, a random group of 'technical' individuals can be structured to become a highly effective team capable of delivering much more than the sum of its members.

The US and the FRG in the Third World.

DTIC Science & Technology

1982-06-01

cont.asnt, imports from developed countries were only 0.5% cheaper than American products . This saves U.S. consumers more than $2 billion a year. It is...positive impact on the growth rates of the developed coun- tries. The total demand of the LDCs was important in maintaining the production level of...progress for the less-developed countries: with rapidly rising exports, they collectively increased their real national product such faster than the

Development of a commercial scale process for production of 1,4-butanediol from sugar.

PubMed

Burgard, Anthony; Burk, Mark J; Osterhout, Robin; Van Dien, Stephen; Yim, Harry

2016-12-01

A sustainable bioprocess for the production of 1,4-butanediol (BDO) from carbohydrate feedstocks was developed. BDO is a chemical intermediate that goes into a variety of products including automotive parts, electronics, and apparel, and is currently manufactured commercially through energy-intensive petrochemical processes using fossil raw materials. This review highlights the development of an Escherichia coli strain and an overall process that successfully performed at commercial scale for direct production of bio-BDO from dextrose. Achieving such high level performance required an integrated technology platform enabling detailed engineering of enzyme, pathway, metabolic network, and organism, as well as development of effective fermentation and downstream recovery processes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Advances in metabolic pathway and strain engineering paving the way for sustainable production of chemical building blocks.

PubMed

Chen, Yun; Nielsen, Jens

2013-12-01

Bio-based production of chemical building blocks from renewable resources is an attractive alternative to petroleum-based platform chemicals. Metabolic pathway and strain engineering is the key element in constructing robust microbial chemical factories within the constraints of cost effective production. Here we discuss how the development of computational algorithms, novel modules and methods, omics-based techniques combined with modeling refinement are enabling reduction in development time and thus advance the field of industrial biotechnology. We further discuss how recent technological developments contribute to the development of novel cell factories for the production of the building block chemicals: adipic acid, succinic acid and 3-hydroxypropionic acid. Copyright © 2013 Elsevier Ltd. All rights reserved.

Trends in entropy production during ecosystem development in the Amazon Basin.

PubMed

Holdaway, Robert J; Sparrow, Ashley D; Coomes, David A

2010-05-12

Understanding successional trends in energy and matter exchange across the ecosystem-atmosphere boundary layer is an essential focus in ecological research; however, a general theory describing the observed pattern remains elusive. This paper examines whether the principle of maximum entropy production could provide the solution. A general framework is developed for calculating entropy production using data from terrestrial eddy covariance and micrometeorological studies. We apply this framework to data from eight tropical forest and pasture flux sites in the Amazon Basin and show that forest sites had consistently higher entropy production rates than pasture sites (0.461 versus 0.422 W m(-2) K(-1), respectively). It is suggested that during development, changes in canopy structure minimize surface albedo, and development of deeper root systems optimizes access to soil water and thus potential transpiration, resulting in lower surface temperatures and increased entropy production. We discuss our results in the context of a theoretical model of entropy production versus ecosystem developmental stage. We conclude that, although further work is required, entropy production could potentially provide a much-needed theoretical basis for understanding the effects of deforestation and land-use change on the land-surface energy balance.

Fed-batch culture of Escherichia coli for L-valine production based on in silico flux response analysis.

PubMed

Park, Jin Hwan; Kim, Tae Yong; Lee, Kwang Ho; Lee, Sang Yup

2011-04-01

We have previously reported the development of a 100% genetically defined engineered Escherichia coli strain capable of producing L-valine from glucose with a high yield of 0.38 g L-valine per gram glucose (0.58 mol L-valine per mol glucose) by batch culture. Here we report a systems biological strategy of employing flux response analysis in bioprocess development using L-valine production by fed-batch culture as an example. Through the systems-level analysis, the source of ATP was found to be important for efficient L-valine production. There existed a trade-off between L-valine production and biomass formation, which was optimized for the most efficient L-valine production. Furthermore, acetic acid feeding strategy was optimized based on flux response analysis. The final fed-batch cultivation strategy allowed production of 32.3 g/L L-valine, the highest concentration reported for E. coli. This approach of employing systems-level analysis of metabolic fluxes in developing fed-batch cultivation strategy would also be applicable in developing strategies for the efficient production of other bioproducts. Copyright © 2010 Wiley Periodicals, Inc.

An economic production model for deteriorating items and time dependent demand with rework and multiple production setups

NASA Astrophysics Data System (ADS)

Uthayakumar, R.; Tharani, S.

2017-12-01

Recently, much emphasis has given to study the control and maintenance of production inventories of the deteriorating items. Rework is one of the main issues in reverse logistic and green supply chain, since it can reduce production cost and the environmental problem. Many researchers have focused on developing rework model, but few of them have developed model for deteriorating items. Due to this fact, we take up productivity and rework with deterioration as the major concern in this paper. In this paper, a production-inventory model with deteriorative items in which one cycle has n production setups and one rework setup (n, 1) policy is considered for deteriorating items with stock-dependent demand in case 1 and exponential demand in case 2. An effective iterative solution procedure is developed to achieve optimal time, so that the total cost of the system is minimized. Numerical and sensitivity analyses are discussed to examine the outcome of the proposed solution procedure presented in this research.

Current status and challenges for automotive battery production technologies

NASA Astrophysics Data System (ADS)

Kwade, Arno; Haselrieder, Wolfgang; Leithoff, Ruben; Modlinger, Armin; Dietrich, Franz; Droeder, Klaus

2018-04-01

Production technology for automotive lithium-ion battery (LIB) cells and packs has improved considerably in the past five years. However, the transfer of developments in materials, cell design and processes from lab scale to production scale remains a challenge due to the large number of consecutive process steps and the significant impact of material properties, electrode compositions and cell designs on processes. This requires an in-depth understanding of the individual production processes and their interactions, and pilot-scale investigations into process parameter selection and prototype cell production. Furthermore, emerging process concepts must be developed at lab and pilot scale that reduce production costs and improve cell performance. Here, we present an introductory summary of the state-of-the-art production technologies for automotive LIBs. We then discuss the key relationships between process, quality and performance, as well as explore the impact of materials and processes on scale and cost. Finally, future developments and innovations that aim to overcome the main challenges are presented.

30 CFR 250.245 - What hydrogen sulfide (H2S) information must accompany the DPP or DOCD?

Code of Federal Regulations, 2010 CFR

2010-07-01

... you request that the Regional Supervisor classify the area of your proposed development and production... Information Contents of Development and Production Plans (dpp) and Development Operations Coordination... concentration of any H2S you might encounter or handle while you conduct your proposed development and...

The Development of Vocabulary in Spanish Children with Down Syndrome: Comprehension, Production, and Gestures

ERIC Educational Resources Information Center

Galeote, Miguel; Sebastian, Eugenia; Checa, Elena; Rey, Rocio; Soto, Pilar

2011-01-01

Background: Our main purpose was to compare the lexical development of Spanish children with Down syndrome (DS) and children with typical development (TD) to investigate the relationship between cognitive and vocabulary development in comprehension and oral and gestural production. Method: Participants were 186 children with DS and 186 children…

Lost productivity due to premature mortality in developed and emerging countries: an application to smoking cessation.

PubMed

Menzin, Joseph; Marton, Jeno P; Menzin, Jordan A; Willke, Richard J; Woodward, Rebecca M; Federico, Victoria

2012-06-25

Researchers and policy makers have determined that accounting for productivity costs, or "indirect costs," may be as important as including direct medical expenditures when evaluating the societal value of health interventions. These costs are also important when estimating the global burden of disease. The estimation of indirect costs is commonly done on a country-specific basis. However, there are few studies that evaluate indirect costs across countries using a consistent methodology. Using the human capital approach, we developed a model that estimates productivity costs as the present value of lifetime earnings (PVLE) lost due to premature mortality. Applying this methodology, the model estimates productivity costs for 29 selected countries, both developed and emerging. We also provide an illustration of how the inclusion of productivity costs contributes to an analysis of the societal burden of smoking. A sensitivity analysis is undertaken to assess productivity costs on the basis of the friction cost approach. PVLE estimates were higher for certain subpopulations, such as men, younger people, and people in developed countries. In the case study, productivity cost estimates from our model showed that productivity loss was a substantial share of the total cost burden of premature mortality due to smoking, accounting for over 75 % of total lifetime costs in the United States and 67 % of total lifetime costs in Brazil. Productivity costs were much lower using the friction cost approach among those of working age. Our PVLE model is a novel tool allowing researchers to incorporate the value of lost productivity due to premature mortality into economic analyses of treatments for diseases or health interventions. We provide PVLE estimates for a number of emerging and developed countries. Including productivity costs in a health economics study allows for a more comprehensive analysis, and, as demonstrated by our illustration, can have important effects on the results and conclusions.

Suomi NPP VIIRS active fire product status

NASA Astrophysics Data System (ADS)

Ellicott, E. A.; Csiszar, I. A.; Schroeder, W.; Giglio, L.; Wind, B.; Justice, C. O.

2012-12-01

We provide an overview of the evaluation and development of the Active Fires product derived from the Visible Infrared Imager Radiometer Suite (VIIRS) sensor on the Suomi National Polar-orbiting Partnership (SNPP) satellite during the first year of on-orbit data. Results from the initial evaluation of the standard SNPP Active Fires product, generated by the SNPP Interface Data Processing System (IDPS), supported the stabilization of the VIIRS Sensor Data Record (SDR) product. This activity focused in particular on the processing of the dual-gain 4 micron VIIRS M13 radiometric measurements into 750m aggregated data, which are fundamental for active fire detection. Following the VIIRS SDR product's Beta maturity status in April 2012, correlative analysis between VIIRS and near-simultaneous fire detections from the Moderate Resolution Imaging Spectroradiometer (MODIS) on the NASA Earth Observing System Aqua satellite confirmed the expected relative detection rates driven primarily by sensor differences. The VIIRS Active Fires Product Development and Validation Team also developed a science code that is based on the latest MODIS Collection 6 algorithm and provides a full spatially explicit fire mask to replace the sparse array output of fire locations from a MODIS Collection 4 equivalent algorithm in the current IDPS product. The Algorithm Development Library (ADL) was used to support the planning for the transition of the science code into IDPS operations in the future. Product evaluation and user outreach was facilitated by a product website that provided end user access to fire data in user-friendly format over North America as well as examples of VIIRS-MODIS comparisons. The VIIRS fire team also developed an experimental product based on 375m VIIRS Imagery band measurements and provided high quality imagery of major fire events in US. By August 2012 the IDPS product achieved Beta maturity, with some known and documented shortfalls related to the processing of incorrect SDR input data and to apparent algorithm deficiencies in select observing and environmental conditions.

Lost productivity due to premature mortality in developed and emerging countries: an application to smoking cessation

PubMed Central

2012-01-01

Background Researchers and policy makers have determined that accounting for productivity costs, or “indirect costs,” may be as important as including direct medical expenditures when evaluating the societal value of health interventions. These costs are also important when estimating the global burden of disease. The estimation of indirect costs is commonly done on a country-specific basis. However, there are few studies that evaluate indirect costs across countries using a consistent methodology. Methods Using the human capital approach, we developed a model that estimates productivity costs as the present value of lifetime earnings (PVLE) lost due to premature mortality. Applying this methodology, the model estimates productivity costs for 29 selected countries, both developed and emerging. We also provide an illustration of how the inclusion of productivity costs contributes to an analysis of the societal burden of smoking. A sensitivity analysis is undertaken to assess productivity costs on the basis of the friction cost approach. Results PVLE estimates were higher for certain subpopulations, such as men, younger people, and people in developed countries. In the case study, productivity cost estimates from our model showed that productivity loss was a substantial share of the total cost burden of premature mortality due to smoking, accounting for over 75 % of total lifetime costs in the United States and 67 % of total lifetime costs in Brazil. Productivity costs were much lower using the friction cost approach among those of working age. Conclusions Our PVLE model is a novel tool allowing researchers to incorporate the value of lost productivity due to premature mortality into economic analyses of treatments for diseases or health interventions. We provide PVLE estimates for a number of emerging and developed countries. Including productivity costs in a health economics study allows for a more comprehensive analysis, and, as demonstrated by our illustration, can have important effects on the results and conclusions. PMID:22731620

The Inspiration Given by the Successful Practice of Development of Higher Vocational Education in the Developed Countries

ERIC Educational Resources Information Center

Wu, Gaoling

2010-01-01

Higher vocational education is the product of economic development, scientific and technological progress. If the country does not have a well-developed vocational education, it is impossible to make a good advanced science and technology into productive forces, it is also impossible to achieve economy development in a high speed. In turn, powers…

Microbial bioinformatics for food safety and production

PubMed Central

Alkema, Wynand; Boekhorst, Jos; Wels, Michiel

2016-01-01

In the production of fermented foods, microbes play an important role. Optimization of fermentation processes or starter culture production traditionally was a trial-and-error approach inspired by expert knowledge of the fermentation process. Current developments in high-throughput ‘omics’ technologies allow developing more rational approaches to improve fermentation processes both from the food functionality as well as from the food safety perspective. Here, the authors thematically review typical bioinformatics techniques and approaches to improve various aspects of the microbial production of fermented food products and food safety. PMID:26082168

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

Fred D. Brent; Lalit Shah; Earl Berry

The overall objective of this project is the three phase development of an Early Entrance Coproduction Plant (EECP) which uses petroleum coke to produce at least one product from at least two of the following three categories: (1) electric power (or heat), (2) fuels, and (3) chemicals using ChevronTexaco's proprietary gasification technology. The objective of Phase I is to determine the feasibility and define the concept for the EECP located at a specific site; develop a Research, Development, and Testing (RD&T) Plan to mitigate technical risks and barriers; and prepare a Preliminary Project Financing Plan. The objective of Phase IImore » is to implement the work as outlined in the Phase I RD&T Plan to enhance the development and commercial acceptance of coproduction technology. The objective of Phase III is to develop an engineering design package and a financing and testing plan for an EECP located at a specific site. The project's intended result is to provide the necessary technical, economic, and environmental information needed by industry to move the EECP forward to detailed design, construction, and operation. The partners in this project are Texaco Energy Systems LLC or TES (a subsidiary of ChevronTexaco), General Electric (GE), Praxair, and Kellogg Brown & Root (KBR) in addition to the U.S. Department of Energy (DOE). TES is providing gasification technology and Fischer-Tropsch (F-T) technology developed by Rentech, GE is providing combustion turbine technology, Praxair is providing air separation technology, and KBR is providing engineering. Each of the EECP subsystems was assessed for technical risks and barriers. A plan was developed to mitigate the identified risks (Phase II RD&T Plan, October 2000). The potential technical and economic risks to the EECP from Task 2.5 can be mitigated by demonstrating that the end-use products derived from the upgrading of the F-T synthesis total liquid product can meet or exceed current specifications for the manufacture of ethylene and propylene chemicals from F-T naphtha, for the generation of hydrogen from F-T naphtha to power fuel cells, for direct blending of F-T diesels into transportation fuels, for the conversion of F-T heavy product wax to transportation fuels, and the conversion of F-T Heavy product wax to a valuable high melting point food-grade specialty wax product. Product evaluations conducted under Task 2.5 of Phase II successfully mitigated the above technical and economic risks to the EECP with the development of product yields and product qualities for the production of chemicals, transportation fuels, and specialty food-grade waxes from the F-T synthesis products.« less

A quality system for PET: An industry perspective

NASA Astrophysics Data System (ADS)

Zigler, Steven S.; Breslow, Kenneth; Nazerias, Michael

2005-12-01

Quality systems have been employed in a variety of industries to develop and supply products that meet customer expectations and regulatory requirements. Most quality systems address organizational structure, design controls, production, complaints, audits, corrective actions and preventive actions. This paper describes PETNET's efforts to develop a quality system for use in the production of PET tracers. Our goal is to ensure quality products and to facilitate compliance with impending PET good manufacturing practice (GMP) regulations.

Dearomatization Strategies in the Synthesis of Complex Natural Products

PubMed Central

Roche, Stéphane P.; Porco, John A.

2014-01-01

Evolution in the field of the total synthesis of natural products has led to exciting developments over the last decade. Numerous chemo-selective and enantioselective methodologies have emerged from total syntheses, resulting in efficient access to many important natural product targets. This Review highlights recent developments concerning dearomatization, a powerful strategy for the total synthesis of architecturally complex natural products wherein planar, aromatic scaffolds are converted to three-dimensional molecular architectures. PMID:21506209

Impact of accelerated plant growth on seed variety development

NASA Astrophysics Data System (ADS)

Christophersen, Eric

1998-01-01

The commercial lives of agricultural seed products have steadily declined in recent years. The introduction of genetically engineered crop seeds in 1966 has accentuated that trend. Widespread grower demand for genetically engineered seed requires competitive response by industry followers in order to avert market share losses to the industry leaders. Limitations on plant transformation technology, regulatory requirements and patent impediments require companies to rapidly convert transformed lines into elite commercial products. Massive multigenerational backcrossing efforts are required to distribute genetically engineered traits into a broad product mix. Significant incidents of expression failures, or ``gene silencing,'' have occurred unexpectedly, requiring product substitution strategies. First-to-market strategies, competitive response, broad germplasm conversion and rescue of product failures all share the element of urgency. Technologies which reliably accelerate product development rates can expect favorable reception by commercial seed developers. A growth chamber which dramatically accelerates the rate of plant growth is described.

Biomass use, production, feed efficiencies, and greenhouse gas emissions from global livestock systems

PubMed Central

Herrero, Mario; Havlík, Petr; Valin, Hugo; Notenbaert, An; Rufino, Mariana C.; Thornton, Philip K.; Blümmel, Michael; Weiss, Franz; Grace, Delia; Obersteiner, Michael

2013-01-01

We present a unique, biologically consistent, spatially disaggregated global livestock dataset containing information on biomass use, production, feed efficiency, excretion, and greenhouse gas emissions for 28 regions, 8 livestock production systems, 4 animal species (cattle, small ruminants, pigs, and poultry), and 3 livestock products (milk, meat, and eggs). The dataset contains over 50 new global maps containing high-resolution information for understanding the multiple roles (biophysical, economic, social) that livestock can play in different parts of the world. The dataset highlights: (i) feed efficiency as a key driver of productivity, resource use, and greenhouse gas emission intensities, with vast differences between production systems and animal products; (ii) the importance of grasslands as a global resource, supplying almost 50% of biomass for animals while continuing to be at the epicentre of land conversion processes; and (iii) the importance of mixed crop–livestock systems, producing the greater part of animal production (over 60%) in both the developed and the developing world. These data provide critical information for developing targeted, sustainable solutions for the livestock sector and its widely ranging contribution to the global food system. PMID:24344273

New Vistas in Chemical Product and Process Design.

