Science.gov

Sample records for biological product deviation

  1. 21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Reporting of biological product deviations by licensed manufacturers. 600.14 Section 600.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... addresses in § 600.2), or an electronic filing through CBER's Web site at...

  2. 21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reporting of biological product deviations by licensed manufacturers. 600.14 Section 600.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... addresses in § 600.2), or an electronic filing through CBER's Web site at...

  3. 21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Reporting of biological product deviations by licensed manufacturers. 600.14 Section 600.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... addresses in § 600.2), or an electronic filing through CBER's Web site at...

  4. 21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 803 of this chapter; (ii) Persons who manufacture blood and blood components, including licensed...; (iii) Persons who manufacture Source Plasma or any other blood component and use that Source Plasma or any other blood component in the further manufacture of another licensed biological product...

  5. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments,...

  6. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments,...

  7. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments,...

  8. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments,...

  9. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments,...

  10. Biological hydrogen production

    SciTech Connect

    Benemann, J.R.

    1995-11-01

    Biological hydrogen production can be accomplished by either thermochemical (gasification) conversion of woody biomass and agricultural residues or by microbiological processes that yield hydrogen gas from organic wastes or water. Biomass gasification is a well established technology; however, the synthesis gas produced, a mixture of CO and H{sub 2}, requires a shift reaction to convert the CO to H{sub 2}. Microbiological processes can carry out this reaction more efficiently than conventional catalysts, and may be more appropriate for the relatively small-scale of biomass gasification processes. Development of a microbial shift reaction may be a near-term practical application of microbial hydrogen production.

  11. 40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... production runs that cause parameters to deviate from operating limits? 63.2990 Section 63.2990 Protection of... Plan § 63.2990 Can I conduct short-term experimental production runs that cause parameters to deviate... production runs during which your operating parameters deviate from the operating limits. Experimental...

  12. 40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... production runs that cause parameters to deviate from operating limits? 63.2990 Section 63.2990 Protection of... Plan § 63.2990 Can I conduct short-term experimental production runs that cause parameters to deviate... production runs during which your operating parameters deviate from the operating limits. Experimental...

  13. 40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... production runs that cause parameters to deviate from operating limits? 63.2990 Section 63.2990 Protection of... Plan § 63.2990 Can I conduct short-term experimental production runs that cause parameters to deviate... production runs during which your operating parameters deviate from the operating limits. Experimental...

  14. FDA 101: Regulating Biological Products

    MedlinePlus

    ... animal, and microorganism—and may be produced by biotechnology methods. Gene-based and cellular biologics, at the ... other categories of biological products mostly produced by biotechnology methods, including: monoclonal antibodies designed as targeted therapies ...

  15. 40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... production runs that cause parameters to deviate from operating limits? 63.2990 Section 63.2990 Protection of... I conduct short-term experimental production runs that cause parameters to deviate from operating limits? With the approval of the Administrator, you may conduct short-term experimental production...

  16. 40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... production runs that cause parameters to deviate from operating limits? 63.2990 Section 63.2990 Protection of... I conduct short-term experimental production runs that cause parameters to deviate from operating limits? With the approval of the Administrator, you may conduct short-term experimental production...

  17. Unification of Small and Large Time Scales for Biological Evolution: Deviations from Power Law

    NASA Astrophysics Data System (ADS)

    Chowdhury, Debashish; Stauffer, Dietrich; Kunwar, Ambarish

    2003-02-01

    We develop a unified model that describes both “micro” and “macro” evolutions within a single theoretical framework. The ecosystem is described as a dynamic network; the population dynamics at each node of this network describes the “microevolution” over ecological time scales (i.e., birth, ageing, and natural death of individual organisms), while the appearance of new nodes, the slow changes of the links, and the disappearance of existing nodes accounts for the “macroevolution” over geological time scales (i.e., the origination, evolution, and extinction of species). In contrast to several earlier claims in the literature, we observe strong deviations from power law in the regime of long lifetimes.

  18. A methyl-deviator epigenotype of estrogen receptor-positive breast carcinoma is associated with malignant biology.

    PubMed

    Killian, J Keith; Bilke, Sven; Davis, Sean; Walker, Robert L; Jaeger, Erich; Killian, M Scott; Waterfall, Joshua J; Bibikova, Marina; Fan, Jian-Bing; Smith, William I; Meltzer, Paul S

    2011-07-01

    We broadly profiled DNA methylation in breast cancers (n = 351) and benign parenchyma (n = 47) for correspondence with disease phenotype, using FFPE diagnostic surgical pathology specimens. Exploratory analysis revealed a distinctive primary invasive carcinoma subclass featuring extreme global methylation deviation. Subsequently, we tested the correlation between methylation remodeling pervasiveness and malignant biological features. A methyl deviation index (MDI) was calculated for each lesion relative to terminal ductal-lobular unit baseline, and group comparisons revealed that high-grade and short-survival estrogen receptor-positive (ER(+)) cancers manifest a significantly higher MDI than low-grade and long-survival ER(+) cancers. In contrast, ER(-) cancers display a significantly lower MDI, revealing a striking epigenomic distinction between cancer hormone receptor subtypes. Kaplan-Meier survival curves of MDI-based risk classes showed significant divergence between low- and high-risk groups. MDI showed superior prognostic performance to crude methylation levels, and MDI retained prognostic significance (P < 0.01) in Cox multivariate analysis, including clinical stage and pathological grade. Most MDI targets individually are significant markers of ER(+) cancer survival. Lymphoid and mesenchymal indexes were not substantially different between ER(+) and ER(-) groups and do not explain MDI dichotomy. However, the mesenchymal index was associated with ER(+) cancer survival, and a high lymphoid index was associated with medullary carcinoma. Finally, a comparison between metastases and primary tumors suggests methylation patterns are established early and maintained through disease progression for both ER(+) and ER(-) tumors.

  19. Synthetic Biology Guides Biofuel Production

    PubMed Central

    Connor, Michael R.; Atsumi, Shota

    2010-01-01

    The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improved, progress in synthetic biology has provided tools to guide the engineering of these processes through present and future challenges. PMID:20827393

  20. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...; printing labels in foreign language permissible; other deviations. 317.7 Section 317.7 Animals and Animal... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language... printed in a foreign language and may show the statement of the quantity of contents in accordance...

  1. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...; printing labels in foreign language permissible; other deviations. 317.7 Section 317.7 Animals and Animal... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language... printed in a foreign language and may show the statement of the quantity of contents in accordance...

  2. Deviated Septum

    MedlinePlus

    ... only when he or she also has a "cold" (an upper respiratory tract infection). In these individuals, ... problems related to the deviated septum. Once the "cold" resolves, and the nasal inflammation subsides, symptoms of ...

  3. 9 CFR 114.4 - Identification of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Identification of biological products... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.4 Identification of biological products. Suitable tags or labels of... biological products, all component parts to be combined to form a biological product, all biological...

  4. 9 CFR 114.4 - Identification of biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Identification of biological products... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.4 Identification of biological products. Suitable tags or labels of... biological products, all component parts to be combined to form a biological product, all biological...

  5. 9 CFR 114.4 - Identification of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Identification of biological products... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.4 Identification of biological products. Suitable tags or labels of... biological products, all component parts to be combined to form a biological product, all biological...

  6. Biological production of products from waste gases

    DOEpatents

    Gaddy, James L.

    2002-01-22

    A method and apparatus are designed for converting waste gases from industrial processes such as oil refining, and carbon black, coke, ammonia, and methanol production, into useful products. The method includes introducing the waste gases into a bioreactor where they are fermented to various products, such as organic acids, alcohols, hydrogen, single cell protein, and salts of organic acids by anaerobic bacteria within the bioreactor. These valuable end products are then recovered, separated and purified.

  7. Synthetic biology advances for pharmaceutical production

    PubMed Central

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

  8. Patent landscape for biological hydrogen production.

    PubMed

    Levin, David B; Lubieniechi, Simona

    2013-12-01

    Research and development of biological hydrogen production have expanded significantly in the past decade. Production of renewable hydrogen from agricultural, forestry, or other organic waste streams offers the possibility to contribute to hydrogen production capacity with no net, or at least with lower, greenhouse gas emissions. Significant improvements in the volumetric or molar yields of hydrogen production have been accomplished through genetic engineering of hydrogen synthesizing microorganisms. Although no commercial scale renewable biohydrogen production facilities are currently in operation, a few pilot scale systems have been demonstrated successfully, and while industrial scale production of biohydrogen still faces a number of technical and economic barriers, understanding the patent landscape is an important step in developing a viable commercialization strategy. In this paper, we review patents filed on biological hydrogen production. Patents on biohydrogen production from both the Canadian and American Patents databases were classified into three main groups: (1) patents for biological hydrogen by direct photolysis; (2) patents for biological hydrogen by dark fermentation; and (3) patents for process engineering for biological hydrogen production.

  9. 21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (BPDR) is enclosed. (f) How does this regulation affect other FDA regulations? This part supplements and... from current good manufacturing practice, applicable regulations, applicable standards, or established... report under this section You must report on Form FDA-3486. (e) Where do I report under this section?...

  10. Biological production of organic compounds

    DOEpatents

    Yu, Jianping; Paddock, Troy; Carrieri, Damian; Maness, Pin-Ching; Seibert, Michael

    2016-04-12

    Strains of cyanobacteria that produce high levels of alpha ketoglutarate (AKG) and pyruvate are disclosed herein. Methods of culturing these cyanobacteria to produce AKG or pyruvate and recover AKG or pyruvate from the culture are also described herein. Nucleic acid sequences encoding polypeptides that function as ethylene-forming enzymes and their use in the production of ethylene are further disclosed herein. These nucleic acids may be expressed in hosts such as cyanobacteria, which in turn may be cultured to produce ethylene.

  11. Natural production of biological optical systems

    NASA Astrophysics Data System (ADS)

    Choi, Seung Ho; Kim, Young L.

    2015-03-01

    Synthesis and production in nature often provide ideas to design and fabricate advanced biomimetic photonic materials and structures, leading to excellent physical properties and enhanced performance. In addition, the recognition and utilization of natural or biological substances have been typical routes to develop biocompatible and biodegradable materials for medical applications. In this respect, biological lasers utilizing such biomaterials and biostructures have been received considerable attention, given a variety of implications and potentials for bioimaging, biosensing, implantation, and therapy. However, without relying on industrial facilities, eco-friendly massive production of such optical components or systems has not yet been investigated. We show examples of bioproduction of biological lasers using agriculture and fisheries. We anticipate that such approaches will open new possibilities for scalable eco-friendly `green' production of biological photonics components and systems.

  12. 9 CFR 114.6 - Mixing biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Mixing biological products. 114.6 Section 114.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... BIOLOGICAL PRODUCTS § 114.6 Mixing biological products. Each biological product, when in liquid form,...

  13. 9 CFR 114.6 - Mixing biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Mixing biological products. 114.6 Section 114.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... BIOLOGICAL PRODUCTS § 114.6 Mixing biological products. Each biological product, when in liquid form,...

  14. Synthetic biology of fungal natural products

    PubMed Central

    Mattern, Derek J.; Valiante, Vito; Unkles, Shiela E.; Brakhage, Axel A.

    2015-01-01

    Synthetic biology is an ever-expanding field in science, also encompassing the research area of fungal natural product (NP) discovery and production. Until now, different aspects of synthetic biology have been covered in fungal NP studies from the manipulation of different regulatory elements and heterologous expression of biosynthetic pathways to the engineering of different multidomain biosynthetic enzymes such as polyketide synthases or non-ribosomal peptide synthetases. The following review will cover some of the exemplary studies of synthetic biology in filamentous fungi showing the capacity of these eukaryotes to be used as model organisms in the field. From the vast array of different NPs produced to the ease for genetic manipulation, filamentous fungi have proven to be an invaluable source for the further development of synthetic biology tools. PMID:26284053

  15. Standardization for natural product synthetic biology.

    PubMed

    Zhao, Huimin; Medema, Marnix H

    2016-08-27

    Standardization is one of the foundational features of modern-day engineering, and the use of standardized parts and processes is a key element that distinguishes bona fide synthetic biology from traditional genetic engineering. Here, we discuss the role of standardization in natural product synthetic biology, focusing on standardization of data on biosynthetic pathways and gene clusters, as well as the role of standardization in the process of biosynthetic gene cluster engineering. PMID:27313083

  16. 9 CFR 114.4 - Identification of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Identification of biological products... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.4 Identification of biological products. Suitable tags or labels...

  17. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Reprocessing of biological products. 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.18 Reprocessing of biological products. The Administrator...

  18. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Rebottling of biological products. 114.17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.17 Rebottling of biological products. The Administrator...

  19. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Reprocessing of biological products. 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.18 Reprocessing of biological products. The Administrator...

  20. 9 CFR 106.1 - Biological products; exemption.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products; exemption....

  1. Strategies for improving biological hydrogen production.

    PubMed

    Hallenbeck, Patrick C; Abo-Hashesh, Mona; Ghosh, Dipankar

    2012-04-01

    Biological hydrogen production presents a possible avenue for the large scale sustainable generation of hydrogen needed to fuel a future hydrogen economy. Amongst the possible approaches that are under active investigation and that will be briefly discussed; biophotolysis, photofermentation, microbial electrolysis, and dark fermentation, dark fermentation has the additional advantages of largely relying on already developed bioprocess technology and of potentially using various waste streams as feedstock. However, the major roadblock to developing a practical process has been the low yields, typically around 25%, well below those achievable for the production of other biofuels from the same feedstocks. Moreover, low yields also lead to the generation of side products whose large scale production would generate a waste disposal problem. Here recent attempts to overcome these barriers are reviewed and recent progress in efforts to increase hydrogen yields through physiological manipulation, metabolic engineering and the use of two-stage systems are described.

  2. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Packaging biological products. 112.6... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.6 Packaging biological products. (a) Each multiple-dose final container of a biological...

  3. 9 CFR 113.50 - Ingredients of biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be...

  4. 9 CFR 113.50 - Ingredients of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be...

  5. 9 CFR 113.50 - Ingredients of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be...

  6. 9 CFR 113.50 - Ingredients of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be...

  7. 9 CFR 113.50 - Ingredients of biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be...

  8. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Rebottling of biological products. 114.17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS §...

  9. Synthetic Biological Approaches to Natural Product Biosynthesis

    PubMed Central

    Winter, Jaclyn M; Tang, Yi

    2012-01-01

    Small molecules produced in Nature continue to be an inspiration for the development of new therapeutic agents. These natural products possess exquisite chemical diversity, which gives rise to their wide range of biological activities. In their host organism, natural products are assembled and modified by dedicated biosynthetic pathways that Nature has meticulously developed. Often times, the complex structures or chemical modifications instated by these pathways are difficult to replicate using traditional synthetic methods. An alternative approach for creating or enhancing the structural variation of natural products is through combinatorial biosynthesis. By rationally reprogramming and manipulating the biosynthetic machinery responsible for their production, unnatural metabolites that were otherwise inaccessible can be obtained. Additionally, new chemical structures can be synthesized or derivatized by developing the enzymes that carry out these complicated chemical reactions into biocatalysts. In this review, we will discuss a variety of combinatorial biosynthetic strategies, their technical challenges, and highlight some recent (since 2007) examples of rationally designed unnatural metabolites, as well as platforms that have been established for the production and modification of clinically important pharmaceutical compounds. PMID:22221832

  10. Biological hydrogen production: prospects and challenges.

    PubMed

    Lee, Hyung-Sool; Vermaas, Wim F J; Rittmann, Bruce E

    2010-05-01

    Hydrogen gas provides exceptional value as an energy carrier and industrial feedstock, but currently is produced entirely by reforming fossil fuels. Biological hydrogen production (BioH(2)), which offers the possibility of being renewable and carbon neutral, can be achieved by photosynthesis, fermentation, and microbial electrolysis cells. This review introduces the principles, advantages and challenges of each approach to BioH(2). Photosynthetic BioH(2) is the ultimate renewable source, since it directly uses inexhaustible resources: sunlight energy and electrons from H(2)O. However, it presents major technical challenges, particularly due to oxygen sensitivity. Fermentative BioH(2) offers a high production rate, but poor conversion efficiency from the organic substrate to H(2). The microbial electrolysis cell can achieve high conversion efficiency, but is an emerging technology.

  11. Systems Biology of Microbial Exopolysaccharides Production

    PubMed Central

    Ates, Ozlem

    2015-01-01

    Exopolysaccharides (EPSs) produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture, and medicine. EPSs are mainly associated with high-value applications, and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility. However, only a few microbial EPSs have achieved to be used commercially due to their high production costs. The emerging need to overcome economic hurdles and the increasing significance of microbial EPSs in industrial and medical biotechnology call for the elucidation of the interrelations between metabolic pathways and EPS biosynthesis mechanism in order to control and hence enhance its microbial productivity. Moreover, a better understanding of biosynthesis mechanism is a significant issue for improvement of product quality and properties and also for the design of novel strains. Therefore, a systems-based approach constitutes an important step toward understanding the interplay between metabolism and EPS biosynthesis and further enhances its metabolic performance for industrial application. In this review, primarily the microbial EPSs, their biosynthesis mechanism, and important factors for their production will be discussed. After this brief introduction, recent literature on the application of omics technologies and systems biology tools for the improvement of production yields will be critically evaluated. Special focus will be given to EPSs with high market value such as xanthan, levan, pullulan, and dextran. PMID:26734603

  12. Systems Biology of Microbial Exopolysaccharides Production.

    PubMed

    Ates, Ozlem

    2015-01-01

    Exopolysaccharides (EPSs) produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture, and medicine. EPSs are mainly associated with high-value applications, and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility. However, only a few microbial EPSs have achieved to be used commercially due to their high production costs. The emerging need to overcome economic hurdles and the increasing significance of microbial EPSs in industrial and medical biotechnology call for the elucidation of the interrelations between metabolic pathways and EPS biosynthesis mechanism in order to control and hence enhance its microbial productivity. Moreover, a better understanding of biosynthesis mechanism is a significant issue for improvement of product quality and properties and also for the design of novel strains. Therefore, a systems-based approach constitutes an important step toward understanding the interplay between metabolism and EPS biosynthesis and further enhances its metabolic performance for industrial application. In this review, primarily the microbial EPSs, their biosynthesis mechanism, and important factors for their production will be discussed. After this brief introduction, recent literature on the application of omics technologies and systems biology tools for the improvement of production yields will be critically evaluated. Special focus will be given to EPSs with high market value such as xanthan, levan, pullulan, and dextran. PMID:26734603

  13. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1992-12-01

    Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H[sub 2], CO[sub 2], CH[sub 4] and sulfur gases, is first produced using traditional gasification techniques. The CO, CO[sub 2] and H[sub 2] are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the wild strain'' produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

  14. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... under this part may be approved for such product by the Administrator in specific cases: Provided, (a... in conflict with the laws of the country to which the product is intended for export, and (c) That the outside container is labeled to show that it is intended for export; but if such product is...

  15. Chemical and biological production of cyclotides

    PubMed Central

    Li, Yilong; Bi, Tao; Camarero, Julio A.

    2016-01-01

    Cyclotides are fascinating naturally occurring micro-proteins (≈30 residues long) present in several plant families, and display various biological properties such as protease inhibitory, anti-microbial, insecticidal, cytotoxic, anti-HIV and hormone-like activities. Cyclotides share a unique head-to-tail circular knotted topology of three disulfide bridges, with one disulfide penetrating through a macrocycle formed by the two other disulfides and interconnecting peptide backbones, forming what is called a cystine knot topology. This cyclic cystine knot (CCK) framework gives the cyclotides exceptional rigidity, resistance to thermal and chemical denaturation, and enzymatic stability against degradation. Interestingly, cyclotides have been shown to be orally bioavailable, and other cyclotides have been shown to cross the cell membranes. Moreover, recent reports have also shown that engineered cyclotides can be efficiently used to target extracellular and intracellular protein-protein interactions, therefore making cyclotides ideal tools for drug development to selectively target protein-protein interactions. In this work we will review all the available methods for production of these interesting proteins using chemical or biological methods. PMID:27064329

  16. The gravimetric method for the determination of residual moisture in freeze-dried biological products.

    PubMed

    May, J C; Wheeler, R M; Grim, E

    1989-06-01

    The gravimetric test for the determination of residual moisture in freeze-dried biological products performed in a humidity- and temperature-controlled room with the use of scrupulous gravimetric analytical technique can be used to accurately determine residual moisture in freeze-dried biological products such as antihemophilic factor (human) or honey bee venom allergenic extract. This method determines the first water of hydration of sodium tartrate dihydrate (7.93%) to within 1.3% of the calculated value with a relative standard deviation of 0.3% for 10 replicates. For this gravimetric procedure, freeze-dried samples containing from 1.12 to 4.4% residual moisture had relative standard deviations ranging from 3.6 to 9.1%. Samples containing less than 1.0% residual moisture by the gravimetric method such as intravenous immune globulin and antihemophilic factor (human) had relative standard deviations ranging from 16.7 to 47.0%. Relative standard deviations for residual moisture tests performed on comparable samples by the Karl Fischer and thermogravimetric methods showed similar variability. PMID:2743789

  17. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Shipment of experimental biological..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.3 Shipment...

  18. 9 CFR 103.1 - Preparation of experimental biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Preparation of experimental biological..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation...

  19. Monascus secondary metabolites: production and biological activity.

    PubMed

    Patakova, Petra

    2013-02-01

    The genus Monascus, comprising nine species, can reproduce either vegetatively with filaments and conidia or sexually by the formation of ascospores. The most well-known species of genus Monascus, namely, M. purpureus, M. ruber and M. pilosus, are often used for rice fermentation to produce red yeast rice, a special product used either for food coloring or as a food supplement with positive effects on human health. The colored appearance (red, orange or yellow) of Monascus-fermented substrates is produced by a mixture of oligoketide pigments that are synthesized by a combination of polyketide and fatty acid synthases. The major pigments consist of pairs of yellow (ankaflavin and monascin), orange (rubropunctatin and monascorubrin) and red (rubropunctamine and monascorubramine) compounds; however, more than 20 other colored products have recently been isolated from fermented rice or culture media. In addition to pigments, a group of monacolin substances and the mycotoxin citrinin can be produced by Monascus. Various non-specific biological activities (antimicrobial, antitumor, immunomodulative and others) of these pigmented compounds are, at least partly, ascribed to their reaction with amino group-containing compounds, i.e. amino acids, proteins or nucleic acids. Monacolins, in the form of β-hydroxy acids, inhibit hydroxymethylglutaryl-coenzyme A reductase, a key enzyme in cholesterol biosynthesis in animals and humans.

  20. Dissociated Vertical Deviation

    MedlinePlus

    ... Eye Terms Conditions Frequently Asked Questions Español Condiciones Chinese Conditions Dissociated Vertical Deviation En Español Read in Chinese What is Dissociated Vertical Deviation (DVD)? DVD is ...

  1. Biological hydrogen production using a membrane bioreactor.

    PubMed

    Oh, Sang-Eun; Iyer, Prabha; Bruns, Mary Ann; Logan, Bruce E

    2004-07-01

    A cross-flow membrane was coupled to a chemostat to create an anaerobic membrane bioreactor (MBR) for biological hydrogen production. The reactor was fed glucose (10,000 mg/L) and inoculated with a soil inoculum heat-treated to kill non-spore-forming methanogens. Hydrogen gas was consistently produced at a concentration of 57-60% in the headspace under all conditions. When operated in chemostat mode (no flow through the membrane) at a hydraulic retention time (HRT) of 3.3 h, 90% of the glucose was removed, producing 2200 mg/L of cells and 500 mL/h of biogas. When operated in MBR mode, the solids retention time (SRT) was increased to SRT = 12 h producing a solids concentration in the reactor of 5800 mg/L. This SRT increased the overall glucose utilization (98%), the biogas production rate (640 mL/h), and the conversion efficiency of glucose-to-hydrogen from 22% (no MBR) to 25% (based on a maximum of 4 mol-H(2)/mol-glucose). When the SRT was increased from 5 h to 48 h, glucose utilization (99%) and biomass concentrations (8,800 +/- 600 mg/L) both increased. However, the biogas production decreased (310 +/- 40 mL/h) and the glucose-to-hydrogen conversion efficiency decreased from 37 +/- 4% to 18 +/- 3%. Sustained permeate flows through the membrane were in the range of 57 to 60 L/m(2) h for three different membrane pore sizes (0.3, 0.5, and 0.8 microm). Most (93.7% to 99.3%) of the membrane resistance was due to internal fouling and the reversible cake resistance, and not the membrane itself. Regular backpulsing was essential for maintaining permeate flux through the membrane. Analysis of DNA sequences using ribosomal intergenic spacer analysis indicated bacteria were most closely related to members of Clostridiaceae and Flexibacteraceae, including Clostridium acidisoli CAC237756 (97%), Linmingia china AF481148 (97%), and Cytophaga sp. MDA2507 AF238333 (99%). No PCR amplification of 16s rRNA genes was obtained when archaea-specific primers were used.

  2. The large deviation principle and steady-state fluctuation theorem for the entropy production rate of a stochastic process in magnetic fields

    NASA Astrophysics Data System (ADS)

    Chen, Yong; Ge, Hao; Xiong, Jie; Xu, Lihu

    2016-07-01

    Fluctuation theorem is one of the major achievements in the field of nonequilibrium statistical mechanics during the past two decades. There exist very few results for steady-state fluctuation theorem of sample entropy production rate in terms of large deviation principle for diffusion processes due to the technical difficulties. Here we give a proof for the steady-state fluctuation theorem of a diffusion process in magnetic fields, with explicit expressions of the free energy function and rate function. The proof is based on the Karhunen-Loève expansion of complex-valued Ornstein-Uhlenbeck process.

  3. [Application of systems biology and synthetic biology in strain improvement for biofuel production].

    PubMed

    Zhao, Xinqing; Bai, Fengwu; Li, Yin

    2010-07-01

    Biofuels are renewable and environmentally friendly, but high production cost makes them economically not competitive, and the development of robust strains is thus one of the prerequisites. In this article, strain improvement studies based on the information from systems biology studies are reviewed, with a focus on their applications on stress tolerance improvement. Furthermore, the contribution of systems biology, synthetic biology and metabolic engineering in strain development for biofuel production is discussed, with an expectation for developing more robust strains for biofuel production.