PubMed

Zhang, Lei; Babi, Deenesh K; Gani, Rafiqul

2016-06-07

Design of chemicals-based products is broadly classified into those that are process centered and those that are product centered. In this article, the designs of both classes of products are reviewed from a process systems point of view; developments related to the design of the chemical product, its corresponding process, and its integration are highlighted. Although significant advances have been made in the development of systematic model-based techniques for process design (also for optimization, operation, and control), much work is needed to reach the same level for product design. Timeline diagrams illustrating key contributions in product design, process design, and integrated product-process design are presented. The search for novel, innovative, and sustainable solutions must be matched by consideration of issues related to the multidisciplinary nature of problems, the lack of data needed for model development, solution strategies that incorporate multiscale options, and reliability versus predictive power. The need for an integrated model-experiment-based design approach is discussed together with benefits of employing a systematic computer-aided framework with built-in design templates.

78 FR 22801 - Request for Comments on Developing a Program To Provide Loan Guarantees to Small- or Medium-Sized...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... manufacturing; manufacture an innovative technology product or an integral component of such a product; or, to... use or production of innovative technologies for manufacturing? Dated: April 10, 2013. Matt Erskine.... SUMMARY: The Economic Development Administration (EDA) seeks public comment on, how to design and...

Specialty Animal Production Curriculum Guide for Vocational Agriculture/Agribusiness. Curriculum Development. Bulletin No. 1806.

ERIC Educational Resources Information Center

University of Southwestern Louisiana, Lafayette.

This curriculum guide was developed to aid vocational agriculture/agribusiness teachers in Louisiana in improving their instruction and to provide students with the opportunity to obtain skills and knowledge in the production of nontraditional specialty animals. The guide covers the techniques of production, management, care, and marketing of…

Research on the Use of Educational Products: (4) Marketing Research: At What Prices?

ERIC Educational Resources Information Center

Rosenau, Fred S.

The production and distribution of educational materials developed by researchers is considered. The current practice of turning over federally or foundation funded products to commercial producers raises the question of pricing policies of these firms as compared to the policies of nonprofit development agencies. Comparative costs of producing…

Development of a Consensus Standard for School Equipment: NSF/NSSEA 380

ERIC Educational Resources Information Center

Breitner, Ashlee

2011-01-01

For many years, the school supplies and equipment industry has investigated methods to ensure product safety and compliance across all its product categories. In early 2010, NSF International and the National School Supply and Equipment Association (NSSEA) came together to develop quality standards for products and equipment designed for use in…

40 CFR 80.158 - Product transfer documents (PTDs).

Code of Federal Regulations, 2010 CFR

2010-07-01

... exempt base gasoline to be used for research, development, or test purposes only, the following warning must also be stated on the PTD: “For use in research, development, and test programs only.” (6) The...) Use of product codes and other non-regulatory language. (1) Product codes and other non-regulatory...

The effect of sprout and disease control products on disease development and weight loss

USDA-ARS?s Scientific Manuscript database

The potato industry utilizes various sprout and disease control products prior to storage and/or packing. Some of these products have not been tested for interference of wound healing and whether effects observed equate to greater disease development or weight loss. The objectives of this study we...

Using a Web-Based System to Estimate the Cost of Online Course Production

ERIC Educational Resources Information Center

Gordon, Stuart; He, Wu; Abdous, M'hammed

2009-01-01

The increasing demand for online courses requires efficient and low cost production. Since the decision to develop online courses is often affected by financial factors, it is becoming increasingly important to determine, upfront, the cost of online course production. Many of the programs and educators interested in developing online courses…

Cooperative fuzzy games approach to setting target levels of ECs in quality function deployment.

PubMed

Yang, Zhihui; Chen, Yizeng; Yin, Yunqiang

2014-01-01

Quality function deployment (QFD) can provide a means of translating customer requirements (CRs) into engineering characteristics (ECs) for each stage of product development and production. The main objective of QFD-based product planning is to determine the target levels of ECs for a new product or service. QFD is a breakthrough tool which can effectively reduce the gap between CRs and a new product/service. Even though there are conflicts among some ECs, the objective of developing new product is to maximize the overall customer satisfaction. Therefore, there may be room for cooperation among ECs. A cooperative game framework combined with fuzzy set theory is developed to determine the target levels of the ECs in QFD. The key to develop the model is the formulation of the bargaining function. In the proposed methodology, the players are viewed as the membership functions of ECs to formulate the bargaining function. The solution for the proposed model is Pareto-optimal. An illustrated example is cited to demonstrate the application and performance of the proposed approach.

Expedited Development of Diphenhydramine Orally Disintegrating Tablet through Integrated Crystal and Particle Engineering.

PubMed

Wang, Chenguang; Hu, Shenye; Sun, Changquan Calvin

2017-10-02

A palatable direct compression (DC) orally disintegrating tablet (ODT) product of a bitter drug, diphenhydramine (DPH), was developed using an integrated crystal and particle engineering approach. A DPH salt with a sweetener, acesulfame (Acs), DPH-Acs, was synthesized and its solid state properties were comprehensively characterized. Tablet formulation composition and compaction parameters were optimized by employing material sparing techniques. In vivo disintegration time, bitterness, and grittiness of the final ODT product, were evaluated by a taste panel. Physical stability of the ODT tablets was assessed to identify appropriate storage conditions. Phase-pure DPH-Acs exhibited significantly better tabletability and palatability than DPH-HCl. A DC formulation was designed and optimized to obtain a new ODT product with good manufacturability and excellent product characteristics, including fast in vivo disintegration, and acceptable bitterness and grittiness. A new ODT product of DPH with excellent pharmaceutical properties was successfully developed using 15 g of DPH and in two months. This example shows that integrated crystal and particle engineering is an effective approach for developing high quality ODT products using the DC process.

Cooperative Fuzzy Games Approach to Setting Target Levels of ECs in Quality Function Deployment

PubMed Central

Yang, Zhihui; Chen, Yizeng; Yin, Yunqiang

2014-01-01

Quality function deployment (QFD) can provide a means of translating customer requirements (CRs) into engineering characteristics (ECs) for each stage of product development and production. The main objective of QFD-based product planning is to determine the target levels of ECs for a new product or service. QFD is a breakthrough tool which can effectively reduce the gap between CRs and a new product/service. Even though there are conflicts among some ECs, the objective of developing new product is to maximize the overall customer satisfaction. Therefore, there may be room for cooperation among ECs. A cooperative game framework combined with fuzzy set theory is developed to determine the target levels of the ECs in QFD. The key to develop the model is the formulation of the bargaining function. In the proposed methodology, the players are viewed as the membership functions of ECs to formulate the bargaining function. The solution for the proposed model is Pareto-optimal. An illustrated example is cited to demonstrate the application and performance of the proposed approach. PMID:25097884

Energy Sprawl Is the Largest Driver of Land Use Change in United States.

PubMed

Trainor, Anne M; McDonald, Robert I; Fargione, Joseph

2016-01-01

Energy production in the United States for domestic use and export is predicted to rise 27% by 2040. We quantify projected energy sprawl (new land required for energy production) in the United States through 2040. Over 200,000 km2 of additional land area will be directly impacted by energy development. When spacing requirements are included, over 800,000 km2 of additional land area will be affected by energy development, an area greater than the size of Texas. This pace of development in the United States is more than double the historic rate of urban and residential development, which has been the greatest driver of conversion in the United States since 1970, and is higher than projections for future land use change from residential development or agriculture. New technology now places 1.3 million km2 that had not previously experienced oil and gas development at risk of development for unconventional oil and gas. Renewable energy production can be sustained indefinitely on the same land base, while extractive energy must continually drill and mine new areas to sustain production. We calculated the number of years required for fossil energy production to expand to cover the same area as renewables, if both were to produce the same amount of energy each year. The land required for coal production would grow to equal or exceed that of wind, solar and geothermal energy within 2-31 years. In contrast, it would take hundreds of years for oil production to have the same energy sprawl as biofuels. Meeting energy demands while conserving nature will require increased energy conservation, in addition to distributed renewable energy and appropriate siting and mitigation.

Energy Sprawl Is the Largest Driver of Land Use Change in United States

PubMed Central

McDonald, Robert I.

2016-01-01

Energy production in the United States for domestic use and export is predicted to rise 27% by 2040. We quantify projected energy sprawl (new land required for energy production) in the United States through 2040. Over 200,000 km2 of additional land area will be directly impacted by energy development. When spacing requirements are included, over 800,000 km2 of additional land area will be affected by energy development, an area greater than the size of Texas. This pace of development in the United States is more than double the historic rate of urban and residential development, which has been the greatest driver of conversion in the United States since 1970, and is higher than projections for future land use change from residential development or agriculture. New technology now places 1.3 million km2 that had not previously experienced oil and gas development at risk of development for unconventional oil and gas. Renewable energy production can be sustained indefinitely on the same land base, while extractive energy must continually drill and mine new areas to sustain production. We calculated the number of years required for fossil energy production to expand to cover the same area as renewables, if both were to produce the same amount of energy each year. The land required for coal production would grow to equal or exceed that of wind, solar and geothermal energy within 2–31 years. In contrast, it would take hundreds of years for oil production to have the same energy sprawl as biofuels. Meeting energy demands while conserving nature will require increased energy conservation, in addition to distributed renewable energy and appropriate siting and mitigation. PMID:27607423

The development of daily monitoring tool in a service part manufacturing company

NASA Astrophysics Data System (ADS)

Marpaung, Seamus Tadeo; Rosyidi, Cucuk Nur

2018-02-01

Production lead time is one of the key measures to assess whether a production system is running well or not. A short lead time will lead to higher customer satisfaction and will be a solid proof that a system is well-organized. To shorten the production lead time, a good production planning and control are required. There are many obstacles which can occur at any time, for instance shortage of material and worker, or poor production scheduling. Service Parts Planning Department works with many parties from the beginning of service parts production until it is delivered to the customer. This research was conducted to find an appropriate production monitoring tool for Service Parts Planning Department, which is a control method that make problems appears to the surface and can be overcome quickly so that the production process can run normally. The tool development started with a field study to find out the production flow from start to finish, a literature review and a interview with some employees who will later use the production control tool, and the creation of a daily control that went through several modifications until finally meet the needs of the department. In this research, a production monitoring tool which is developed can be used to monitor the entire order status, the production lead time, and also serves as the records and reports for presentation.

Fetal programming in meat production.

PubMed

Du, Min; Wang, Bo; Fu, Xing; Yang, Qiyuan; Zhu, Mei-Jun

2015-11-01

Nutrient fluctuations during the fetal stage affects fetal development, which has long-term impacts on the production efficiency and quality of meat. During the early development, a pool of mesenchymal progenitor cells proliferate and then diverge into either myogenic or adipogenic/fibrogenic lineages. Myogenic progenitor cells further develop into muscle fibers and satellite cells, while adipogenic/fibrogenic lineage cells develop into adipocytes, fibroblasts and resident fibro-adipogenic progenitor cells. Enhancing the proliferation and myogenic commitment of progenitor cells during fetal development enhances muscle growth and lean production in offspring. On the other hand, promoting the adipogenic differentiation of adipogenic/fibrogenic progenitor cells inside the muscle increases intramuscular adipocytes and reduces connective tissue, which improves meat marbling and tenderness. Available studies in mammalian livestock, including cattle, sheep and pigs, clearly show the link between maternal nutrition and the quantity and quality of meat production. Similarly, chicken muscle fibers develop before hatching and, thus, egg and yolk sizes and hatching temperature affect long-term growth performance and meat production of chicken. On the contrary, because fishes are able to generate new muscle fibers lifelong, the impact of early nutrition on fish growth performance is expected to be minor, which requires further studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Aerospace Engineering Systems and the Advanced Design Technologies Testbed Experience

NASA Technical Reports Server (NTRS)

VanDalsem, William R.; Livingston, Mary E.; Melton, John E.; Torres, Francisco J.; Stremel, Paul M.

1999-01-01

Continuous improvement of aerospace product development processes is a driving requirement across much of the aerospace community. As up to 90% of the cost of an aerospace product is committed during the first 10% of the development cycle, there is a strong emphasis on capturing, creating, and communicating better information (both requirements and performance) early in the product development process. The community has responded by pursuing the development of computer-based systems designed to enhance the decision-making capabilities of product development individuals and teams. Recently, the historical foci on sharing the geometrical representation and on configuration management are being augmented: 1) Physics-based analysis tools for filling the design space database; 2) Distributed computational resources to reduce response time and cost; 3) Web-based technologies to relieve machine-dependence; and 4) Artificial intelligence technologies to accelerate processes and reduce process variability. The Advanced Design Technologies Testbed (ADTT) activity at NASA Ames Research Center was initiated to study the strengths and weaknesses of the technologies supporting each of these trends, as well as the overall impact of the combination of these trends on a product development event. Lessons learned and recommendations for future activities are reported.

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.

The steel scrap age.

PubMed

Pauliuk, Stefan; Milford, Rachel L; Müller, Daniel B; Allwood, Julian M

2013-04-02

Steel production accounts for 25% of industrial carbon emissions. Long-term forecasts of steel demand and scrap supply are needed to develop strategies for how the steel industry could respond to industrialization and urbanization in the developing world while simultaneously reducing its environmental impact, and in particular, its carbon footprint. We developed a dynamic stock model to estimate future final demand for steel and the available scrap for 10 world regions. Based on evidence from developed countries, we assumed that per capita in-use stocks will saturate eventually. We determined the response of the entire steel cycle to stock saturation, in particular the future split between primary and secondary steel production. During the 21st century, steel demand may peak in the developed world, China, the Middle East, Latin America, and India. As China completes its industrialization, global primary steel production may peak between 2020 and 2030 and decline thereafter. We developed a capacity model to show how extensive trade of finished steel could prolong the lifetime of the Chinese steelmaking assets. Secondary steel production will more than double by 2050, and it may surpass primary production between 2050 and 2060: the late 21st century can become the steel scrap age.

The Reality of Virtual Reality Product Development

NASA Astrophysics Data System (ADS)

Dever, Clark

Virtual Reality and Augmented Reality are emerging areas of research and product development in enterprise companies. This talk will discuss industry standard tools and current areas of application in the commercial market. Attendees will gain insights into how to research, design, and (most importantly) ship, world class products. The presentation will recount the lessons learned to date developing a Virtual Reality tool to solve physics problems resulting from trying to perform aircraft maintenance on ships at sea.

The influence of different screw concepts while processing fibre reinforced thermoplastics with the concept of inline-compounding on an injection moulding machine

NASA Astrophysics Data System (ADS)

Moritzer, E.; Müller, E.; Kleeschulte, R.

2014-05-01

Today, the global market poses major challenges for industrial product development. Complexity, the wide range of variants, flexibility and individuality are just some of the features that products have to fulfil. Product series additionally have shorter and shorter lifetimes. Because of their high capacity for adaptation, polymers are increasingly able to substitute traditional materials such as wood, glass and metals in various fields of application [1]. But polymers can only substitute other materials if they are optimally suited to the applications in question. Hence, product-specific material development is becoming increasingly important [2]. The problem is that the traditional development process for new polymer formulations is much too complex, too slow and therefore too expensive. Product-specific material development is thus out of the question for most processors. Integrating the compounding step in the injection moulding process would lead to a more efficient and faster development process for a new polymer formulation, providing an opportunity to create new product-specific materials. This process is called inline-compounding on an injection moulding machine. In order to develop this innovative formulation concept, with the focus on fibre reinforced thermoplastics, different screw-concepts are compared with regard to the resultant performance characteristics in the part, such as mechanical properties and fibre length distribution.

Potential emissions reduction in road transport sector using biofuel in developing countries

NASA Astrophysics Data System (ADS)

Liaquat, A. M.; Kalam, M. A.; Masjuki, H. H.; Jayed, M. H.

2010-10-01

Use of biofuels as transport fuel has high prospect in developing countries as most of them are facing severe energy insecurity and have strong agricultural sector to support production of biofuels from energy crops. Rapid urbanization and economic growth of developing countries have spurred air pollution especially in road transport sector. The increasing demand of petroleum based fuels and their combustion in internal combustion (IC) engines have adverse effect on air quality, human health and global warming. Air pollution causes respiratory problems, adverse effects on pulmonary function, leading to increased sickness absenteeism and induces high health care service costs, premature birth and even mortality. Production of biofuels promises substantial improvement in air quality through reducing emission from biofuel operated automotives. Some of the developing countries have started biofuel production and utilization as transport fuel in local market. This paper critically reviews the facts and prospects of biofuel production and utilization in developing countries to reduce environmental pollution and petro dependency. Expansion of biofuel industries in developing countries can create more jobs and increase productivity by non-crop marginal lands and wastelands for energy crops plantation. Contribution of India and China in biofuel industry in production and utilization can dramatically change worldwide biofuel market and leap forward in carbon cut as their automotive market is rapidly increasing with a souring proportional rise of GHG emissions.

Development of the Internet-Based Customer-Oriented Ordering System Framework for Complicated Mechanical Product

NASA Astrophysics Data System (ADS)

Ong, Mingwei; Watanuki, Keiichi

Recently, as consumers gradually prefer buying products that reflect their own personality, there exist some consumers who wish to involve in the product design process. Parallel with the popularization of e-business, many manufacturers have utilized the Internet to promote their products, and some have even built websites that enable consumers to select their desirable product specifications. Nevertheless, this method has not been applied on complicated mechanical product due to the facts that complicated mechanical product has a large number of specifications that inter-relate among one another. In such a case, ordinary consumers who are lacking of design knowledge, are not capable of determining these specifications. In this paper, a prototype framework called Internet-based consumer-oriented product ordering system has been developed in which it enables ordinary consumers to have large freedom in determining complicated mechanical product specifications, and meanwhile ensures that the manufacturing of the determined product is feasible.