  4. 9 CFR 114.6 - Mixing biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Mixing biological products. 114.6 Section 114.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS...

  5. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Packaging biological products. 112.6 Section 112.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND...

  6. 9 CFR 106.1 - Biological products; exemption.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Biological products; exemption. 106.1 Section 106.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR...

  7. 9 CFR 114.4 - Identification of biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Identification of biological products. 114.4 Section 114.4 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  8. 9 CFR 103.1 - Preparation of experimental biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Preparation of experimental biological products. 103.1 Section 103.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  9. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Shipment of experimental biological products. 103.3 Section 103.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  10. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Packaging biological products. 112.6 Section 112.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND...

  11. 9 CFR 106.1 - Biological products; exemption.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Biological products; exemption. 106.1 Section 106.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR...

  12. 9 CFR 103.1 - Preparation of experimental biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Preparation of experimental biological products. 103.1 Section 103.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  13. 9 CFR 103.1 - Preparation of experimental biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Preparation of experimental biological products. 103.1 Section 103.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  14. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Shipment of experimental biological products. 103.3 Section 103.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  15. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Shipment of experimental biological products. 103.3 Section 103.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  16. 9 CFR 106.1 - Biological products; exemption.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Biological products; exemption. 106.1 Section 106.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR...

  17. 9 CFR 103.1 - Preparation of experimental biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Preparation of experimental biological products. 103.1 Section 103.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  18. Biologically based pest controls: Markets, industries, and products. Special report

    SciTech Connect

    Ridgway, R.L.; Inscoe, M.N.; Thorpe, K.W.

    1994-05-20

    Numbers and amounts of conventional pesticides to combat insect pests, weeds and plant diseases are likely to decline. Although biologically based pest control products have been touted as possible replacements, such products now comprise less than 2% of the market in the United States. Twelve large multinational companies market 80% of the world`s pesticides, valued at about $200 billion, and are responsible for about 20% of the activities to develop and/or produce biological products. In the U.S. about 65 small companies are responsible for 80% of the activities on biological products, which are valued at about $165 million. Without major changes in the research, development, and delivery system, biological products are not likely to be practical replacements for significant amounts of conventional pesticides in the foreseeable future.

  19. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false U.S. Veterinary Biological Product... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by...

  20. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... used to rehydrate a desiccated product or a liquid used to dilute another substance. (h) Serial. The... by a serial number: Provided, That, when all or part of a serial of liquid biological product is packaged as diluent for all or part of a serial of desiccated product, the resulting combination...

  1. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1990-01-01

    A batch kinetic study involving Clostridium lungdahlii in a mineral medium was carried out in order to provide baseline data for the effects of nutrients on product ratio and kinetics. The use of this minimal medium containing vitamins, minerals, select amino acids and salts showed both a lower maximum specific growth rate and a lower maximum specific uptake rate than found when using a complex medium supplemented with 0.01% yeast extract. At the same time, the product ratio was improved slightly in favor of ethanol over acetate. Future experiments will measure the effects of ammonia and phosphate limitation on product ratio and process kinetics.

  2. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1991-01-01

    Previously studies have shown the importance of both medium composition and concentration and medium pH on ethanol production of Clostridium ljungdahlii in fermenting CO, CO{sub 2} and H{sub 2} in synthesis gas. Four additional batch experiments involving medium composition and concentration were carried out in modified basal medium without yeast extract at pH 4.0. These experiments indicate that basal medium with only small amounts of B-vitamins can yield significant cell growth while yielding ethanol as the major product. Product ratios as high as 11.0 g ethanol per g acetate were obtained with half strength B-vitamins. Further experiments indicates that Ca-pantothenate may be necessary for the growth of C. ljungdahlii and that growth and ethanol production can occur simultaneously.

  3. 9 CFR 115.2 - Inspections of biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... United States veterinary license number or a United States veterinary permit number or other mark...) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product by the Secretary, veterinary biologics licensees or permittees shall: (1) Stop the...

  4. Biological Activity of Recently Discovered Halogenated Marine Natural Products

    PubMed Central

    Gribble, Gordon W.

    2015-01-01

    This review presents the biological activity—antibacterial, antifungal, anti-parasitic, antiviral, antitumor, antiinflammatory, antioxidant, and enzymatic activity—of halogenated marine natural products discovered in the past five years. Newly discovered examples that do not report biological activity are not included. PMID:26133553

  5. Biological production of ethanol fom coal

    SciTech Connect

    Not Available

    1992-05-01

    Research is continuing in an attempt to increase both the ethanol concentration and product ratio using C. ljungdahlii. The purpose of this report is to present data (acetate to ethanol) utilizing a medium prepared especially for C. ljungdahlii. Medium development studies are presented, as well as reactor studies with the new medium in batch reactors. Continuous stirred tank reactor (CSTR) with cell recycle. The use of this new medium has resulted in significant improvements in cell concentration, ethanol concentration and product ratio.

  6. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1992-01-01

    Research is continuing in an attempt to increase both the ethanol concentration and product ratio using C. ljungdahlii. The purpose of this report is to present data utilizing a medium prepared especially for C. ljungdahlii. Medium development studies are presented, as well as reactor studies with the new medium in batch reactors. CSTRs and CSTRs with cell recycle. The use of this new medium has resulted in significant improvements in cell concentration, ethanol concentration and product ratio.

  7. Total synthesis and biological activity of natural product Urukthapelstatin A.

    PubMed

    Lin, Chun-Chieh; Tantisantisom, Worawan; McAlpine, Shelli R

    2013-07-19

    Herein we report the first total synthesis of the natural product Urkuthaplestatin A (Ustat A) utilizing a convergent synthetic strategy. The characterization and biological activity match those of the previously published natural product. Interestingly, several intermediates, including the linear and serine cyclized precursors, show a 100-fold decrease in cytotoxicity, with IC50's in the low micromolar range. These data indicate that the rigidity and the consecutive aromatic heterocyclic system are responsible for the biological activity. PMID:23819711

  8. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1989-01-01

    Two batch and one continuous reactor study involving Clostridium ljungdahlii were carried out. First, the effects of H{sub 2} partial pressure on growth, CO and H{sub 2} uptake and product formation by C. ljungdahlii were investigated in batch culture. Over the concentration range studied, it was observed that CO was preferentially utilized in favor of H{sub 2}. It was also seen that increasing H{sub 2} partial pressures increased the ratio of ethanol to acetate. Finally, a two-stage CSTR system was successfully operated with C. ljungdahlii in which growth occurred in the first stage and ethanol production occurred in the second stage.

  9. Characterizing biological products and assessing comparability following manufacturing changes.

    PubMed

    Chirino, Arthur J; Mire-Sluis, Anthony

    2004-11-01

    Changes in production methods of a biological product may necessitate an assessment of comparability to ensure that these manufacturing changes have not affected the safety, identity, purity, or efficacy of the product. Depending on the nature of the protein or the change, this assessment consists of a hierarchy of sequential tests in analytical testing, preclinical animal studies and clinical studies. Differences in analytical test results between pre- and post-change products may require functional testing to establish the biological or clinical significance of the observed difference. An underlying principle of comparability is that under certain conditions, protein products may be considered comparable on the basis of analytical testing results alone. However, the ability to compare biological materials is solely dependent on the tests used, since no single analytical method is able to compare every aspect of protein structure or function. The advantages and disadvantages of any given method depends on the protein property being characterized. PMID:15529163

  10. Biological production of liquid fuels from biomass

    SciTech Connect

    1982-01-01

    A scheme for the production of liquid fuels from renewable resources such as poplar wood and lignocellulosic wastes from a refuse hydropulper was investigated. The particular scheme being studied involves the conversion of a cellulosic residue, resulting from a solvent delignified lignocellulosic feed, into either high concentration sugar syrups or into ethyl and/or butyl alcohol. The construction of a pilot apparatus for solvent delignifying 150 g samples of lignocellulosic feeds was completed. Also, an analysis method for characterizing the delignified product has been selected and tested. This is a method recommended in the Forage Fiber Handbook. Delignified samples are now being prepared and tested for their extent of delignification and susceptibility to enzyme hydrolysis. Work is continuing on characterizing the cellulase and cellobiase enzyme systems derived from the YX strain of Thermomonospora.

  11. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1992-05-01

    Research is continuing in attempting to increase both the ethanol concentration and product ratio (acetate to ethanol) from the C. ljungdahlii fermentation. Both batch and continuous reactors are being used for this purpose. The purpose of this report is four-fold. First, the data presented in PETC Report No. 2-4-91 (June--September, 1991) are analyzed and interpreted using normalized specific growth and production rates. This technique eliminates experimental variation due to differences in inoculum history. Secondly, the effects of the sulfur gases H{sub 2}S and COS on the performance of C. ljungdahlii are presented and discussed. Although these are preliminary results, they illustrate the tolerance of the bacterium to low levels of sulfur gases. Thirdly, the results of continuous stirred tank reactor studies are presented, where cell and product concentrations are shown as a function of agitation rate and gas flow rate. Finally, additional data are presented showing the performance of C. ljungdahlii in a CSTR with cell recycle.

  12. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1991-01-01

    Research is continuing in attempting to increase both the ethanol concentration and product ratio from the C. ljungdahlii fermentation. Both batch and continuous reactors are being used for this purpose. The purpose of this report is four-fold. First, the data presented in PETC Report No. 2-4-91 (June--September 1991) are analyzed and interpreted using normalized specific growth and production rates. This technique eliminates experimental variation due to the differences in inoculum history. Secondly, the effects of the sulfur gases H{sub 2}S and COS on the performance of C. ljungdahlii are presented and discussed. Although these are preliminary results, they illustrate the tolerance of the bacterium to low levels of sulfur gases. Thirdly, the results of continuous stirred tank reactor studies are presented, where cell and product concentrations are shown as a function of agitation rate and gas flow rate. Finally, additional data are presented showing the performance of C. ljungdahlii in a CSTR with cell recycle.

  13. Neurotrophic Natural Products: Chemistry and Biology

    PubMed Central

    Xu, Jing; Lacoske, Michelle H.

    2014-01-01

    Neurodegenerative diseases and spinal cord injury affect approximately 50 million people worldwide, bringing the total healthcare cost to over 600 billion dollars per year. Nervous system growth factors, that is, neurotrophins, are a potential solution to these disorders, since they could promote nerve regeneration. An average of 500 publications per year attests to the significance of neurotrophins in biomedical sciences and underlines their potential for therapeutic applications. Nonetheless, the poor pharmacokinetic profile of neurotrophins severely restricts their clinical use. On the other hand, small molecules that modulate neurotrophic activity offer a promising therapeutic approach against neurological disorders. Nature has provided an impressive array of natural products that have potent neurotrophic activities. This Review highlights the current synthetic strategies toward these compounds and summarizes their ability to induce neuronal growth and rehabilitation. It is anticipated that neurotrophic natural products could be used not only as starting points in drug design but also as tools to study the next frontier in biomedical sciences: the brain activity map project. PMID:24353244

  14. 9 CFR 113.3 - Sampling of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... samples of each serial or subserial of a biological product manufactured in the United States or imported... filling operation. (iv) Representative samples of each serial or subserial in each shipment of imported... such samples from each serial and the minimum quantity of product to be provided in each sample...

  15. 9 CFR 106.1 - Biological products; exemption.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... control of the Department in the prevention, control or eradication of animal diseases in connection with (a) an official USDA program; or (b) an emergency animal disease situation, or (c) a USDA... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Biological products; exemption....

  16. Sexual "Variation" without "Deviation"

    ERIC Educational Resources Information Center

    Turnage, John R.; Logan, Daniel L.

    1975-01-01

    Non-heterosexual behavior continues to be labeled "deviant" or "maladaptive" by those propounding a learning formulation of sexual behavior. It is suggested that the term "variation" replace, in part, the term "deviation" when describing non-heterosexual behavior, especially homosexuality. (Author)

  17. The Interstellar Production of Biologically Important Organics

    NASA Technical Reports Server (NTRS)

    Sandford, Scott A.; Bernstein, Max P.; Dworkin, Jason; Allamandola, Louis J.

    2000-01-01

    One of the primary tasks of the Astrochemistry Laboratory at Ames Research Center is to use laboratory simulations to study the chemical processes that occur in dense interstellar clouds. Since new stars are formed in these clouds, their materials may be responsible for the delivery of organics to new habitable planets and may play important roles in the origin of life. These clouds are extremely cold (less than 50 kelvin), and most of the volatiles in these clouds are condensed onto dust grains as thin ice mantles. These ices are exposed to cosmic rays and ultraviolet (UV) photons that break chemical bonds and result in the production of complex molecules when the ices are warmed (as they would be when incorporated into a star-forming region). Using cryovacuum systems and UV lamps, this study simulates the conditions of these clouds and studies the resulting chemistry. Some of the areas of progress made in 1999 are described below. It shows some of the types of molecules that may be formed in the interstellar medium. Laboratory simulations have already confirmed that many of these compounds are made under these conditions.

  18. Milk kefir: composition, microbial cultures, biological activities, and related products.

    PubMed

    Prado, Maria R; Blandón, Lina Marcela; Vandenberghe, Luciana P S; Rodrigues, Cristine; Castro, Guillermo R; Thomaz-Soccol, Vanete; Soccol, Carlos R

    2015-01-01

    In recent years, there has been a strong focus on beneficial foods with probiotic microorganisms and functional organic substances. In this context, there is an increasing interest in the commercial use of kefir, since it can be marketed as a natural beverage that has health promoting bacteria. There are numerous commercially available kefir based-products. Kefir may act as a matrix in the effective delivery of probiotic microorganisms in different types of products. Also, the presence of kefir's exopolysaccharides, known as kefiran, which has biological activity, certainly adds value to products. Kefiran can also be used separately in other food products and as a coating film for various food and pharmaceutical products. This article aims to update the information about kefir and its microbiological composition, biological activity of the kefir's microflora and the importance of kefiran as a beneficial health substance.

  19. Assessment of biological Hydrogen production processes: A review

    NASA Astrophysics Data System (ADS)

    Najafpour, G. D.; Shahavi, M. H.; Neshat, S. A.

    2016-06-01

    Energy crisis created a special attention on renewable energy sources. Among these sources; hydrogen through biological processes is well-known as the most suitable and renewable energy sources. In terms of process yield, hydrogen production from various sources was evaluated. A summary of microorganisms as potential hydrogen producers discussed along with advantages and disadvantages of several bioprocesses. The pathway of photo-synthetic and dark fermentative organisms was discussed. In fact, the active enzymes involved in performance of biological processes for hydrogen generation were identified and their special functionalities were discussed. The influential factors affecting on hydrogen production were known as enzymes assisting liberation specific enzymes such as nitrogenase, hydrogenase and uptake hydrogenase. These enzymes were quite effective in reduction of proton and form active molecular hydrogen. Several types of photosynthetic systems were evaluated with intension of maximum hydrogen productivities. In addition dark fermentative and light intensities on hydrogen productions were evaluated. The hydrogen productivities of efficient hydrogen producing strains were evaluated.

  20. Milk kefir: composition, microbial cultures, biological activities, and related products

    PubMed Central

    Prado, Maria R.; Blandón, Lina Marcela; Vandenberghe, Luciana P. S.; Rodrigues, Cristine; Castro, Guillermo R.; Thomaz-Soccol, Vanete; Soccol, Carlos R.

    2015-01-01

    In recent years, there has been a strong focus on beneficial foods with probiotic microorganisms and functional organic substances. In this context, there is an increasing interest in the commercial use of kefir, since it can be marketed as a natural beverage that has health promoting bacteria. There are numerous commercially available kefir based-products. Kefir may act as a matrix in the effective delivery of probiotic microorganisms in different types of products. Also, the presence of kefir’s exopolysaccharides, known as kefiran, which has biological activity, certainly adds value to products. Kefiran can also be used separately in other food products and as a coating film for various food and pharmaceutical products. This article aims to update the information about kefir and its microbiological composition, biological activity of the kefir’s microflora and the importance of kefiran as a beneficial health substance. PMID:26579086

  1. Natural product synthesis at the interface of chemistry and biology

    PubMed Central

    2014-01-01

    Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in drug discovery and chemical biology. With the introduction of novel, innovative concepts and strategies for synthetic efficiency, natural product synthesis in the 21st century is well poised to address the challenges and complexities faced by natural product chemistry and will remain essential to progress in biomedical sciences. PMID:25043880

  2. Natural product synthesis at the interface of chemistry and biology.

    PubMed

    Hong, Jiyong

    2014-08-11

    Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in drug discovery and chemical biology. With the introduction of novel, innovative concepts and strategies for synthetic efficiency, natural product synthesis in the 21st century is well poised to address the challenges and complexities faced by natural product chemistry and will remain essential to progress in biomedical sciences.

  3. The Structural Biology of Enzymes Involved in Natural Product Glycosylation

    PubMed Central

    Singh, Shanteri; Phillips, George N.

    2012-01-01

    The glycosylation of microbial natural products often dramatically influences the biological and/or pharmacological activities of the parental metabolite. Over the past decade, crystal structures of several enzymes involved in the biosynthesis and attachment of novel sugars found appended to natural products have emerged. In many cases, these studies have paved the way to a better understanding of the corresponding enzyme mechanism of action and have served as a starting point for engineering variant enzymes to facilitate to production of differentially-glycosylated natural products. This review specifically summarizes the structural studies of bacterial enzymes involved in biosynthesis of novel sugar nucleotides. PMID:22688446

  4. Pharmacist Substitution of Biological Products: Issues and Considerations.

    PubMed

    Li, Edward; Ramanan, Sundar; Green, Larry

    2015-07-01

    Biosimilars are biological products that are highly similar to their biological reference products, notwithstanding minor differences in clinically inactive components. However, unlike generics of small-molecule drugs, biosimilars are not identical to their reference products, since each manufacturer uses unique cell lines and processes, and these lead to slight structural differences between products. Because these structural variations can lead to differences in clinical response, clinical studies demonstrating biosimilarity are required before and robust pharmacovigilance after approval. Although the FDA has not yet issued formal guidance on interchangeable biosimilars, higher standards of similarity will be required in order to achieve an interchangeable designation. In this commentary, we review the differences between generics and biosimilars, describe their respective regulatory approval pathways, discuss interchangeability and substitution, and review substitution of interchangeable biosimilars, focusing on key professional considerations for pharmacists.

  5. Pharmacist Substitution of Biological Products: Issues and Considerations.

    PubMed

    Li, Edward; Ramanan, Sundar; Green, Larry

    2015-07-01

    Biosimilars are biological products that are highly similar to their biological reference products, notwithstanding minor differences in clinically inactive components. However, unlike generics of small-molecule drugs, biosimilars are not identical to their reference products, since each manufacturer uses unique cell lines and processes, and these lead to slight structural differences between products. Because these structural variations can lead to differences in clinical response, clinical studies demonstrating biosimilarity are required before and robust pharmacovigilance after approval. Although the FDA has not yet issued formal guidance on interchangeable biosimilars, higher standards of similarity will be required in order to achieve an interchangeable designation. In this commentary, we review the differences between generics and biosimilars, describe their respective regulatory approval pathways, discuss interchangeability and substitution, and review substitution of interchangeable biosimilars, focusing on key professional considerations for pharmacists. PMID:26108377

  6. 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. PMID:26153056

  7. PRODUCTION AND BIOLOGICAL SIGNIFICANCE OF METHYLATED TRIVALENT ARSENICALS

    EPA Science Inventory

    PRODUCTION AND BIOLOGICAL SIGNIFICANCE OF METHYLATED TRIVALENT ARSENICALS

    Miroslav Styblo1,2,*, Zuzana Drobna1, Felecia S. Walton1, Ilona Jaspers1,2, Shan Lin3,
    Stephen B. Waters3, David J. Thomas4

    1Department of Pediatrics, 2Center for Environmental Medicine an...

  8. Natural products with health benefits from marine biological resources

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The ocean is the cradle of lives, which provides a diverse array of intriguing natural products that has captured scientists’ attention in the past few decades due to their significant and extremely potent biological activities. In addition to being rich sources for pharmaceutical drugs, marine nat...

  9. Biodegradation of phytosanitary products in biological wastewater treatment.

    PubMed

    Massot, A; Estève, K; Noilet, P; Méoule, C; Poupot, C; Mietton-Peuchot, M

    2012-04-15

    Agricultural activity generates two types of waste: firstly, biodegradable organic effluents generally treated by biological processes and, secondly, phytosanitary effluents which contain residues of plant protection products. The latter are collected and treated. Current technological solutions are essentially based on concentration or physical-chemical processes. However, recent improvements in the biodegradability of pesticides open the way to the consideration of alternative, biological, treatment using mixed liquor from wastewater plant activated sludge. The feasibility of the biological treatment of viticultural effluents has been evaluated by the application of pesticides to activated sludge. The necessity for selection of a pesticide-resistant biomass has been highlighted. The elimination of the phytosanitary products shows the potential of a resistant biomass in the treatment of pesticides. The aerated biological storage ponds at three wineries, followed by a sand or reed-bed filter, were used for the treatment of the total annual volume of the viticulture effluents and validate the laboratory experiments. The results show that the biological purification of pesticides by activated sludge is possible by allowing approximately 8 days for biomass adaptation. Stability of purification occurs between 20 and 30 days. PMID:22284913

  10. Microbial Production of Isoprenoids Enabled by Synthetic Biology

    PubMed Central

    Immethun, Cheryl M.; Hoynes-O’Connor, Allison G.; Balassy, Andrea; Moon, Tae Seok

    2013-01-01

    Microorganisms transform inexpensive carbon sources into highly functionalized compounds without toxic by-product generation or significant energy consumption. By redesigning the natural biosynthetic pathways in an industrially suited host, microbial cell factories can produce complex compounds for a variety of industries. Isoprenoids include many medically important compounds such as antioxidants and anticancer and antimalarial drugs, all of which have been produced microbially. While a biosynthetic pathway could be simply transferred to the production host, the titers would become economically feasible when it is rationally designed, built, and optimized through synthetic biology tools. These tools have been implemented by a number of research groups, with new tools pledging further improvements in yields and expansion to new medically relevant compounds. This review focuses on the microbial production of isoprenoids for the health industry and the advancements though synthetic biology. PMID:23577007

  11. Reinvigorating natural product combinatorial biosynthesis with synthetic biology.

    PubMed

    Kim, Eunji; Moore, Bradley S; Yoon, Yeo Joon

    2015-09-01

    Natural products continue to play a pivotal role in drug-discovery efforts and in the understanding if human health. The ability to extend nature's chemistry through combinatorial biosynthesis--altering functional groups, regiochemistry and scaffold backbones through the manipulation of biosynthetic enzymes--offers unique opportunities to create natural product analogs. Incorporating emerging synthetic biology techniques has the potential to further accelerate the refinement of combinatorial biosynthesis as a robust platform for the diversification of natural chemical drug leads. Two decades after the field originated, we discuss the current limitations, the realities and the state of the art of combinatorial biosynthesis, including the engineering of substrate specificity of biosynthetic enzymes and the development of heterologous expression systems for biosynthetic pathways. We also propose a new perspective for the combinatorial biosynthesis of natural products that could reinvigorate drug discovery by using synthetic biology in combination with synthetic chemistry.

  12. Reinvigorating natural product combinatorial biosynthesis with synthetic biology

    PubMed Central

    Kim, Eunji; Moore, Bradley S.; Yoon, Yeo Joon

    2016-01-01

    Natural products continue to play a pivotal role in drug discovery efforts and in understanding human health. The ability to extend nature’s chemistry through combinatorial biosynthesis – altering functional groups, regiochemistry, and scaffold backbones through manipulation of biosynthetic enzymes – offers unique opportunities to create natural product analogues. Incorporating emerging synthetic biology techniques has the potential to further accelerate the refinement of combinatorial biosynthesis as a robust platform for the diversification of natural chemical drug leads. Two decades after the field originated, we discuss the current limitations, realities, and the state of the art of combinatorial biosynthesis, including the engineering of substrate specificity of biosynthetic enzymes and the development heterologous expression systems for biosynthetic pathways. We also propose a new perspective for the combinatorial biosynthesis of natural products that could reinvigorate drug discovery by using synthetic biology in combination with synthetic chemistry. PMID:26284672

  13. Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care.

    PubMed

    Perez-Pinera, Pablo; Han, Ningren; Cleto, Sara; Cao, Jicong; Purcell, Oliver; Shah, Kartik A; Lee, Kevin; Ram, Rajeev; Lu, Timothy K

    2016-01-01

    Current biopharmaceutical manufacturing systems are not compatible with portable or distributed production of biologics, as they typically require the development of single biologic-producing cell lines followed by their cultivation at very large scales. Therefore, it remains challenging to treat patients in short time frames, especially in remote locations with limited infrastructure. To overcome these barriers, we developed a platform using genetically engineered Pichia pastoris strains designed to secrete multiple proteins on programmable cues in an integrated, benchtop, millilitre-scale microfluidic device. We use this platform for rapid and switchable production of two biologics from a single yeast strain as specified by the operator. Our results demonstrate selectable and near-single-dose production of these biologics in <24 h with limited infrastructure requirements. We envision that combining this system with analytical, purification and polishing technologies could lead to a small-scale, portable and fully integrated personal biomanufacturing platform that could advance disease treatment at point-of-care. PMID:27470089

  14. Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care

    PubMed Central

    Perez-Pinera, Pablo; Han, Ningren; Cleto, Sara; Cao, Jicong; Purcell, Oliver; Shah, Kartik A.; Lee, Kevin; Ram, Rajeev; Lu, Timothy K.

    2016-01-01

    Current biopharmaceutical manufacturing systems are not compatible with portable or distributed production of biologics, as they typically require the development of single biologic-producing cell lines followed by their cultivation at very large scales. Therefore, it remains challenging to treat patients in short time frames, especially in remote locations with limited infrastructure. To overcome these barriers, we developed a platform using genetically engineered Pichia pastoris strains designed to secrete multiple proteins on programmable cues in an integrated, benchtop, millilitre-scale microfluidic device. We use this platform for rapid and switchable production of two biologics from a single yeast strain as specified by the operator. Our results demonstrate selectable and near-single-dose production of these biologics in <24 h with limited infrastructure requirements. We envision that combining this system with analytical, purification and polishing technologies could lead to a small-scale, portable and fully integrated personal biomanufacturing platform that could advance disease treatment at point-of-care. PMID:27470089

  15. Capturing Biological Activity in Natural Product Fragments by Chemical Synthesis

    PubMed Central

    Crane, Erika A.