Implementing AORN recommended practices for product selection.

PubMed

Conrardy, Julie A

2012-06-01

This article focuses on the revised AORN "Recommended practices for product selection in perioperative practice settings." Hospitals and ambulatory surgery facilities should have protocols in place for product evaluation that includes a multidisciplinary team approach. The process for product evaluation and selection includes gathering information; establishing consistent requirements for product evaluation; performing a financial impact analysis; investigating a plan to standardize products; conducting an environmental impact analysis; determining whether to purchase single-use, reposable, or reusable products or reprocess single-use devices; developing an evaluation process based on objective criteria; and developing and implementing a comprehensive plan to introduce and use new products. Use of an evaluation tool that is based on objective criteria is one way to obtain valuable input during product evaluations. Because of varied roles and experiences, the perioperative RN is an integral member of the product selection committee. Published by Elsevier Inc.

Ares I-X Range Safety Flight Envelope Analysis

NASA Technical Reports Server (NTRS)

Starr, Brett R.; Olds, Aaron D.; Craig, Anthony S.

2011-01-01

Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

Ares I-X Range Safety Analyses Overview

NASA Technical Reports Server (NTRS)

Starr, Brett R.; Gowan, John W., Jr.; Thompson, Brian G.; Tarpley, Ashley W.

2011-01-01

Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

Techniques for extraction and isolation of natural products: a comprehensive review.

PubMed

Zhang, Qing-Wen; Lin, Li-Gen; Ye, Wen-Cai

2018-01-01

Natural medicines were the only option for the prevention and treatment of human diseases for thousands of years. Natural products are important sources for drug development. The amounts of bioactive natural products in natural medicines are always fairly low. Today, it is very crucial to develop effective and selective methods for the extraction and isolation of those bioactive natural products. This paper intends to provide a comprehensive view of a variety of methods used in the extraction and isolation of natural products. This paper also presents the advantage, disadvantage and practical examples of conventional and modern techniques involved in natural products research.

Fermented Soy Product Intake Is Inversely Associated with the Development of High Blood Pressure: The Japan Public Health Center-Based Prospective Study.

PubMed

Nozue, Miho; Shimazu, Taichi; Sasazuki, Shizuka; Charvat, Hadrien; Mori, Nagisa; Mutoh, Michihiro; Sawada, Norie; Iwasaki, Motoki; Yamaji, Taiki; Inoue, Manami; Kokubo, Yoshihiro; Yamagishi, Kazumasa; Iso, Hiroyasu; Tsugane, Shoichiro

2017-09-01

Background: Randomized controlled studies have investigated the short-term effect of soy product intake on blood pressure (BP) in normotensive people. To our knowledge, no prospective studies exist on the effect of habitual intake of fermented soy products, separate from total soy products, on BP in the general population. Objective: We examined the association between the habitual intake of soy products, including fermented soy products, and the development of high BP during a 5-y period among participants in a population-based prospective cohort study in Japan. Methods: The study included normotensive participants aged 40-69 y at baseline (926 men and 3239 women) who completed 2 questionnaires and whose BP was measured at the baseline survey between 1993 and 1994 and the 5-y follow-up in the Japan Public Health Center-Based Prospective Study Cohort II. The intake of soy products was assessed with a food-frequency questionnaire. High BP was defined as systolic blood pressure ≥130 mm Hg, diastolic blood pressure ≥85 mm Hg, or antihypertensive medication use. ORs and 95% CIs of high BP by frequency of soy products (miso, natto, and tofu) consumption, intake of total and fermented soy products, and intake of isoflavones from total and fermented soy products were estimated with the use of multiple logistic regression analysis. Results: Multivariable-adjusted ORs of high BP for the highest compared with the lowest tertile of total and fermented soy product intake were 1.03 (95% CI: 0.84, 1.25; P -trend = 0.786) and 0.72 (95% CI: 0.56, 0.92; P -trend = 0.009), respectively. The frequency of nonfermented soy product (tofu) intake was not associated with the development of high BP ( P -trend = 0.597). Conclusions: The intake of fermented soy products, but not total or nonfermented soy products, was inversely associated with developing high BP in men and women with normal BP. © 2017 American Society for Nutrition.

Development of Hybrid Product Breakdown Structure for NASA Ground Systems

NASA Technical Reports Server (NTRS)

Monaghan, Mark W.; Henry, Robert J.

2013-01-01

The Product Breakdown Structure is traditionally a method of identification of the products of a project in a tree structure. It is a tool used to assess, plan, document, and display the equipment requirements for a project. It is part of a product based planning technique, and attempts to break down all components of a project in as much detail as possible, so that nothing is overlooked. The PBS for ground systems at the Kennedy Space Center is being developed to encompass the traditional requirements including the alignment of facility, systems, and components to the organizational hierarchy. The Ground Operations Product Breakdown Structure is a hybrid in nature in that some aspects of a work breakdown structure will be incorporated and merged with the Architecture Concept of Operations, Master Subsystem List, customer interface, and assigned management responsibility. The Ground Operations Product Breakdown Structure needs to be able to identify the flexibility of support differing customers (internal and external) usage of ground support equipment within the Kennedy Space Center launch and processing complex. The development of the Product Breakdown Structure is an iterative activity Initially documenting the organization hierarchy structure and relationships. The Product Breakdown Structure identifies the linkage between the customer program requirements, allocation of system resources, development of design goals, and identification logistics products. As the Product Breakdown Structure progresses the incorporation of the results of requirement planning for the customer occurs identifying facility needs and systems. The mature Product Breakdown Structure is baselined with a hierarchical drawing, the Product Breakdown Structure database, and an associated document identifying the verification of the data through the life cycle of the program/product line. This paper will document, demonstrate, and identify key aspects of the life cycle of a Hybrid Product Breakdown Structure. The purpose is to show how a project management and system engineering approach can be utilized for providing flexible customer service in an evolving manned space flight launch processing environment.

Operational space weather product development and validation at the joint SMC-AFRL Rapid Prototyping Center

NASA Astrophysics Data System (ADS)

Quigley, S.

The Air Force Research Laboratory (AFRL/VSB) and Detachment 11, Space &Missile Systems Center (SMC, Det 11/CIT) have combined efforts to design, develop, test, and implement graphical products for the Air Force's space weather operations center. These products are generated to analyze, specify, and forecast the effects of the near-earth space environment on Department of Defense systems and communications. Jointly-developed products that have been, or will soon be added to real-time operations include: 1) the Operational Space Environment Network Display (OpSEND) suit - a set of four products that address HF communication, UHF satellite communication scintillation, radar auroral clutter, and GP S single- frequency errors; 2) a solar radio background and burst effects (SoRBE) product suite; and C) a meteor effects (ME) product suite. The RPC is also involved in a rather substantial "V&V" effort to produce multiple operational product verifications and validations, with an added end goal of a generalized validation software package. The presentation will provide a general overview of the RPC and each of the products mentioned above, to include background science, operational history, inputs, outputs, dissemination, and customer uses for each.

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.

Physiologically Based Absorption Modeling to Design Extended-Release Clinical Products for an Ester Prodrug.

PubMed

Ding, Xuan; Day, Jeffrey S; Sperry, David C

2016-11-01

Absorption modeling has demonstrated its great value in modern drug product development due to its utility in understanding and predicting in vivo performance. In this case, we integrated physiologically based modeling in the development processes to effectively design extended-release (ER) clinical products for an ester prodrug LY545694. By simulating the trial results of immediate-release products, we delineated complex pharmacokinetics due to prodrug conversion and established an absorption model to describe the clinical observations. This model suggested the prodrug has optimal biopharmaceutical properties to warrant developing an ER product. Subsequently, we incorporated release profiles of prototype ER tablets into the absorption model to simulate the in vivo performance of these products observed in an exploratory trial. The models suggested that the absorption of these ER tablets was lower than the IR products because the extended release from the formulations prevented the drug from taking advantage of the optimal absorption window. Using these models, we formed a strategy to optimize the ER product to minimize the impact of the absorption window limitation. Accurate prediction of the performance of these optimized products by modeling was confirmed in a third clinical trial.

Direct Capture Technologies for Genomics-Guided Discovery of Natural Products.

PubMed

Chan, Andrew N; Santa Maria, Kevin C; Li, Bo

2016-01-01

Microbes are important producers of natural products, which have played key roles in understanding biology and treating disease. However, the full potential of microbes to produce natural products has yet to be realized; the overwhelming majority of natural product gene clusters encoded in microbial genomes remain "cryptic", and have not been expressed or characterized. In contrast to the fast-growing number of genomic sequences and bioinformatic tools, methods to connect these genes to natural product molecules are still limited, creating a bottleneck in genome-mining efforts to discover novel natural products. Here we review developing technologies that leverage the power of homologous recombination to directly capture natural product gene clusters and express them in model hosts for isolation and structural characterization. Although direct capture is still in its early stages of development, it has been successfully utilized in several different classes of natural products. These early successes will be reviewed, and the methods will be compared and contrasted with existing traditional technologies. Lastly, we will discuss the opportunities for the development of direct capture in other organisms, and possibilities to integrate direct capture with emerging genome-editing techniques to accelerate future study of natural products.

Hurdles in low k1 mass production

NASA Astrophysics Data System (ADS)

Yim, Donggyu; Yang, Hyunjo; Park, Chanha; Hong, Jongkyun; Choi, Jaeseung

2005-05-01

As the optical lithography pushes toward its theoretical resolution limit 0.25k1, the application of aggressive Resolution Enhancement Techniques (RETs) are required in order to ensure necessary resolution, sufficient process window, and reasonable MEEF in critical layers. When chip makers are adopting RETs in low k1 device, there are a lot of crucial factors to take into account in the development and mass production. Those hurdles are not only difficult to overcome but also highly risky to the company, which adopts low k1 mass production strategy. But, low k1 production strategy is very attractive to all chip makers, owing to improving production capacity and cost of ownership. So, low k1 technology has been investigated by many lithography engineers. Lots of materials have been introduced. Most of them are just in RnD level. In this study, low k1 mass production issues shall be introduced, mainly. The definition of low k1 in mass production shall be suggested. And, a lot of low_k1 issues shall be introduced, also. Most of them were investigated/experienced in RnD development stage and final mass production line. Low k1 mass production, is some what different from only RnD development.

Experimental study of the space-time development of the particle production process in hadron-nucleon collisions, using massive target nucleus as a detector

NASA Technical Reports Server (NTRS)

Strugalski, Z.

1985-01-01

Experimental study of the space-time development of the particle production process in hadronic collisions at its initial stage was performed. Massive target nuclei have been used as fine detectors of properties of the particle production process development within time intervals smaller than 10 to the 22nd power s and spatial distances smaller than 10 to the 12th power cm. In hadron-nucleon collisions, in particular in nucleon-nucleon collisions, the particle production process goes through intermediate objects in 2 yields 2 type endoergic reactions. The objects decay into commonly observed resonances and paricles.

How to develop a proactive formulary system.

PubMed

Crane, V S; Gonzalez, E R; Hull, B L

1994-10-01

To develop a quality formulary system, a proactive approach is necessary. This approach incorporates a prospective product and concurrent product analyses. A prospective product analysis, in turn, involves a review of current formulary agents, those likely to enter the marketplace shortly, and the formation of an expert review panel. This panel's tasks are to examine therapeutic, economic, and humanistic aspects of therapy and to set initial parameters for appropriate and cost-effective use of accepted products. Keys to a successful formulary system are to continuously monitor drug use and compliance with criteria and to work collaboratively with all institutional professionals in the development, implementation, and monitoring of the system.

On-demand Hydrogen Production from Organosilanes at Ambient Temperature Using Heterogeneous Gold Catalysts

NASA Astrophysics Data System (ADS)

Mitsudome, Takato; Urayama, Teppei; Kiyohiro, Taizo; Maeno, Zen; Mizugaki, Tomoo; Jitsukawa, Koichiro; Kaneda, Kiyotomi

2016-11-01

An environmentally friendly (“green”), H2-generation system was developed that involved hydrolytic oxidation of inexpensive organosilanes as hydrogen storage materials with newly developed heterogeneous gold nanoparticle catalysts. The gold catalyst functioned well at ambient temperature under aerobic conditions, providing efficient production of pure H2. The newly developed size-selective gold nanoparticle catalysts could be separated easily from the reaction mixture containing organosilanes, allowing an on/off-switchable H2-production by the introduction and removal of the catalyst. This is the first report of an on/off-switchable H2-production system employing hydrolytic oxidation of inexpensive organosilanes without requiring additional energy.

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.

Training mechanical engineering students to utilize biological inspiration during product development.

PubMed

Bruck, Hugh A; Gershon, Alan L; Golden, Ira; Gupta, Satyandra K; Gyger, Lawrence S; Magrab, Edward B; Spranklin, Brent W

2007-12-01

The use of bio-inspiration for the development of new products and devices requires new educational tools for students consisting of appropriate design and manufacturing technologies, as well as curriculum. At the University of Maryland, new educational tools have been developed that introduce bio-inspired product realization to undergraduate mechanical engineering students. These tools include the development of a bio-inspired design repository, a concurrent fabrication and assembly manufacturing technology, a series of undergraduate curriculum modules and a new senior elective in the bio-inspired robotics area. This paper first presents an overview of the two new design and manufacturing technologies that enable students to realize bio-inspired products, and describes how these technologies are integrated into the undergraduate educational experience. Then, the undergraduate curriculum modules are presented, which provide students with the fundamental design and manufacturing principles needed to support bio-inspired product and device development. Finally, an elective bio-inspired robotics project course is present, which provides undergraduates with the opportunity to demonstrate the application of the knowledge acquired through the curriculum modules in their senior year using the new design and manufacturing technologies.

A techno-economic evaluation of anaerobic biogas producing systems in developing countries.

PubMed

Morgan, Hervan Marion; Xie, Wei; Liang, Jianghui; Mao, Hanping; Lei, Hanwu; Ruan, Roger; Bu, Quan

2018-02-01

Biogas production has been the focus of many individuals in the developing world; there have been several investigations that focus on improving the production process and product quality. In the developing world the lack of advanced technology and capital has hindered the development of energy production. Renewable energy has the potential to improve the standard of living for most of the 196 countries which are classified as developing economies. One of the easiest renewable energy compounds that can be produced is biogas (bio-methane). Biogas can be produced from almost any source of biomass through the anaerobic respiration of micro-organisms. Low budget energy systems are reviewed in this article along with various feedstock sources. Adapted gas purification and storage systems are also reviewed, along with the possible economic, social, health and environmental benefits of its implementation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Real-Time Simulation

NASA Technical Reports Server (NTRS)

1997-01-01

Coryphaeus Software, founded in 1989 by former NASA electronic engineer Steve Lakowske, creates real-time 3D software. Designer's Workbench, the company flagship product, is a modeling and simulation tool for the development of both static and dynamic 3D databases. Other products soon followed. Activation, specifically designed for game developers, allows developers to play and test the 3D games before they commit to a target platform. Game publishers can shorten development time and prove the "playability" of the title, maximizing their chances of introducing a smash hit. Another product, EasyT, lets users create massive, realistic representation of Earth terrains that can be viewed and traversed in real time. Finally, EasyScene software control the actions among interactive objects within a virtual world. Coryphaeus products are used on Silican Graphics workstation and supercomputers to simulate real-world performance in synthetic environments. Customers include aerospace, aviation, architectural and engineering firms, game developers, and the entertainment industry.

Hormone replacement therapy in the developing countries.

PubMed

Oei, P L; Ratnam, S S

1998-05-01

The sales data of oestrogen replacement products for 8 developing countries from 1993 to 1995 were analyzed. The data from Malaysia, Pakistan, Taiwan, Thailand, Indonesia, Philippines and South Korea showed the increasing use of oestrogen replacement products. The total usage however varied widely, from only US$11,153 (Philippines in 1993) to as much as US$6,306,717 (Taiwan in 1995). In Singapore, where oestrogen replacement is an accepted and established form of therapy for the postmenopausal woman, there has been an increase in the usage of the nonoestrogen replacement products. There are multiple reasons for the increasing sales of hormone replacement products in the developing countries and these are explored in this article. In some of the developing countries, for example China and India, hormone replacement therapy has just been introduced. However, in those developing countries in which hormone replacement therapy is already available, sales figures show increasing usage. The future augurs well for hormone replacement therapy.

Experiences of multidisciplinary development team members during user-centered design of telecare products and services: a qualitative study.

PubMed

Vermeulen, Joan; Verwey, Renée; Hochstenbach, Laura M J; van der Weegen, Sanne; Man, Yan Ping; de Witte, Luc P

2014-05-19

User-centered design (UCD) methodologies can help take the needs and requirements of potential end-users into account during the development of innovative telecare products and services. Understanding how members of multidisciplinary development teams experience the UCD process might help to gain insight into factors that members with different backgrounds consider critical during the development of telecare products and services. The primary objective of this study was to explore how members of multidisciplinary development teams experienced the UCD process of telecare products and services. The secondary objective was to identify differences and similarities in the barriers and facilitators they experienced. Twenty-five members of multidisciplinary development teams of four Research and Development (R&D) projects participated in this study. The R&D projects aimed to develop telecare products and services that can support self-management in elderly people or patients with chronic conditions. Seven participants were representatives of end-users (elderly persons or patients with chronic conditions), three were professional end-users (geriatrician and nurses), five were engineers, four were managers (of R&D companies or engineering teams), and six were researchers. All participants were interviewed by a researcher who was not part of their own development team. The following topics were discussed during the interviews: (1) aim of the project, (2) role of the participant, (3) experiences during the development process, (4) points of improvement, and (5) what the project meant to the participant. Experiences of participants related to the following themes: (1) creating a development team, (2) expectations regarding responsibilities and roles, (3) translating user requirements into technical requirements, (4) technical challenges, (5) evaluation of developed products and services, and (6) valorization. Multidisciplinary team members from different backgrounds often reported similar experienced barriers (eg, different members of the development team speak a "different language") and facilitators (eg, team members should voice expectations at the start of the project to prevent miscommunication at a later stage). However, some experienced barriers and facilitators were reported only by certain groups of participants. For example, only managers reported the experience that having different ideas about what a good business case is within one development team was a barrier, whereas only end-users emphasized the facilitating role of project management in end-user participation and the importance of continuous feedback from researchers on input of end-users. Many similarities seem to exist between the experienced barriers and facilitators of members of multidisciplinary development teams during UCD of telecare products and services. However, differences in experiences between team members from various backgrounds exist as well. Insights into these similarities and differences can improve understanding between team members from different backgrounds, which can optimize collaboration during the development of telecare products and services.