    2016-01-01

    Abstract Natural products have had an immense influence on science and have directly led to the introduction of many drugs. Organic chemistry, and its unique ability to tailor natural products through synthesis, provides an extraordinary approach to unlock the full potential of natural products. In this Review, an approach based on natural product derived fragments is presented that can successfully address some of the current challenges in drug discovery. These fragments often display significantly reduced molecular weights, reduced structural complexity, a reduced number of synthetic steps, while retaining or even improving key biological parameters such as potency or selectivity. Examples from various stages of the drug development process up to the clinic are presented. In addition, this process can be leveraged by recent developments such as genome mining, antibody–drug conjugates, and computational approaches. All these concepts have the potential to identify the next generation of drug candidates inspired by natural products. PMID:26833854

  16. Capturing Biological Activity in Natural Product Fragments by Chemical Synthesis.

    PubMed

    Crane, Erika A; Gademann, Karl

    2016-03-14

    Natural products have had an immense influence on science and have directly led to the introduction of many drugs. Organic chemistry, and its unique ability to tailor natural products through synthesis, provides an extraordinary approach to unlock the full potential of natural products. In this Review, an approach based on natural product derived fragments is presented that can successfully address some of the current challenges in drug discovery. These fragments often display significantly reduced molecular weights, reduced structural complexity, a reduced number of synthetic steps, while retaining or even improving key biological parameters such as potency or selectivity. Examples from various stages of the drug development process up to the clinic are presented. In addition, this process can be leveraged by recent developments such as genome mining, antibody-drug conjugates, and computational approaches. All these concepts have the potential to identify the next generation of drug candidates inspired by natural products.

  17. Systems Biology of Recombinant Protein Production in Bacillus megaterium

    NASA Astrophysics Data System (ADS)

    Biedendieck, Rebekka; Bunk, Boyke; Fürch, Tobias; Franco-Lara, Ezequiel; Jahn, Martina; Jahn, Dieter

    Over the last two decades the Gram-positive bacterium Bacillus megaterium was systematically developed to a useful alternative protein production host. Multiple vector systems for high yield intra- and extracellular protein production were constructed. Strong inducible promoters were combined with DNA sequences for optimised ribosome binding sites, various leader peptides for protein export and N- as well as C-terminal affinity tags for affinity chromatographic purification of the desired protein. High cell density cultivation and recombinant protein production were successfully tested. For further system biology based control and optimisation of the production process the genomes of two B. megaterium strains were completely elucidated, DNA arrays designed, proteome, fluxome and metabolome analyses performed and all data integrated using the bioinformatics platform MEGABAC. Now, solid theoretical and experimental bases for primary modeling attempts of the production process are available.

  18. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biological Product..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES FOR BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce...

  19. Systems Biology Approaches to Understand Natural Products Biosynthesis

    PubMed Central

    Licona-Cassani, Cuauhtemoc; Cruz-Morales, Pablo; Manteca, Angel; Barona-Gomez, Francisco; Nielsen, Lars K.; Marcellin, Esteban

    2015-01-01

    Actinomycetes populate soils and aquatic sediments that impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams, and terpenes are well-known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regulation of cellular metabolism in actinomycetes and to the sparse knowledge of their physiology. The past decade, however, has seen the development of omics technologies that have significantly contributed to our better understanding of their biology. Key observations have contributed toward a shift in the exploitation of actinomycete’s biology, such as using their full genomic potential, activating entire pathways through key metabolic elicitors and pathway engineering to improve biosynthesis. Here, we review recent efforts devoted to achieving enhanced discovery, activation, and manipulation of natural product biosynthetic pathways in model actinomycetes using genome-scale biological datasets. PMID:26697425

  20. Systems Biology Approaches to Understand Natural Products Biosynthesis.

    PubMed

    Licona-Cassani, Cuauhtemoc; Cruz-Morales, Pablo; Manteca, Angel; Barona-Gomez, Francisco; Nielsen, Lars K; Marcellin, Esteban

    2015-01-01

    Actinomycetes populate soils and aquatic sediments that impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams, and terpenes are well-known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regulation of cellular metabolism in actinomycetes and to the sparse knowledge of their physiology. The past decade, however, has seen the development of omics technologies that have significantly contributed to our better understanding of their biology. Key observations have contributed toward a shift in the exploitation of actinomycete's biology, such as using their full genomic potential, activating entire pathways through key metabolic elicitors and pathway engineering to improve biosynthesis. Here, we review recent efforts devoted to achieving enhanced discovery, activation, and manipulation of natural product biosynthetic pathways in model actinomycetes using genome-scale biological datasets. PMID:26697425

  1. Large scale animal cell cultivation for production of cellular biologicals.

    PubMed

    van Wezel, A L; van der Velden-de Groot, C A; de Haan, H H; van den Heuvel, N; Schasfoort, R

    1985-01-01

    Through the developments in molecular biology the interest for large scale animal cell cultivation has sharply increased during the last 5 years. At our laboratory, four different cultivation systems were studied, all of which are homogeneous culture systems, as they lend themselves best for scaling up and for the control of culture conditions. The four different systems which were compared are: batch culture, continuous chemostat, continuous recycling and continuous perfusion culture system, both for cells growing in suspension and for anchorage dependent cells in microcarrier culture. Our results indicate that for the production of virus vaccines and cells the batch and recycling culture system are most suitable. Disadvantages of the continued chemostat culture system are: the system is only applicable for cells growing in suspension; relatively low concentrations of cells and cellular products are obtained. The continuous perfusion system appears to be very suitable for the production of cellular components and also for the production of viruses which do not give cell lysis.

  2. Formate Formation and Formate Conversion in Biological Fuels Production

    PubMed Central

    Crable, Bryan R.; Plugge, Caroline M.; McInerney, Michael J.; Stams, Alfons J. M.

    2011-01-01

    Biomethanation is a mature technology for fuel production. Fourth generation biofuels research will focus on sequestering CO2 and providing carbon-neutral or carbon-negative strategies to cope with dwindling fossil fuel supplies and environmental impact. Formate is an important intermediate in the methanogenic breakdown of complex organic material and serves as an important precursor for biological fuels production in the form of methane, hydrogen, and potentially methanol. Formate is produced by either CoA-dependent cleavage of pyruvate or enzymatic reduction of CO2 in an NADH- or ferredoxin-dependent manner. Formate is consumed through oxidation to CO2 and H2 or can be further reduced via the Wood-Ljungdahl pathway for carbon fixation or industrially for the production of methanol. Here, we review the enzymes involved in the interconversion of formate and discuss potential applications for biofuels production. PMID:21687599

  3. Photochemical versus biological production of methyl iodide during Meteor 55

    NASA Astrophysics Data System (ADS)

    Richter, U.; Wallace, D.

    2003-04-01

    The flux of methyl iodide from sea to air represents the largest flux of iodine from the ocean to the atmosphere. Surface water concentrations and hence fluxes are particularly high in tropical regions. This flux may be responsible for the enrichment of iodine in the marine aerosol and may contribute to important processes in the marine boundary layer, including particle formation. Methyl iodide is commonly referred to as a biogenic gas, with both macroalgae and phytoplankton identified as important sources. On the other hand experimental and field data have shown the importance of photochemical production that is not necessarily associated directly with biological activity. During the Meteor cruise 55 along 11°N in the tropical Atlantic Ocean, a series of experiments were conducted to examine the biological vs. photochemical production of methyl iodide. A total of eight separate experiments were conducted. Production of CH3I in quartz glass flasks during 24 hour incubations (dark and natural sunlight) was measured under three experimental treatments: untreated seawater, filtered seawater (0.1 um pore size filter to exclude most phytoplankton and bacteria), and seawater that was poisoned with mercuric chloride. There were two clear findings from these experiments: (1) methyl iodide production was significantly higher in all the incubations that were exposed to the light than in the dark incubations; (2) there was no significant difference between CH3I production under the three experimental treatments. These results argue very strongly for the primary importance of photochemical production of CH3I as opposed to biogenic production at least for the tropical open ocean surface waters. Further experiments are required to investigate the reactants involved, their sources, the wavelength and depth dependence of production, etc. as well as (possibly related) sink processes.

  4. Removal of headspace CO2 increases biological hydrogen production.

    PubMed

    Park, Wooshin; Hyun, Seung H; Oh, Sang-Eun; Logan, Bruce E; Kim, In S

    2005-06-15

    For biological hydrogen production by fermentation to be a useful method of hydrogen generation, molar yields of hydrogen must be increased. While heat treatment of a soil inoculum increases hydrogen yields by preventing loss of hydrogen to methanogenesis, hydrogen is still lost to acetic acid generation from hydrogen and CO2. To reduce hydrogen losses via acetogenesis, CO2 concentrations in the headspace were substantially reduced during hydrogen production using a chemical scavenger (KOH). CO2 in the headspace was decreased from 24.5% (control) to a maximum of 5.2% during the highest gas production phase, resulting in a hydrogen partial pressure of 87.4%. This reduction in CO2 increased the hydrogen yield by 43% (from 1.4 to 2.0 mol of H2/mol of glucose). The soluble byproducts in all tests consisted primarily of acetate and ethanol. Higher concentrations of ethanol (10.9 mM) remained in solution from bottles with CO2 removal than in the control (1.2 mM), likely as a result of hydrogen inhibition of biological ethanol conversion to acetic acid. These results show that hydrogen production can be increased by removing CO2 in the reactor vessel, likely as a result of suppression of acetogenesis.

  5. Intensification of tropical Pacific biological productivity due to volcanic eruptions

    NASA Astrophysics Data System (ADS)

    Chikamoto, Megumi O.; Timmermann, Axel; Yoshimori, Masakazu; Lehner, Flavio; Laurian, Audine; Abe-Ouchi, Ayako; Mouchet, Anne; Joos, Fortunat; Raible, Christoph C.; Cobb, Kim M.

    2016-02-01

    Major volcanic eruptions generate widespread ocean cooling, which reduces upper ocean stratification. This effect has the potential to increase nutrient delivery into the euphotic zone and boost biological productivity. Using externally forced last millennium simulations of three climate/Earth System models (Model for Interdisciplinary Research On Climate (MIROC), Community Earth System Model (CESM), and LOch-Vecode-Ecbilt-CLio-agIsm Model (LOVECLIM)), we test the hypothesis that large volcanic eruptions intensify nutrient-driven export production. It is found that strong volcanic radiative forcing enhances the likelihood of eastern Pacific El Niño-like warming in CESM and LOVECLIM. This leads to an initial reduction of nutrients and export production in the eastern equatorial Pacific. However, this initial response reverses after about 3 years in association with La Niña cooling. The resulting delayed enhancement of biological production resembles the multiyear response in MIROC. The model simulations show that volcanic impacts on tropical Pacific dynamics and biogeochemistry persist for several years, thus providing a new source for potential multiyear ecosystem predictability.

  6. Molecular biology in studies of oceanic primary production

    SciTech Connect

    LaRoche, J.; Falkowski, P.G. ); Geider, R. . Coll. of Marine Studies)

    1992-01-01

    Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies.

  7. Molecular biology in studies of oceanic primary production

    SciTech Connect

    LaRoche, J.; Falkowski, P.G.; Geider, R.

    1992-07-01

    Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies.

  8. Natural products as a resource for biologically active compounds

    SciTech Connect

    Hanke, F.J.

    1986-01-01

    The goal of this study was to investigate various sources of biologically active natural products in an effort to identify the active pesticidal compounds involved. The study is divided into several parts. Chapter 1 contains a discussion of several new compounds from plant and animal sources. Chapter 2 introduces a new NMR technique. In section 2.1 a new technique for better utilizing the lanthanide relaxation agent Gd(fod)/sub 3/ is presented which allows the predictable removal of resonances without line broadening. Section 2.2 discusses a variation of this technique for use in an aqueous solvent by applying this technique towards identifying the binding sites of metals of biological interest. Section 2.3 presents an unambiguous /sup 13/C NMR assignment of melibiose. Chapter 3 deals with work relating to the molting hormone of most arthropods, 20-hydroxyecdysone. Section 3.1 discusses the use of two-dimensional NMR (2D NMR) to assign the /sup 1/H NMR spectrum of this biologically important compound. Section 3.2 presents a new application for Droplet countercurrent chromatography (DCCC). Chapter 4 presents a basic improvement to the commercial DCCC instrument that is currently being applied to future commercial instruments. Chapter 5 discusses a curious observation of the effects that two previously known compounds, nagilactone C and (-)-epicatechin, have on lettuce and rice and suggest a possible new role for the ubiquitous flavanol (-)-epicatechin in plants.

  9. Current studies on physiological functions and biological production of lactosucrose.

    PubMed

    Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

    2013-08-01

    Lactosucrose (O-β-D-galactopyranosyl-(1,4)-O-α-D-glucopyranosyl-(1,2)-β-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by β-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by β-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes. PMID:23828605

  10. Current studies on physiological functions and biological production of lactosucrose.

    PubMed

    Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

    2013-08-01

    Lactosucrose (O-β-D-galactopyranosyl-(1,4)-O-α-D-glucopyranosyl-(1,2)-β-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by β-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by β-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes.

  11. Systems biological approaches towards understanding cellulase production by Trichoderma reesei.

    PubMed

    Kubicek, Christian P

    2013-01-20

    Recent progress and improvement in "-omics" technologies has made it possible to study the physiology of organisms by integrated and genome-wide approaches. This bears the advantage that the global response, rather than isolated pathways and circuits within an organism, can be investigated ("systems biology"). The sequencing of the genome of Trichoderma reesei (teleomorph Hypocrea jecorina), a fungus that serves as a major producer of biomass-degrading enzymes for the use of renewable lignocellulosic material towards production of biofuels and biorefineries, has offered the possibility to study this organism and its enzyme production on a genome wide scale. In this review, I will highlight the use of genomics, transcriptomics, proteomics and metabolomics towards an improved and novel understanding of the biochemical processes that involve in the massive overproduction of secreted proteins.

  12. An overview of biological production of L-theanine.

    PubMed

    Mu, Wanmeng; Zhang, Tao; Jiang, Bo

    2015-01-01

    L-Theanine (γ-glutamylethylamide) is a unique non-protein amino acid that is naturally found in tea plants. It contributes to the umami taste and unique flavor to green tea infusion, and thus its content in tea leaves highly impacts the tea quality and price. In addition to the graceful taste, it has been proved to have many beneficial physiological effects, especially promoting relaxation and improving concentration and learning ability. Based on these promising advantages, L-theanine has been commercially developed as a valuable ingredient for use in food and beverages to improve and/or maintain human health. L-Theanine can be obtained by chemical synthesis or isolation from tea, while chemical synthesis of L-theanine is hard to be accepted by consumers and is not allowed to use in food industry, and isolation of L-theanine in high purity generally involves time-consuming, cost-ineffective, and complicated operational processes. Accordingly, the biological production of L-theanine has recently attracted much attention. Four kinds of bacterial enzymes, including L-glutamine synthetase, γ-glutamylmethylamide synthetase, γ-glutamyltranspeptidase, and L-glutaminase, have been characterized to have L-theanine-producing ability. Herein, an overview of recent studies on the biological production of L-theanine was presented.

  13. 37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the...

  14. 37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the...

  15. 37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the...

  16. 37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the...

  17. Biological evaluation of nanosilver incorporated cellulose pulp for hygiene products.

    PubMed

    Kavitha Sankar, P C; Ramakrishnan, Reshmi; Rosemary, M J

    2016-04-01

    Cellulose pulp has a visible market share in personal hygiene products such as sanitary napkins and baby diapers. However it offers good surface for growth of microorganisms. Huge amount of research is going on in developing hygiene products that do not initiate microbial growth. The objective of the present work is to produce antibacterial cellulose pulp by depositing silver nanopowder on the cellulose fiber. The silver nanoparticles used were of less than 100 nm in size and were characterised using transmission electron microscopy and X-ray powder diffraction studies. Antibacterial activity of the functionalized cellulose pulp was proved by JIS L 1902 method. The in-vitro cytotoxicity, in-vivo vaginal irritation and intracutaneous reactivity studies were done with silver nanopowder incorporated cellulose pulp for introducing a new value added product to the market. Cytotoxicity evaluation suggested that the silver nanoparticle incorporated cellulose pulp is non-cytotoxic. No irritation and skin sensitization were identified in animals tested with specific extracts prepared from the test material in the in-vivo experiments. The results indicated that the silver nanopowder incorporated cellulose pulp meets the requirements of the standard practices recommended for evaluating the biological reactivity and has good biocompatibility, hence can be classified as a safe hygiene product. PMID:26838891

  18. Biological production of monoethanolamine by engineered Pseudomonas putida S12.

    PubMed

    Foti, Mirjam; Médici, Rosario; Ruijssenaars, Harald J

    2013-09-10

    Pseudomonas putida S12 was engineered for the production of monoethanolamine (MEA) from glucose via the decarboxylation of the central metabolite L-serine, which is catalyzed by the enzyme L-serine decarboxylase (SDC). The host was first evaluated for its tolerance towards MEA as well as its endogenous ability to degrade this alkanolamine. Growth inhibition was observed at MEA concentrations above 100 mM, but growth was never completely arrested even at 750 mM of MEA. P. putida S12 was able to catabolize MEA in the absence of ammonia, but deletion of the eutBC genes that encode ethanolamine ammonia-lyase (EAL) enzyme sufficed to eliminate this capacity. For the biological production of MEA, the sdc genes from Arabidopsis thaliana (full-length and a truncated version) and Volvox carteri were expressed in P. putida S12. From 20 mM of glucose, negligible amounts of MEA were produced by P. putida S12 ΔeutBC expressing the sdc genes from A. thaliana and V. carteri. However, 0.07 mmol of MEA was obtained per g of cell dry weight of P. putida S12 ΔeutBC expressing the truncated variant of the A. thaliana SDC. When the medium was supplemented with L-serine (30 mM), MEA production increased to 1.25 mmol MEA g⁻¹ CDW, demonstrating that L-serine availability was limiting MEA production. PMID:23876477

  19. Suitability of Gray Water for Hydroponic Crop Production Following Biological and Physical Chemical and Biological Subsystems

    NASA Technical Reports Server (NTRS)

    Bubenheim, David L.; Harper, Lynn D.; Wignarajah, Kanapathipillai; Greene, Catherine

    1994-01-01

    The water present in waste streams from a human habitat must be recycled in Controlled Ecological Life Support Systems (CELSS) to limit resupply needs and attain self-sufficiency. Plants play an important role in providing food, regenerating air, and producing purified water via transpiration. However, we have shown that the surfactants present in hygiene waste water have acute toxic effects on plant growth (Bubenheim et al. 1994; Greene et al., 1994). These phytotoxic affects can be mitigated by allowing the microbial population on the root surface to degrade the surfactant, however, a significant suppression (several days) in crop performance is experienced prior to reaching sub-toxic surfactant levels and plant recovery. An effective alternative is to stabilize the microbial population responsible for degradation of the surfactant on an aerobic bioreactor and process the waste water prior to utilization in the hydroponic solution (Wisniewski and Bubenheim, 1993). A sensitive bioassay indicates that the surfactant phytotoxicity is suppressed by more than 90% within 5 hours of introduction of the gray water to the bioreactor; processing for more than 12 hours degrades more than 99% of the phytotoxin. Vapor Compression Distillation (VCD) is a physical / chemical method for water purification which employees sequential distillation steps to separate water from solids and to volatilize contaminants. The solids from the waste water are concentrated in a brine and the pure product water (70 - 90% of the total waste water volume depending on operating conditions) retains non of the phytotoxic effects. Results of the bioassay were used to guide evaluations of the suitability of recovered gray water following biological and VCD processing for hydroponic lettuce production in controlled environments. Lettuce crops were grown for 28 days with 100% of the input water supplied with recovered water from the biological processor or VCD. When compared with the growth of plants

  20. [Behavior therapy in sexual deviation].

    PubMed

    Schmieschek, H

    1977-12-01

    The author, after discussing theoretical aspects of the development and treatment of sexual deviations, describes methods of behavior therapy which when used in combination and by experienced clinicians will yield promising results. In addition, a number of cases are reported, and these indicate some special problems associated with the therapy of sexual deviations.

  1. Systems biology of recombinant protein production using Bacillus megaterium.

    PubMed

    Biedendieck, Rebekka; Borgmeier, Claudia; Bunk, Boyke; Stammen, Simon; Scherling, Christian; Meinhardt, Friedhelm; Wittmann, Christoph; Jahn, Dieter

    2011-01-01

    The Gram-negative bacterium Escherichia coli is the most widely used production host for recombinant proteins in both academia and industry. The Gram-positive bacterium Bacillus megaterium represents an increasingly used alternative for high yield intra- and extracellular protein synthesis. During the past two decades, multiple tools including gene expression plasmids and production strains have been developed. Introduction of free replicating and integrative plasmids into B. megaterium is possible via protoplasts transformation or transconjugation. Using His(6)- and StrepII affinity tags, the intra- or extracellular produced proteins can easily be purified in one-step procedures. Different gene expression systems based on the xylose controlled promoter P(xylA) and various phage RNA polymerase (T7, SP6, K1E) driven systems enable B. megaterium to produce up to 1.25g of recombinant protein per liter. Biomass concentrations of up to 80g/l can be achieved by high cell density cultivations in bioreactors. Gene knockouts and gene replacements in B. megaterium are possible via an optimized gene disruption system. For a safe application in industry, sporulation and protease-deficient as well as UV-sensitive mutants are available. With the help of the recently published B. megaterium genome sequence, it is possible to characterize bottle necks in the protein production process via systems biology approaches based on transcriptome, proteome, metabolome, and fluxome data. The bioinformatical platform (Megabac, http://www.megabac.tu-bs.de) integrates obtained theoretical and experimental data. PMID:21943898

  2. Biological production of ethanol from coal. Final report

    SciTech Connect

    Not Available

    1992-12-01

    Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H{sub 2}, CO{sub 2}, CH{sub 4} and sulfur gases, is first produced using traditional gasification techniques. The CO, CO{sub 2} and H{sub 2} are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the ``wild strain`` produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

  3. Production and decomposition of nitrous oxide during biological denitrification

    SciTech Connect

    Spector, M.

    1998-07-01

    Nitrate (NO{sub 3}) was reduced with methanol (MeOH) over denitrification-filter sludge in a closed reactor. The initial reaction product was nitrous oxide (N{sub 2}O). It accumulated to a maximum (N{sub 2}O{sub max}) and was then rapidly reduced to nitrogen (N{sub 2}). At the time of maximum accumulation (t{sub max}), 50 to 80% of the nitrate-nitrogen reduced was in the form of N{sub 2}O. These results led to a higher estimate of N{sub 2}O emission from biological denitrification than previously considered. The results also suggest the concept of a multistage anoxic reactor in which nitrate can be reduced to N{sub 2} with minimal emission of N{sub 2}O. The design would provide for retention of N{sub 2}O in the upstream stages and reduction of N{sub 2}O downstream.

  4. 9 CFR 112.9 - Biological products imported for research and evaluation.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A...

  5. 9 CFR 112.9 - Biological products imported for research and evaluation.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A...

  6. Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment.

    PubMed

    Fatehi, Leili; Hall, Ralph F

    2015-01-01

    Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges. This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value ofPOA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes

  7. 9 CFR 118.3 - Movement of detained biological products; Termination of detention.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological...

  8. 9 CFR 118.3 - Movement of detained biological products; Termination of detention.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological...

  9. 9 CFR 118.3 - Movement of detained biological products; Termination of detention.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological...

  10. 9 CFR 118.3 - Movement of detained biological products; Termination of detention.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological...

  11. 9 CFR 118.3 - Movement of detained biological products; Termination of detention.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological...

  12. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... serial or subserial of a veterinary biological product under the provisions of paragraph (a) or (b) of this section, veterinary biologics licensees or permittees shall: (1) Stop the preparation... veterinary biological product pending further instructions from APHIS. (2) Immediately, but no later than...

  13. 77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics...

  14. 76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In...

  15. Biological conversion of pyrolytic products to ethanol and lipids

    NASA Astrophysics Data System (ADS)

    Lian, Jieni

    Pyrolysis is a promising technology that can convert up to 75 % of lignocellulosic biomass into crude bio-oil. However, due to the complex chemical compositions of bio-oil, its further refining into fuels and high value chemicals faces great challenges. This dissertation research proposed new technologies for biological conversion of pyrolytic products derived from cellulose and hemicellulose, such as anhydrosugars and carbolic acids to fuels and chemicals. First, the pyrolytic anhydrosugars (chiefly levoglucosan (LG)) were hydrolysed into glucose followed by neutralization, detoxification and fermentation to produce ethanol by ethanogenetic yeast and lipids by oleaginous yeasts. Second, a novel process for the conversion of C1-C4 pyrolytic products to lipid with oleaginous yeasts was investigated. Third, oleaginous yeasts that can directly convert LG to lipids were studied and a recombined yeast with LG kinase was constructed for the direct convertion of LG into lipids. This allowed a reduction of existing process for LG fermentation from four steps into two steps and eliminated the need for acids and bases as well as the disposal of chemicals. The development of genetic modified organisms with LG kinase opens a promising avenue for the direct LG fermentation to produce a wide range of fuels and chemicals. The simplification of LG utilization process would enhance the economic viability of this technology.

  16. Biological hydrogen production measured in batch anaerobic respirometers.

    PubMed

    Logan, Bruce E; Oh, Sang-Eun; Kim, In S; Van Ginkel, Steven

    2002-06-01

    The biological production of hydrogen from the fermentation of different substrates was examined in batch tests using heat-shocked mixed cultures with two techniques: an intermittent pressure release method (Owen method) and a continuous gas release method using a bubble measurement device (respirometric method). Under otherwise identical conditions, the respirometric method resulted in the production of 43% more hydrogen gas from glucose than the Owen method. The lower conversion of glucose to hydrogen using the Owen protocol may have been produced by repression of hydrogenase activity from high partial pressures in the gastight bottles, but this could not be proven using a thermodynamic/rate inhibition analysis. In the respirometric method, total pressure in the headspace never exceeded ambient pressure, and hydrogen typically composed as much as 62% of the headspace gas. High conversion efficiencies were consistently obtained with heat-shocked soils taken at different times and those stored for up to a month. Hydrogen gas composition was consistently in the range of 60-64% for glucose-grown cultures during logarithmic growth but declined in stationary cultures. Overall, hydrogen conversion efficiencies for glucose cultures were 23% based on the assumption of a maximum of 4 mol of hydrogen/ mol of glucose. Hydrogen conversion efficiencies were similar for sucrose (23%) and somewhat lower for molasses (15%) but were much lower for lactate (0.50%) and cellulose (0.075%).

  17. Competency development in antibody production in cancer cell biology

    SciTech Connect

    Park, M.S.

    1998-12-01

    This is the final report of a three-year, Laboratory Directed Research and Development (LDRD) project at Los Alamos National Laboratory (LANL). The main objective of this project was to develop a rapid recombinant antibody production technology. To achieve the objective, the authors employed (1) production of recombinant antigens that are important for cell cycle regulation and DNA repair, (2) immunization and specific selection of antibody-producing lymphocytes using the flow cytometry and magnetic bead capturing procedure, (3) construction of single chain antibody library, (4) development of recombinant vectors that target, express, and regulate the expression of intracellular antibodies, and (5) specific inhibition of tumor cell growth in tissue culture. The authors have accomplished (1) optimization of a selection procedure to isolate antigen-specific lymphocytes, (2) optimization of the construction of a single-chain antibody library, and (3) development of a new antibody expression vector for intracellular immunization. The future direction of this research is to continue to test the potential use of the intracellular immunization procedure as a tool to study functions of biological molecules and as an immuno-cancer therapy procedure to inhibit the growth of cancer cells.

  18. Biological risks associated with consumption of reptile products.

    PubMed

    Magnino, Simone; Colin, Pierre; Dei-Cas, Eduardo; Madsen, Mogens; McLauchlin, Jim; Nöckler, Karsten; Maradona, Miguel Prieto; Tsigarida, Eirini; Vanopdenbosch, Emmanuel; Van Peteghem, Carlos

    2009-09-15

    The consumption of a wide variety of species of reptiles caught from the wild has been an important source of protein for humans world-wide for millennia. Terrapins, snakes, lizards, crocodiles and iguanas are now farmed and the consumption and trade of their meat and other edible products have recently increased in some areas of the world. Biological risks associated with the consumption of products from both farmed and wild reptile meat and eggs include infections caused by bacteria (Salmonella spp., Vibrio spp.), parasites (Spirometra, Trichinella, Gnathostoma, pentastomids), as well as intoxications by biotoxins. For crocodiles, Salmonella spp. constitute a significant public health risk due to the high intestinal carrier rate which is reflected in an equally high contamination rate in their fresh and frozen meat. There is a lack of information about the presence of Salmonella spp. in meat from other edible reptilians, though captive reptiles used as pets (lizards or turtles) are frequently carriers of these bacteria in Europe. Parasitic protozoa in reptiles represent a negligible risk for public health compared to parasitic metazoans, of which trichinellosis, pentastomiasis, gnathostomiasis and sparganosis can be acquired through consumption of contaminated crocodile, monitor lizard, turtle and snake meat, respectively. Other reptiles, although found to harbour the above parasites, have not been implicated with their transmission to humans. Freezing treatment inactivates Spirometra and Trichinella in crocodile meat, while the effectiveness of freezing of other reptilian meat is unknown. Biotoxins that accumulate in the flesh of sea turtles may cause chelonitoxism, a type of food poisoning with a high mortality rate in humans. Infections by fungi, including yeasts, and viruses widely occur in reptiles but have not been linked to a human health risk through the contamination of their meat. Currently there are no indications that natural transmissible spongiform

  19. Sustainable production of biologically active molecules of marine based origin.

    PubMed

    Murray, Patrick M; Moane, Siobhan; Collins, Catherine; Beletskaya, Tanya; Thomas, Olivier P; Duarte, Alysson W F; Nobre, Fernando S; Owoyemi, Ifeloju O; Pagnocca, Fernando C; Sette, L D; McHugh, Edward; Causse, Eric; Pérez-López, Paula; Feijoo, Gumersindo; Moreira, Ma T; Rubiolo, Juan; Leirós, Marta; Botana, Luis M; Pinteus, Susete; Alves, Celso; Horta, André; Pedrosa, Rui; Jeffryes, Clayton; Agathos, Spiros N; Allewaert, Celine; Verween, Annick; Vyverman, Wim; Laptev, Ivan; Sineoky, Sergei; Bisio, Angela; Manconi, Renata; Ledda, Fabio; Marchi, Mario; Pronzato, Roberto; Walsh, Daniel J

    2013-09-25

    The marine environment offers both economic and scientific potential which are relatively untapped from a biotechnological point of view. These environments whilst harsh are ironically fragile and dependent on a harmonious life form balance. Exploitation of natural resources by exhaustive wild harvesting has obvious negative environmental consequences. From a European industry perspective marine organisms are a largely underutilised resource. This is not due to lack of interest but due to a lack of choice the industry faces for cost competitive, sustainable and environmentally conscientious product alternatives. Knowledge of the biotechnological potential of marine organisms together with the development of sustainable systems for their cultivation, processing and utilisation are essential. In 2010, the European Commission recognised this need and funded a collaborative RTD/SME project under the Framework 7-Knowledge Based Bio-Economy (KBBE) Theme 2 Programme 'Sustainable culture of marine microorganisms, algae and/or invertebrates for high value added products'. The scope of that project entitled 'Sustainable Production of Biologically Active Molecules of Marine Based Origin' (BAMMBO) is outlined. Although the Union is a global leader in many technologies, it faces increasing competition from traditional rivals and emerging economies alike and must therefore improve its innovation performance. For this reason innovation is placed at the heart of a European Horizon 2020 Strategy wherein the challenge is to connect economic performance to eco performance. This article provides a synopsis of the research activities of the BAMMBO project as they fit within the wider scope of sustainable environmentally conscientious marine resource exploitation for high-value biomolecules.

  20. Maximizing overall liking results in a superior product to minimizing deviations from ideal ratings: an optimization case study with coffee-flavored milk

    PubMed Central

    Li, Bangde; Hayes, John E.; Ziegler, Gregory R.

    2015-01-01

    In just-about-right (JAR) scaling and ideal scaling, attribute delta (i.e., “Too Little” or “Too Much”) reflects a subject’s dissatisfaction level for an attribute relative to their hypothetical ideal. Dissatisfaction (attribute delta) is a different construct from consumer acceptability, operationalized as liking. Therefore, we hypothesized minimizing dissatisfaction and maximizing liking would yield different optimal formulations. The objective of this research was to compare product optimization strategies, i.e. maximizing liking vis-à-vis minimizing dissatisfaction. Coffee-flavored dairy beverages (n = 20) were formulated using a fractional mixture design that constrained the proportions of coffee extract, milk, sucrose, and water. Participants (n = 388) were randomly assigned to one of three research conditions, where they evaluated 4 of the 20 samples using an incomplete block design. Samples were rated for overall liking and for intensity of the attributes sweetness, milk flavor, thickness and coffee flavor. Where appropriate, measures of overall product quality (Ideal_Delta and JAR_Delta) were calculated as the sum of the absolute values of the four attribute deltas. Optimal formulations were estimated by: a) maximizing liking; b) minimizing Ideal_Delta; or c) minimizing JAR_Delta. A validation study was conducted to evaluate product optimization models. Participants indicated a preference for a coffee-flavored dairy beverage with more coffee extract and less milk and sucrose in the dissatisfaction model compared to the formula obtained by maximizing liking. That is, when liking was optimized, participants generally liked a weaker, milkier and sweeter coffee-flavored dairy beverage. Predicted liking scores were validated in a subsequent experiment, and the optimal product formulated to maximize liking was significantly preferred to that formulated to minimize dissatisfaction by a paired preference test. These findings are consistent with the view

  1. [Design and construction of artificial biological systems for complex natural products biosynthesis].

    PubMed

    Wang, Jianfeng; Meng, Hailin; Xiong, Zhiqiang; Wang, Yong

    2013-08-01

    Natural products (NPs) are important drug pools for human disease prevention and treatment. The great advances in synthetic biology have greatly revolutionized the strategies of NPs development and production. This review entitled with design and construction of artificial biological systems for complex NPs biosynthesis, mainly introduced the progresses in artificial design of synthetic biological parts, naturally mining novel synthetic parts of NPs, the assembly & adaption of the artificial biological modules & systems.

  2. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from...

  3. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from...

  4. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from...

  5. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from...

  6. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from...

  7. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS §...

  8. Development of biological platform for the autotrophic production of biofuels

    NASA Astrophysics Data System (ADS)

    Khan, Nymul

    The research described herein is aimed at developing an advanced biofuel platform that has the potential to surpass the natural rate of solar energy capture and CO2 fixation. The underlying concept is to use the electricity from a renewable source, such as wind or solar, to capture CO 2 via a biological agent, such as a microbe, into liquid fuels that can be used for the transportation sector. In addition to being renewable, the higher rate of energy capture by photovoltaic cells than natural photosynthesis is expected to facilitate higher rate of liquid fuel production than traditional biofuel processes. The envisioned platform is part of ARPA-E's (Advanced Research Projects Agency - Energy) Electrofuels initiative which aims at supplementing the country's petroleum based fuel production with renewable liquid fuels that can integrate easily with the existing refining and distribution infrastructure (http://arpae. energy.gov/ProgramsProjects/Electrofuels.aspx). The Electrofuels initiative aimed to develop liquid biofuels that avoid the issues encountered in the current generation of biofuels: (1) the reliance of biomass-derived technologies on the inefficient process of photosynthesis, (2) the relatively energy- and resource-intensive nature of agronomic processes, and (3) the occupation of large areas of arable land for feedstock production. The process proceeds by the capture of solar energy into electrical energy via photovoltaic cells, using the generated electricity to split water into molecular hydrogen (H2) and oxygen (O2), and feeding these gases, along with carbon dioxide (CO2) emitted from point sources such as a biomass or coal-fired power plant, to a microbial bioprocessing platform. The proposed microbial bioprocessing platform leverages a chemolithoautotrophic microorganism (Rhodobacter capsulatus or Ralstonia eutropha) naturally able to utilize these gases as growth substrates, and genetically modified to produce a triterpene hydrocarbon fuel

  9. Biological evaluation of recombinant human erythropoietin in pharmaceutical products.

    PubMed

    Ramos, A S; Schmidt, C A; Andrade, S S; Fronza, M; Rafferty, B; Dalmora, S L

    2003-11-01

    The potencies of mammalian cell-derived recombinant human erythropoietin pharmaceutical preparations, from a total of five manufacturers, were assessed by in vivo bioassay using standardized protocols. Eight-week-old normocythemic mice received a single subcutaneous injection followed by blood sampling 96 h later or multiple daily injections with blood sampling 24 h after the last injection. Reticulocyte counting by microscopic examination was employed as the end-point using the brilliant cresyl blue or selective hemolysis methods, together with automated flow cytometry. Different injection schedules were investigated and dose-response curves for the European Pharmacopoeia Biological Reference Preparation of erythropoietin were compared. Manual and automated methods of reticulocyte counting were correlated with respect to assay validity and precision. Using 8 mice per treatment group, intra-assay precision determined for all of the assays in the study showed coefficients of variation of 12.1-28.4% for the brilliant cresyl blue method, 14.1-30.8% for the selective hemolysis method and 8.5-19.7% for the flow cytometry method. Applying the single injection protocol, a combination of at least two independent assays was required to achieve the precision potency and confidence limits indicated by the manufacturers, while the multiple daily injection protocol yielded the same acceptable results within a single assay. Although the latter protocol using flow cytometry for reticulocyte counting gave more precise and reproducible results (intra-assay coefficients of variation: 5.9-14.2%), the well-characterized manual methods provide equally valid alternatives for the quality control of recombinant human erythropoietin therapeutic products.

  10. Volatilization and efflux of mercury from biologically productive ocean regions

    SciTech Connect

    Kim, J.P.

    1987-01-01

    Mercury volatilization and oceanic evasion to the atmosphere were investigated in the tropical Pacific Ocean with emphasis on the biologically productive equatorial region. Further studies were conducted at two stations in the oligiotrophic North Pacific gyre, and in the estuarine mesocosms at the Marine Ecosystems Research Laboratory (MERL), University of Rhode Island. Dissolved gaseous Hg (DGM) in the tropical Pacific along 150/degree/ W at 4 stations ranged from 35-85 femtomoles per liter (fM) in surface waters and from 105-185 fM in deeper waters. Speciation experiments indicated that Hg/degree/was the dominant form in surface waters, while evidence for (CH/sub 3/)/sub 2/Hg was found at depth. In equatorial Pacific surface waters, DGM varied between 60 and 225 fM. Elemental Hg appears to comprise the major fraction of DGM. Elevated DGM concentrations corresponded with increased chlorophyll a levels and cooler, nutrient-rich waters. Surface waters of the equatorial Pacific were supersaturated with respect to Hg/degree/. Local Hg effluxes, estimated with a thin-film gas exchange model, were between 225 and 1050 pmoles/m/sup 2/ day. The annual Hg efflux from the equatorial Pacific, 1.6 /+-/ 1.3 /times/ 10/sup +6/ moles, was estimated at 4-5% of the total global Hg flux to the atmosphere. Dissolved gaseous Hg in the MERL mesocosms ranged from less than or equal to30 to 185 fM. In general, Hg/degree/ was the principal species, although (CH/sub 3/)/sub 2/minus// Hg was detected twice. Supersaturated levels of Hg/degrees/ corresponded with phytoplankton blooms of Cerataulina pelagica, Leptocylindrus danicus, Leptocylindrus mimimus, and Phaeocystis poucheti, suggesting that these phytoplankton could volatilize Hg in estuarine waters.

  11. Volatilization and Efflux of Mercury from Biologically Productive Ocean Regions.

    NASA Astrophysics Data System (ADS)

    Kim, Jonathan Philip

    Mercury volatilization and oceanic evasion to the atmosphere were investigated in the tropical Pacific Ocean with emphasis on the biologically productive equatorial region. Further studies were conducted at two stations in the oligiotrophic North Pacific gyre, and in the estuarine mesocosms at the Marine Ecosystems Research Laboratory (MERL), University of Rhode Island. Dissolved gaseous Hg (DGM) in the tropical Pacific along 150^circ W at 4 stations (10^circ N, 0^ circ, 5^circ S, 12^circ S) ranged from 35-85 femtomoles per liter (fM) in surface waters and from 105-185 fM in deeper waters (350-400 meters). Speciation experiments indicated that Hg^circ was the dominant form in surface waters, while evidence for (CH_3)_2Hg was found at depth. The increases of DGM with depth are consistent with a volatile Hg source in deeper waters. A significant correlation between DGM and apparent oxygen utilization (n = 23, r = 0.694) suggested bacterial methylation of Hg in the oxygen minimum zone. In equatorial Pacific surface waters (155-95 ^circ W), DGM varied between 60 and 225 fM. Elemental Hg appears to comprise the major fraction of DGM. Elevated DGM concentrations corresponded with increased chlorophyll a levels and cooler, nutrient-rich waters. These results suggest that phytoplankton might volatilize Hg in surface seawater or bacteria could produce Hg^circ in deeper waters which upwell to the sea surface. Surface waters of the equatorial Pacific were supersaturated with respect to Hg^circ (179-1769%). Local Hg effluxes, estimated with a thin-film gas exchange model, were between 225 and 1050 pmoles/m^2day. The anual Hg efflux from the equatorial Pacific, 1.6 +/- 1.3 times 10^{+6 } moles (megamoles), was estimated at 4-5% of the total global Hg flux to the atmosphere. When normalized to primary production, a yearly Hg efflux of 14 +/- 9 megamoles was predicted for the oceans. This is about 35% of the annual atmospheric Hg flux and is comparable to human-derived Hg

  12. 75 FR 47605 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends...

  13. Development of biological platform for the autotrophic production of biofuels

    NASA Astrophysics Data System (ADS)

    Khan, Nymul

    The research described herein is aimed at developing an advanced biofuel platform that has the potential to surpass the natural rate of solar energy capture and CO2 fixation. The underlying concept is to use the electricity from a renewable source, such as wind or solar, to capture CO 2 via a biological agent, such as a microbe, into liquid fuels that can be used for the transportation sector. In addition to being renewable, the higher rate of energy capture by photovoltaic cells than natural photosynthesis is expected to facilitate higher rate of liquid fuel production than traditional biofuel processes. The envisioned platform is part of ARPA-E's (Advanced Research Projects Agency - Energy) Electrofuels initiative which aims at supplementing the country's petroleum based fuel production with renewable liquid fuels that can integrate easily with the existing refining and distribution infrastructure (http://arpae. energy.gov/ProgramsProjects/Electrofuels.aspx). The Electrofuels initiative aimed to develop liquid biofuels that avoid the issues encountered in the current generation of biofuels: (1) the reliance of biomass-derived technologies on the inefficient process of photosynthesis, (2) the relatively energy- and resource-intensive nature of agronomic processes, and (3) the occupation of large areas of arable land for feedstock production. The process proceeds by the capture of solar energy into electrical energy via photovoltaic cells, using the generated electricity to split water into molecular hydrogen (H2) and oxygen (O2), and feeding these gases, along with carbon dioxide (CO2) emitted from point sources such as a biomass or coal-fired power plant, to a microbial bioprocessing platform. The proposed microbial bioprocessing platform leverages a chemolithoautotrophic microorganism (Rhodobacter capsulatus or Ralstonia eutropha) naturally able to utilize these gases as growth substrates, and genetically modified to produce a triterpene hydrocarbon fuel

  14. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous...

  15. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous...

  16. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous...

  17. Standard Deviation for Small Samples

    ERIC Educational Resources Information Center

    Joarder, Anwar H.; Latif, Raja M.

    2006-01-01

    Neater representations for variance are given for small sample sizes, especially for 3 and 4. With these representations, variance can be calculated without a calculator if sample sizes are small and observations are integers, and an upper bound for the standard deviation is immediate. Accessible proofs of lower and upper bounds are presented for…

  18. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... products for mass administration (including but not limited to administration through drinking water and... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND...

  19. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... products for mass administration (including but not limited to administration through drinking water and... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND...

  20. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL... Administrator may require in order to assess the product's impact on the environment....

  1. 21 CFR 510.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Biologics; products subject to license control. 510.4 Section 510.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Biologics; products subject to license control. An animal drug produced and distributed in full...

  2. 21 CFR 510.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Biologics; products subject to license control. 510.4 Section 510.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Biologics; products subject to license control. An animal drug produced and distributed in full...

  3. 21 CFR 510.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Biologics; products subject to license control. 510.4 Section 510.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Biologics; products subject to license control. An animal drug produced and distributed in full...

  4. 21 CFR 310.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS General Provisions § 310.4 Biologics; products...

  5. 78 FR 58311 - Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... HUMAN SERVICES Food and Drug Administration Complex Issues in Developing Drug and Biological Products... announcing the following public workshop entitled ``Complex Issues in Developing Drug and Biological Products for Rare Diseases.'' The purpose of the public workshop is twofold: To discuss complex issues...

  6. 76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review,...

  7. 78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for...

  8. 78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... of Retroviruses and Laboratory of Immunoregulation, Division of Viral Products, Office of...

  9. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-08

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and...

  10. 77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-18

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... lines derived from human tumors for vaccine manufacture. FDA intends to make background...

  11. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season....

  12. 76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research...

  13. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of July 22, 2011 (76 FR... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory...

  14. 77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November...

  15. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends...

  16. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION... authorize a licensee to reprocess a serial of completed product subject to the conditions prescribed in this... conducted on the reprocessed product. A serial found unsatisfactory by a required test shall not be...

  17. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION... authorize a licensee to reprocess a serial of completed product subject to the conditions prescribed in this... conducted on the reprocessed product. A serial found unsatisfactory by a required test shall not be...

  18. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Plant Health Inspection Service that such product is eligible for release. Production records shall show....17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  19. 48 CFR 801.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations. 801... Individual deviations. (a) Authority to authorize individual deviations from the FAR and VAAR is delegated to... nature of the deviation. (d) The DSPE may authorize individual deviations from the FAR and VAAR when...

  20. 48 CFR 2001.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2001... Individual deviations. In individual cases, deviations from either the FAR or the NRCAR will be authorized... deviations clearly in the best interest of the Government. Individual deviations must be authorized...

  1. Perception of aircraft Deviation Cues

    NASA Technical Reports Server (NTRS)

    Martin, Lynne; Azuma, Ronald; Fox, Jason; Verma, Savita; Lozito, Sandra

    2005-01-01

    To begin to address the need for new displays, required by a future airspace concept to support new roles that will be assigned to flight crews, a study of potentially informative display cues was undertaken. Two cues were tested on a simple plan display - aircraft trajectory and flight corridor. Of particular interest was the speed and accuracy with which participants could detect an aircraft deviating outside its flight corridor. Presence of the trajectory cue significantly reduced participant reaction time to a deviation while the flight corridor cue did not. Although non-significant, the flight corridor cue seemed to have a relationship with the accuracy of participants judgments rather than their speed. As this is the second of a series of studies, these issues will be addressed further in future studies.

  2. 9 CFR 112.9 - Biological products imported for research and evaluation.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND...

  3. 9 CFR 112.9 - Biological products imported for research and evaluation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND...

  4. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false U.S. Veterinary Biological Product License. 102.5 Section 102.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES...

  5. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false U.S. Veterinary Biological Product License. 102.5 Section 102.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES...

  6. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false U.S. Veterinary Biological Product License. 102.5 Section 102.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES...

  7. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF...

  8. 9 CFR 112.9 - Biological products imported for research and evaluation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND...

  9. Synthetic biology for microbial production of lipid-based biofuels.

    PubMed

    d'Espaux, Leo; Mendez-Perez, Daniel; Li, Rachel; Keasling, Jay D

    2015-12-01

    The risks of maintaining current CO2 emission trends have led to interest in producing biofuels using engineered microbes. Microbial biofuels reduce emissions because CO2 produced by fuel combustion is offset by CO2 captured by growing biomass, which is later used as feedstock for biofuel fermentation. Hydrocarbons found in petroleum fuels share striking similarity with biological lipids. Here we review synthetic metabolic pathways based on fatty acid and isoprenoid metabolism to produce alkanes and other molecules suitable as biofuels. We further discuss engineering strategies to optimize engineered biosynthetic routes, as well as the potential of synthetic biology for sustainable manufacturing.

  10. 48 CFR 401.404 - Class deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ACQUISITION REGULATION SYSTEM Deviations From the FAR and AGAR 401.404 Class deviations. Where deviations from the FAR or AGAR are considered necessary for classes of contracts, requests for authority to...

  11. 48 CFR 401.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ACQUISITION REGULATION SYSTEM Deviations From the FAR and AGAR 401.404 Class deviations. Where deviations from the FAR or AGAR are considered necessary for classes of contracts, requests for authority to...

  12. Biological production of ethanol from waste gases with Clostridium ljungdahlii

    DOEpatents

    Gaddy, James L.

    2000-01-01

    A method and apparatus for converting waste gases from industrial processes such as oil refining, carbon black, coke, ammonia, and methanol production, into useful products is disclosed. The method includes introducing the waste gases into a bioreactor where they are fermented to various product, such as organic acids, alcohols H.sub.2, SCP, and salts of organic acids by anaerobic bacteria within the bioreactor. These valuable end products are then recovered, separated and purified.

  13. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION... section. (a) All or part of a serial which has not left the licensed establishment may be aseptically... product shall be adequately identified by serial number or subserial number, as the case may be....

  14. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION... section. (a) All or part of a serial which has not left the licensed establishment may be aseptically... product shall be adequately identified by serial number or subserial number, as the case may be....

  15. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION... for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The...

  16. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture... bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products,...

  17. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture... bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products,...

  18. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture... bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products,...

  19. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture... bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products,...

  20. Sex Roles: A Product of Socialization or a Biological Heritage.

    ERIC Educational Resources Information Center

    Shaha, Steven H.

    This paper reviews selected studies of aggression in males and females and concludes that physiological, emotional and behavioral differences exist between the sexes. Primate studies, conducted by Harlow, are employed as evidence that sex differences in aggression are primarily biological and not primarily cultural phenomena. It is further…

  1. Importance of systems biology in engineering microbes for biofuel production

    SciTech Connect

    Mukhopadhyay, Aindrila; Redding, Alyssa M.; Rutherford, Becky J.; Keasling, Jay D.

    2009-12-02

    Microorganisms have been rich sources for natural products, some of which have found use as fuels, commodity chemicals, specialty chemicals, polymers, and drugs, to name a few. The recent interest in production of transportation fuels from renewable resources has catalyzed numerous research endeavors that focus on developing microbial systems for production of such natural products. Eliminating bottlenecks in microbial metabolic pathways and alleviating the stresses due to production of these chemicals are crucial in the generation of robust and efficient production hosts. The use of systems-level studies makes it possible to comprehensively understand the impact of pathway engineering within the context of the entire host metabolism, to diagnose stresses due to product synthesis, and provides the rationale to cost-effectively engineer optimal industrial microorganisms.

  2. 9 CFR 114.6 - Mixing biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR... constantly mixed sufficient to maintain physical uniformity of the entire fill. A serial number, with any other markings that may be necessary for ready identification of the serial, shall be applied...

  3. 9 CFR 114.6 - Mixing biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR... constantly mixed sufficient to maintain physical uniformity of the entire fill. A serial number, with any other markings that may be necessary for ready identification of the serial, shall be applied...

  4. Strategies for optimizing algal biology for enhanced biomass production

    SciTech Connect

    Barry, Amanda N.; Starkenburg, Shawn R.; Sayre, Richard T.