The Production Data Approach for Full Lifecycle Management

NASA Astrophysics Data System (ADS)

Schopf, J.

2012-04-01

The amount of data generated by scientists is growing exponentially, and studies have shown [Koe04] that un-archived data sets have a resource half-life that is only a fraction of those resources that are electronically archived. Most groups still lack standard approaches and procedures for data management. Arguably, however, scientists know something about building software. A recent article in Nature [Mer10] stated that 45% of research scientists spend more time now developing software than they did 5 years ago, and 38% spent at least 1/5th of their time developing software. Fox argues [Fox10] that a simple release of data is not the correct approach to data curation. In addition, just as software is used in a wide variety of ways never initially envisioned by its developers, we're seeing this even to a greater extent with data sets. In order to address the need for better data preservation and access, we propose that data sets should be managed in a similar fashion to building production quality software. These production data sets are not simply published once, but go through a cyclical process, including phases such as design, development, verification, deployment, support, analysis, and then development again, thereby supporting the full lifecycle of a data set. The process involved in academically-produced software changes over time with respect to issues such as how much it is used outside the development group, but factors in aspects such as knowing who is using the code, enabling multiple developers to contribute to code development with common procedures, formal testing and release processes, developing documentation, and licensing. When we work with data, either as a collection source, as someone tagging data, or someone re-using it, many of the lessons learned in building production software are applicable. Table 1 shows a comparison of production software elements to production data elements. Table 1: Comparison of production software and production data. Production Software Production Data End-user considerations End-user considerations Multiple Coders: Repository with check-in procedures Coding standards Multiple producers/collectors Local archive with check-in procedure Metadata Standards Formal testing Formal testing Bug tracking and fixes Bug tracking and fixes, QA/QC Documentation Documentation Formal Release Process Formal release process to external archive License Citation/usage statement The full presentation of this abstract will include a detailed discussion of these issues so that researchers can produce usable and accessible data sets as a first step toward reproducible science. By creating production-quality data sets, we extend the potential of our data, both in terms of usability and usefulness to ourselves and other researchers. The more we treat data with formal processes and release cycles, the more relevant and useful it can be to the scientific community.

User-driven product data manager system design

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

NONE

1995-03-01

With the infusion of information technologies into product development and production processes, effective management of product data is becoming essential to modern production enterprises. When an enterprise-wide Product Data Manager (PDM) is implemented, PDM designers must satisfy the requirements of individual users with different job functions and requirements, as well as the requirements of the enterprise as a whole. Concern must also be shown for the interrelationships between information, methods for retrieving archival information and integration of the PDM into the product development process. This paper describes a user-driven approach applied to PDM design for an agile manufacturing pilot projectmore » at Sandia National Laboratories that has been successful in achieving a much faster design-to-production process for a precision electro mechanical surety device.« less

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.

Recent developments in high-quality drying of vegetables, fruits, and aquatic products.

PubMed

Zhang, Min; Chen, Huizhi; Mujumdar, Arun S; Tang, Juming; Miao, Song; Wang, Yuchuan

2017-04-13

Fresh foods like vegetables, fruits, and aquatic products have high water activity and they are highly heat-sensitive and easily degradable. Dehydration is one of the most common methods used to improve food shelf-life. However, drying methods used for food dehydration must not only be efficient and economic but also yield high-quality products based on flavor, nutrients, color, rehydration, uniformity, appearance, and texture. This paper reviews some new drying technologies developed for dehydration of vegetables, fruits, and aquatic products. These include: infrared drying, microwave drying, radio frequency drying, electrohydrodynamic drying, etc., as well as hybrid drying methods combining two or more different drying techniques. A comprehensive review of recent developments in high-quality drying of vegetables, fruits and aquatic products is presented and recommendations are made for future research.

Quality and safety aspects of meat products as affected by various physical manipulations of packaging materials.

PubMed

Lee, Keun Taik

2010-09-01

This article explores the effects of physically manipulated packaging materials on the quality and safety of meat products. Recently, innovative measures for improving quality and extending the shelf-life of packaged meat products have been developed, utilizing technologies including barrier film, active packaging, nanotechnology, microperforation, irradiation, plasma and far-infrared ray (FIR) treatments. Despite these developments, each technology has peculiar drawbacks which will need to be addressed by meat scientists in the future. To develop successful meat packaging systems, key product characteristics affecting stability, environmental conditions during storage until consumption, and consumers' packaging expectations must all be taken into consideration. Furthermore, the safety issues related to packaging materials must also be taken into account when processing, packaging and storing meat products.

Public-private partnerships for health: their main targets, their diversity, and their future directions.

PubMed Central

Widdus, R.

2001-01-01

The global burden of disease, especially the part attributable to infectious diseases, disproportionately affects populations in developing countries. Inadequate access to pharmaceuticals plays a role in perpetuating this disparity. Drugs and vaccines may not be accessible because of weak distribution infrastructures or because development of the desired products has been neglected. This situation can be tackled with push interventions to lower the costs and risks of product development for industry, with pull interventions providing economic and market incentives, and with the creation of infrastructures allowing products to be put into use. If appropriately motivated, pharmaceutical companies can bring to partnerships expertise in product development, production process development, manufacturing, marketing, and distribution--all of which are lacking in the public sector. A large variety of public-private partnerships, combining the skills and resources of a wide range of collaborators, have arisen for product development, disease control through product donation and distribution, or the general strengthening or coordination of health services. Administratively, such partnerships may either involve affiliation with international organizations, i.e. they are essentially public-sector programmes with private-sector participation, or they may be legally independent not-for-profit bodies. These partnerships should be regarded as social experiments; they show promise but are not a panacea. New ventures should be built on need, appropriateness, and lessons on good practice learnt from experience. Suggestions are made for public, private, and joint activities that could help to improve the access of poor populations to the pharmaceuticals and health services they need. PMID:11545327

Pipeline for contraceptive development.

PubMed

Blithe, Diana L

2016-11-01

The high rates of unplanned pregnancy reflect an unmet need for effective contraceptive methods for women, especially for individuals with health risks such as obesity, diabetes, hypertension, and other conditions that may contraindicate use of an estrogen-containing product. Improvements in safety, user convenience, acceptability, and availability of products remain important goals of the contraceptive development program. Another important goal is to minimize the impact of the products on the environment. Development of new methods for male contraception has the potential to address many of these issues of safety for women who have contraindications to effective contraceptive methods but want to protect against pregnancy. It would also address a huge unmet need for men who want to control their fertility. Products under development for men would not introduce ecotoxic hormones into the water system. Published by Elsevier Inc.

The development of small-scale mechanization means positioning algorithm using radio frequency identification technology in industrial plants

NASA Astrophysics Data System (ADS)

Astafiev, A.; Orlov, A.; Privezencev, D.

2018-01-01

The article is devoted to the development of technology and software for the construction of positioning and control systems for small mechanization in industrial plants based on radio frequency identification methods, which will be the basis for creating highly efficient intelligent systems for controlling the product movement in industrial enterprises. The main standards that are applied in the field of product movement control automation and radio frequency identification are considered. The article reviews modern publications and automation systems for the control of product movement developed by domestic and foreign manufacturers. It describes the developed algorithm for positioning of small-scale mechanization means in an industrial enterprise. Experimental studies in laboratory and production conditions have been conducted and described in the article.

Advanced program development management software system. Software description and user's manual

NASA Technical Reports Server (NTRS)

1990-01-01

The objectives of this project were to apply emerging techniques and tools from the computer science discipline of paperless management to the activities of the Space Transportation and Exploration Office (PT01) in Marshall Space Flight Center (MSFC) Program Development, thereby enhancing the productivity of the workforce, the quality of the data products, and the collection, dissemination, and storage of information. The approach used to accomplish the objectives emphasized the utilization of finished form (off-the-shelf) software products to the greatest extent possible without impacting the performance of the end product, to pursue developments when necessary in the rapid prototyping environment to provide a mechanism for frequent feedback from the users, and to provide a full range of user support functions during the development process to promote testing of the software.

An Evolutionary History of Oriented Strandboard (OSB)

Treesearch

John I. Zerbe; Zhiyong Cai; George B. Harpole

2015-01-01

To improve wood utilization efficiency, oriented strandboard (OSB) was developed; 80% of the wood removed from the forest can now be processed into marketable products. This manuscript describes the history of developing this most profitable wood product, OSB, and the early FPL contribution in development.

77 FR 6791 - Biomass Research and Development Technical Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY: Energy... announces an open meeting of the Biomass Research and Development Technical Advisory Committee. The Federal... leading to the production of biobased fuels and biobased products. Tentative Agenda Update on USDA Biomass...

Water requirements for livestock production: a global perspective.

PubMed

Schlink, A C; Nguyen, M L; Viljoen, G J

2010-12-01

Water is a vital but poorly studied component of livestock production. It is estimated that livestock industries consume 8% of the global water supply, with most of that water being used for intensive, feed-based production. This study takes a broad perspective of livestock production as a component of the human food chain, and considers the efficiency of its water use. Global models are in the early stages of development and do not distinguish between developing and developed countries, or the production systems within them. However, preliminary indications are that, when protein production is adjusted for biological value in the human diet, no plant protein is significantly more efficient at using water than protein produced from eggs, and only soybean is more water efficient than milk and goat and chicken meat. In some regions, especially developing countries, animals are not used solely for food production but also provide draught power, fibre and fertiliser for crops. In addition, animals make use of crop by-products that would otherwise go to waste. The livestock sector is the fastest-growing agricultural sector, which has led to increasing industrialisation and, in some cases, reduced environmental constraints. In emerging economies, increasing involvement in livestock is related to improving rural wealth and increasing consumption of animal protein. Water usage for livestock production should be considered an integral part of agricultural water resource management, taking into account the type of production system (e.g. grain-fed or mixed crop-livestock) and scale (intensive or extensive), the species and breeds of livestock, and the social and cultural aspects of livestock farming in various countries.

Kinetic studies on batch cultivation of Trichoderma reesei and application to enhance cellulase production by fed-batch fermentation.

PubMed

Ma, Lijuan; Li, Chen; Yang, Zhenhua; Jia, Wendi; Zhang, Dongyuan; Chen, Shulin

2013-07-20

Reducing the production cost of cellulase as the key enzyme for cellulose hydrolysis to fermentable sugars remains a major challenge for biofuel production. Because of the complexity of cellulase production, kinetic modeling and mass balance calculation can be used as effective tools for process design and optimization. In this study, kinetic models for cell growth, substrate consumption and cellulase production in batch fermentation were developed, and then applied in fed-batch fermentation to enhance cellulase production. Inhibition effect of substrate was considered and a modified Luedeking-Piret model was developed for cellulase production and substrate consumption according to the growth characteristics of Trichoderma reesei. The model predictions fit well with the experimental data. Simulation results showed that higher initial substrate concentration led to decrease of cellulase production rate. Mass balance and kinetic simulation results were applied to determine the feeding strategy. Cellulase production and its corresponding productivity increased by 82.13% after employing the proper feeding strategy in fed-batch fermentation. This method combining mathematics and chemometrics by kinetic modeling and mass balance can not only improve cellulase fermentation process, but also help to better understand the cellulase fermentation process. The model development can also provide insight to other similar fermentation processes. Copyright © 2013 Elsevier B.V. All rights reserved.

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.

New Tobacco and Tobacco-Related Products: Early Detection of Product Development, Marketing Strategies, and Consumer Interest

PubMed Central

Staal, Yvonne CM; van de Nobelen, Suzanne; Havermans, Anne

2018-01-01

Background A wide variety of new tobacco and tobacco-related products have emerged on the market in recent years. Objective To understand their potential implications for public health and to guide tobacco control efforts, we have used an infoveillance approach to identify new tobacco and tobacco-related products. Methods Our search for tobacco(-related) products consists of several tailored search profiles using combinations of keywords such as “e-cigarette” and “new” to extract information from almost 9000 preselected sources such as websites of online shops, tobacco manufacturers, and news sites. Results Developments in e-cigarette design characteristics show a trend toward customization by possibilities to adjust temperature and airflow, and by the large variety of flavors of e-liquids. Additionally, more e-cigarettes are equipped with personalized accessories, such as mobile phones, applications, and Bluetooth. Waterpipe products follow the trend toward electronic vaping. Various heat-not-burn products were reintroduced to the market. Conclusions Our search for tobacco(-related) products was specific and timely, though advances in product development require ongoing optimization of the search strategy. Our results show a trend toward products resembling tobacco cigarettes vaporizers that can be adapted to the consumers’ needs. Our search for tobacco(-related) products could aid in the assessment of the likelihood of new products to gain market share, as a possible health risk or as an indicator for the need on independent and reliable information of the product to the general public. PMID:29807884

The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.

PubMed

Selen, Arzu; Dickinson, Paul A; Müllertz, Anette; Crison, John R; Mistry, Hitesh B; Cruañes, Maria T; Martinez, Marilyn N; Lennernäs, Hans; Wigal, Tim L; Swinney, David C; Polli, James E; Serajuddin, Abu T M; Cook, Jack A; Dressman, Jennifer B

2014-11-01

The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development and performance by using therapy-driven target drug delivery profiles as a framework to achieve the desired therapeutic outcome. Hence, clinical relevance is directly built into early formulation development. Biopharmaceutics tools are used to identify and address potential challenges to optimize the drug product for patient benefit. For illustration, BioRAM is applied to four relatively common therapy-driven drug delivery scenarios: rapid therapeutic onset, multiphasic delivery, delayed therapeutic onset, and maintenance of target exposure. BioRAM considers the therapeutic target with the drug substance characteristics and enables collection of critical knowledge for development of a dosage form that can perform consistently for meeting the patient's needs. Accordingly, the key factors are identified and in vitro, in vivo, and in silico modeling and simulation techniques are used to elucidate the optimal drug delivery rate and pattern. BioRAM enables (1) feasibility assessment for the dosage form, (2) development and conduct of appropriate "learning and confirming" studies, (3) transparency in decision-making, (4) assurance of drug product quality during lifecycle management, and (5) development of robust linkages between the desired clinical outcome and the necessary product quality attributes for inclusion in the quality target product profile. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

An integrated new product development framework - an application on green and low-carbon products

NASA Astrophysics Data System (ADS)

Lin, Chun-Yu; Lee, Amy H. I.; Kang, He-Yau

2015-03-01

Companies need to be innovative to survive in today's competitive market; thus, new product development (NPD) has become very important. This research constructs an integrated NPD framework for developing new products. In stage one, customer attributes (CAs) and engineering characteristics (ECs) for developing products are collected, and fuzzy interpretive structural modelling (FISM) is applied to understand the relationships among these critical factors. Based on quality function deployment (QFD), a house of quality is then built, and fuzzy analytic network process (FANP) is adopted to calculate the relative importance of ECs. In stage two, fuzzy failure mode and effects analysis (FFMEA) is applied to understand the potential failures of the ECs and to determine the importance of ECs with respect to risk control. In stage three, a goal programming (GP) model is constructed to consider the outcome from the FANP-QFD, FFMEA and other objectives, in order to select the most important ECs. Due to pollution and global warming, environmental protection has become an important topic. With both governments and consumers developing environmental consciousness, successful green and low-carbon NPD provides an important competitive advantage, enabling the survival or renewal of firms. The proposed framework is implemented in a panel manufacturing firm for designing a green and low-carbon product.

New Product Development for Green and Low-Carbon Products—A Case Study of Taiwan's TFT-LCD Manufacturer

NASA Astrophysics Data System (ADS)

Lin, Chun-Yu; Lee, Amy H. I.

2011-11-01

Green supply chain has become an important topic these days due to pollution, global warming, extreme climatic events, etc. A green product is manufactured with the goal of reducing the damage to the environment and limiting the use of energy and other resources at any stage of its life, including raw materials, manufacture, use, and disposal. Carbon footprint is a good measure of the impact that a product has on the environment, especially in climate change, in the entire lifetime of the product. Carbon footprint is directly linked to CO2 emission; thus, the reduction of CO2 emission must be considered in the product life cycle. Although more and more researchers are working on the green supply chain management in the past few years, few have incorporated CO2 emission or carbon footprint into the green supply chain system. Therefore, this research aims to propose an integrated model for facilitating the new product development (NPD) for green and low-carbon products. In this research, a systematic model based on quality function deployment (QFD) is constructed for developing green and low-carbon products in a TFT-LCD manufacturer. Literature review and interviews with experts are done first to collect the factors for developing and manufacturing green and low-carbon products. Fuzzy Delphi method (FDM) is applied next to extract the important factors, and fuzzy interpretive structural modeling (FISM) is used subsequently to understand the relationships among factors. A house of quality (HOQ) for product planning is built last. The results shall provide important information for a TFT-LCD firm in designing a new product.

Development of feedstocks for cellulosic biofuels

PubMed Central

Somerville, Chris

2012-01-01

The inclusion of cellulosic ethanol in the Energy Independence and Security Act (EISA) of 2007 and the revised Renewable Fuel Standard (RFS2) has spurred development of the first commercial scale cellulosic ethanol biorefineries. These efforts have also revived interest in the development of dedicated energy crops selected for biomass productivity and for properties that facilitate conversion of biomass to liquid fuels. While many aspects of developing these feedstocks are compatible with current agricultural activities, improving biomass productivity may provide opportunities to expand the potential for biofuel production beyond the classical research objectives associated with improving traditional food and feed crops. PMID:22615716

Fungal Laccases: Production, Function, and Applications in Food Processing

PubMed Central

Brijwani, Khushal; Rigdon, Anne; Vadlani, Praveen V.