    2015-02-02

    One of the most environmentally sustainable ways to produce high-energy density (oils) feed stocks for the production of liquid transportation fuels is from biomass. Photosynthetic carbon capture combined with biomass combustion (point source) and subsequent carbon capture and sequestration has also been proposed in the intergovernmental panel on climate change report as one of the most effective and economical strategies to remediate atmospheric greenhouse gases. To maximize photosynthetic carbon capture efficiency and energy-return-on-investment, we must develop biomass production systems that achieve the greatest yields with the lowest inputs. Numerous studies have demonstrated that microalgae have among the greatest potentials for biomass production. This is in part due to the fact that all alga cells are photoautotrophic, they have active carbon concentrating mechanisms to increase photosynthetic productivity, and all the biomass is harvestable unlike plants. All photosynthetic organisms, however, convert only a fraction of the solar energy they capture into chemical energy (reduced carbon or biomass). To increase aerial carbon capture rates and biomass productivity, it will be necessary to identify the most robust algal strains and increase their biomass production efficiency often by genetic manipulation. We review recent large-scale efforts to identify the best biomass producing strains and metabolic engineering strategies to improve aerial productivity. In addition, these strategies include optimization of photosynthetic light-harvesting antenna size to increase energy capture and conversion efficiency and the potential development of advanced molecular breeding techniques. To date, these strategies have resulted in up to twofold increases in biomass productivity.

  5. Biology Needs a Modern Assessment System for Professional Productivity

    ERIC Educational Resources Information Center

    McDade, Lucinda A.; Maddison, David R.; Guralnick, Robert; Piwowar, Heather A.; Jameson, Mary Liz; Helgen, Kristofer M.; Herendeen, Patrick S.; Hill, Andrew; Vis, Morgan L.

    2011-01-01

    Stimulated in large part by the advent of the Internet, research productivity in many academic disciplines has changed dramatically over the last two decades. However, the assessment system that governs professional success has not kept pace, creating a mismatch between modes of scholarly productivity and academic assessment criteria. In this…

  6. Large deviations and portfolio optimization

    NASA Astrophysics Data System (ADS)

    Sornette, Didier

    Risk control and optimal diversification constitute a major focus in the finance and insurance industries as well as, more or less consciously, in our everyday life. We present a discussion of the characterization of risks and of the optimization of portfolios that starts from a simple illustrative model and ends by a general functional integral formulation. A major item is that risk, usually thought of as one-dimensional in the conventional mean-variance approach, has to be addressed by the full distribution of losses. Furthermore, the time-horizon of the investment is shown to play a major role. We show the importance of accounting for large fluctuations and use the theory of Cramér for large deviations in this context. We first treat a simple model with a single risky asset that exemplifies the distinction between the average return and the typical return and the role of large deviations in multiplicative processes, and the different optimal strategies for the investors depending on their size. We then analyze the case of assets whose price variations are distributed according to exponential laws, a situation that is found to describe daily price variations reasonably well. Several portfolio optimization strategies are presented that aim at controlling large risks. We end by extending the standard mean-variance portfolio optimization theory, first within the quasi-Gaussian approximation and then using a general formulation for non-Gaussian correlated assets in terms of the formalism of functional integrals developed in the field theory of critical phenomena.

  7. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A...

  8. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A...

  9. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A...

  10. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A...

  11. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A...

  12. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND...

  13. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND...

  14. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND...

  15. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND...

  16. Synoptic events force biological productivity in Patagonian fjord ecosystems

    NASA Astrophysics Data System (ADS)

    Daneri, Giovanni

    2016-04-01

    The annual cycle of primary productivity of the Patagonian fjords has, to date, been described as a two phase system consisting of a short non productive winter phase (during June and July) and a productive phase extending from late winter (August) to autumn (May). Low levels of primary production, phytoplankton biomass and high concentrations of surface nutrients have been described as characterizing winter conditions while pulsed productivity events typifies the productivity pattern during the extended productive season. Pulsed productivity events characterize coastal waters where inorganic nutrients in surface layers are replenished following periods of intensive utilization by autotrophs. Freshwater input in Patagonian fjords in southern Chile (41-55°S) results in one of the largest estuarine regions worldwide. Here strong haline water column stratification prevents nutrient mixing to the surface layers thus potentially shutting off algal production. Our working hypothesis considered that in order to reconcile the observed pulsed productivity pattern, periodic breaking (associated to surface nutrient replenishment) and re-establishment of estuarine conditions (associated to water column stratification) would be required. Up to now however our understanding of the physical processes that control water column conditions in the Patagonian fjord area has been extremely limited. Here we present evidence linking the passage of synoptic low pressure fronts to pulsed productivity events in the Patagonian fjord area. These front controls and influence local processes of interaction between the fjord and the atmosphere generating a rapid water column response. In the specific case of the Puyuhuapi fjord we have been able to show that such synoptic fronts induce surface flow reversal and water column mixing. Phytoplankton blooming occurs after the passage of the synoptic front once calmer conditions prevail and estuarine conditions are re established. The occurrence of

  17. 48 CFR 1501.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Class deviations. 1501.404 Section 1501.404 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY GENERAL GENERAL Deviations 1501.404 Class deviations. Requests for class deviations to the FAR and the EPAAR shall...

  18. 48 CFR 401.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... AGRICULTURE ACQUISITION REGULATION SYSTEM Deviations From the FAR and AGAR 401.403 Individual deviations. In individual cases, deviations from either the FAR or the AGAR will be authorized only when essential to effect... AGAR, after coordinating with the General Counsel and the SPE. No deviations from the FAR or AGAR...

  19. 48 CFR 401.403 - Individual deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... AGRICULTURE ACQUISITION REGULATION SYSTEM Deviations From the FAR and AGAR 401.403 Individual deviations. In individual cases, deviations from either the FAR or the AGAR will be authorized only when essential to effect... AGAR, after coordinating with the General Counsel and the SPE. No deviations from the FAR or AGAR...

  20. 48 CFR 2401.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2401... DEVELOPMENT GENERAL FEDERAL ACQUISITION REGULATION SYSTEM Deviations 2401.403 Individual deviations. In individual cases, proposed deviations from the FAR or HUDAR shall be submitted to the Senior...

  1. 48 CFR 501.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 501... Individual deviations. (a) An individual deviation affects only one contract action. (1) The Head of the Contracting Activity (HCA) must approve an individual deviation to the FAR. The authority to grant...

  2. 48 CFR 1301.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations... DEPARTMENT OF COMMERCE ACQUISITION REGULATIONS SYSTEM Deviations From the FAR 1301.403 Individual deviations. The designee authorized to approve individual deviations from the FAR is set forth in CAM 1301.70....

  3. 48 CFR 1501.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 1501.403 Section 1501.403 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY GENERAL GENERAL Deviations 1501.403 Individual deviations. Requests for individual deviations from the FAR and...

  4. 48 CFR 2801.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2801... OF JUSTICE ACQUISITION REGULATIONS SYSTEM Deviations From the FAR and JAR 2801.403 Individual deviations. Individual deviations from the FAR or the JAR shall be approved by the head of the...

  5. 48 CFR 301.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 301... ACQUISITION REGULATION SYSTEM Deviations From the FAR 301.403 Individual deviations. Contracting activities shall prepare requests for individual deviations to either the FAR or HHSAR in accordance with 301.470....

  6. 10 CFR 602.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... proposed deviation from this part would be a deviation from 10 CFR part 600, the deviation must also be... 10 Energy 4 2010-01-01 2010-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL...

  7. 9 CFR 115.2 - Inspections of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS INSPECTIONS... excuse any person from compliance with the Virus-Serum-Toxin Act. (Approved by the Office of...

  8. 9 CFR 115.2 - Inspections of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS INSPECTIONS... excuse any person from compliance with the Virus-Serum-Toxin Act. (Approved by the Office of...

  9. 9 CFR 115.2 - Inspections of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS INSPECTIONS... excuse any person from compliance with the Virus-Serum-Toxin Act. (Approved by the Office of...

  10. 9 CFR 115.2 - Inspections of biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS INSPECTIONS... excuse any person from compliance with the Virus-Serum-Toxin Act. (Approved by the Office of...

  11. 75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using...

  12. Strategies for optimizing algal biology for enhanced biomass production

    DOE PAGESBeta

    Barry, Amanda N.; Starkenburg, Shawn R.; Sayre, Richard T.

    2015-02-02

    One of the most environmentally sustainable ways to produce high-energy density (oils) feed stocks for the production of liquid transportation fuels is from biomass. Photosynthetic carbon capture combined with biomass combustion (point source) and subsequent carbon capture and sequestration has also been proposed in the intergovernmental panel on climate change report as one of the most effective and economical strategies to remediate atmospheric greenhouse gases. To maximize photosynthetic carbon capture efficiency and energy-return-on-investment, we must develop biomass production systems that achieve the greatest yields with the lowest inputs. Numerous studies have demonstrated that microalgae have among the greatest potentials formore » biomass production. This is in part due to the fact that all alga cells are photoautotrophic, they have active carbon concentrating mechanisms to increase photosynthetic productivity, and all the biomass is harvestable unlike plants. All photosynthetic organisms, however, convert only a fraction of the solar energy they capture into chemical energy (reduced carbon or biomass). To increase aerial carbon capture rates and biomass productivity, it will be necessary to identify the most robust algal strains and increase their biomass production efficiency often by genetic manipulation. We review recent large-scale efforts to identify the best biomass producing strains and metabolic engineering strategies to improve aerial productivity. In addition, these strategies include optimization of photosynthetic light-harvesting antenna size to increase energy capture and conversion efficiency and the potential development of advanced molecular breeding techniques. To date, these strategies have resulted in up to twofold increases in biomass productivity.« less

  13. Biological Methanol Production by a Type II Methanotroph Methylocystis bryophila.

    PubMed

    Patel, Sanjay K S; Mardina, Primata; Kim, Sang-Yong; Lee, Jung-Kul; Kim, In-Won

    2016-04-28

    Methane (CH₄) is the most abundant component in natural gas. To reduce its harmful environmental effect as a greenhouse gas, CH₄ can be utilized as a low-cost feed for the synthesis of methanol by methanotrophs. In this study, several methanotrophs were examined for their ability to produce methanol from CH₄; including Methylocella silvestris, Methylocystis bryophila, Methyloferula stellata, and Methylomonas methanica. Among these methanotrophs, M. bryophila exhibited the highest methanol production. The optimum process parameters aided in significant enhancement of methanol production up to 4.63 mM. Maximum methanol production was observed at pH 6.8, 30°C, 175 rpm, 100 mM phosphate buffer, 50 mM MgCl₂ as a methanol dehydrogenase inhibitor, 50% CH₄ concentration, 24 h of incubation, and 9 mg of dry cell mass ml(-1) inoculum load, respectively. Optimization of the process parameters, screening of methanol dehydrogenase inhibitors, and supplementation with formate resulted in significant improvements in methanol production using M. bryophila. This report suggests, for the first time, the potential of using M. bryophila for industrial methanol production from CH₄.

  14. Systems-Level Synthetic Biology for Advanced Biofuel Production

    SciTech Connect

    Ruffing, Anne; Jensen, Travis J.; Strickland, Lucas Marshall; Meserole, Stephen; Tallant, David

    2015-03-01

    Cyanobacteria have been shown to be capable of producing a variety of advanced biofuels; however, product yields remain well below those necessary for large scale production. New genetic tools and high throughput metabolic engineering techniques are needed to optimize cyanobacterial metabolisms for enhanced biofuel production. Towards this goal, this project advances the development of a multiple promoter replacement technique for systems-level optimization of gene expression in a model cyanobacterial host: Synechococcus sp. PCC 7002. To realize this multiple-target approach, key capabilities were developed, including a high throughput detection method for advanced biofuels, enhanced transformation efficiency, and genetic tools for Synechococcus sp. PCC 7002. Moreover, several additional obstacles were identified for realization of this multiple promoter replacement technique. The techniques and tools developed in this project will help to enable future efforts in the advancement of cyanobacterial biofuels.

  15. Synthetic biology tools for bioprospecting of natural products in eukaryotes.

    PubMed

    Unkles, Shiela E; Valiante, Vito; Mattern, Derek J; Brakhage, Axel A

    2014-04-24

    Filamentous fungi have the capacity to produce a battery of natural products of often unknown function, synthesized by complex metabolic pathways. Unfortunately, most of these pathways appear silent, many in intractable organisms, and their products consequently unidentified. One basic challenge is the difficulty of expressing a biosynthesis pathway for a complex natural product in a heterologous eukaryotic host. Here, we provide a proof-of concept solution to this challenge and describe how the entire penicillin biosynthesis pathway can be expressed in a heterologous host. The method takes advantage of a combination of improved yeast in vivo cloning technology, generation of polycistronic mRNA for the gene cluster under study, and an amenable and easily manipulated fungal host, i.e., Aspergillus nidulans. We achieve expression from a single promoter of the pathway genes to yield a large polycistronic mRNA by using viral 2A peptide sequences to direct successful cotranslational cleavage of pathway enzymes.

  16. Recent advances in biological production of sugar alcohols.

    PubMed

    Park, Yong-Cheol; Oh, Eun Joong; Jo, Jung-Hyun; Jin, Yong-Su; Seo, Jin-Ho

    2016-02-01

    Sugar alcohols, such as xylitol, mannitol, sorbitol, and erythritol are emerging food ingredients that provide similar or better sweetness/sensory properties of sucrose, but are less calorigenic. Also, sugar alcohols can be converted into commodity chemicals through chemical catalysis. Biotechnological production offers the safe and sustainable supply of sugar alcohols from renewable biomass. In contrast to early studies that aimed to produce sugar alcohols with microorganisms capable of producing sugar alcohols naturally, recent studies have focused on rational engineering of metabolic pathways to improve yield and productivity as well as to use inexpensive and abundant substrates. Metabolic engineering strategies to utilize inexpensive substrates, alleviate catabolite repression, reduce byproduct formation, and manipulate redox balances led to enhanced production of sugar alcohols. PMID:26723007

  17. Recent advances in biological production of sugar alcohols.

    PubMed

    Park, Yong-Cheol; Oh, Eun Joong; Jo, Jung-Hyun; Jin, Yong-Su; Seo, Jin-Ho

    2016-02-01

    Sugar alcohols, such as xylitol, mannitol, sorbitol, and erythritol are emerging food ingredients that provide similar or better sweetness/sensory properties of sucrose, but are less calorigenic. Also, sugar alcohols can be converted into commodity chemicals through chemical catalysis. Biotechnological production offers the safe and sustainable supply of sugar alcohols from renewable biomass. In contrast to early studies that aimed to produce sugar alcohols with microorganisms capable of producing sugar alcohols naturally, recent studies have focused on rational engineering of metabolic pathways to improve yield and productivity as well as to use inexpensive and abundant substrates. Metabolic engineering strategies to utilize inexpensive substrates, alleviate catabolite repression, reduce byproduct formation, and manipulate redox balances led to enhanced production of sugar alcohols.

  18. Combination biological and microwave treatments of used rubber products

    DOEpatents

    Fliermans, Carl B.; Wicks, George G.

    2002-01-01

    A process and resulting product is provided in which a vulcanized solid particulate, such as vulcanized crumb rubber, has select chemical bonds altered by biotreatment with thermophillic microorganisms selected from natural isolates from hot sulfur springs. Following the biotreatment, microwave radiation is used to further treat the surface and to treat the bulk interior of the crumb rubber. The resulting combined treatments render the treated crumb rubber more suitable for use in new rubber formulations. As a result, larger loading levels and sizes of the treated crumb rubber can be used in new rubber mixtures and good properties obtained from the new recycled products.

  19. Xenicane Natural Products: Biological Activity and Total Synthesis.

    PubMed

    Betschart, Leo; Altmann, Karl-Heinz

    2015-01-01

    The xenicanes are a large class of mostly bicyclic marine diterpenoids featuring a cyclononane ring as a common structural denominator. After a brief introduction into the characteristic structural features of xenicanes and some biogenetic considerations, the major focus of this review will be on the various biological activities that have been reported for xenicanes and on efforts towards the total synthesis of these structures. Several xenicanes have been shown to be potent antiproliferative agents in vitro, but activities have also been reported in relation to inflammatory processes. However, so far, data on the possible in vivo activity of xenicanes are lacking. The major challenge in the total synthesis of xenicanes is the construction of the nine-membered ring. Different strategies have been pursued to establish this crucial substructure, including Grob fragmentation, ring-closing olefin metathesis, or Suzuki cross coupling as the enabling transformations. PMID:26429717

  20. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA...

  1. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA...

  2. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA...

  3. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA...

  4. Bovine mammary stem cells: Cell biology meets production agriculture

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Mammary stem cells (MaSC) provide for net growth, renewal and turnover of mammary epithelial cells, and are therefore potential targets for strategies to increase production efficiency. Appropriate regulation of MaSC can potentially benefit milk yield, persistency, dry period management and tissue ...

  5. DISINFECTION BY-PRODUCT CONTROL THROUGH BIOLOGICAL FILTRATION

    EPA Science Inventory

    Disinfection by-product (DBP) control through biofiltration is defined as the removal of DBP precursor mateterial (PM) by bacteria attached to the filte nedia. The PM consists of dissolved organic matter (DOM) and is utilized by the filter bacteria as a substrate for cell mainten...

  6. Considerations of the chemical biology of microbial natural products provide an effective drug discovery strategy.

    PubMed

    Choi, Hyukjae; Oh, Dong-Chan

    2015-09-01

    Conventional approaches to natural product drug discovery rely mainly on random searches for bioactive compounds using bioassays. These traditional approaches do not incorporate a chemical biology perspective. Searching for bioactive molecules using a chemical and biological rationale constitutes a powerful search paradigm. Here, the authors review recent examples of the discovery of bioactive natural products based on chemical and biological interactions between hosts and symbionts, and propose this method provides a more effective means of exploring natural chemical diversity and eventually of discovering new drugs.

  7. Chemistry and Biology of Bengamides and Bengazoles, Bioactive Natural Products from Jaspis Sponges

    PubMed Central

    García-Ruiz, Cristina; Sarabia, Francisco

    2014-01-01

    Sponges corresponding to the Jaspidae family have proved to be a prolific source of bioactive natural products. Among these, the bengamides and the bengazoles stand out by virtue of their unprecedented molecular architectures and impressive biological profiles, including antitumor, antibiotic and anthelmintic properties. As a consequence, intense research activity has been devoted to these compounds from both chemical and biological standpoints. This review describes in detail the research into these classes of natural products and the benefits they offer in chemistry and biology. PMID:24646945

  8. Assessment and classification of protocol deviations

    PubMed Central

    Ghooi, Ravindra Bhaskar; Bhosale, Neelambari; Wadhwani, Reena; Divate, Pathik; Divate, Uma

    2016-01-01

    Introduction: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. Methods: A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects’ well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years. Results: It was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5). Discussion: This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact. PMID:27453830

  9. Extensive Dark Biological Production of Reactive Oxygen Species in Brackish and Freshwater Ponds.

    PubMed

    Zhang, Tong; Hansel, Colleen M; Voelker, Bettina M; Lamborg, Carl H

    2016-03-15

    Within natural waters, photodependent processes are generally considered the predominant source of reactive oxygen species (ROS), a suite of biogeochemically important molecules. However, recent discoveries of dark particle-associated ROS production in aquatic environments and extracellular ROS production by various microorganisms point to biological activity as a significant source of ROS in the absence of light. Thus, the objective of this study was to explore the occurrence of dark biological production of the ROS superoxide (O2(-)) and hydrogen peroxide (H2O2) in brackish and freshwater ponds. Here we show that the ROS superoxide and hydrogen peroxide were present in dark waters at comparable concentrations as in sunlit waters. This suggests that, at least for the short-lived superoxide species, light-independent processes were an important control on ROS levels in these natural waters. Indeed, we demonstrated that dark biological production of ROS extensively occurred in brackish and freshwater environments, with greater dark ROS production rates generally observed in the aphotic relative to the photic zone. Filtering and formaldehyde inhibition confirmed the biological nature of a majority of this dark ROS production, which likely involved phytoplankton, particle-associated heterotrophic bacteria, and NADH-oxidizing enzymes. We conclude that biological ROS production is widespread, including regions devoid of light, thereby expanding the relevance of these reactive molecules to all regions of our oxygenated global habit.

  10. Biological Impact of Bioactive Glasses and Their Dissolution Products.

    PubMed

    Hoppe, Alexander; Boccaccini, Aldo R

    2015-01-01

    For many years, bioactive glasses (BGs) have been widely considered for bone tissue engineering applications due to their ability to bond to hard as well as soft tissue (a property termed bioactivity) and for their stimulating effects on bone formation. Ionic dissolution products released during the degradation of the BG matrix induce osteogenic gene expression leading to enhanced bone regeneration. Recently, adding bioactive metallic ions (e.g. boron, copper, cobalt, silver, zinc and strontium) to silicate (or phosphate and borate) glasses has emerged as a promising route for developing novel BG formulations with specific therapeutic functionalities, including antibacterial, angiogenic and osteogenic properties. The degradation behaviour of BGs can be tailored by adjusting the glass chemistry making these glass matrices potential carrier systems for controlled therapeutic ion release. This book chapter summarises the fundamental aspects of the effect of ionic dissolution products from BGs on osteogenesis and angiogenesis, whilst discussing novel BG compositions with controlled therapeutic ion release. PMID:26201273

  11. Time-Ordered Product Expansions for Computational Stochastic Systems Biology

    PubMed Central

    Mjolsness, Eric

    2013-01-01

    The time-ordered product framework of quantum field theory can also be used to understand salient phenomena in stochastic biochemical networks. It is used here to derive Gillespie’s Stochastic Simulation Algorithm (SSA) for chemical reaction networks; consequently, the SSA can be interpreted in terms of Feynman diagrams. It is also used here to derive other, more general simulation and parameter-learning algorithms including simulation algorithms for networks of stochastic reaction-like processes operating on parameterized objects, and also hybrid stochastic reaction/differential equation models in which systems of ordinary differ-ential equations evolve the parameters of objects that can also undergo stochastic reactions. Thus, the time-ordered product expansion (TOPE) can be used systematically to derive simulation and parameter-fitting algorithms for stochastic systems. PMID:23735739

  12. Biological Impact of Bioactive Glasses and Their Dissolution Products.

    PubMed

    Hoppe, Alexander; Boccaccini, Aldo R

    2015-01-01

    For many years, bioactive glasses (BGs) have been widely considered for bone tissue engineering applications due to their ability to bond to hard as well as soft tissue (a property termed bioactivity) and for their stimulating effects on bone formation. Ionic dissolution products released during the degradation of the BG matrix induce osteogenic gene expression leading to enhanced bone regeneration. Recently, adding bioactive metallic ions (e.g. boron, copper, cobalt, silver, zinc and strontium) to silicate (or phosphate and borate) glasses has emerged as a promising route for developing novel BG formulations with specific therapeutic functionalities, including antibacterial, angiogenic and osteogenic properties. The degradation behaviour of BGs can be tailored by adjusting the glass chemistry making these glass matrices potential carrier systems for controlled therapeutic ion release. This book chapter summarises the fundamental aspects of the effect of ionic dissolution products from BGs on osteogenesis and angiogenesis, whilst discussing novel BG compositions with controlled therapeutic ion release.

  13. [Biological effects of nuclear fission products. Repeated exposures].

    PubMed

    Vasilenko, I Ia

    1994-01-01

    The results of experimental studies on the repeated exposure to radioiodine (131I) and nuclear fission products (NFP) are presented, the doses used being equal to those resulted in radiation disease under first and second input. The animals satisfactory withstood the repeated exposure. The residual injuries appeared slightly. The animals' state was satisfactory during 5 years. Blastomogenic effect of NFP was revealed in remote periods.

  14. Selection for milk production from a lactation biology viewpoint.

    PubMed

    Akers, R M

    2000-05-01

    The success of selection for increased milk production in dairy cows is apparent. Certainly, many herds now have average production levels that would have only been associated with the best producers in the herd 30 yr ago. There are, of course, many reasons for this success. Among these are improvements in genetic selection methods and associated use of artificial insemination, better fulfillment of nutritional needs and diet formulation, and careful attention to mastitis control and milking management. Development of new management tools (i.e., bovine somatotropin, improved crops, estrus detection devices, estrus synchronization, monitoring of individual animal performance, and disease prevention) should not be forgotten. Although many aspects of a dairy operation determine overall performance and profitability, the focus of this paper is the udder. Information indicates that both the structure and function of the bovine mammary gland have been directly impacted by long-term selection for increased milk production but improved functionality may have been more important. This review also considered studies that attempt to develop techniques and measurements for possible selection of genetically superior animals including measurement of circulating hormones and direct assay of mammary tissue function. PMID:10821592

  15. A turning point for natural product discovery--ESF-EMBO research conference: synthetic biology of antibiotic production.

    PubMed

    Takano, Eriko; Bovenberg, Roel A L; Breitling, Rainer

    2012-03-01

    Synthetic Biology is in a critical phase of its development: it has finally reached the point where it can move from proof-of-principle studies to real-world applications. Secondary metabolite biosynthesis, especially the discovery and production of antibiotics, is a particularly relevant target area for such applications of synthetic biology. The first international conference to explore this subject was held in Spain in October 2011. In four sessions on General Synthetic Biology, Filamentous Fungal Systems, Actinomyces Systems, and Tools and Host Structures, scientists presented the most recent technological and scientific advances, and a final-day Forward Look Plenary Discussion identified future trends in the field.

  16. BIOLOGICALLY ACTIVE NATURAL PRODUCTS OF THE GENUS CALLICARPA.

    PubMed

    Jones, William P; Kinghorn, A Douglas

    2008-06-01

    About 20 species from Callicarpa have reported ethnobotanical and ethnomedical uses, and several members of this genus are well known in the traditional medical systems of China and South Asia. Ethnomedical reports indicate their use in the treatment of hepatitis, rheumatism, fever, headache, indigestion, and other ailments. Several species of Callicarpa have been reported to be used against cancer (e.g., Callicarpa americana root to treat skin cancer and Callicarpa rubella bark to treat tumors of the large intestine). Extracts from about 14 species in this genus have been evaluated for biological activity, including antibacterial, antifungal, anti-insect growth, cytotoxic, and phytotoxic activities. In addition to amino acids, benzenoids, simple carbohydrates, and lipids, numerous diterpenes, flavonoids, phenylpropanoids, phytosterols, sesquiterpenes, and triterpenes have been detected in or isolated from the genus Callicarpa. The essential oils of Callicarpa americana have recently been reported to have antialgal and phytotoxic activities, and several isolates from this species (and C. japonica) were identified as contributing to the mosquito bite-deterrent activity that was first indicated by folkloric usage. Recent bioassay-guided investigations of C. americana extracts have resulted in the isolation of several active compounds, mainly of the clerodane diterpene structural type. PMID:19830264

  17. Production and flocculating performance of sludge bioflocculant from biological sludge.

    PubMed

    Zhang, Xiuhong; Sun, Jie; Liu, Xiuxiu; Zhou, Jiti

    2013-10-01

    Excess biological sludge was utilized to prepared bioflocculant with hydrochloric acid. The prepared crude bioflocculant was purified and fractionally precipitated to attain four purified sludge bioflocculant defined as PSB1-4. The PSB-2 has higher flocculating rate for kaolin suspension than others. When the pH of the flocculation system ranged from 4.0 to 11.0 the flocculating rates of PSB-2 were over 96.0%. X-ray photoelectron spectroscopy (XPS) and Fourier transform infrared (FTIR) spectra showed that amino and hydroxyl groups were present in the bioflocculant molecules. More amine group existed in the bioflocculant PSB-2 relatively. The amino group was believed to play an important role in flocculation. The experiment of zeta potential measuring indicated that the charge neutralization contributed to flocculation process. Flocculating mechanism investigation reveals that the sludge bioflocculant caused kaolin suspension instability by means of charge neutralization firstly and then promoted the aggregation of suspension particles by adsorption and bridge. PMID:23916978

  18. BIOLOGICALLY ACTIVE NATURAL PRODUCTS OF THE GENUS CALLICARPA⊥

    PubMed Central

    JONES, WILLIAM P.; KINGHORN, A. DOUGLAS

    2009-01-01

    About 20 species from Callicarpa have reported ethnobotanical and ethnomedical uses, and several members of this genus are well known in the traditional medical systems of China and South Asia. Ethnomedical reports indicate their use in the treatment of hepatitis, rheumatism, fever, headache, indigestion, and other ailments. Several species of Callicarpa have been reported to be used against cancer (e.g., Callicarpa americana root to treat skin cancer and Callicarpa rubella bark to treat tumors of the large intestine). Extracts from about 14 species in this genus have been evaluated for biological activity, including antibacterial, antifungal, anti-insect growth, cytotoxic, and phytotoxic activities. In addition to amino acids, benzenoids, simple carbohydrates, and lipids, numerous diterpenes, flavonoids, phenylpropanoids, phytosterols, sesquiterpenes, and triterpenes have been detected in or isolated from the genus Callicarpa. The essential oils of Callicarpa americana have recently been reported to have antialgal and phytotoxic activities, and several isolates from this species (and C. japonica) were identified as contributing to the mosquito bite-deterrent activity that was first indicated by folkloric usage. Recent bioassay-guided investigations of C. americana extracts have resulted in the isolation of several active compounds, mainly of the clerodane diterpene structural type. PMID:19830264

  19. Biological Hydrogen Production Using Chloroform-treated Methanogenic Granules

    NASA Astrophysics Data System (ADS)

    Hu, Bo; Chen, Shulin

    In fermentative hydrogen production, the low-hydrogen-producing bacteria retention rate limits the suspended growth reactor productivity because of the long hydraulic retention time (HRT) required to maintain adequate bacteria population. Traditional bacteria immobilization methods such as calcium alginate entrapment have many application limitations in hydrogen fermentation, including limited duration time, bacteria leakage, cost, and so on. The use of chloroform-treated anaerobic granular sludge as immobilized hydrogen-producing bacteria in an immobilized hydrogen culture may be able to overcome the limitations of traditional immobilization methods. This paper reports the findings on the performance of fed-batch cultures and continuous cultures inoculated with chloroform-treated granules. The chloroform-treated granules were able to be reused over four fed-batch cultures, with pH adjustment. The upflow reactor packed with chloroform-treated granules was studied, and the HRT of the upflow reactor was found to be as low as 4 h without any decrease in hydrogen production yield. Initial pH and glucose concentration of the culture medium significantly influenced the performance of the reactor. The optimum initial pH of the culture medium was neutral, and the optimum glucose concentration of the culture medium was below 20 g chemical oxygen demand/L at HRT 4 h. This study also investigated the possibility of integrating immobilized hydrogen fermentation using chloroform-treated granules with immobilized methane production using untreated granular sludge. The results showed that the integrated batch cultures produced 1.01 mol hydrogen and 2 mol methane per mol glucose. Treating the methanogenic granules with chloroform and then using the treated granules as immobilized hydrogen-producing sludge demonstrated advantages over other immobilization methods because the treated granules provide hydrogen-producing bacteria with a protective niche, a long duration of an active

  20. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

    PubMed

    Schuck, Robert N; Grillo, Joseph A

    2016-05-01

    Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels. PMID:26912182

  1. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

    PubMed

    Schuck, Robert N; Grillo, Joseph A

    2016-05-01

    Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.

  2. Metabolic Engineering for Production of Biorenewable Fuels and Chemicals: Contributions of Synthetic Biology

    PubMed Central

    Jarboe, Laura R.; Zhang, Xueli; Wang, Xuan; Moore, Jonathan C.; Shanmugam, K. T.; Ingram, Lonnie O.

    2010-01-01

    Production of fuels and chemicals through microbial fermentation of plant material is a desirable alternative to petrochemical-based production. Fermentative production of biorenewable fuels and chemicals requires the engineering of biocatalysts that can quickly and efficiently convert sugars to target products at a cost that is competitive with existing petrochemical-based processes. It is also important that biocatalysts be robust to extreme fermentation conditions, biomass-derived inhibitors, and their target products. Traditional metabolic engineering has made great advances in this area, but synthetic biology has contributed and will continue to contribute to this field, particularly with next-generation biofuels. This work reviews the use of metabolic engineering and synthetic biology in biocatalyst engineering for biorenewable fuels and chemicals production, such as ethanol, butanol, acetate, lactate, succinate, alanine, and xylitol. We also examine the existing challenges in this area and discuss strategies for improving biocatalyst tolerance to chemical inhibitors. PMID:20414363

  3. 48 CFR 501.404 - Class deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... HCA to GSA's SPE for approval. Prior to approving a class deviation to the FAR, the SPE will consult...). (2) A class deviation to the GSAR must be forwarded by the cognizant HCA to GSA's SPE for approval. (3) When an HCA knows that a proposed class deviation will be required on a permanent basis, the...

  4. 48 CFR 501.404 - Class deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... HCA to GSA's SPE for approval. Prior to approving a class deviation to the FAR, the SPE will consult...). (2) A class deviation to the GSAR must be forwarded by the cognizant HCA to GSA's SPE for approval. (3) When an HCA knows that a proposed class deviation will be required on a permanent basis, the...

  5. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the deviation and nuclear power reactor(s) affected; (e) A statement as to whether the deviation has... 10 Energy 4 2011-01-01 2011-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE...

  6. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the deviation and nuclear power reactor(s) affected; (e) A statement as to whether the deviation has... 10 Energy 4 2010-01-01 2010-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE...

  7. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... the deviation and nuclear power reactor(s) affected; (e) A statement as to whether the deviation has... 10 Energy 4 2014-01-01 2014-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE...

  8. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the deviation and nuclear power reactor(s) affected; (e) A statement as to whether the deviation has... 10 Energy 4 2012-01-01 2012-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE...

  9. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the deviation and nuclear power reactor(s) affected; (e) A statement as to whether the deviation has... 10 Energy 4 2013-01-01 2013-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE...

  10. 48 CFR 1.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Individual deviations. 1.403 Section 1.403 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations from the FAR 1.403 Individual deviations....

  11. 48 CFR 601.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 601.403 Section 601.403 Federal Acquisition Regulations System DEPARTMENT OF STATE GENERAL DEPARTMENT OF STATE ACQUISITION REGULATIONS SYSTEM Deviations from the FAR 601.403 Individual deviations....

  12. 48 CFR 1901.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 1901.403 Section 1901.403 Federal Acquisition Regulations System BROADCASTING BOARD OF GOVERNORS GENERAL... Individual deviations. Deviations from the IAAR or the FAR in individual cases shall be authorized by...

  13. 48 CFR 3401.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Individual deviations. 3401.403 Section 3401.403 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.403 Individual deviations. An...

  14. 48 CFR 2501.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2501.403 Section 2501.403 Federal Acquisition Regulations System NATIONAL SCIENCE FOUNDATION GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations From the FAR 2501.403 Individual deviations....

  15. Introducing the Mean Absolute Deviation "Effect" Size

    ERIC Educational Resources Information Center

    Gorard, Stephen

    2015-01-01

    This paper revisits the use of effect sizes in the analysis of experimental and similar results, and reminds readers of the relative advantages of the mean absolute deviation as a measure of variation, as opposed to the more complex standard deviation. The mean absolute deviation is easier to use and understand, and more tolerant of extreme…

  16. The Production Processes and Biological Effects of Intravenous Immunoglobulin

    PubMed Central

    Barahona Afonso, Ana Filipa; João, Cristina Maria Pires

    2016-01-01

    Immunoglobulin is a highly diverse autologous molecule able to influence immunity in different physiological and diseased situations. Its effect may be visible both in terms of development and function of B and T lymphocytes. Polyclonal immunoglobulin may be used as therapy in many diseases in different circumstances such as primary and secondary hypogammaglobulinemia, recurrent infections, polyneuropathies, cancer, after allogeneic transplantation in the presence of infections and/or GVHD. However, recent studies have broadened the possible uses of polyclonal immunoglobulin showing that it can stimulate certain sub-populations of T cells with effects on T cell proliferation, survival and function in situations of lymphopenia. These results present a novel and considerable impact of intravenous immunoglobulin (IVIg) treatment in situations of severe lymphopenia, a situation that can occur in cancer patients after chemo and radiotherapy treatments. In this review paper the established and experimental role of polyclonal immunoglobulin will be presented and discussed as well as the manufacturing processes involved in their production. PMID:27005671

  17. Phototrophic pigment production with microalgae: biological constraints and opportunities.

    PubMed

    Mulders, Kim J M; Lamers, Packo P; Martens, Dirk E; Wijffels, René H

    2014-04-01

    There is increasing interest in naturally produced colorants, and microalgae represent a bio-technologically interesting source due to their wide range of colored pigments, including chlorophylls (green), carotenoids (red, orange and yellow), and phycobiliproteins (red and blue). However, the concentration of these pigments, under optimal growth conditions, is often too low to make microalgal-based pigment production economically feasible. In some Chlorophyta (green algae), specific process conditions such as oversaturating light intensities or a high salt concentration induce the overproduction of secondary carotenoids (β-carotene in Dunaliella salina (Dunal) Teodoresco and astaxanthin in Haematococcus pluvialis (Flotow)). Overproduction of all other pigments (including lutein, fucoxanthin, and phycocyanin) requires modification in gene expression or enzyme activity, most likely combined with the creation of storage space outside of the photosystems. The success of such modification strategies depends on an adequate understanding of the metabolic pathways and the functional roles of all the pigments involved. In this review, the distribution of commercially interesting pigments across the most common microalgal groups, the roles of these pigments in vivo and their biosynthesis routes are reviewed, and constraints and opportunities for overproduction of both primary and secondary pigments are presented.

  18. Models of risk assessments for biologicals or related products in the European Union.

    PubMed

    Moos, M

    1995-12-01

    In the context of veterinary biologicals, environmental risk assessment means the evaluation of the risk to human health and the environment (which includes plants and animals) connected with the release of such products. The following categories or types of veterinary biologicals can be distinguished: non-genetically modified organisms (non-GMOs) (inactivated/live) GMOs (inactivated/live) carrier products related products (e.g. non-specific "inducers'). Suitable models used in risk assessment for these products should aim to identify all possible adverse effects. A good working model should lead, at least, to a qualitative judgement on the environmental risk of the biological product (e.g. negligible, low, medium, severe, unacceptable). Quantifiable outcomes are rare; therefore, the producer of a biological product and the European control authorities should accept only models which are based on testable points and which are relevant to the type of product and its instructions for use. In view of animal welfare aspects, models working without animals should be preferred. In recent years, some of these methods have been integrated into safety tests described in European Union Directives and in monographs of the European Pharmacopoeia. By reviewing vaccine/registration problems (e.g. Aujeszky's disease live vaccine for pigs, and vaccinia-vectored rabies vaccine), several models used in risk assessment are demonstrated and discussed.

  19. Occurrence, pathways and implications of biological production of reactive oxygen species in natural waters

    NASA Astrophysics Data System (ADS)

    Zhang, T.; Hansel, C. M.; Voelker, B. M.; Lamborg, C. H.

    2014-12-01

    Reactive oxygen species (ROS), such as superoxide (O2-) and hydrogen peroxide (H2O2) play a critical role in the redox cycling of both toxic (e.g., Hg) and nutrient (e.g., Fe) metals. Despite the discovery of extracellular ROS production in various microbial cultures, including fungi, algae and bacteria, photo-dependent processes are generally considered as the predominant source of ROS in natural waters. Here we show that biological production of ROS is ubiquitous and occurs at a significant rate in freshwater and brackish water environments. Water samples were collected from three freshwater and one brackish water ponds in Cape Cod, Massachusetts, USA, periodically from 2012 to 2014. Production of O2- and H2O2 were measured in dark incubations of natural water using a chemiluminescent and a colorimetric probe, respectively. Rates of biological ROS production were obtained by comparing unfiltered with 0.2-μm filtered samples. The role of biological activity in ROS production was confirmed by the cessation of ROS production upon addition of formaldehyde. In surface water, production rates of O2- ranged from undetectable to 96.0 ± 30.0 nmol L-1 h-1, and production rates of H2O2 varied between 9.9 ± 1.3 nmol L-1 h-1 and 145.6 ± 11.2 nmol L-1 h-1. The maximum production rates of both ROS were observed in mid-summer 2013, which coincides with peak biological activity. ROS production in the water from aphotic zone was greater than in the water from photic zone. Thus, non-light dependent biological processes are likely the major contributors to ROS production in this system. Moreover, O2- production appeared to be enhanced by NADH and inhibited by proteinase-K, suggesting the possible involvement of NADH oxidoreductases in this process. The potential role of different microbial communities in ROS production, and the implications of biological ROS production for mercury speciation will also be discussed.

  20. The Standard Deviation of Launch Vehicle Environments

    NASA Technical Reports Server (NTRS)

    Yunis, Isam

    2005-01-01

    Statistical analysis is used in the development of the launch vehicle environments of acoustics, vibrations, and shock. The standard deviation of these environments is critical to accurate statistical extrema. However, often very little data exists to define the standard deviation and it is better to use a typical standard deviation than one derived from a few measurements. This paper uses Space Shuttle and expendable launch vehicle flight data to define a typical standard deviation for acoustics and vibrations. The results suggest that 3dB is a conservative and reasonable standard deviation for the source environment and the payload environment.

  1. Mapping the patent landscape of synthetic biology for fine chemical production pathways.

    PubMed

    Carbonell, Pablo; Gök, Abdullah; Shapira, Philip; Faulon, Jean-Loup

    2016-09-01

    A goal of synthetic biology bio-foundries is to innovate through an iterative design/build/test/learn pipeline. In assessing the value of new chemical production routes, the intellectual property (IP) novelty of the pathway is important. Exploratory studies can be carried using knowledge of the patent/IP landscape for synthetic biology and metabolic engineering. In this paper, we perform an assessment of pathways as potential targets for chemical production across the full catalogue of reachable chemicals in the extended metabolic space of chassis organisms, as computed by the retrosynthesis-based algorithm RetroPath. Our database for reactions processed by sequences in heterologous pathways was screened against the PatSeq database, a comprehensive collection of more than 150M sequences present in patent grants and applications. We also examine related patent families using Derwent Innovations. This large-scale computational study provides useful insights into the IP landscape of synthetic biology for fine and specialty chemicals production.

  2. Recent progress in synthetic biology for microbial production of C3–C10 alcohols

    PubMed Central

    Lamsen, Edna N.; Atsumi, Shota

    2012-01-01

    The growing need to address current energy and environmental problems has sparked an interest in developing improved biological methods to produce liquid fuels from renewable sources. While microbial ethanol production is well established, higher-chain alcohols possess chemical properties that are more similar to gasoline. Unfortunately, these alcohols (except 1-butanol) are not produced efficiently in natural microorganisms, and thus economical production in industrial volumes remains a challenge. Synthetic biology, however, offers additional tools to engineer synthetic pathways in user-friendly hosts to help increase titers and productivity of these advanced biofuels. This review concentrates on recent developments in synthetic biology to produce higher-chain alcohols as viable renewable replacements for traditional fuel. PMID:22701113

  3. Studies on production and biological potential of prodigiosin by Serratia marcescens.

    PubMed

    Suryawanshi, Rahul K; Patil, Chandrashekhar D; Borase, Hemant P; Salunke, Bipinchandra K; Patil, Satish V

    2014-07-01

    Efficacy of Serratia marcescens for pigment production and biological activity was investigated. Natural substrates like sweet potato, mahua flower extract (Madhuca latifolia L.), and sesam at different concentrations were taken. As a carbon source microorganism favored potato powder was followed by sesam and mannitol, and as nitrogen source casein hydrolysate was followed by yeast and malt extract. The effect of inorganic salts on pigment production was also studied. At final optimized composition of suitable carbon, nitrogen source, and trace materials and at suitable physiological conditions, prodigiosin production was 4.8 g L(-1). The isolated pigment showed antimicrobial activity against different pathogenic bacteria and fungi. Extracted pigment was characterized by spectroscopy, Fourier transform infrared (FTIR), and thin layer chromatography (TLC) which confirm production of biological compound prodigiosin. This study suggests that use of sweet potato powder and casein can be a potential alternative bioresource for commercial production of pigment prodigiosin.

  4. Bioinformatics for the synthetic biology of natural products: integrating across the Design–Build–Test cycle

    PubMed Central

    Currin, Andrew; Jervis, Adrian J.; Rattray, Nicholas J. W.; Swainston, Neil; Yan, Cunyu; Breitling, Rainer

    2016-01-01

    Covering: 2000 to 2016 Progress in synthetic biology is enabled by powerful bioinformatics tools allowing the integration of the design, build and test stages of the biological engineering cycle. In this review we illustrate how this integration can be achieved, with a particular focus on natural products discovery and production. Bioinformatics tools for the DESIGN and BUILD stages include tools for the selection, synthesis, assembly and optimization of parts (enzymes and regulatory elements), devices (pathways) and systems (chassis). TEST tools include those for screening, identification and quantification of metabolites for rapid prototyping. The main advantages and limitations of these tools as well as their interoperability capabilities are highlighted. PMID:27185383

  5. New opportunities by synthetic biology for biopharmaceutical production in Pichia pastoris.

    PubMed

    Vogl, Thomas; Hartner, Franz S; Glieder, Anton

    2013-12-01

    Biopharmaceuticals are an integral part of modern medicine and pharmacy. Both, the development and the biotechnological production of biopharmaceuticals are highly cost-intensive and require suitable expression systems. In this review we discuss established and emerging tools for reengineering the methylotrophic yeast Pichia pastoris for biopharmaceutical production. Recent advancements of this industrial expression system through synthetic biology include synthetic promoters to avoid methanol induction and to fine-tune protein production. New platform strains and molecular cloning tools as well as in vivo glycoengineering to produce humanized glycoforms have made P. pastoris an important host for biopharmaceutical production. PMID:23522654

  6. New approaches to estimation of peat deposits for production of biologically active compounds

    NASA Astrophysics Data System (ADS)

    Stepchenko, L. M.; Yurchenko, V. I.; Krasnik, V. G.; Syedykh, N. J.

    2009-04-01

    It is known, that biologically active preparations from peat increase animals productivity as well as resistance against stress-factors and have adaptogeneous, antioxidant, immunomodulative properties. Optymal choice of peat deposits for the production of biologically active preparations supposes the detailed comparative analysis of peat properties from different deposits. For this the cadastre of peat of Ukraine is developed in the humic substances laboratory named after prof. Khristeva L.A. (Dnipropetrovsk Agrarian University, Ukraine). It based on the research of its physical and chemical properties, toxicity and biological activity, and called Biocadastre. The Biocadastre is based on the set of parameters, including the descriptions of physical and chemical properties (active acidity, degree of decomposition, botanical composition etc.), toxicity estimation (by parabyotyc, infusorial, inhibitor and other tests), biological activity indexes (growth-promoting, antioxidative, adaptogeneous, immunomodulative antistress and other actions). The blocks of Biocadastre indexes are differentiated, taking into account their use for creation the preparations for vegetable, animals and microorganisms. The Biocadastre will allow to choose the peat deposits, most suitable for the production of different biologically active preparations, both wide directed and narrow spectrum of action, depending on application fields (medicine, agriculture, veterinary medicine, microbiological industry, balneology, cosmetology).

  7. The Role of Synthetic Biology in the Design of Microbial Cell Factories for Biofuel Production

    PubMed Central

    Colin, Verónica Leticia; Rodríguez, Analía; Cristóbal, Héctor Antonio

    2011-01-01

    Insecurity in the supply of fossil fuels, volatile fuel prices, and major concerns regarding climate change have sparked renewed interest in the production of fuels from renewable resources. Because of this, the use of biodiesel has grown dramatically during the last few years and is expected to increase even further in the future. Biodiesel production through the use of microbial systems has marked a turning point in the field of biofuels since it is emerging as an attractive alternative to conventional technology. Recent progress in synthetic biology has accelerated the ability to analyze, construct, and/or redesign microbial metabolic pathways with unprecedented precision, in order to permit biofuel production that is amenable to industrial applications. The review presented here focuses specifically on the role of synthetic biology in the design of microbial cell factories for efficient production of biodiesel. PMID:22028591

  8. Biological production of acetaldehyde from ethanol using non-growing Pichia pastoris whole cells

    SciTech Connect

    Chiang, Heien-Kun; Foutch, G.L.; Fish, W.W.

    1991-12-31

    Acetaldehyde has been produced biologically using whole-cell Pichia Pass in a semibatch fermentor. Ethanol and air were fed continuously, and the product, acetaldehyde, was removed by the air stream. Operation of the reactor exceeded 100 h, maintaining high alcohol oxidase activity. Low cell-mass concentration (9.9 g/L) minimized product inhibition. Ethanol concentration in the broth, oxygen concentration in the air, and pH were evaluated for their effects on the fermentation process.

  9. Biological and Chemical Properties of the Epidioxide Isomer of Abscisic Acid and its Rearrangement Products

    PubMed Central

    Sondheimer, Ernest; Michniewicz, Barbara M.; Powell, Loyd E.

    1969-01-01

    The growth inhibitory activity of the epidioxide (II), a precursor in the synthesis of abscisic acid (ABA), has been confirmed with additional assay systems. Under physiological conditions the epidioxide is rearranged to give ABA and an isomer of ABA which has probably the structure V. This major product has very low, if any, biological activity. The biological activity of the epidioxide is explained by its partial conversion (about 20%) to ABA. The reaction rate was enhanced by heavy metal ions and decreased by EDTA. At pH 12.5, the decomposition of the epidioxide is slower than it is near neutrality and ABA is the predominant product. In the biological systems studied the activity of the epidioxide can be accounted for by nonenzymatic conversion to ABA. PMID:16657047

  10. 75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing... avoid duplicative animal and human testing, sponsors may wish, to the extent permissible, to rely on.... Most biological products are produced in a living system such as a microorganism, or plant or...

  11. 78 FR 67985 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ...,'' 30 FR 993, January 30, 1965). Over the years, FDA has clarified the types of labeling changes that...''; final rule, 50 FR 7452 at 7470, February 22, 1985). In 2006, FDA amended its regulations governing the... Human Prescription Drug and Biological Products''; final rule, 71 FR 3922, January 24, 2006)....

  12. Do biological medicinal products pose a risk to the environment?: a current view on ecopharmacovigilance.

    PubMed

    Kühler, Thomas C; Andersson, Mikael; Carlin, Gunnar; Johnsson, Ann; Akerblom, Lennart

    2009-01-01

    The occurrence of active pharmaceutical substances in the environment is of growing concern. The vast majority of the compounds in question are of low molecular weight, intended for oral use and designed to tolerate, for example, the digestive enzymes in the upper alimentary tract, the harsh milieus found in the acidic stomach, or the microbe rich intestine. Accordingly, these xenobiotic compounds may, due to their inherent biological activity, constitute a risk to the environment. Biological medicinal products, for example recombinant human insulin or monoclonal antibodies, however, are different. They are primarily made up of oligomers or polymers of amino acids, sugars or nucleotides and are thus readily metabolized. They are therefore generally not considered to pose any risk to the environment. Certain classes of biological medicinal products, however, are associated with specific safety issues. Genetically modified organisms as vectors in vaccines or in gene therapy products have attracted much attention in this regard. Issues include the degree of attenuation of the live recombinant vaccine, replication restrictions of the vaccine vector, alteration of the host and tissue tropism of the vector, the possibility of reversion to virulence, and risk to the ecosystem. In this review we discuss the fate and the potential environmental impact of biological medicinal products following clinical use from an ecopharmacovigilance point of view, and review relevant policy documents and regulatory statements. PMID:19810773

  13. [Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].

    PubMed

    Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

    2013-11-01

    The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions

  14. [Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].

    PubMed

    Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

    2013-11-01

    The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions

  15. Advanced glycation end-products: a biological consequence of lifestyle contributing to cancer disparity.

    PubMed

    Turner, David P

    2015-05-15

    Low income, poor diet, obesity, and a lack of exercise are interrelated lifestyle factors that can profoundly alter our biologic make up to increase cancer risk, growth, and development. We recently reported a potential mechanistic link between carbohydrate-derived metabolites and cancer, which may provide a biologic consequence of lifestyle that can directly affect tumor biology. Advanced glycation end-products (AGE) are reactive metabolites produced as a by-product of sugar metabolism. Failure to remove these highly reactive metabolites can lead to protein damage, aberrant cell signaling, increased stress responses, and decreased genetic fidelity. Critically, AGE accumulation is also directly affected by our lifestyle choices and shows a race-specific, tumor-dependent pattern of accumulation in cancer patients. This review will discuss the contribution of AGEs to the cancer phenotype, with a particular emphasis on their biologic links with the socioeconomic and environmental risk factors that drive cancer disparity. Given the potential benefits of lifestyle changes and the potential biologic role of AGEs in promoting cancer, opportunities exist for collaborations affecting basic, translational, epidemiologic, and cancer prevention initiatives. PMID:25920350

  16. Integrated catalytic wet air oxidation and biological treatment of wastewater from Vitamin B 6 production

    NASA Astrophysics Data System (ADS)

    Kang, Jianxiong; Zhan, Wei; Li, Daosheng; Wang, Xiaocong; Song, Jing; Liu, Dongqi

    This study investigated the feasibility of coupling a catalytic wet air oxidation (CWAO), with CuO/Al 2O 3 as catalyst, and an anaerobic/aerobic biological process to treat wastewater from Vitamin B 6 production. Results showed that the CWAO enhanced the biodegradability (BOD 5/COD) from 0.10 to 0.80. The oxidized effluents with COD of 10,000 mg l -1 was subjected to subsequent continuous anaerobic/aerobic oxidation, and 99.3% of total COD removal was achieved. The quality of the effluent obtained met the discharge standards of water pollutants for pharmaceutical industry Chemical Synthesis Products Category (GB21904-2008), and thereby it implies that the integrated CWAO and anaerobic/aerobic biological treatment may offer a promising process to treat wastewater from Vitamin B 6 production.