2010-01-01

Laccases are increasingly being used in food industry for production of cost-effective and healthy foods. To sustain this trend widespread availability of laccase and efficient production systems have to be developed. The present paper delineate the recent developments that have taken place in understanding the role of laccase action, efforts in overexpression of laccase in heterologous systems, and various cultivation techniques that have been developed to efficiently produce laccase at the industrial scale. The role of laccase in different food industries, particularly the recent developments in laccase application for food processing, is discussed. PMID:21048859

Municipal solid waste development phases: Evidence from EU27.

PubMed

Vujić, Goran; Gonzalez-Roof, Alvaro; Stanisavljević, Nemanja; Ragossnig, Arne M

2015-12-01

Many countries in the European Union (EU) have very developed waste management systems. Some of its members have managed to reduce their landfilled waste to values close to zero during the last decade. Thus, European Union legislation is very stringent regarding waste management for their members and candidate countries, too. This raises the following questions: Is it possible for developing and developed countries to comply with the European Union waste legislation, and under what conditions? How did waste management develop in relation to the economic development in the countries of the European Union? The correlation between waste management practices and economic development was analysed for 27 of the European Union Member States for the time period between 1995 and 2007. In addition, a regression analysis was performed to estimate landfilling of waste in relation to gross domestic product for every country. The results showed a strong correlation between the waste management variables and the gross domestic product of the EU27 members. The definition of the municipal solid waste management development phases followed a closer analysis of the relation between gross domestic product and landfilled waste. The municipal solid waste management phases are characterised by high landfilling rates at low gross domestic product levels, and landfilling rates near zero at high gross domestic product levels. Hence the results emphasize the importance of wider understanding of what is required for developing countries to comply with the European Union initiatives, and highlight the importance of allowing developing countries to make their own paths of waste management development. © The Author(s) 2015.

Dynamic Domains in Data Production Planning

NASA Technical Reports Server (NTRS)

Golden, Keith; Pang, Wanlin

2005-01-01

This paper discusses a planner-based approach to automating data production tasks, such as producing fire forecasts from satellite imagery and weather station data. Since the set of available data products is large, dynamic and mostly unknown, planning techniques developed for closed worlds are unsuitable. We discuss a number of techniques we have developed to cope with data production domains, including a novel constraint propagation algorithm based on planning graphs and a constraint-based approach to interleaved planning, sensing and execution.

Quantitative perceptual differences among over-the-counter vaginal products using a standardized methodology: implications for microbicide development.

PubMed

Mahan, Ellen D; Morrow, Kathleen M; Hayes, John E

2011-08-01

Increasing prevalence of HIV infection among women worldwide has motivated the development of female-initiated prevention methods, including gel-based microbicides. User acceptability is vital for microbicide success; however, varying cultural vaginal practices indicate multiple formulations must be developed to appeal to different populations. Perceptual attributes of microbicides have been identified as primary drivers of acceptability; however, previous studies do not allow for direct comparison of these qualities between multiple formulations. Six vaginal products were analyzed ex vivo using descriptive analysis. Perceptual attributes of samples were identified by trained participants (n=10) and rated quantitatively using scales based on a panel-developed lexicon. Data were analyzed using two-way ANOVAs for each attribute; product differences were assessed via Tukey's honestly significant difference test. Significant differences were found between products for multiple attributes. Patterns were also seen for attributes across intended product usage (i.e., contraceptive, moisturizer or lubricant). For example, Options© Gynol II® (Caldwell Consumer Health, LLC) was significantly stickier and grainier than other products. Descriptive analysis, a quantitative approach that is based on consensus lexicon usage among participants, successfully quantified perceptual differences among vaginal products. Since perceptual attributes of products can be directly compared quantitatively, this study represents a novel approach that could be used to inform rational design of microbicides. Copyright © 2011 Elsevier Inc. All rights reserved.

Non-Specific Microbicide Product Development: Then and Now

PubMed Central

Romano, Joseph W.; Robbiani, Melissa; Doncel, Gustavo F.; Moench, Thomas

2015-01-01

Despite the identification of HIV-1 as the etiological agent responsible for AIDS nearly 30 years ago, a sterilizing vaccine capable of preventing transmission of the virus remains elusive. In response to struggles on the vaccine development front, significant effort has been devoted to preventing the transmission of HIV with alternative products, technologies, and strategies. One of the early alternative HIV prevention strategies was microbicides, which are topical products that can be used to prevent sexual transmission of HIV either vaginally or rectally. First generation microbicide products were designed to be simple gel formulations comprised of readily available active agents that were inexpensive and broadly active (i.e., non-specific). Unfortunately, despite the clinical investigation of multiple product concepts satisfying these requirements, none were shown to be efficacious in pivotal trials. More recently, microbicide and oral prevention strategies involving highly specific and potent anti-retroviral (ARV) drugs have shown to be efficacious in trials. Although building on these successes continues, these products have a number of issues including potential toxicity with long term use, selection of HIV resistance, and cost. Further, all of the original justifications for non-specific microbicide products remain valid. This review provides a brief history of non-specific microbicide development, outlines the evolution to, and limitations of, ARV based microbicides, and summarizes the current activity on non-specific microbicide product development. PMID:22264041

Learning Outcomes in Vocational Education: A Business Plan Development by Production-Based Learning Model Approach

ERIC Educational Resources Information Center

Kusumaningrum, Indrati; Hidayat, Hendra; Ganefri; Anori, Sartika; Dewy, Mega Silfia

2016-01-01

This article describes the development of a business plan by using production-based learning approach. In addition, this development also aims to maximize learning outcomes in vocational education. Preliminary analysis of curriculum and learning and the needs of the market and society become the basic for business plan development. To produce a…

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.

Development of a Multilayer MODIS IST-Albedo Product of Greenland

NASA Technical Reports Server (NTRS)

Hall, D. K.; Comiso, J. C.; Cullather, R. I.; Digirolamo, N. E.; Nowicki, S. M.; Medley, B. C.

2017-01-01

A new multilayer IST-albedo Moderate Resolution Imaging Spectroradiometer (MODIS) product of Greenland was developed to meet the needs of the ice sheet modeling community. The multiple layers of the product enable the relationship between IST and albedo to be evaluated easily. Surface temperature is a fundamental input for dynamical ice sheet models because it is a component of the ice sheet radiation budget and mass balance. Albedo influences absorption of incoming solar radiation. The daily product will combine the existing standard MODIS Collection-6 ice-surface temperature, derived melt maps, snow albedo and water vapor products. The new product is available in a polar stereographic projection in NetCDF format. The product will ultimately extend from March 2000 through the end of 2017.

77 FR 74194 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... FDA to authorize the marketing of a tobacco product before it may be introduced or delivered into... development or marketing of tobacco products. This guidance does not pertain to other types of meetings or... research to inform the regulation of tobacco products, or to support the development or marketing of...

The Role of Knowledge Acquisition in Facilitating Customer Involvement in Product Development: Examining the Mediation Effect of Absorptive Capacity

ERIC Educational Resources Information Center

Dahiyat, Samer E.; Al-Zu'bi, Zu'bi M. F.

2012-01-01

Knowledge management has often been linked to product development, innovation, and customisation. In particular, effective exploitation of customer knowledge, through engaging customers in a process of co-creation of products, exemplifies such a link. Accordingly, this research aims to identify those dimensions of knowledge management activities…

Drama and Imagination: A Cognitive Theory of Drama's Effect on Narrative Comprehension and Narrative Production

ERIC Educational Resources Information Center

Mages, Wendy K.

2006-01-01

This article proposes a cognitive theory of how drama affects two aspects of language development: narrative comprehension and narrative production. It is a theoretical model that explicitly posits the role of the imagination in drama's potential to enhance the development of both narrative comprehension and narrative production. (Contains 2…

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 process-based simulation models for cotton production: A review of past, present, and future directions

USDA-ARS?s Scientific Manuscript database

The development and application of cropping system simulation models for cotton production has a long and rich history, beginning in the southeast United States in the 1960's and now expanded to major cotton production regions globally. This paper briefly reviews the history of cotton simulation mo...

The Building Blocks of Digital Media Literacy: Socio-Material Participation and the Production of Media Knowledge

ERIC Educational Resources Information Center

Dezuanni, Michael

2015-01-01

This article outlines the knowledge and skills students develop when they engage in digital media production and analysis in school settings. The metaphor of "digital building blocks" is used to describe the material practices, conceptual understandings and production of knowledge that lead to the development of digital media literacy.…

The Development of Narrative Productivity, Syntactic Complexity, Referential Cohesion and Event Content in Four- to Eight-Year-Old Finnish Children

ERIC Educational Resources Information Center

Mäkinen, Leena; Loukusa, Soile; Nieminen, Lea; Leinonen, Eeva; Kunnari, Sari

2014-01-01

This study focuses on the development of narrative structure and the relationship between narrative productivity and event content. A total of 172 Finnish children aged between four and eight participated. Their picture-elicited narrations were analysed for productivity, syntactic complexity, referential cohesion and event content. Each measure…

Estimation of livestock appropriation of net primary productivity in Texas Drylands

Treesearch

Robert Washington-Allen; Jody Fitzgerald; Stephanie Grounds; Faisar Jihadi; John Kretzschmar; Kathryn Ramirez; John Mitchell

2009-01-01

The ecological state of US Drylands is unknown. This research is developing procedures to determine the impact of the ecological footprint of grazing livestock on the productive capacity of US Drylands. A pilot geodatabase was developed for the state of Texas that includes 2002 data for county boundaries, net primary productivity (NPP) derived from the Moderate...

Development Status for the Stennis Space Center LIDAR Product Characterization Range

NASA Technical Reports Server (NTRS)

Zanoni, Vicki; Berglund, Judith; Ross, Kenton

2004-01-01

The presentation describes efforts to develop a LIDAR in-flight product characterization range at Stennis Space Center as the next phase of the NASA Verification and Validation activities. It describes the status of surveying efforts on targets of interest to LIDAR vendors as well as the potential guidelines that will be used for product characterization.

31 CFR 576.206 - Protection granted to the Development Fund for Iraq, Iraqi Petroleum and Petroleum Products, and...

Code of Federal Regulations, 2011 CFR

2011-07-01

... Fund for Iraq, Iraqi Petroleum and Petroleum Products, and the Central Bank of Iraq. 576.206 Section... Prohibitions § 576.206 Protection granted to the Development Fund for Iraq, Iraqi Petroleum and Petroleum... petroleum and petroleum products, and interests therein, but only until title passes to the initial...

Contributions to Economic Development of Science and Technology Institutions in Nigeria and Opportunities for Bilateral Cooperation.

DTIC Science & Technology

1979-09-01

interactions among these institutions and between their activities and the activities of production organizations. Figure 1 FUNCTIONS OF THE SCIENCE...32 25. Production of Refrigerators ........ ................. .32 26. Developing the Communications Industry...technology adaptations are infrequent and seldom reflected in production activities. Limited service and maintenance personnel and facilities are unable

[Some engineering problems on developing production industry of modern traditional Chinese medicine].

PubMed

Qu, Hai-bin; Cheng, Yi-yu; Wang, Yue-sheng

2003-10-01

Based on the review of some engineering problems on developing modern production industry of Traditional Chinese Medicine (TCM), the differences of TCM production industry between China and abroad were pointed out. Accelerating the application and extension of high-tech and computer integrated manufacturing system (CIMS) were suggested to promote the technology advancement of TCM industry.

Brief history of electronic stereoscopic displays

NASA Astrophysics Data System (ADS)

Lipton, Lenny

2012-02-01

A brief history of recent developments in electronic stereoscopic displays is given concentrating on products that have succeeded in the market place and hence have had a significant influence on future implementations. The concentration is on plano-stereoscopic (two-view) technology because it is now the dominant display modality in the marketplace. Stereoscopic displays were created for the motion picture industry a century ago, and this technology influenced the development of products for science and industry, which in turn influenced product development for entertainment.

Innovation through developing consumers communities. Part II: Digitalizing the innovation processes

NASA Astrophysics Data System (ADS)

Avasilcai, S.; Galateanu (Avram, E.

2015-11-01

The current research recognises the concept of innovation as the main driver for organisational growth and profitability. The companies seek to develop new ways to engage consumers and customers into co - creation value through the product design, development and distribution processes. However the main concern is manifested for new and creative ways of customization products based on consumers’ requirements and needs. Thus the need for innovative virtual instruments arose as the demand from social communities for personalised products or services increased. Basically companies should develop own innovative platforms, where consumers can participate, with ideas, concepts or other relevant contributions, and interact with designers or engineers for product development. This paper aims to present the most important features of platform development within BMW Group as a concept and as innovative instrument. From this point of view it is important to enhance past experiences of the company in the field of co - creation projects. There will be highlighted the dual consumers’ character as co - creator and co - evaluator based on their involvement in the proposed and developed projects and platform structure. The significant impact on platform functioning it has the diversity of company's concerns for Research & Development and innovation activities. From this point of view there will be assessed the platform structure, the main proposed themes and the evaluation process. The main outcome is to highlight the significance of platform development as innovative tool for consumers’ communities’ enhancement. Based on the analysis of “BMW Co-Creation Lab”, there will be revealed the main consumers concerns in terms of safety, comfort and appearance of the products. Thus it is important to understand the evaluation process of gathered ideas and intellectual property policy. The importance of platform development and implementation will be highlighted by company's results in terms of Research & Development investments and future projects which will be proposed, assessed and implemented by BMW Group in order to show the responsibility for their products and consumers.

The Importance of Method Selection in Determining Product Integrity for Nutrition Research1234

PubMed Central

Mudge, Elizabeth M; Brown, Paula N

2016-01-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. PMID:26980823

Lessons learned in deploying software estimation technology and tools

NASA Technical Reports Server (NTRS)

Panlilio-Yap, Nikki; Ho, Danny

1994-01-01

Developing a software product involves estimating various project parameters. This is typically done in the planning stages of the project when there is much uncertainty and very little information. Coming up with accurate estimates of effort, cost, schedule, and reliability is a critical problem faced by all software project managers. The use of estimation models and commercially available tools in conjunction with the best bottom-up estimates of software-development experts enhances the ability of a product development group to derive reasonable estimates of important project parameters. This paper describes the experience of the IBM Software Solutions (SWS) Toronto Laboratory in selecting software estimation models and tools and deploying their use to the laboratory's product development groups. It introduces the SLIM and COSTAR products, the software estimation tools selected for deployment to the product areas, and discusses the rationale for their selection. The paper also describes the mechanisms used for technology injection and tool deployment, and concludes with a discussion of important lessons learned in the technology and tool insertion process.

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.

Microgravity

NASA Image and Video Library

1998-10-01

Research with plants in microgravity offers many exciting opportunities to gain new insights and could improve products on Earth ranging from crop production to fragrances and food flavorings. The ASTROCULTURE facility is a lead commercial facility for plant growth and plant research in microgravity and was developed by the Wisconsin Center for Space Automation and Robotics (WSCAR), a NASA Commercial Space Center. On STS-95 it will support research that could help improve crop development leading to plants that are more disease resistant or have a higher yield and provide data on the production of plant essential oils---oils that contain the essence of the plant and provide both fragrance and flavoring. On STS-95, a flowering plant will be grown in ASTROCULTURE and samples taken using a method developed by the industry partner for this investigation. On Earth the samples will be analyzed by gas chromatography/mass spectrometry and the data used to evaluate both the production of fragrant oils in microgravity and in the development of one or more products.

The ASTROCULTURE Facility

NASA Technical Reports Server (NTRS)

1998-01-01

Research with plants in microgravity offers many exciting opportunities to gain new insights and could improve products on Earth ranging from crop production to fragrances and food flavorings. The ASTROCULTURE facility is a lead commercial facility for plant growth and plant research in microgravity and was developed by the Wisconsin Center for Space Automation and Robotics (WSCAR), a NASA Commercial Space Center. On STS-95 it will support research that could help improve crop development leading to plants that are more disease resistant or have a higher yield and provide data on the production of plant essential oils---oils that contain the essence of the plant and provide both fragrance and flavoring. On STS-95, a flowering plant will be grown in ASTROCULTURE and samples taken using a method developed by the industry partner for this investigation. On Earth the samples will be analyzed by gas chromatography/mass spectrometry and the data used to evaluate both the production of fragrant oils in microgravity and in the development of one or more products.

Case history of Yakin field: its development and sand control

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

Sawolo, N.; Krueger, R.F.; Maly, G.P.

1983-01-01

This paper deals with the development of the Yakin field in East Kalimantan, Indonesia, with emphasis on the sand control methods used. Implementation of an effective sand control program ensured the successful development of this field. Gravel-packed wells had substantially lower production decline rates than the initial completions without gravel packs. Control of sand production also has been demonstrated by the lack of sand problems during the 4 1/2 years since the sand control program was initiated. During this time there have been no submersible pump failures associated with sand production. The successful sand control program was achieved by amore » well-coordinated and cooperative effort of drilling, reservoir engineering, production research, and service company personnel. Establishment of communication among all people involved, starting early in the planning process and continuing through the rig operations to the final production phase, coupled with intensive training at all levels of responsibility, on-site supervision, and quality control were important factors in the success of the development program.« less

The Importance of Method Selection in Determining Product Integrity for Nutrition Research.

PubMed

Mudge, Elizabeth M; Betz, Joseph M; Brown, Paula N

2016-03-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. © 2016 American Society for Nutrition.

76 FR 10403 - Hewlett Packard (HP), Global Product Development, Engineering Workstation Refresh Team, Working...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

...), Global Product Development, Engineering Workstation Refresh Team, Working On-Site at General Motors... groups: The Non-Information Technology Business Development Team, the Engineering Application Support Team, and the Engineering Workstation Refresh Team. On February 2, 2011, the Department issued an...

77 FR 38305 - Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-27

... ``Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment...] Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

Cost accounting, management control, and planning in health care.