  17. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... categories of information in product labeling for use as terms to search repositories of approved... clinical decision support tools and electronic prescribing systems to rapidly search and sort product... consistently to enable comprehensive searches to find all relevant information, including appropriate...

  18. 14 CFR 139.113 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Deviations. 139.113 Section 139.113 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR CARRIERS... life or property, the certificate holder may deviate from any requirement of subpart D of this part,...

  19. 41 CFR 105-1.110 - Deviation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Deviation. 105-1.110 Section 105-1.110 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION 1-INTRODUCTION 1.1-Regulations System § 105-1.110 Deviation....

  20. 14 CFR 1216.318 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Deviations. 1216.318 Section 1216.318 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION ENVIRONMENTAL QUALITY Procedures for Implementing the National Environmental Policy Act (NEPA) Agency Procedures § 1216.318 Deviations. From time...

  1. 34 CFR 74.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Deviations. 74.4 Section 74.4 Education Office of the Secretary, Department of Education ADMINISTRATION OF GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 74.4 Deviations. The Secretary,...

  2. 34 CFR 74.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Deviations. 74.4 Section 74.4 Education Office of the Secretary, Department of Education ADMINISTRATION OF GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 74.4 Deviations. The Secretary, after consultation with the Office of...

  3. 48 CFR 2901.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... through the Director, DAMS. (b) Requests for deviations under paragraph (a) of this section must be... contracting actions which will be affected. (c) For a FAR class deviation the Director, DAMS will consult with... Director, DAMS as required in FAR 1.404....

  4. 48 CFR 1401.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations. 1401.403 Section 1401.403 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR GENERAL DEPARTMENT OF THE INTERIOR ACQUISITION REGULATION SYSTEM Deviations from the FAR and DIAR 1401.403...

  5. 48 CFR 1201.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) 48 CFR 1.405(e) applies). However, see TAM 1201.403. ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations... FEDERAL ACQUISITION REGULATIONS SYSTEM 70-Deviations From the FAR and TAR 1201.403 Individual...

  6. 34 CFR 74.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Deviations. 74.4 Section 74.4 Education Office of the Secretary, Department of Education ADMINISTRATION OF GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 74.4 Deviations. The Secretary,...

  7. 22 CFR 145.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Deviations. 145.4 Section 145.4 Foreign Relations DEPARTMENT OF STATE CIVIL RIGHTS GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 145.4 Deviations. The Office of Management...

  8. 48 CFR 1901.403 - Individual deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Individual deviations. 1901.403 Section 1901.403 Federal Acquisition Regulations System BROADCASTING BOARD OF GOVERNORS GENERAL THE BROADCASTING BOARD OF GOVERNORS ACQUISITION REGULATION SYSTEM Deviations From the FAR...

  9. 48 CFR 1901.404 - Class deviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Class deviations. 1901.404 Section 1901.404 Federal Acquisition Regulations System BROADCASTING BOARD OF GOVERNORS GENERAL THE BROADCASTING BOARD OF GOVERNORS ACQUISITION REGULATION SYSTEM Deviations From the FAR 1901.404 Class...

  10. 48 CFR 1901.403 - Individual deviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Individual deviations. 1901.403 Section 1901.403 Federal Acquisition Regulations System BROADCASTING BOARD OF GOVERNORS GENERAL THE BROADCASTING BOARD OF GOVERNORS ACQUISITION REGULATION SYSTEM Deviations From the FAR...

  11. 48 CFR 1901.404 - Class deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Class deviations. 1901.404 Section 1901.404 Federal Acquisition Regulations System BROADCASTING BOARD OF GOVERNORS GENERAL THE BROADCASTING BOARD OF GOVERNORS ACQUISITION REGULATION SYSTEM Deviations From the FAR 1901.404 Class...

  12. 10 CFR 800.204 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Deviations. 800.204 Section 800.204 Energy DEPARTMENT OF ENERGY LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE Loans § 800.204 Deviations. (a) To the extent consistent with the Act, relevant...

  13. 10 CFR 800.204 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Deviations. 800.204 Section 800.204 Energy DEPARTMENT OF ENERGY LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE Loans § 800.204 Deviations. (a) To the extent consistent with the Act, relevant...

  14. 10 CFR 800.204 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Deviations. 800.204 Section 800.204 Energy DEPARTMENT OF ENERGY LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE Loans § 800.204 Deviations. (a) To the extent consistent with the Act, relevant...

  15. 10 CFR 800.204 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Deviations. 800.204 Section 800.204 Energy DEPARTMENT OF ENERGY LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE Loans § 800.204 Deviations. (a) To the extent consistent with the Act, relevant...

  16. Exploring Students' Conceptions of the Standard Deviation

    ERIC Educational Resources Information Center

    delMas, Robert; Liu, Yan

    2005-01-01

    This study investigated introductory statistics students' conceptual understanding of the standard deviation. A computer environment was designed to promote students' ability to coordinate characteristics of variation of values about the mean with the size of the standard deviation as a measure of that variation. Twelve students participated in an…

  17. 32 CFR 34.3 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... deviations. Individual deviations affecting only one award may be approved by DoD Components in accordance with procedures stated in 32 CFR 21.335(a) and 21.340. (b) Small awards. DoD Components may apply less..., the Director, Defense Research and Engineering, or his or her designee, may grant exceptions from...

  18. 32 CFR 34.3 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... deviations. Individual deviations affecting only one award may be approved by DoD Components in accordance with procedures stated in 32 CFR 21.335(a) and 21.340. (b) Small awards. DoD Components may apply less..., the Director, Defense Research and Engineering, or his or her designee, may grant exceptions from...

  19. 10 CFR 609.18 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Deviations. 609.18 Section 609.18 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE TECHNOLOGIES § 609.18 Deviations. To the extent that such requirements are not specified by the Act or...

  20. 10 CFR 609.18 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Deviations. 609.18 Section 609.18 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE TECHNOLOGIES § 609.18 Deviations. To the extent that such requirements are not specified by the Act or...

  1. 10 CFR 609.18 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Deviations. 609.18 Section 609.18 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE TECHNOLOGIES § 609.18 Deviations. To the extent that such requirements are not specified by the Act or...

  2. 10 CFR 609.18 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Deviations. 609.18 Section 609.18 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE TECHNOLOGIES § 609.18 Deviations. To the extent that such requirements are not specified by the Act or...

  3. 10 CFR 609.18 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Deviations. 609.18 Section 609.18 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE TECHNOLOGIES § 609.18 Deviations. To the extent that such requirements are not specified by the Act or...

  4. 41 CFR 105-1.110 - Deviation.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (Continued) GENERAL SERVICES ADMINISTRATION 1-INTRODUCTION 1.1-Regulations System § 105-1.110 Deviation. (a..., deviations; i.e., the use of any policy or procedure in any manner that is inconsistent with a policy or... have been requested from and approved by the Administrator of General Services or his...

  5. 41 CFR 105-1.110 - Deviation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (Continued) GENERAL SERVICES ADMINISTRATION 1-INTRODUCTION 1.1-Regulations System § 105-1.110 Deviation. (a..., deviations; i.e., the use of any policy or procedure in any manner that is inconsistent with a policy or... have been requested from and approved by the Administrator of General Services or his...

  6. What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study

    NASA Astrophysics Data System (ADS)

    Lachkar, Z.; Gruber, N.

    2011-06-01

    The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS) is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003). Here, using a comparative modeling study of the California Current System (California CS) and Canary Current System (Canary CS), we show how physical and environmental factors, such as light, temperature and cross-shore circulation modulate the response of biological productivity to upwelling strength. To this end, we made a series of eddy-resolving simulations of the California CS and Canary CS using the Regional Ocean Modeling System (ROMS), coupled to a nitrogen based Nutrient-Phytoplankton-Zooplankton-Detritus (NPZD) ecosystem model. We find the nutrient content of the euphotic zone to be 20 % smaller in the Canary CS relative to the California CS. Yet, the biological productivity is 50 % smaller in the latter. This is due to: (1) a faster nutrient-replete growth in the Canary CS relative to the California CS, related to a more favorable light and temperature conditions in the Canary CS, and (2) the longer nearshore water residence times in the Canary CS which lead to larger buildup of biomass in the upwelling zone, thereby enhancing the productivity. The longer residence times in the Canary CS appear to be associated with the wider continental shelves and the lower eddy activity characterizing this upwelling system. This results in a weaker offshore export of nutrients and organic matter, thereby increasing local nutrient recycling and enhancing the coupling between new and export production in the Northwest African system. Our results suggest that climate change induced perturbations such as upwelling favorable wind intensification might lead to contrasting biological responses in the California CS and the Canary CS, with major implications for the biogeochemical cycles and fisheries

  7. From systems biology to fuel--Chlamydomonas reinhardtii as a model for a systems biology approach to improve biohydrogen production.

    PubMed

    Rupprecht, Jens

    2009-06-01

    With economic wealth the need for energy is rising. Hence we are facing two problems: to satisfy the increasing energy demand and concomitantly deliver emission-free energy to avoid global warming. The process of photosynthesis offers a natural and highly efficient method to produce emission-neutral biofuels. However, using higher plants for such purposes causes several problems which are difficult to overcome and includes competition with food producing agriculture in terms of arable land, the need for fresh water, low process efficiency and the application of energy-intensive fertilizer in order to enhance growth performance. Photosynthetic microorganisms and, in particular, microalgae offer an alternative approach. In this case production sites in photo-bioreactors can be located on cheap, rural land and the organisms can be cultured in sea water rather than fresh water. However microorganisms are not naturally adapted as efficient producers of biofuels. Due to the complex regulatory network and mutual interaction of physiological processes and organelles, identifying the optimal production strategy is impossible without a greater understanding of the complex interplay of all cellular processes. Systems biology has emerged recently as a discipline to gain an understanding of these networks and their translation into a mathematical in silico model. An in silico model allows simulating optimization steps and, therefore, provides a useful method to identify targets for directed genetic/physiological modification to optimize the system for a biotechnological approach.

  8. From systems biology to fuel--Chlamydomonas reinhardtii as a model for a systems biology approach to improve biohydrogen production.

    PubMed

    Rupprecht, Jens

    2009-06-01

    With economic wealth the need for energy is rising. Hence we are facing two problems: to satisfy the increasing energy demand and concomitantly deliver emission-free energy to avoid global warming. The process of photosynthesis offers a natural and highly efficient method to produce emission-neutral biofuels. However, using higher plants for such purposes causes several problems which are difficult to overcome and includes competition with food producing agriculture in terms of arable land, the need for fresh water, low process efficiency and the application of energy-intensive fertilizer in order to enhance growth performance. Photosynthetic microorganisms and, in particular, microalgae offer an alternative approach. In this case production sites in photo-bioreactors can be located on cheap, rural land and the organisms can be cultured in sea water rather than fresh water. However microorganisms are not naturally adapted as efficient producers of biofuels. Due to the complex regulatory network and mutual interaction of physiological processes and organelles, identifying the optimal production strategy is impossible without a greater understanding of the complex interplay of all cellular processes. Systems biology has emerged recently as a discipline to gain an understanding of these networks and their translation into a mathematical in silico model. An in silico model allows simulating optimization steps and, therefore, provides a useful method to identify targets for directed genetic/physiological modification to optimize the system for a biotechnological approach. PMID:19480943

  9. 21 CFR 114.89 - Deviations from scheduled processes.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Deviations from scheduled processes. 114.89 Section 114.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS Production and Process Controls § 114.89...

  10. 21 CFR 114.89 - Deviations from scheduled processes.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Deviations from scheduled processes. 114.89 Section 114.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS Production and Process Controls § 114.89...

  11. 21 CFR 114.89 - Deviations from scheduled processes.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Deviations from scheduled processes. 114.89 Section 114.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS Production and Process Controls § 114.89...

  12. 21 CFR 114.89 - Deviations from scheduled processes.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Deviations from scheduled processes. 114.89 Section 114.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS Production and Process Controls § 114.89...

  13. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Written procedures; deviations. 211.100 Section 211.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production...

  14. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Written procedures; deviations. 211.100 Section 211.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production...

  15. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Written procedures; deviations. 211.100 Section 211.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production...

  16. Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels

    SciTech Connect

    Kuk Lee, Sung; Chou, Howard; Ham, Timothy S.; Soon Lee, Taek; Keasling, Jay D.

    2009-12-02

    The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology will provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.

  17. Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels.

    PubMed

    Lee, Sung Kuk; Chou, Howard; Ham, Timothy S; Lee, Taek Soon; Keasling, Jay D

    2008-12-01

    The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology will provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.

  18. Enhancing biological hydrogen production from cyanobacteria by removal of excreted products.

    PubMed

    Ananyev, Gennady M; Skizim, Nicholas J; Dismukes, G Charles

    2012-11-30

    Hydrogen is produced by a [NiFe]-hydrogenase in the cyanobacterium Arthrospira (Spirulina) maxima during autofermentation of photosynthetically accumulated glycogen under dark anaerobic conditions. Herein we show that elimination of H₂ backpressure by continuous H₂ removal ("milking") can significantly increase the yield of H₂ in this strain. We show that "milking" by continuous selective consumption of H₂ using an electrochemical cell produces the maximum increase in H₂ yield (11-fold) and H₂ rate (3.4-fold), which is considerably larger than through "milking" by non-selective dilution of the biomass in media (increases H₂ yield 3.7-fold and rate 3.1-fold). Exhaustive autofermentation under electrochemical milking conditions consumes >98% of glycogen and 27.6% of biomass over 7-8 days and extracts 39% of the energy content in glycogen as H₂. Non-selective dilution stimulates H₂ production by shifting intracellular equilibria competing for NADH from excreted products and terminal electron sinks into H₂ production. Adding a mixture of the carbon fermentative products shifts the equilibria towards reactants, resulting in increased intracellular NADH and an increased H₂ yield (1.4-fold). H₂ production is sustained for a period of time up to 7days, after which the PSII activity of the cells decreases by 80-90%, but can be restored by regeneration under photoautotrophic growth. PMID:22503939

  19. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  20. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  1. 21 CFR 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... biological product. IV. Animal safety data. A. Individual active components. 1. Controlled studies. 2.... Alternate methods, such as serological response evaluation in clinical studies and appropriate animal and... considered. (3) The benefit-to-risk ratio of a biological product shall be considered in determining...

  2. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  3. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  4. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  5. Milk proteins-derived bioactive peptides in dairy products: molecular, biological and methodological aspects.

    PubMed

    Dziuba, Bartłomiej; Dziuba, Marta

    2014-01-01

    Proteins are one of the primary components of the food, both in terms of nutrition and function. They are main source of amino acids, essential for synthesis of proteins, and also source of energy. Additionally, many proteins exhibit specific biological activities, which may have effect on functional or pro-health properties of food products. These proteins and their hydrolysis products, peptides, may influence the properties of food and human organism. The number of commercially available food products containing bioactive peptides is very low, apart from that milk proteins are their rich source. It could be supposed that number of available products with declared activity will rise in near future because of observed strong uptrend on interest in such products. Molecular and biological properties of milk proteins, as precursors of bioactive peptides was characterised in the work. Therefore, the strategy of research and obtaining of such peptides both in laboratory and industrial scale, as well as the range of their commercial application, was presented. Several examples of research efforts presenting high potential to develop new products containing bioactive peptides from milk proteins and predetermined as nutraceuticals was described.

  6. High-latitude controls of thermocline nutrients and low latitude biological productivity.

    PubMed

    Sarmiento, J L; Gruber, N; Brzezinski, M A; Dunne, J P

    2004-01-01

    The ocean's biological pump strips nutrients out of the surface waters and exports them into the thermocline and deep waters. If there were no return path of nutrients from deep waters, the biological pump would eventually deplete the surface waters and thermocline of nutrients; surface biological productivity would plummet. Here we make use of the combined distributions of silicic acid and nitrate to trace the main nutrient return path from deep waters by upwelling in the Southern Ocean and subsequent entrainment into subantarctic mode water. We show that the subantarctic mode water, which spreads throughout the entire Southern Hemisphere and North Atlantic Ocean, is the main source of nutrients for the thermocline. We also find that an additional return path exists in the northwest corner of the Pacific Ocean, where enhanced vertical mixing, perhaps driven by tides, brings abyssal nutrients to the surface and supplies them to the thermocline of the North Pacific. Our analysis has important implications for our understanding of large-scale controls on the nature and magnitude of low-latitude biological productivity and its sensitivity to climate change.

  7. High-latitude controls of thermocline nutrients and low latitude biological productivity.

    PubMed

    Sarmiento, J L; Gruber, N; Brzezinski, M A; Dunne, J P

    2004-01-01

    The ocean's biological pump strips nutrients out of the surface waters and exports them into the thermocline and deep waters. If there were no return path of nutrients from deep waters, the biological pump would eventually deplete the surface waters and thermocline of nutrients; surface biological productivity would plummet. Here we make use of the combined distributions of silicic acid and nitrate to trace the main nutrient return path from deep waters by upwelling in the Southern Ocean and subsequent entrainment into subantarctic mode water. We show that the subantarctic mode water, which spreads throughout the entire Southern Hemisphere and North Atlantic Ocean, is the main source of nutrients for the thermocline. We also find that an additional return path exists in the northwest corner of the Pacific Ocean, where enhanced vertical mixing, perhaps driven by tides, brings abyssal nutrients to the surface and supplies them to the thermocline of the North Pacific. Our analysis has important implications for our understanding of large-scale controls on the nature and magnitude of low-latitude biological productivity and its sensitivity to climate change. PMID:14702082

  8. [Microbiological and biological methods of the European Pharmacopoeia. Relevant for each medicinal product].

    PubMed

    Norwig, J

    2014-10-01

    According to the EU Directive 2001/83 the European Pharmacopoeia is the official Pharmacopoeia of the European Union. Therefore the European Pharmacopoeia is one of the legal pharmacopoeial compendia in Germany. Any licensed medicinal product on the German market complies with the requirements of the compendial monographs, if applicable. Because the general monographs of the European Pharmacopoeia on Dosage Forms, Substances for Pharmaceutical Use and Pharmaceutical Preparations refer to the microbiological and biological methods of the Pharmacopoeia, the methods are relevant for medicinal products, too. This article presents a rough summary of the microbiological and biological methods of the European Pharmacopoeia and is intended to be a stimulus for the reader to better understand the original compendia. The short description of the methods mentioned, here, is a summary from the Pharmacopoeia and the non-official collection of comments on the texts of the European Pharmacopoeia. PMID:25200487

  9. [Biologic age as a criterion for work evaluation (exemplified by titanium alloys production)].

    PubMed

    Afanas'eva, R F; Prokopenko, L V

    2009-01-01

    The article deals with results of studies concerning biologic age of workers (males) under occupational hazards of titanium alloys (jeopardy classes 3.3, 3.4.4) in Verkhne-Saldinsky metallurgic production association. Based on mathematic statistic analysis, the authors worked out an equation of multiple regression for ageing pace to forecast the ageing with consideration of age, length of service, occupation. The authors determined occupational groups characterized by premature ageing and increased risk of health disorders.

  10. Activity and biological effects of neem products against arthropods of medical and veterinary importance.

    PubMed

    Mulla, M S; Su, T

    1999-06-01

    Botanical insecticides are relatively safe and degradable, and are readily available sources of biopesticides. The most prominent phytochemical pesticides in recent years are those derived from neem trees, which have been studied extensively in the fields of entomology and phytochemistry, and have uses for medicinal and cosmetic purposes. The neem products have been obtained from several species of neem trees in the family Meliaceae. Six species in this family have been the subject of botanical pesticide research. They are Azadirachta indica A. Juss, Azadirachta excelsa Jack, Azadirachta siamens Valeton, Melia azedarach L., Melia toosendan Sieb. and Zucc., and Melia volkensii Gürke. The Meliaceae, especially A. indica (Indian neem tree), contains at least 35 biologically active principles. Azadirachtin is the predominant insecticidal active ingredient in the seed, leaves, and other parts of the neem tree. Azadirachtin and other compounds in neem products exhibit various modes of action against insects such as antifeedancy, growth regulation, fecundity suppression and sterilization, oviposition repellency or attractancy, changes in biological fitness, and blocking development of vector-borne pathogens. Some of these bioactivity parameters of neem products have been investigated at least in some species of insects of medical and veterinary importance, such as mosquitoes, flies, triatomines, cockroaches, fleas, lice, and others. Here we review, synthesize, and analyze published information on the activity, modes of action, and other biological effects of neem products against arthropods of medical and veterinary importance. The amount of information on the activity, use, and application of neem products for the control of disease vectors and human and animal pests is limited. Additional research is needed to determine the potential usefulness of neem products in vector control programs. PMID:10412110

  11. The potential of plants as a system for the development and production of human biologics.

    PubMed

    Chen, Qiang; Davis, Keith R

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

  12. The potential of plants as a system for the development and production of human biologics.

    PubMed

    Chen, Qiang; Davis, Keith R

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology. PMID:27274814

  13. Mapping the patent landscape of synthetic biology for fine chemical production pathways.

    PubMed

    Carbonell, Pablo; Gök, Abdullah; Shapira, Philip; Faulon, Jean-Loup

    2016-09-01

    A goal of synthetic biology bio-foundries is to innovate through an iterative design/build/test/learn pipeline. In assessing the value of new chemical production routes, the intellectual property (IP) novelty of the pathway is important. Exploratory studies can be carried using knowledge of the patent/IP landscape for synthetic biology and metabolic engineering. In this paper, we perform an assessment of pathways as potential targets for chemical production across the full catalogue of reachable chemicals in the extended metabolic space of chassis organisms, as computed by the retrosynthesis-based algorithm RetroPath. Our database for reactions processed by sequences in heterologous pathways was screened against the PatSeq database, a comprehensive collection of more than 150M sequences present in patent grants and applications. We also examine related patent families using Derwent Innovations. This large-scale computational study provides useful insights into the IP landscape of synthetic biology for fine and specialty chemicals production. PMID:27489206

  14. The potential of plants as a system for the development and production of human biologics

    PubMed Central

    Chen, Qiang; Davis, Keith R.

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology. PMID:27274814

  15. Interactive influences of bioactive trace metals on biological production in oceanic waters

    SciTech Connect

    Bruland, K.W.; Donat, J.R.; Hutchins, D.A. )

    1991-12-01

    The authors present an overview of the oceanic chemistries of the bioactive trace metals, Mn, Fe, Co, Ni, Cu, and Zn; the authors combine field data with results from laboratory phytoplankton culture-trace metal studies and speculate on the potential influences of these trace metals on oceanic plankton production and species composition. Most field studies have focused on the effects of single metals. However, they propose that synergistic and antagonistic interactions between multiple trace metals could be very important in the oceans. Trace metal antagonisms that may prove particularly important are those between Cu and the potential biolimiting metals Fe, Mn, and Zn. These antagonistic interactions could have the greatest influence on biological productivity in areas of the open ocean isolated from terrestrial inputs, such as the remote high nutrient regions of the Pacific and Antarctic Oceans. The emerging picture of trace metal-biota interactions in these oceanic areas is one in which biology strongly influences distribution and chemical speciation of all these bioactive trace metals. It also seems likely that many of these bioactive trace metals and their speciation may influence levels of primary productivity, species composition, and trophic structure. Future investigations should give more complete consideration to the interactive effects of biologically important trace metals.

  16. Different products for biological control of Botrytis cinerea examined on wounded stem tissue of tomato plants.

    PubMed

    Gielen, S; Aerts, R; Seels, B

    2004-01-01

    For the moment the agents that are used against Botrytis cinerea, in glasshouses were tomatoes are cultivated, are from chemical origin. For reducing the use of chemical agents in the future it is important to search for effective biological control agents against the fight of Botrytis cinerae. The following biological products Vital pasta, Vital gel and Elot-Vis were examined in there possibility to control Botrytis cinerea. Elot Vis was tested out in experiments that were carried out in climate chambers were leafs of 3 week old tomato plants were artificially infected with Botrytis cinerea spores. Also the biological products of Vital were first investigated in experiments that were carried out in climate chambers. In stead off leafs of tomato plants it were stem wounds of tomato plants who were treated with the pasta or the gel that was spread over the wounded surface after this has been inoculated with a suspension of conidia of Botrytis cinerae. The results of these first tests that were executed in the climate chambers were the circumstances for Botrytis cinerea were ideal seemed promising. In the next step these products were tested out on large scale in glasshouses. For each plant 5 wounds were created by removing the leafs, these wounds were or first treated with the Biological product and thereafter artificially infected with Botrytis cinerea spores to check out if these products can be used as a preventive agent or the wounds were first inoculated with a suspension of Botrytis cinerea spores and thereafter treated with the product. For the product Elot-Vis a few plants were totally sprayed with an Elot-Vis suspension before leafs were removed and the wounds were inoculated with conidia of Botrytis cinerea to check out if this product was able to activated the induced systemic resistance pathway. The experiments that were executed in glasshouses showed different percentages of succeeded Botrytis cinerea infections. This is probable due to the different

  17. Different products for biological control of Botrytis cinerea examined on wounded stem tissue of tomato plants.

    PubMed

    Gielen, S; Aerts, R; Seels, B

    2004-01-01

    For the moment the agents that are used against Botrytis cinerea, in glasshouses were tomatoes are cultivated, are from chemical origin. For reducing the use of chemical agents in the future it is important to search for effective biological control agents against the fight of Botrytis cinerae. The following biological products Vital pasta, Vital gel and Elot-Vis were examined in there possibility to control Botrytis cinerea. Elot Vis was tested out in experiments that were carried out in climate chambers were leafs of 3 week old tomato plants were artificially infected with Botrytis cinerea spores. Also the biological products of Vital were first investigated in experiments that were carried out in climate chambers. In stead off leafs of tomato plants it were stem wounds of tomato plants who were treated with the pasta or the gel that was spread over the wounded surface after this has been inoculated with a suspension of conidia of Botrytis cinerae. The results of these first tests that were executed in the climate chambers were the circumstances for Botrytis cinerea were ideal seemed promising. In the next step these products were tested out on large scale in glasshouses. For each plant 5 wounds were created by removing the leafs, these wounds were or first treated with the Biological product and thereafter artificially infected with Botrytis cinerea spores to check out if these products can be used as a preventive agent or the wounds were first inoculated with a suspension of Botrytis cinerea spores and thereafter treated with the product. For the product Elot-Vis a few plants were totally sprayed with an Elot-Vis suspension before leafs were removed and the wounds were inoculated with conidia of Botrytis cinerea to check out if this product was able to activated the induced systemic resistance pathway. The experiments that were executed in glasshouses showed different percentages of succeeded Botrytis cinerea infections. This is probable due to the different

  18. Current studies on biological tagatose production using L-arabinose isomerase: a review and future perspective.

    PubMed

    Kim, Pil

    2004-08-01

    D-Tagatose is a hexoketose monosaccharide sweetener, which is an isomer of D-galactose and is rarely found in nature. Recently, there has been industrial interest in D-tagatose as a low-calorie sugar-substituting sweetener. This article describes the properties and metabolism of tagatose as well as its commercial importance. The comparison between the biological tagatose production and the chemical production was reviewed based on the example of the glucose isomerization into fructose. The industrial problems facing its commercial application is described and evolving potential solutions are suggested.