PubMed

Siegrist, R B; Blish, C S

1988-02-01

Advantages and pharmacy applications of computerized hospital management-control and planning systems are described. Hospitals must define their product lines; patient cases, not tests or procedures, are the end product. Management involves operational control, management control, and strategic planning. Operational control deals with day-to-day management on the task level. Management control involves ensuring that managers use resources effectively and efficiently to accomplish the organization's objectives. Management control includes both control of unit costs of intermediate products, which are procedures and services used to treat patients and are managed by hospital department heads, and control of intermediate product use per case (managed by the clinician). Information from the operation and management levels feeds into the strategic plan; conversely, the management level controls the plan and the operational level carries it out. In the system developed at New England Medical Center, Boston, Massachusetts, the intermediate product-management system enables managers to identify intermediate products, develop standard costs, simulate changes in departmental costs, and perform variance analysis. The end-product management system creates a patient-level data-base, identifies end products (patient-care groupings), develops standard resource protocols, models alternative assumptions, performs variance analysis, and provides concurrent reporting. Examples are given of pharmacy managers' use of such systems to answer questions in the areas of product costing, product pricing, variance analysis, productivity monitoring, flexible budgeting, modeling and planning, and comparative analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

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.

47 CFR 6.7 - Product design, development, and evaluation.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Manufacturers and service providers shall evaluate the accessibility, usability, and compatibility of equipment... identify barriers to accessibility and usability as part of such a product design and development process...

47 CFR 6.7 - Product design, development, and evaluation.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Manufacturers and service providers shall evaluate the accessibility, usability, and compatibility of equipment... identify barriers to accessibility and usability as part of such a product design and development process...

Assistive technology products: a position paper from the first global research, innovation, and education on assistive technology (GREAT) summit.

PubMed

Smith, Roger O; Scherer, Marcia; Cooper, Rory; Bell, Diane; Hobbs, David A; Pettersson, Cecilia; Seymour, Nicky; Borg, Johan; Johnson, Michelle J; Lane, Joseph P; Srinivasan, S Sujatha; Rao, Pvm; Obiedat, Qussai M; MacLachlan, Mac; Bauer, Stephen

2018-06-06

This paper is based on work from the Global Research, Innovation, and Education on Assistive Technology (GREAT) Summit that was coordinated by WHO's Global Cooperation on Assistive Technology (GATE). The purpose of this paper is to describe the needs and opportunities embedded in the assistive product lifecycle as well as issues relating to the various stages of assistive product mobilization worldwide. The paper discusses assistive technology product terminology and the dangers of focusing on products outside the context and rolling out products without a plan. Additionally, the paper reviews concepts and issues around technology transfer, particularly in relation to meeting global needs and among countries with limited resources. Several opportunities are highlighted including technology advancement and the world nearing a state of readiness through a developing capacity of nations across the world to successfully adopt and support the assistive technology products and applications. The paper is optimistic about the future of assistive technology products reaching the people that can use it the most and the excitement across large and small nations in increasing their own capacities for implementing assistive technology. This is expressed as hope in future students as they innovate and in modern engineering that will enable assistive technology to pervade all corners of current and potential marketplaces. Importantly, the paper poses numerous topics where discussions are just superficially opened. The hope is that a set of sequels will follow to continue this critical dialog. Implications for Rehabilitation Successful assistive technology product interventions are complex and include much more than the simple selection of the right product. Assistive technology product use is highly context sensitive in terms of an individual user's environment. The development of assistive technology products is tricky as it must be contextually sensitive to the development environment and market as well. As a field we have much to study and develop around assistive technology product interventions from a global perspective.

Integrating the results of user research into medical device development: insights from a case study.

PubMed

Martin, Jennifer L; Barnett, Julie

2012-07-19

It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product.

Integrating the results of user research into medical device development: insights from a case study

PubMed Central

2012-01-01

Background It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product. PMID:22812565

Implementation effect of productive 4-stage field orientation on the student technopreneur skill in vocational schools

NASA Astrophysics Data System (ADS)

Ismail, Edy; Samsudi, Widjanarko, Dwi; Joyce, Peter; Stearns, Roman

2018-03-01

This model integrates project base learning by creating a product based on environmental needs. The Produktif Orientasi Lapangan 4 Tahap (POL4T) combines technical skills and entrepreneurial elements together in the learning process. This study is to implement the result of technopreneurship learning model development which is environment-oriented by combining technology and entrepreneurship components on Machining Skill Program. This study applies research and development design by optimizing experimental subject. Data were obtained from questionnaires, learning material validation, interpersonal, intrapersonal observation forms, skills, product, teachers and students' responses, and cognitive tasks. Expert validation and t-test calculation are applied to see how effective POL4T learning model. The result of the study is in the form of 4 steps learning model to enhance interpersonal and intrapersonal attitudes, develop practical products which orient to society and appropriate technology so that the products can have high selling value. The model is effective based on the students' post test result, which is better than the pre-test. The product obtained from POL4T model is proven to be better than the productive learning. POL4T model is recommended to be implemented for XI grade students. This is can develop entrepreneurial attitudes that are environment oriented, community needs and technical competencies students.

Regulatory concerns in the development of biologic-biomaterial combinations. United States Food and Drug Administration.

PubMed

Chapekar, M S

1996-01-01

Several biologic-biomaterial combinations are currently under development in an attempt to modulate tissue or organ function in patients. The FDA regulations on combination products and the intercenter agreements among the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drugs Evaluation and Research (CDER) provide further guidance on center jurisdiction of combination products and other products where there are jurisdictional concerns. The biological component of biologic-biomaterial combinations raises a number of issues that relate to the safety and bioactivity of the final product. For example, transmission of adventitious agents to patients via somatic cells, tissue, or cell-derived products is a major safety concern as are in vivo inflammatory responses elicited by the biomaterial component. CBER has drafted a number of "Points to Consider" documents to provide further guidance in the development of biological products. The intent of this article is to provide the highlights of the FDA regulations for combination products and the intercenter agreement between CBER and CDRH delineating the responsibilities of each center for medical device activities. In addition, the article focuses on the CBER's concerns related to the development of somatic cell-biomaterial combinations for therapeutic use.

The role of sensory perception in the development and targeting of tobacco products.

PubMed

Carpenter, Carrie M; Wayne, Geoffrey Ferris; Connolly, Gregory N

2007-01-01

To examine tobacco industry research on smoking-related sensory effects, including differences in sensory perception across smoker groups, and to determine whether this research informed targeted product development and impacted the development of commercial tobacco products. We searched previously secret internal tobacco industry documents available online through document databases housed at Tobacco Documents Online, the British American Tobacco Document Archive and the Legacy Tobacco Documents Library. We identified relevant documents using a snowball sampling method to first search the databases using an initial set of key words and to then establish further search terms. Sensory research is a priority within the tobacco industry directly impacting commercial markets both in the United States and internationally. Sensory factors contribute to smoker satisfaction and product acceptance, and play an important role in controlling puffing behavior. Cigarette manufacturers have capitalized on distinct sensory preferences across gender, age and ethnic groups by tailoring products for specific populations. Regulation of tobacco products is needed to address product changes that are used to reinforce or contribute to tobacco dependence; for instance, the incorporation of additives that target attributes such as smoothness, harshness and aftertaste. Greater understanding of the role of sensory effects on smoking behavior may also help to inform the development of tobacco treatment options that support long-term tobacco abstinence.

Flat-plate solar array project. Volume 5: Process development

NASA Technical Reports Server (NTRS)

Gallagher, B.; Alexander, P.; Burger, D.

1986-01-01

The goal of the Process Development Area, as part of the Flat-Plate Solar Array (FSA) Project, was to develop and demonstrate solar cell fabrication and module assembly process technologies required to meet the cost, lifetime, production capacity, and performance goals of the FSA Project. R&D efforts expended by Government, Industry, and Universities in developing processes capable of meeting the projects goals during volume production conditions are summarized. The cost goals allocated for processing were demonstrated by small volume quantities that were extrapolated by cost analysis to large volume production. To provide proper focus and coverage of the process development effort, four separate technology sections are discussed: surface preparation, junction formation, metallization, and module assembly.

Software metrics: The quantitative impact of four factors on work rates experienced during software development. [reliability engineering

NASA Technical Reports Server (NTRS)

Gaffney, J. E., Jr.; Judge, R. W.

1981-01-01

A model of a software development process is described. The software development process is seen to consist of a sequence of activities, such as 'program design' and 'module development' (or coding). A manpower estimate is made by multiplying code size by the rates (man months per thousand lines of code) for each of the activities relevant to the particular case of interest and summing up the results. The effect of four objectively determinable factors (organization, software product type, computer type, and code type) on productivity values for each of nine principal software development activities was assessed. Four factors were identified which account for 39% of the observed productivity variation.

Applying probabilistic well-performance parameters to assessments of shale-gas resources

USGS Publications Warehouse

Charpentier, Ronald R.; Cook, Troy

2010-01-01

In assessing continuous oil and gas resources, such as shale gas, it is important to describe not only the ultimately producible volumes, but also the expected well performance. This description is critical to any cost analysis or production scheduling. A probabilistic approach facilitates (1) the inclusion of variability in well performance within a continuous accumulation, and (2) the use of data from developed accumulations as analogs for the assessment of undeveloped accumulations. In assessing continuous oil and gas resources of the United States, the U.S. Geological Survey analyzed production data from many shale-gas accumulations. Analyses of four of these accumulations (the Barnett, Woodford, Fayetteville, and Haynesville shales) are presented here as examples of the variability of well performance. For example, the distribution of initial monthly production rates for Barnett vertical wells shows a noticeable change with time, first increasing because of improved completion practices, then decreasing from a combination of decreased reservoir pressure (in infill wells) and drilling in less productive areas. Within a partially developed accumulation, historical production data from that accumulation can be used to estimate production characteristics of undrilled areas. An understanding of the probabilistic relations between variables, such as between initial production and decline rates, can improve estimates of ultimate production. Time trends or spatial trends in production data can be clarified by plots and maps. The data can also be divided into subsets depending on well-drilling or well-completion techniques, such as vertical in relation to horizontal wells. For hypothetical or lightly developed accumulations, one can either make comparisons to a specific well-developed accumulation or to the entire range of available developed accumulations. Comparison of the distributions of initial monthly production rates of the four shale-gas accumulations that were studied shows substantial overlap. However, because of differences in decline rates among them, the resulting estimated ultimate recovery (EUR) distributions are considerably different.

Scale-up bioprocess development for production of the antibiotic valinomycin in Escherichia coli based on consistent fed-batch cultivations.

PubMed

Li, Jian; Jaitzig, Jennifer; Lu, Ping; Süssmuth, Roderich D; Neubauer, Peter

2015-06-12

Heterologous production of natural products in Escherichia coli has emerged as an attractive strategy to obtain molecules of interest. Although technically feasible most of them are still constrained to laboratory scale production. Therefore, it is necessary to develop reasonable scale-up strategies for bioprocesses aiming at the overproduction of targeted natural products under industrial scale conditions. To this end, we used the production of the antibiotic valinomycin in E. coli as a model system for scalable bioprocess development based on consistent fed-batch cultivations. In this work, the glucose limited fed-batch strategy based on pure mineral salt medium was used throughout all scales for valinomycin production. The optimal glucose feed rate was initially detected by the use of a biocatalytically controlled glucose release (EnBase® technology) in parallel cultivations in 24-well plates with continuous monitoring of pH and dissolved oxygen. These results were confirmed in shake flasks, where the accumulation of valinomycin was highest when the specific growth rate decreased below 0.1 h(-1). This correlation was also observed for high cell density fed-batch cultivations in a lab-scale bioreactor. The bioreactor fermentation produced valinomycin with titers of more than 2 mg L(-1) based on the feeding of a concentrated glucose solution. Valinomycin production was not affected by oscillating conditions (i.e. glucose and oxygen) in a scale-down two-compartment reactor, which could mimic similar situations in industrial bioreactors, suggesting that the process is very robust and a scaling of the process to a larger industrial scale appears a realistic scenario. Valinomycin production was scaled up from mL volumes to 10 L with consistent use of the fed-batch technology. This work presents a robust and reliable approach for scalable bioprocess development and represents an example for the consistent development of a process for a heterologously expressed natural product towards the industrial scale.

Surveillance methods for identifying, characterizing, and monitoring tobacco products: potential reduced exposure products as an example

PubMed Central

O’Connor, Richard J.; Cummings, K. Michael; Rees, Vaughan W.; Connolly, Gregory N.; Norton, Kaila J.; Sweanor, David; Parascandola, Mark; Hatsukami, Dorothy K.; Shields, Peter G.

2015-01-01

Tobacco products are widely sold and marketed, yet integrated data systems for identifying, tracking, and characterizing products are lacking. Tobacco manufacturers recently have developed potential reduction exposure products (PREPs) with implied or explicit health claims. Currently, a systematic approach for identifying, defining, and evaluating PREPs sold at the local, state or national levels in the US has not been developed. Identifying, characterizing, and monitoring new tobacco products could be greatly enhanced with a responsive surveillance system. This paper critically reviews available surveillance data sources for identifying and tracking tobacco products, including PREPs, evaluating strengths and weaknesses of potential data sources in light of their reliability and validity. Absent regulations mandating disclosure of product-specific information, it is likely that public health officials will need to rely on a variety of imperfect data sources to help identify, characterize, and monitor tobacco products, including PREPs. PMID:19959680

Fuel ethanol production: process design trends and integration opportunities.

PubMed

Cardona, Carlos A; Sánchez, Oscar J

2007-09-01

Current fuel ethanol research and development deals with process engineering trends for improving biotechnological production of ethanol. In this work, the key role that process design plays during the development of cost-effective technologies is recognized through the analysis of major trends in process synthesis, modeling, simulation and optimization related to ethanol production. Main directions in techno-economical evaluation of fuel ethanol processes are described as well as some prospecting configurations. The most promising alternatives for compensating ethanol production costs by the generation of valuable co-products are analyzed. Opportunities for integration of fuel ethanol production processes and their implications are underlined. Main ways of process intensification through reaction-reaction, reaction-separation and separation-separation processes are analyzed in the case of bioethanol production. Some examples of energy integration during ethanol production are also highlighted. Finally, some concluding considerations on current and future research tendencies in fuel ethanol production regarding process design and integration are presented.

Root production method system

Treesearch

Wayne Lovelace

2002-01-01

The RPM system (Root Production Method) is a multistep production system of container tree production that places primary emphasis on the root system because the root system ultimately determines the tree's survival and performance in its outplanted environment. This particular container production system has been developed to facilitate volume production, in a...

Introduction to Session 5

NASA Astrophysics Data System (ADS)

Zullo, Luca; Snyder, Seth W.

Production of bio-based products that are cost competitive in the market place requires well-developed operations that include innovative processes and separation solutions. Separations costs can make the difference between an interesting laboratory project and a successful commercial process. Bioprocessing and separations research and development addresses some of the most significant cost barriers in production of bioffuels and bio-based chemicals. Models of integrated biorefineries indicate that success will require production of higher volume fuels in conjunction with high margin chemical products. Addressing the bioprocessing and separations cost barriers will be critical to the overall success of the integrated biorefinery.

Building the Core Architecture of a Multiagent System Product Line: With an example from a future NASA Mission

NASA Technical Reports Server (NTRS)

Pena, Joaquin; Hinchey, Michael G.; Ruiz-Cortes, Antonio

2006-01-01

The field of Software Product Lines (SPL) emphasizes building a core architecture for a family of software products from which concrete products can be derived rapidly. This helps to reduce time-to-market, costs, etc., and can result in improved software quality and safety. Current AOSE methodologies are concerned with developing a single Multiagent System. We propose an initial approach to developing the core architecture of a Multiagent Systems Product Line (MAS-PL), exemplifying our approach with reference to a concept NASA mission based on multiagent technology.

Early assessment of medical technologies to inform product development and market access: a review of methods and applications.

PubMed

Ijzerman, Maarten J; Steuten, Lotte M G

2011-09-01

Worldwide, billions of dollars are invested in medical product development and there is an increasing pressure to maximize the revenues of these investments. That is, governments need to be informed about the benefits of spending public resources, companies need more information to manage their product development portfolios and even universities may need to direct their research programmes in order to maximize societal benefits. Assuming that all medical products need to be adopted by the heavily regulated healthcare market at one point in time, it is worthwhile to look at the logic behind healthcare decision making, specifically, decisions on the coverage of medical products and decisions on the use of these products under competing and uncertain conditions. With the growing tension between leveraging economic growth through R&D spending on the one hand and stricter control of healthcare budgets on the other, several attempts have been made to apply the health technology assessment (HTA) methodology to earlier stages of technology development and implementation. For instance, horizon scanning was introduced to systematically assess emerging technologies in order to inform health policy. Others have introduced iterative economic evaluation, e.g. economic evaluations in earlier stages of clinical research. However, most of these methods are primarily intended to support governments in making decisions regarding potentially expensive new medical products. They do not really inform biomedical product developers on the probability of return on investment, nor do they inform about the market needs and specific requirements of technologies in development. It is precisely this aspect that increasingly receives attention, i.e. is it possible to use HTA tools and methods to inform biomedical product development and to anticipate further development and market access. Several methods have been used in previous decades, but have never been compiled in a comprehensive review. The main objective of this article was to provide an overview of previous work and methods in the field of early HTA, and to put these approaches in perspective through a conceptual framework introduced in this paper. A particular goal of the review was to familiarize decision makers with available techniques that can be employed in early-stage decision making, and to identify opportunities for further methodological growth in this emerging field of HTA.

Creativity in ergonomic design: a supplemental value-adding source for product and service development.

PubMed

Zeng, Liang; Proctor, Robert W; Salvendy, Gavriel

2010-08-01

This article investigates the role of creativity in ergonomic design and the generic process of developing creative products and services. Creativity is gaining increased emphasis in both academia and industry. More than 50 years of research in creativity indicates that creativity is key to product and service innovation. Nevertheless, there is scarcely any comprehensive review dedicated to appraising the complex construct of creativity, the underlying cognitive process, and the role of creativity in product and service development. We review relevant literature regarding creativity, creative cognition, and the engineering design process to appraise the role of creativity in ergonomic design and to construct a conceptual model of creative product and service development. A framework of ergodesign creativity is advanced that highlights the central role of creativity in synergistically addressing the four dimensions of ergonomic design: functionality, safety, usability, and affectivity. A conceptual model of creative design process is then constructed that is goal oriented and is initiated by active problem finding and problem formulating. This process is carried out in a recursive and dynamic way, facilitated by creative thinking strategies. It is proposed that ergodesign creativity can add supplemental value to products and services, which subsequently affects consumer behavior and helps organizations gain competitive advantage. The proposed conceptual framework of ergodesign creativity and creative design process can serve as the ground for future theory development. Propositions advanced in this study should facilitate designers generating products and services that are creative and commercially competitive.

15 CFR 16.2 - Description and goal of program.

Code of Federal Regulations, 2014 CFR

2014-01-01

... standardized test methods by which selected product performance characteristics can be measured; (2) Developing... voluntarily to test and label their products according to the selected or developed methods; and (4...

15 CFR 16.2 - Description and goal of program.

Code of Federal Regulations, 2013 CFR

2013-01-01

... standardized test methods by which selected product performance characteristics can be measured; (2) Developing... voluntarily to test and label their products according to the selected or developed methods; and (4...

15 CFR 16.2 - Description and goal of program.

Code of Federal Regulations, 2012 CFR

2012-01-01

... standardized test methods by which selected product performance characteristics can be measured; (2) Developing... voluntarily to test and label their products according to the selected or developed methods; and (4...

Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

PubMed

Brooks, Steven S

2017-06-01

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.

The new role of HSE in chemical product development

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

Purinton, R.J. Jr.; Manning, T.S.; Dowell, S.

1996-11-01

Today, Health, Safety, and Environmental issues take a more prominent role than ever before in chemical product development for the global oilfield service industry. Prior to widespread regulatory guidelines, technical problems were solved and well treatment programs were developed using the chemicals which performed the best and were the least expensive for the application. HSE concerns were sometimes addressed from a remedial standpoint, rather than a preventive one throughout the process. With a clearer understanding of the potential impact of chemicals upon people and the environment, along with the ever-increasing array of government regulations, service companies are taking a newmore » approach to product development. HSE-related risks and costs are being assessed early and continued throughout chemical development, with both product and treatment process features then designed accordingly. One service company reflects this approach with its {open_quotes}cradle-to-grave{close_quotes} Product Development and Stewardship program. Integral to this program are planned HSE assessments at each step of development, including Feasibility, Lab Development, Field Testing, Manufacturing, and Commercial Field Introduction. These assessments provide the data necessary to {open_quotes}engineer-in{close_quotes} solutions to potential HSE-related problems, produce viable Risk Management Plans, and promote a smoother path to commercialization. This avoids arriving at the commercial launch point with a product which poses unacceptably high personal or environmental risks, may be restricted or banned in key markets, or requires lengthy and expensive government registrations. In order to optimize R&E resources and ensure continuous evaluation, decision points (to continue, modify, or abandon) are built into the process. Early HSE screenings must be accurate but also relatively quick and inexpensive to be meaningful and economical.« less

Analyzing the greenhouse gas impact potential of smallholder development actions across a global food security program

NASA Astrophysics Data System (ADS)

Grewer, Uwe; Nash, Julie; Gurwick, Noel; Bockel, Louis; Galford, Gillian; Richards, Meryl; Costa Junior, Ciniro; White, Julianna; Pirolli, Gillian; Wollenberg, Eva

2018-04-01

This article analyses the greenhouse gas (GHG) impact potential of improved management practices and technologies for smallholder agriculture promoted under a global food security development program. Under ‘business-as-usual’ development, global studies on the future of agriculture to 2050 project considerable increases in total food production and cultivated area. Conventional cropland intensification and conversion of natural vegetation typically result in increased GHG emissions and loss of carbon stocks. There is a strong need to understand the potential greenhouse gas impacts of agricultural development programs intended to achieve large-scale change, and to identify pathways of smallholder agricultural development that can achieve food security and agricultural production growth without drastic increases in GHG emissions. In an analysis of 134 crop and livestock production systems in 15 countries with reported impacts on 4.8 million ha, improved management practices and technologies by smallholder farmers significantly reduce GHG emission intensity of agricultural production, increase yields and reduce post-harvest losses, while either decreasing or only moderately increasing net GHG emissions per area. Investments in both production and post-harvest stages meaningfully reduced GHG emission intensity, contributing to low emission development. We present average impacts on net GHG emissions per hectare and GHG emission intensity, while not providing detailed statistics of GHG impacts at scale that are associated to additional uncertainties. While reported improvements in smallholder systems effectively reduce future GHG emissions compared to business-as-usual development, these contributions are insufficient to significantly reduce net GHG emission in agriculture beyond current levels, particularly if future agricultural production grows at projected rates.

Modeling pure culture heterotrophic production of polyhydroxybutyrate (PHB).

PubMed

Mozumder, Md Salatul Islam; Goormachtigh, Laurens; Garcia-Gonzalez, Linsey; De Wever, Heleen; Volcke, Eveline I P

2014-03-01

In this contribution a mechanistic model describing the production of polyhydroxybutyrate (PHB) through pure-culture fermentation was developed, calibrated and validated for two different substrates, namely glucose and waste glycerol. In both cases, non-growth-associated PHB production was triggered by applying nitrogen limitation. The occurrence of some growth-associated PHB production besides non-growth-associated PHB production was demonstrated, although it is inhibited in the presence of nitrogen. Other phenomena observed experimentally and described by the model included biomass growth on PHB and non-linear product inhibition of PHB production. The accumulated impurities from the waste substrate negatively affected the obtained maximum PHB content. Overall, the developed mathematical model provided an accurate prediction of the dynamic behavior of heterotrophic biomass growth and PHB production in a two-phase pure culture system. Copyright © 2013 Elsevier Ltd. All rights reserved.

Synthesizing Graphene Production with Polymeric Injection Molding for Enhancing EMI Shielding Effectiveness of Plastics

DTIC Science & Technology

2017-09-01

Ulrich, Karl T., and Steven D. Eppinger. 2012. Product Design and Development, 5th ed. New York: McGraw-Hill Irwin. Warner, Jamie H., Franziska Schaffel...of tasks that an organization or business generally follows to transform a thought or idea of a product to a manufactured good. In the early stages...established product design and development processes. Karl Ulrich and Steven Eppinger (2012) state that one of the initial steps in the opportunity

Concurrency in product realization

NASA Astrophysics Data System (ADS)

Kelly, Michael J.

1994-03-01

Technology per se does not provide a competitive advantage. Timely exploitation of technology is what gives the competitive edge, and this demands a major shift in the product development process and management of the industrial enterprise. `Teaming to win' is more than a management theme; it is the disciplined engineering practice that is essential to success in today's global marketplace. Teaming supports the concurrent engineering practices required to integrate the activities of people responsible for product realization through achievement of shorter development cycles, lower costs, and defect-free products.

Design of the subject of quality engineering and security of the product of the degree in engineering in industrial design and development of product based in the methodology of the case

NASA Astrophysics Data System (ADS)

González, M. R.; Lambán, M. P.

2012-04-01

This paper presents the result of designing the subject Quality Engineering and Security of the Product, belonging to the Degree of Engineering in Industrial Design and Product Development, on the basis of the case methodology. Practical sessions of this subject are organized using the whole documents of the Quality System Management of the virtual company BeaLuc S.A.

Which Factor, Teaching or Writing, Contributes More to Faculty Development?

ERIC Educational Resources Information Center

Boice, Robert

The effect of a highly-structured faculty development program that focused on improving teaching skills and writing productivity through weekly individual sessions was studied with 16 social sciences faculty. Participants were alternatively assigned to one of four groups that emphasized development in teaching skills, writing productivity, or a…

Critical review and appraisal of published clinical literature: useful skill in biotechnology product development.

PubMed

Foote, Maryann

2008-01-01

Critical review of published literature may be necessary during several stages of biotechnology product development. The reviewer should develop a standardized method for reviewing and comparing published papers on a given topic and should be aware of common errors found in published papers.

24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Administrator qualifications and procedures for HUD building products certification programs. 200.935 Section 200.935 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued) OFFICE OF ASSISTANT SECRETARY...

Development of a factory/refinery method to measure total, soluble, and insoluble starch in sugar products

USDA-ARS?s Scientific Manuscript database

An easy, rapid, and inexpensive method was developed to measure total, soluble, and insoluble starch in products at the factory and refinery, using microwave-assisted neutralization chemistry. The method was optimized using the previously developed USDA Starch Research method as a reference. Optimal...

77 FR 47047 - Biomass Research and Development Technical Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... research and development leading to the production of biobased fuels and biobased products. Tentative... Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements... at the beginning of the meeting. Reasonable provision will be made to include the scheduled oral...

Product development: the making of the Abbott ARCHITECT.

PubMed

Kisner, H J

1997-01-01

Many laboratorians have a limited perspective on what is involved in developing an instrument and bringing it to market. This article traces the product development process used by Abbott Diagnostics Division that resulted in Abbott being named the 1996 Concurrent Engineering Company of the Year for the design of the ARCHITECT.

System Development of Estimated Figures of Volume Production Plan

ERIC Educational Resources Information Center

Brazhnikov, Maksim A.; Khorina, Irina V.; Minina, Yulia I.; Kolyasnikova, Lyudmila V.; Streltsov, Aleksey V.

2016-01-01

The relevance of this problem is primarily determined by a necessity of improving production efficiency in conditions of innovative development of the economy and implementation of Import Substitution Program. The purpose of the article is development of set of criteria and procedures for the comparative assessment of alternative volume production…

The Role of Research in Making Interactive Products Effective.

ERIC Educational Resources Information Center

Rossi, Robert J.

1986-01-01

Argues that research and development (R&D) methods should be utilized to develop new technologies for training and retailing and describes useful research tools--critical incident methodology, task analysis, performance recording. Discussion covers R&D applications to interactive systems development in the areas of product need, customer…

50 CFR 296.7 - Burden of proof and presumption of causation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... commercial fishing and was located in an area affected by OCS oil and gas exploration, development, or... associated with oil and gas exploration, development, or production activities on the Outer Continental Shelf... by items associated with oil and gas exploration, development, or production activities on the OCS if...

Medical device development.

PubMed

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

Collaborative Knowledge Production Model in the Field of Organizational Development

ERIC Educational Resources Information Center

Ramstad, Elise

2008-01-01

The paper proposes a framework for collaborative knowledge production in order to enhance the amount and quality of knowledge in the field of organizational development (OD). We distinguish three types of actors that offer development services for work organizations: academic R&D units, training and educational institutes and management…

75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical... entitled ``Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for... biological products, and medical devices for the treatment of lupus nephritis (LN) caused by systemic lupus...

75 FR 35493 - Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] (formerly Docket No. 2005D-0106) Guidance for Industry on Systemic Lupus Erythematosus--Developing Medical... entitled ``Systemic Lupus Erythematosus--Developing Medical Products for Treatment.'' This guidance... medical devices for the treatment of systemic lupus erythematosus (SLE). This guidance finalizes the draft...

Understanding Acceptance of Software Metrics--A Developer Perspective

ERIC Educational Resources Information Center

Umarji, Medha

2009-01-01

Software metrics are measures of software products and processes. Metrics are widely used by software organizations to help manage projects, improve product quality and increase efficiency of the software development process. However, metrics programs tend to have a high failure rate in organizations, and developer pushback is one of the sources…

[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.

TRC research products: Components for service robots

NASA Technical Reports Server (NTRS)

Lob, W. Stuart

1994-01-01

Transitions Research Corporation has developed a variety of technologies to accomplish its central mission: the creation of commercially viable robots for the service industry. Collectively, these technologies comprise the TRC 'robot tool kit.' The company started by developing a robot base that serves as a foundation for mobile robot research and development, both within TRC and at customer sites around the world. A diverse collection of sensing techniques evolved more recently, many of which have been made available to the international mobile robot research community as commercial products. These 'tool-kit' research products are described in this paper. The largest component of TRC's commercial operation is a product called HelpMate for material transport and delivery in health care institutions.

Synthetic biology: regulating industry uses of new biotechnologies.

PubMed

Erickson, Brent; Singh, Rina; Winters, Paul

2011-09-02

In our view, synthetic biology is an extension of the continuum of genetic science that has been used safely for more than 40 years by the biotechnology industry in the development of commercial products. Examples of synthetic biology use by biotechnology companies illustrate the potential to substantially reduce research and development time and to increase speed to market. Improvements in the speed and cost of DNA synthesis are enabling scientists to design modified bacterial chromosomes that can be used in the production of renewable chemicals, biofuels, bioproducts, renewable specialty chemicals, pharmaceutical intermediates, fine chemicals, food ingredients, and health care products. Regulatory options should support innovation and commercial development of new products while protecting the public from potential harms.

Genome engineering for microbial natural product discovery.

PubMed

Choi, Si-Sun; Katsuyama, Yohei; Bai, Linquan; Deng, Zixin; Ohnishi, Yasuo; Kim, Eung-Soo

2018-03-03

The discovery and development of microbial natural products (MNPs) have played pivotal roles in the fields of human medicine and its related biotechnology sectors over the past several decades. The post-genomic era has witnessed the development of microbial genome mining approaches to isolate previously unsuspected MNP biosynthetic gene clusters (BGCs) hidden in the genome, followed by various BGC awakening techniques to visualize compound production. Additional microbial genome engineering techniques have allowed higher MNP production titers, which could complement a traditional culture-based MNP chasing approach. Here, we describe recent developments in the MNP research paradigm, including microbial genome mining, NP BGC activation, and NP overproducing cell factory design. Copyright © 2018 Elsevier Ltd. All rights reserved.

Advanced Manufacturing and Value-added Products from US Agriculture

NASA Technical Reports Server (NTRS)

Villet, Ruxton H.; Child, Dennis R.; Acock, Basil

1992-01-01

An objective of the US Department of Agriculture (USDA) Agriculture Research Service (ARS) is to develop technology leading to a broad portfolio of value-added marketable products. Modern scientific disciplines such as chemical engineering are brought into play to develop processes for converting bulk commodities into high-margin products. To accomplish this, the extremely sophisticated processing devices which form the basis of modern biotechnology, namely, genes and enzymes, can be tailored to perform the required functions. The USDA/ARS is a leader in the development of intelligent processing equipment (IPE) for agriculture in the broadest sense. Applications of IPE are found in the production, processing, grading, and marketing aspects of agriculture. Various biotechnology applications of IPE are discussed.

New Catalyst Reduces Wasted Carbon in Biofuel Process, Lowers Cost

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

Researchers at NREL recently developed a catalyst formulation that incorporates more hydrogen into the DME-to-high-octane gasoline process, resulting in a higher yield to gasoline-range products. Further, the researchers developed a secondary process that efficiently couples a portion of the gasoline-range product to yield jet/diesel fuels. The modified catalyst doubles the conversion rate of DME, which can be produced from biomass, to the high-octane gasoline product and significantly decreases the formation of wasted byproducts. For the distillate-range product, 80% of the mixture is in line with ASTM standards for use as a jet fuel blendstock. The increased productivity of high-octane gasolinemore » and the development of a value-added distillate blendstock process further improve the economic viability toward commercially implementing this renewable fuels process.« less

Different implications of paternal and maternal atopy for perinatal IgE production and asthma development.

PubMed

Wu, Chih-Chiang; Chen, Rong-Fu; Kuo, Ho-Chang

2012-01-01

Asthma is a hereditary disease associated with IgE-mediated reaction. Whether maternal atopy and paternal atopy have different impacts on perinatal IgE production and asthma development remains unclear. This paper reviews and summarizes the effects of maternal and paternal atopy on the developmental aspects of IgE production and asthma. Maternal atopy affects both pre- and postnatal IgE production, whereas paternal atopy mainly affects the latter. Maternally transmitted genes GSTP1 and FceRI-beta are associated with lung function and allergic sensitization, respectively. In IgE production and asthma development, the maternal influence on gene-environment interaction is greater than paternal influence. Maternal, paternal, and/or postnatal environmental modulation of allergic responses have been linked to epigenetic mechanisms, which may be good targets for early prevention of asthma.

Different Implications of Paternal and Maternal Atopy for Perinatal IgE Production and Asthma Development

PubMed Central

Wu, Chih-Chiang; Chen, Rong-Fu; Kuo, Ho-Chang

2012-01-01

Asthma is a hereditary disease associated with IgE-mediated reaction. Whether maternal atopy and paternal atopy have different impacts on perinatal IgE production and asthma development remains unclear. This paper reviews and summarizes the effects of maternal and paternal atopy on the developmental aspects of IgE production and asthma. Maternal atopy affects both pre- and postnatal IgE production, whereas paternal atopy mainly affects the latter. Maternally transmitted genes GSTP1 and FceRI-beta are associated with lung function and allergic sensitization, respectively. In IgE production and asthma development, the maternal influence on gene-environment interaction is greater than paternal influence. Maternal, paternal, and/or postnatal environmental modulation of allergic responses have been linked to epigenetic mechanisms, which may be good targets for early prevention of asthma. PMID:22272211

Recommendations for sustainable development of non-timber forest products

Treesearch

Gina H. Mohammed

2001-01-01

Non-timber forest products--or NTFPs--are considered here to be botanical products harvested or originating from forest-based species, but excluding primary timber products, industrial boards and composites, and paper products. A recent study of non-timber forest products in Ontario, Canada, identified at least 50 types of NTFPs and hundreds of specific products used...

Conditions for Employee Learning and Innovation--Interweaving Competence Development Activities Provided by a Workplace Development Programme with Everyday Work Activities in SMEs

ERIC Educational Resources Information Center

Halvarsson Lundkvist, Agneta; Gustavsson, Maria

2018-01-01

The aim of this article is to investigate how the formal competence development activities provided by the Production Leap, a workplace development programme (WPDP), were interwoven with everyday work activities and to identify the conditions that enabled learning and employee-driven innovation that contributed to production improvement, in small…

Product Development as a Fuzzy Interface between Technical and Non-technical Education.

ERIC Educational Resources Information Center

Masarnau, Juan

1988-01-01

Discusses a product development structure, including marketing, design, technology, industrial manufacturing, reasoning, and objects. Describes needs of the interface in terms of marketing, industrial design, technology, and industry. (YP)

Production-Built Homes: The Cost Advantages of Smart Growth

EPA Pesticide Factsheets

This study identifies the components and techniques of home building in traditional versus conventional developments, and attempts to help production builders better understand the cost differences between the two types of developments.

[Present status and sustainable development of Dendrobium officinale industry].

PubMed

Wu, Yunqin; Si, Jinping

2010-08-01

To understand the present status and characteristics of Dendrobium officinale industry and to provide a rationale for the sustainable industrial development. Based on references and an on-site investigation of main Dendrobium officinale-producing enterprises and market, to analyze main existing problems and to propose suggestions for sustainable development. More than 10 provinces and regions are involved in the production around the center of Zhejiang and Yunnan provinces. These two provinces are different from each other in development pattern. Yunnan adopts a mode of companies minus farmer households but Zhejiang mainly employs a mode that a leading company establishes a production base with production, processing and marketing combined together. Zhejiang mode is characterized by high tech, high investment, high risk and high return. Existence of non-genuine species, stagnancy in development and application of varieties and techniques for quality control and a narrow channel for marketing are the key problems limiting sustainable development of the industry. The key to sustainable development of the industry is to establish a technological alliance to speed up development of common techniques and application of integrated innovations, to strengthen self-discipline and monitoring of production, and to expand sales market.

Nanotherapeutics--product development along the "nanomaterial" discussion.

PubMed

Wacker, Matthias G

2014-03-01

Nanomaterials have become part of formulation development in the pharmaceutical industry and offer exciting opportunities in the area of targeted drug delivery. But they may also exert unexpected toxicities and potentially pose a threat to human health and the environment. Since the Scientific Committee on Emerging and Newly Identified Health Risks recommended a definition of "nanomaterials" for implementation into the existing and upcoming regulatory framework in the European Union, a discussion about safety requirements of new nanoscale products has emerged. At the same time, the Food and Drug Administration of the United States still observes recent developments in this area. Although the impact on the pharmaceutical product chain is still uncertain, guidelines on risk assessment in food products and cosmetics are available and offer a preview of future developments in the regimens of pharmaceuticals. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

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.

Accelerating the introduction of HTS products for a broad range of electric power and industrial applications

NASA Astrophysics Data System (ADS)

Eaton, Russell

2002-01-01

The Department of Energy (DOE), as part of its Superconductivity Program for Electric Systems, is successfully pursuing the development of electric power and industrial devices, incorporating significant high-temperature superconducting (HTS) components or subsystems, through its innovative Superconducting Partnership Initiative (SPI). The objective of the SPI is to accelerate the commercial introduction of the HTS products for a broad range of electric power and industrial applications. DOE's approach to accomplishing the SPI objective is to support cost shared projects carried out by industry led teams. DOE will fund projects to develop HTS devices that are either in (1) the research and development stage (Phase 1), (2) the pre-commercialization stage (Phase II), or (3) the commercial entry stage (Phase III). DOE's industry partners must contribute at least half a project's costs. These teams will include capabilities needed to develop the device as well as to develop the business plan for the commercial product introduction. DOE's partners consist of vertically integrated teams consisting of equipment manufacturers, HTS wire and coil suppliers, national laboratories, and end users, primarily utilities. These partners carry out the multi-year technology development efforts, consisting generally of design, construction, and testing of the HTS system. Finally, commercialization of HTS products will be discussed primarily in terms of benefits these products will have over competing products based upon conventional conductors and the critical need for affordable, practical HTS materials and conductors for these applications. .

Joint Peru/United States report on Peru/United States cooperative energy assessment. Volume 4 of 4 Volumes Annexes 8-11

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

Not Available

1979-08-01

A comprehensive assessment of the biofuel potential of Peru is presented. Topics discussed cover current biofuel utilization practices; evaluation of Peruvian biomass productivity; identification of Peruvian agricultural and forestry resources; assessment of resource development and management concerns; identification of market considerations; description of biofuel technological options; and regional identification of biofuel technology applications. The discussion of current biofuel utilization centers on a qualitative description of the main conversion approaches now being practiced in Peru. Biomass productivity is evaluated in the context of the terrain, soil, and climatic conditions found in Peru. A quantitative description of the energy potential that couldmore » be realized from agricultural and forestry resources of Peru follows. A regional picture is given for the production of agricultural residues and forest resources that could potentially supply energy. The assessment of resource development and management concerns focuses on harvesting, reforestation, training, and the environmental consequences of utilization of forest resources. Market factors assessed include: importation, internal market development, external market development, energy policy and pricing, and transportation. Ten biofuel technology options for Peru were identified: small- to medium-scale gasification, a wood waste inventory, stationary and mobile charcoal production systems, wood distillation, forest resource development and management, electrical cogeneration, anaerobic digestion technology, development of ethanol production capabilities, and agricultural strategies for fuel production.Based upon these biofuel options, nine applications were identified for the Costa Region, eight for the Sierra Region, and ten for the Selva Region.« less

The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group.

PubMed

Natanegara, Fanni; Neuenschwander, Beat; Seaman, John W; Kinnersley, Nelson; Heilmann, Cory R; Ohlssen, David; Rochester, George

2014-01-01

Bayesian applications in medical product development have recently gained popularity. Despite many advances in Bayesian methodology and computations, increase in application across the various areas of medical product development has been modest. The DIA Bayesian Scientific Working Group (BSWG), which includes representatives from industry, regulatory agencies, and academia, has adopted the vision to ensure Bayesian methods are well understood, accepted more broadly, and appropriately utilized to improve decision making and enhance patient outcomes. As Bayesian applications in medical product development are wide ranging, several sub-teams were formed to focus on various topics such as patient safety, non-inferiority, prior specification, comparative effectiveness, joint modeling, program-wide decision making, analytical tools, and education. The focus of this paper is on the recent effort of the BSWG Education sub-team to administer a Bayesian survey to statisticians across 17 organizations involved in medical product development. We summarize results of this survey, from which we provide recommendations on how to accelerate progress in Bayesian applications throughout medical product development. The survey results support findings from the literature and provide additional insight on regulatory acceptance of Bayesian methods and information on the need for a Bayesian infrastructure within an organization. The survey findings support the claim that only modest progress in areas of education and implementation has been made recently, despite substantial progress in Bayesian statistical research and software availability. Copyright © 2013 John Wiley & Sons, Ltd.

Assessment of Peruvian biofuel resources and alternatives

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

Harper, J.P.; Smith, W.; Mariani, E.

1979-08-01

Comprehensive assessment of the biofuel potential of Peru is based on: determination of current biofuel utilization practices, evauation of Peruvian biomass productivity, identification of Peruvian agricultural and forestry resources, assessment of resource development and management concerns, identification of market considerations, description of biofuel technological options, and identification of regional biofuel technology applications. Discussion of current biofuel utilization centers on a qualitative description of the main conversion approaches currently being practiced in Peru. Biomass productivity evaluations consider the terrain and soil, and climatic conditions found in Peru. The potential energy from Peruvian agricultural and forestry resources is described quantitatively. Potental regionalmore » production of agricultural residues and forest resources that could supply energy are identified. Assessment of resource development and management concerns focuses on harvesting, reforestation, training, and environmental consequences of utilization of forest resources. Market factors assessed include: importation, internal market development, external market development, energy policy and pricing, and transportation. Nine biofuel technology options for Peru are identified: (1) small-to-medium-scale gasification, (2) a wood waste inventory, (3) stationary and mobile charcoal production systems, (4) wood distillation, (5) forest resource development and management, (6) electrical cogeneration, (7) anaerobic digestion technology, (8) development of ethanol production capabilities, and (9) agricultural strategies for fuel production. Applications of these biofuel options are identified for each of the three major regions - nine applications for the Costa Region, eight for the Sierra Region, and ten for the Selva Region.« less

Bacillus thuringiensis: fermentation process and risk assessment. A short review.

PubMed

Capalbo, D M

1995-01-01

Several factors make the local production of Bacillus thuringiensis (Bt) highly appropriate for pest control in developing nations. Bt can be cheaply produced on a wide variety of low cost, organic substrates. Local production results in considerable savings in hard currency which otherwise would be spent on importation of chemical and biological insecticides. The use of Bt in Brazil has been limited in comparison with chemical insecticides. Although Bt is imported, some Brazilian researchers have been working on its development and production. Fermentation processes (submerged and semi-solid) were applied, using by-products from agro-industries. As the semi-solid fermentation process demonstrated to be interesting for Bt endotoxins production, it could be adopted for small scale local production. Although promising results had been achieved, national products have not been registered due to the absence of a specific legislation for biological products. Effective actions are being developed in order to solve this gap. Regardless of the biocontrol agents being considered atoxic and harmless to the environment, information related to direct and indirect effects of microbials are still insufficient in many cases. The risk analysis of the use of microbial control agents is of upmost importance nowadays, and is also discussed.

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

Das, K. C., Adams; Thomas, T; Eiteman, Mark A

In this project we focused on several aspects of technology development that advances the formation of an integrated biorefinery. These focus areas include: [ 1] pretreatment of biomass to enhance quality of products from thermochemical conversion; [2] characterization of and development of coproduct uses; [3] advancement in fermentation of lignocellulosics and particularly C5 and C6 sugars simultaneously, and [ 4] development of algal biomass as a potential substrate for the biorefinery. These advancements are intended to provide a diverse set of product choices within the biorefinery, thus improving the cost effectiveness of the system. Technical effectiveness was demonstrated in themore » thermochemical product quality in the form of lower tar production, simultaneous of use of multiple sugars in fermentation, use ofbiochar in environmental (ammonia adsorption) and agricultural applications, and production of algal biomass in wastewaters. Economic feasibility of algal biomass production systems seems attractive, relative to the other options. However, further optimization in all paths, and testing/demonstration at larger scales are required to fully understand the economic viabilities. The coproducts provide a clear picture that multiple streams of value can be generated within an integrated biorefinery, and these include fuels and products.« less

Modelling milk production from feed intake in dairy cattle

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

Clarke, D.L.

1985-05-01

Predictive models were developed for both Holstein and Jersey cows. Since Holsteins comprised eighty-five percent of the data, the predictive models developed for Holsteins were used for the development of a user-friendly computer model. Predictive models included: milk production (squared multiple correlation .73), natural log (ln) of milk production (.73), four percent fat-corrected milk (.67), ln four percent fat-corrected milk (.68), fat-free milk (.73), ln fat-free milk (.73), dry matter intake (.61), ln dry matter intake (.60), milk fat (.52), and ln milk fat (.56). The predictive models for ln milk production, ln fat-free milk and ln dry matter intakemore » were incorporated into a computer model. The model was written in standard Fortran for use on mainframe or micro-computers. Daily milk production, fat-free milk production, and dry matter intake were predicted on a daily basis with the previous day's dry matter intake serving as an independent variable in the prediction of the daily milk and fat-free milk production. 21 refs.« less

Early Benchmarks of Product Generation Capabilities of the GOES-R Ground System for Operational Weather Prediction

NASA Astrophysics Data System (ADS)

Kalluri, S. N.; Haman, B.; Vititoe, D.

2014-12-01

The ground system under development for Geostationary Operational Environmental Satellite-R (GOES-R) series of weather satellite has completed a key milestone in implementing the science algorithms that process raw sensor data to higher level products in preparation for launch. Real time observations from GOES-R are expected to make significant contributions to Earth and space weather prediction, and there are stringent requirements to product weather products at very low latency to meet NOAA's operational needs. Simulated test data from all the six GOES-R sensors are being processed by the system to test and verify performance of the fielded system. Early results show that the system development is on track to meet functional and performance requirements to process science data. Comparison of science products generated by the ground system from simulated data with those generated by the algorithm developers show close agreement among data sets which demonstrates that the algorithms are implemented correctly. Successful delivery of products to AWIPS and the Product Distribution and Access (PDA) system from the core system demonstrate that the external interfaces are working.

Problems Analysis on Increasing Rice Production Through Food Estate Program in Bulungan Regency, North Kalimantan

NASA Astrophysics Data System (ADS)

Setyo, P.; Elly, J.

2018-05-01

To increase rice production in the Province of North Kalimantan, the provincial government has launched a Food Estate Program. The program is also a central government program in relation to government policies on food security. One of the food estate development areas is the Delta Kayan Food Estate of 50,000 hectares in Bulungan Regency, where about 30,000 hectares area is a tidal land with a very fertile alluvial soil type. This policy study aims to identify and analyze problems of increasing rice production through food estate development in North Kalimantan Province and formulate priority programs as recommendations for policy making in increasing rice production. The study has identified a number of problems of increasing rice production, such as land tenure, land suitability, water system, infrastructure, accessibility of production factors, institutional, and capacity of human resources. The Analytic Hierarchy Process was applied to develop priority programs, resulting in the three most important programs being water management, improving access to production factors, and improving the capacity of human resources. Action plans related to priority programs have also been identified.

Conception of Self-Construction Production Scheduling System

NASA Astrophysics Data System (ADS)

Xue, Hai; Zhang, Xuerui; Shimizu, Yasuhiro; Fujimura, Shigeru

With the high speed innovation of information technology, many production scheduling systems have been developed. However, a lot of customization according to individual production environment is required, and then a large investment for development and maintenance is indispensable. Therefore now the direction to construct scheduling systems should be changed. The final objective of this research aims at developing a system which is built by it extracting the scheduling technique automatically through the daily production scheduling work, so that an investment will be reduced. This extraction mechanism should be applied for various production processes for the interoperability. Using the master information extracted by the system, production scheduling operators can be supported to accelerate the production scheduling work easily and accurately without any restriction of scheduling operations. By installing this extraction mechanism, it is easy to introduce scheduling system without a lot of expense for customization. In this paper, at first a model for expressing a scheduling problem is proposed. Then the guideline to extract the scheduling information and use the extracted information is shown and some applied functions are also proposed based on it.

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

Microbial Production of Short Chain Fatty Acids from Lignocellulosic Biomass: Current Processes and Market.

PubMed

Baumann, Ivan; Westermann, Peter

2016-01-01

Biological production of organic acids from conversion of biomass derivatives has received increased attention among scientists and engineers and in business because of the attractive properties such as renewability, sustainability, degradability, and versatility. The aim of the present review is to summarize recent research and development of short chain fatty acids production by anaerobic fermentation of nonfood biomass and to evaluate the status and outlook for a sustainable industrial production of such biochemicals. Volatile fatty acids (VFAs) such as acetic acid, propionic acid, and butyric acid have many industrial applications and are currently of global economic interest. The focus is mainly on the utilization of pretreated lignocellulosic plant biomass as substrate (the carbohydrate route) and development of the bacteria and processes that lead to a high and economically feasible production of VFA. The current and developing market for VFA is analyzed focusing on production, prices, and forecasts along with a presentation of the biotechnology companies operating in the market for sustainable biochemicals. Finally, perspectives on taking sustainable product of biochemicals from promise to market introduction are reviewed.

Microbial Production of Short Chain Fatty Acids from Lignocellulosic Biomass: Current Processes and Market

PubMed Central

Baumann, Ivan

2016-01-01

Biological production of organic acids from conversion of biomass derivatives has received increased attention among scientists and engineers and in business because of the attractive properties such as renewability, sustainability, degradability, and versatility. The aim of the present review is to summarize recent research and development of short chain fatty acids production by anaerobic fermentation of nonfood biomass and to evaluate the status and outlook for a sustainable industrial production of such biochemicals. Volatile fatty acids (VFAs) such as acetic acid, propionic acid, and butyric acid have many industrial applications and are currently of global economic interest. The focus is mainly on the utilization of pretreated lignocellulosic plant biomass as substrate (the carbohydrate route) and development of the bacteria and processes that lead to a high and economically feasible production of VFA. The current and developing market for VFA is analyzed focusing on production, prices, and forecasts along with a presentation of the biotechnology companies operating in the market for sustainable biochemicals. Finally, perspectives on taking sustainable product of biochemicals from promise to market introduction are reviewed. PMID:27556042

Product development in large furniture companies: a descriptive model with implications for character-marked products

Treesearch

Matt Bumgardner; Robert J. Bush; Cynthia D. West

2001-01-01

Previous research has shown that substantial yield improvements are possible when character-marks are not removed from hardwood furniture parts. Attempts to promote increased use of character-marked wood in fumiture should be based on an understimn&ing of how design concepts originate and move through the stages of product development. However, very little has...

Soybean Production and Marketing. An Instructional Unit for Teachers of Adult Education in Agriculture.

ERIC Educational Resources Information Center

Irish, Paul; Iverson, Maynard J.

The instructional unit was developed for use as a guide for planning and teaching adult or young farmer classes in Kentucky. The unit consists of 12 lessons covering various aspects of soybean production and marketing. The course objective is to develop the effective ability of farmers to plan for profitable soybean production. Transparency and…

Basic Language Comprehension and Production in Greater than 100,000 Young Children from Sixteen Developing Nations

ERIC Educational Resources Information Center

Bornstein, Marc H.; Hendricks, Charlene

2012-01-01

Using the Multiple Indicator Cluster Survey, language comprehension and production were compared in a sample of 101,250 children aged 2 ; 00 to 9 ; 11 and a focus subsample of 38,845 children aged 2 ; 00 to 4 ; 11 from sixteen under-researched developing nations. In the whole sample, comprehension slightly exceeded production; correlations between…

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...

Planting density and silvicultural intensity impacts on loblolly pine stand development in the western gulf coastal plain through age 8

Treesearch

Michael B. Kane; Dehai Zhao; John W. Rheney; Michael G. Messina; Mohd S. Rahman; Nicholas Chappell

2012-01-01

Commercial plantation growers need to know how planting density and cultural regime intensity affect loblolly pine plantation productivity, development and value to make sound management decisions. This knowledge is especially important given the diversity of traditional products, such as pulpwood, chip-n-saw, and sawtimber, and potential products, such as bioenergy...

"It's Not Like a Normal 9 to 5!": The Learning Journeys of Media Production Apprentices in Distributed Working Conditions

ERIC Educational Resources Information Center

Lahiff, Ann; Guile, David

2016-01-01

An apprenticeship in media production in England is at the centre of this case study exploration. The context is exemplified by the organisation of the process of production around project teams and the development of project-based working cultures. Given these developments, the working conditions and learning opportunities presented to…

Ultra-low gossypol cottonseed: gene-silencing opens up a vast, but underutilized protein resource for human nutrition

USDA-ARS?s Scientific Manuscript database

Cotton, grown mainly for its fiber, is a major crop in several developing and developed countries across the globe. In 2012, 48.8 million metric tons (MMT) of cottonseed was produced worldwide as a by-product of the 25.9 MMT of cotton lint production (FAO Production Statistics). This amount of cot...