  19. Acoustic Anisotropy Measurement and Interpretation in Deviated Wells

    NASA Astrophysics Data System (ADS)

    Tang, X.; Patterson, D.

    2005-05-01

    A current trend in petroleum exploration and production is that more and more deviated/horizontal wells are drilled, especially in deep water reservoirs like Gulf of Mexico. The issue of anisotropy is particularly important for deviated wells penetrating the soft sedimentary rocks of the reservoirs. In sedimentary formations, shales can be highly anisotropic due to mineral alignment, and sands can also be anisotropic due to their sensitivity to formation stresses. Many acoustic anisotropy measurements using cross-dipole tools have been made in deviated wells. However, interpreting the acoustic anisotropy data can be quite complicated, especially in the presence of strong anisotropy. In a deviated well, the well trajectory is neither perpendicular to, nor parallel with, the formation bedding planes. Consequently, the measured anisotropy is not the true formation anisotropy, but an apparent anisotropy at a given well deviation. Besides, several anisotropy parameters (e.g., Thomsen parameters) are needed to characterize the formation anisotropy while the cross-dipole measures only one of them. Nevertheless, the variation of the anisotropy and its associated azimuth relative to the well trajectory contains the information about the anisotropy parameters. By analyzing the anisotropy data in conjunction with the well configuration, we can characterize the relationship among the anisotropy parameters. By combining the data with lithology, we can also distinguish stress-induced anisotropy from other sources of anisotropy. The result is an improved characterization of formation anisotropy and its geological environment.

  20. 48 CFR 201.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    .... 2341(2)), or with United Nations or NATO organizations; and (ii) Such governments or organizations will...). (2) Contracting officers outside the United States may deviate from prescribed nonstatutory FAR...

  1. 48 CFR 201.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Air Force, and the Directors of the Defense Commissary Agency, the Defense Contract Management Agency, and the Defense Logistics Agency, may approve any class deviation, other than those described in...

  2. Potential of chicken by-products as sources of useful biological resources

    SciTech Connect

    Lasekan, Adeseye; Abu Bakar, Fatimah; Hashim, Dzulkifly

    2013-03-15

    By-products from different animal sources are currently being utilised for beneficial purposes. Chicken processing plants all over the world generate large amount of solid by-products in form of heads, legs, bones, viscera and feather. These wastes are often processed into livestock feed, fertilizers and pet foods or totally discarded. Inappropriate disposal of these wastes causes environmental pollution, diseases and loss of useful biological resources like protein, enzymes and lipids. Utilisation methods that make use of these biological components for producing value added products rather than the direct use of the actual waste material might be another viable option for dealing with these wastes. This line of thought has consequently led to researches on these wastes as sources of protein hydrolysates, enzymes and polyunsaturated fatty acids. Due to the multi-applications of protein hydrolysates in various branches of science and industry, and the large body of literature reporting the conversion of animal wastes to hydrolysates, a large section of this review was devoted to this subject. Thus, this review reports the known functional and bioactive properties of hydrolysates derived from chicken by-products as well their utilisation as source of peptone in microbiological media. Methods of producing these hydrolysates including their microbiological safety are discussed. Based on the few references available in the literature, the potential of some chicken by-product as sources of proteases and polyunsaturated fatty acids are pointed out along with some other future applications.

  3. Current good manufacturing practice in plant automation of biological production processes.

    PubMed

    Dorresteijn, R C; Wieten, G; van Santen, P T; Philippi, M C; de Gooijer, C D; Tramper, J; Beuvery, E C

    1997-01-01

    The production of biologicals is subject to strict governmental regulations. These are drawn up in current good manufacturing practices (cGMP), a.o. by the U.S. Food and Drug Administration. To implement cGMP in a production facility, plant automation becomes an essential tool. For this purpose Manufacturing Execution Systems (MES) have been developed that control all operations inside a production facility. The introduction of these recipe-driven control systems that follow ISA S88 standards for batch processes has made it possible to implement cGMP regulations in the control strategy of biological production processes. Next to this, an MES offers additional features such as stock management, planning and routing tools, process-dependent control, implementation of software sensors and predictive models, application of historical data and on-line statistical techniques for trend analysis and detection of instrumentation failures. This paper focuses on the development of new production strategies in which cGMP guidelines are an essential part.

  4. Potential of chicken by-products as sources of useful biological resources.

    PubMed

    Lasekan, Adeseye; Abu Bakar, Fatimah; Hashim, Dzulkifly

    2013-03-01

    By-products from different animal sources are currently being utilised for beneficial purposes. Chicken processing plants all over the world generate large amount of solid by-products in form of heads, legs, bones, viscera and feather. These wastes are often processed into livestock feed, fertilizers and pet foods or totally discarded. Inappropriate disposal of these wastes causes environmental pollution, diseases and loss of useful biological resources like protein, enzymes and lipids. Utilisation methods that make use of these biological components for producing value added products rather than the direct use of the actual waste material might be another viable option for dealing with these wastes. This line of thought has consequently led to researches on these wastes as sources of protein hydrolysates, enzymes and polyunsaturated fatty acids. Due to the multi-applications of protein hydrolysates in various branches of science and industry, and the large body of literature reporting the conversion of animal wastes to hydrolysates, a large section of this review was devoted to this subject. Thus, this review reports the known functional and bioactive properties of hydrolysates derived from chicken by-products as well their utilisation as source of peptone in microbiological media. Methods of producing these hydrolysates including their microbiological safety are discussed. Based on the few references available in the literature, the potential of some chicken by-product as sources of proteases and polyunsaturated fatty acids are pointed out along with some other future applications. PMID:22985619

  5. Mimicking/extracting structure and functions of natural products: synthetic approaches that address unexplored needs in chemical biology.

    PubMed

    Hirai, Go

    2015-04-01

    Natural products are often attractive and challenging targets for synthetic chemists, and many have interesting biological activities. However, synthetic chemists need to be more than simply suppliers of compounds to biologists. Therefore, we have been seeking ways to actively apply organic synthetic methods to chemical biology studies of natural products and their activities. In this personal review, I would like to introduce our work on the development of new biologically active compounds inspired by, or extracted from, the structures of natural products, focusing on enhancement of functional activity and specificity and overcoming various drawbacks of the parent natural products.

  6. Impact of synthetic biology and metabolic engineering on industrial production of fine chemicals.

    PubMed

    Jullesson, David; David, Florian; Pfleger, Brian; Nielsen, Jens

    2015-11-15

    Industrial bio-processes for fine chemical production are increasingly relying on cell factories developed through metabolic engineering and synthetic biology. The use of high throughput techniques and automation for the design of cell factories, and especially platform strains, has played an important role in the transition from laboratory research to industrial production. Model organisms such as Saccharomyces cerevisiae and Escherichia coli remain widely used host strains for industrial production due to their robust and desirable traits. This review describes some of the bio-based fine chemicals that have reached the market, key metabolic engineering tools that have allowed this to happen and some of the companies that are currently utilizing these technologies for developing industrial production processes.

  7. Construction of a microbial natural product library for chemical biology studies.

    PubMed

    Kato, Naoki; Takahashi, Shunji; Nogawa, Toshihiko; Saito, Tamio; Osada, Hiroyuki

    2012-04-01

    The RIKEN Natural Products Depository (NPDepo) is a public depository of small molecules. Currently, the NPDepo chemical library contains 39,200 pure compounds, half of which are natural products and their derivatives. In order to reinforce the uniqueness of our chemical library, we have improved our strategies for the collection of microbial natural products. Firstly, a microbial metabolite fraction library coupled with an MP (microbial products) plot database provides a powerful resource for the efficient isolation of microbial metabolites. Secondly, biosynthetic studies of microbial metabolites have enabled us to not only access ingenious biosynthetic machineries, but also obtain a variety of biosynthetic intermediates. Our chemical library contributes to the discovery of molecular probes for increasing our understanding of complex biological processes and for eventually developing new drug leads.

  8. Microbial production of amino acids and derived chemicals: synthetic biology approaches to strain development.

    PubMed

    Wendisch, Volker F

    2014-12-01

    Amino acids are produced at the multi-million-ton-scale with fermentative production of l-glutamate and l-lysine alone being estimated to amount to more than five million tons in the year 2013. Metabolic engineering constantly improves productivities of amino acid producing strains, mainly Corynebacterium glutamicum and Escherichia coli strains. Classical mutagenesis and screening have been accelerated by combination with intracellular metabolite sensing. Synthetic biology approaches have allowed access to new carbon sources to realize a flexible feedstock concept. Moreover, new pathways for amino acid production as well as fermentative production of non-native compounds derived from amino acids or their metabolic precursors were developed. These include dipeptides, α,ω-diamines, α,ω-diacids, keto acids, acetylated amino acids and ω-amino acids. PMID:24922334

  9. Techno-economic evaluation of a two-step biological process for hydrogen production.

    PubMed

    Ljunggren, Mattias; Zacchi, Guido

    2010-01-01

    An integrated biological process for the production of hydrogen based on thermophilic and photo-heterotrophic fermentation was evaluated from a technical and economic standpoint. Besides the two fermentation steps the process also includes pretreatment of the raw material (potato steam peels) and purification of hydrogen using amine absorption. The study aimed neither at determining the absolute cost of biohydrogen nor at an economic optimization of the production process, but rather at studying the effects of different parameters on the production costs of biohydrogen as a guideline for future improvements. The effect of the key parameters, hydrogen productivity and yield and substrate concentration in the two fermentations on the cost of the hydrogen produced was studied. The selection of the process conditions was based mainly on laboratory data. The process was simulated by use of the software Aspen Plus and the capital costs were estimated using the program Aspen Icarus Process Evaluator. The study shows that the photo-fermentation is the main contributor to the hydrogen production cost mainly because of the cost of plastic tubing, for the photo-fermentors, which represents 40.5% of the hydrogen production cost. The costs of the capital investment and chemicals were also notable contributors to the hydrogen production cost. Major economic improvements could be achieved by increasing the productivity of the two fermentation steps on a medium-term to long-term scale.

  10. Modeling the impact of tidal flows on the biological productivity of the Alboran Sea

    NASA Astrophysics Data System (ADS)

    Sánchez-Garrido, José C.; Naranjo, C.; Macías, D.; García-Lafuente, J.; Oguz, T.

    2015-11-01

    The control of phytoplankton production by tidal forcing in the Alboran Sea is investigated with a high-resolution ocean circulation model coupled to an ecosystem model. The aim of the modeling efforts was to elucidate the role of tides in sustaining the high biological productivity of the Alboran Sea, as compared with the rest of the Mediterranean subbasins. It is shown that tidal forcing accounts for an increase of phytoplankton biomass and primary productivity in the basin of about 40% with respect to a nontidal circulation, and about 60% in the western Alboran Sea alone. The tidal dynamics of the Strait of Gibraltar is shown to be the primary factor in determining the enhancement of productivity, pumping nutrients from depth to the photic zone in the Alboran Sea. Model results indicate that the biological implications of the propagating internal tides are small. These results imply that nutrient transports through the Strait of Gibraltar have to be parametrized in ocean models that do not resolve tides in order to properly represent the biochemical budgets of the Alboran Sea.

  11. Laser-initiated decomposition products of indocyanine green (ICG) and carbon black sensitized biological tissues

    NASA Astrophysics Data System (ADS)

    Kokosa, John M.; Przyjazny, Andrzej; Bartels, Kenneth E.; Motamedi, Massoud; Hayes, Donald J.; Wallace, David B.; Frederickson, Christopher J.

    1997-05-01

    Organic dyes have found increasing use a s sensitizers in laser surgical procedures, due to their high optical absorbances. Little is known, however, about the nature of the degradation products formed when these dyes are irradiated with a laser. Previous work in our laboratories has shown that irradiation of polymeric and biological tissues with CO2 and Nd:YAG lasers produces a host of volatile and semivolatile by-products, some of which are known to be potential carcinogens. This work focuses on the identification of the chemical by-products formed by diode laser and Nd:YAG laser irradiation of indocyanine green (ICG) and carbon black based ink sensitized tissues, including bone, tendon and sheep's teeth. Samples were mounted in a 0.5-L Pyrex sample chamber equipped with quartz optical windows, charcoal filtered air inlet and an outlet attached to an appropriate sample trap and a constant flow pump. By-products were analyzed by GC/MS and HPLC. Volatiles identified included benzene and formaldehyde. Semi-volatiles included traces of polycyclic aromatics, arising from the biological matrix and inks, as well as fragments of ICG and the carbon ink components. The significance of these results will be discussed, including the necessity of using appropriate evacuation devices when utilizing lasers for surgical procedures.

  12. Biological Pretreatment of Rubberwood with Ceriporiopsis subvermispora for Enzymatic Hydrolysis and Bioethanol Production

    PubMed Central

    Nazarpour, Forough; Abdullah, Dzulkefly Kuang; Abdullah, Norhafizah; Motedayen, Nazila; Zamiri, Reza

    2013-01-01

    Rubberwood (Hevea brasiliensis), a potential raw material for bioethanol production due to its high cellulose content, was used as a novel feedstock for enzymatic hydrolysis and bioethanol production using biological pretreatment. To improve ethanol production, rubberwood was pretreated with white rot fungus Ceriporiopsis subvermispora to increase fermentation efficiency. The effects of particle size of rubberwood (1 mm, 0.5 mm, and 0.25 mm) and pretreatment time on the biological pretreatment were first determined by chemical analysis and X-ray diffraction and their best condition obtained with 1 mm particle size and 90 days pretreatment. Further morphological study on rubberwood with 1 mm particle size pretreated by fungus was performed by FT-IR spectra analysis and SEM observation and the result indicated the ability of this fungus for pretreatment. A study on enzymatic hydrolysis resulted in an increased sugar yield of 27.67% as compared with untreated rubberwood (2.88%). The maximum ethanol concentration and yield were 17.9 g/L and 53% yield, respectively, after 120 hours. The results obtained demonstrate that rubberwood pretreated by C. subvermispora can be used as an alternative material for the enzymatic hydrolysis and bioethanol production. PMID:24167813

  13. Meat production in a feedlot system of Zebu-Holstein steers and heifers with dairy genetics: productive and biological analyses.

    PubMed

    Menezes, Gustavo Chamon de Castro; Valadares Filho, Sebastião de Campos; Ruas, José Reinaldo Mendes; Detmann, Edenio; Menezes, Arismar de Castro; Zanett, Diego; Mariz, Lays Débora Silva; Rennó, Luciana Navajas; da Silva Junior, Jarbas Miguel

    2014-01-01

    The aim of this study was to evaluate the productive and biological efficiency of steers and heifers from dairy genetics in a feedlot system in terms of meat production. Twenty-four steers and 24 heifers at 10 monthes of age, (3/4) Zebu × (1/4) Holstein were utilized. They were distributed over four feedlot times, 30, 60, 90, and 120 days with four replications for each sex, and were slaughtered at the end of each period. The productive and biological analyses were performed through comparative slaughter to determine the body composition. Heifers presented with greater intakes (P < 0.05) of dry matter in grams per kg of body weight. Steers presented with a greater (P < 0.05) final empty body weight, carcass gain, cold carcass weight, and meat proportion in the carcass; however, heifers presented with a greater subcutaneous fat thickness (P < 0.05) and, consequently, a greater (P < 0.05) fat proportion in the carcass. We conclude that steers are more efficient in their productive performance than heifers in a feedlot. For the finishing carcass fat cover, heifers need 90 days in the feedlot. The net energy requirements for maintenance are 67 kcal/EBW(0.75)/d, and the net requirements of energy (NEg) and protein (NPg) for gain can be estimated by the following equations: NEg(Mcal/d) = 0.067 × EBW(0.75) × EBG(1.095) and NPg = 162 × EBG - 5.62 × RE for the two sexes.

  14. Meat Production in a Feedlot System of Zebu—Holstein Steers and Heifers with Dairy Genetics: Productive and Biological Analyses

    PubMed Central

    Menezes, Gustavo Chamon de Castro; Valadares Filho, Sebastião de Campos; Ruas, José Reinaldo Mendes; Detmann, Edenio; Menezes, Arismar de Castro; Zanett, Diego; Mariz, Lays Débora Silva; Rennó, Luciana Navajas; da Silva Junior, Jarbas Miguel

    2014-01-01

    The aim of this study was to evaluate the productive and biological efficiency of steers and heifers from dairy genetics in a feedlot system in terms of meat production. Twenty-four steers and 24 heifers at 10 monthes of age, (3/4) Zebu × (1/4) Holstein were utilized. They were distributed over four feedlot times, 30, 60, 90, and 120 days with four replications for each sex, and were slaughtered at the end of each period. The productive and biological analyses were performed through comparative slaughter to determine the body composition. Heifers presented with greater intakes (P < 0.05) of dry matter in grams per kg of body weight. Steers presented with a greater (P < 0.05) final empty body weight, carcass gain, cold carcass weight, and meat proportion in the carcass; however, heifers presented with a greater subcutaneous fat thickness (P < 0.05) and, consequently, a greater (P < 0.05) fat proportion in the carcass. We conclude that steers are more efficient in their productive performance than heifers in a feedlot. For the finishing carcass fat cover, heifers need 90 days in the feedlot. The net energy requirements for maintenance are 67 kcal/EBW0.75/d, and the net requirements of energy (NEg) and protein (NPg) for gain can be estimated by the following equations: NEg(Mcal/d) = 0.067 × EBW0.75 × EBG1.095 and NPg = 162 × EBG − 5.62 × RE for the two sexes. PMID:25574483

  15. Recent advances in food biopeptides: production, biological functionalities and therapeutic applications.

    PubMed

    Saadi, Sami; Saari, Nazamid; Anwar, Farooq; Hamid, Azizah Abdul; Mohd Ghazali, Hasanah

    2015-01-01

    The growing momentum of several common life-style diseases such as myocardial infarction, cardiovascular disorders, stroke, hypertension, diabetes, and atherosclerosis has become a serious global concern. Recent developments in the field of proteomics offering promising solutions to solving such health problems stimulates the uses of biopeptides as one of the therapeutic agents to alleviate disease-related risk factors. Functional peptides are typically produced from protein via enzymatic hydrolysis under in vitro or in vivo conditions using different kinds of proteolytic enzymes. An array of biological activities, including antioxidative, antihypertensive, antidiabetic and immunomodulating has been ascribed to different types of biopeptides derived from various food sources. In fact, biopeptides are nutritionally and functionally important for regulating some physiological functions in the body; however, these are yet to be extensively addressed with regard to their production through advance strategies, mechanisms of action and multiple biological functionalities. This review mainly focuses on recent biotechnological advances that are being made in the field of production in addition to covering the mode of action and biological activities, medicinal health functions and therapeutic applications of biopeptides. State-of-the-art strategies that can ameliorate the efficacy, bioavailability, and functionality of biopeptides along with their future prospects are likewise discussed. PMID:25499177

  16. A review of biological delignification and detoxification methods for lignocellulosic bioethanol production.

    PubMed

    Moreno, Antonio D; Ibarra, David; Alvira, Pablo; Tomás-Pejó, Elia; Ballesteros, Mercedes

    2015-01-01

    Future biorefineries will integrate biomass conversion processes to produce fuels, power, heat and value-added chemicals. Due to its low price and wide distribution, lignocellulosic biomass is expected to play an important role toward this goal. Regarding renewable biofuel production, bioethanol from lignocellulosic feedstocks is considered the most feasible option for fossil fuels replacement since these raw materials do not compete with food or feed crops. In the overall process, lignin, the natural barrier of the lignocellulosic biomass, represents an important limiting factor in biomass digestibility. In order to reduce the recalcitrant structure of lignocellulose, biological pretreatments have been promoted as sustainable and environmentally friendly alternatives to traditional physico-chemical technologies, which are expensive and pollute the environment. These approaches include the use of diverse white-rot fungi and/or ligninolytic enzymes, which disrupt lignin polymers and facilitate the bioconversion of the sugar fraction into ethanol. As there is still no suitable biological pretreatment technology ready to scale up in an industrial context, white-rot fungi and/or ligninolytic enzymes have also been proposed to overcome, in a separated or in situ biodetoxification step, the effect of the inhibitors produced by non-biological pretreatments. The present work reviews the latest studies regarding the application of different microorganisms or enzymes as useful and environmentally friendly delignification and detoxification technologies for lignocellulosic biofuel production. This review also points out the main challenges and possible ways to make these technologies a reality for the bioethanol industry.

  17. Biological butanol production from microalgae-based biodiesel residues by Clostridium acetobutylicum.

    PubMed

    Cheng, Hai-Hsuan; Whang, Liang-Ming; Chan, Kun-Chi; Chung, Man-Chien; Wu, Shu-Hsien; Liu, Cheng-Pin; Tien, Shih-Yuan; Chen, Shan-Yuan; Chang, Jo-Shu; Lee, Wen-Jhy

    2015-05-01

    This study conducted batch experiments to evaluate the potential of butanol production from microalgae biodiesel residues by Clostridium acetobutylicum. The results indicated that with 90 g/L of glucose as the sole substrate the highest butanol yield of 0.2 g/g-glucose was found, but the addition of butyrate significantly enhanced the butanol yield. The highest butanol yield of 0.4 g/g-glucose was found with 60 g/L of glucose and 18 g/L of butyrate. Using microalgae biodiesel residues as substrate, C. acetobutylicum produced 3.86 g/L of butanol and achieved butanol yield of 0.13 g/g-carbohydrate via ABE fermentation, but the results indicated that approximately one third of carbohydrate was not utilized by C. acetobutylicum. Biological butanol production from microalgae biodiesel residues can be possible, but further research on fermentation strategies are required to improve production yield.

  18. Gamma irradiation induced disintegration of waste activated sludge for biological hydrogen production

    NASA Astrophysics Data System (ADS)

    Yin, Yanan; Wang, Jianlong

    2016-04-01

    In this paper, gamma irradiation was applied for the disintegration and dissolution of waste activated sludge produced during the biological wastewater treatment, and the solubilized sludge was used as substrate for bio-hydrogen production. The experimental results showed that the solubilization of waste activated sludge was 53.7% at 20 kGy and pH=12, and the SCOD, polysaccharides, protein, TN and TP contents in the irradiated sludge solutions was 3789.6 mg/L, 268.3 mg/L, 1881.5 mg/L, 132.3 mg/L and 80.4 mg/L, respectively. The irradiated sludge was used for fermentative hydrogen production, and the hydrogen yield was 10.5±0.7 mL/g SCODconsumed. It can be concluded that the irradiated waste activated sludge could be used as a low-cost substrate for fermentative hydrogen production.

  19. Enzyme and metabolic engineering for the production of novel biopolymers: crossover of biological and chemical processes.

    PubMed

    Matsumoto, Ken'ichiro; Taguchi, Seiichi

    2013-12-01

    The development of synthetic biology has transformed microbes into useful factories for producing valuable polymers and/or their precursors from renewable biomass. Recent progress at the interface of chemistry and biology has enabled the production of a variety of new biopolymers with properties that substantially differ from their petroleum-derived counterparts. This review touches on recent trials and achievements in the field of biopolymer synthesis, including chemo-enzymatically synthesized aliphatic polyesters, wholly biosynthesized lactate-based polyesters, polyhydroxyalkanoates and other unusual bacterially synthesized polyesters. The expanding diversities in structure and the material properties of biopolymers are key for exploring practical applications. The enzyme and metabolic engineering approaches toward this goal are discussed by shedding light on the successful case studies.

  20. Innovation in biological production and upgrading of methane and hydrogen for use as gaseous transport biofuel.

    PubMed

    Xia, Ao; Cheng, Jun; Murphy, Jerry D

    2016-01-01

    Biofuels derived from biomass will play a major role in future renewable energy supplies in transport. Gaseous biofuels have superior energy balances, offer greater greenhouse gas emission reductions and produce lower pollutant emissions than liquid biofuels. Biogas derived through fermentation of wet organic substrates will play a major role in future transport systems. Biogas (which is composed of approximately 60% methane/hydrogen and 40% carbon dioxide) requires an upgrading process to reduce the carbon dioxide content to less than 3% before it is used as compressed gas in transport. This paper reviews recent developments in fermentative biogas production and upgrading as a transport fuel. Third generation gaseous biofuels may be generated using marine-based algae via two-stage fermentation, cogenerating hydrogen and methane. Alternative biological upgrading techniques, such as biological methanation and microalgal biogas upgrading, have the potential to simultaneously upgrade biogas, increase gaseous biofuel yield and reduce carbon dioxide emission.

  1. Alien Biochemistries and Their Metabolic By-Products. Lessons from Synthetic Biology

    NASA Astrophysics Data System (ADS)

    Benner, S.

    2014-03-01

    While the metabolisms of terran organisms are accessible for study and their byproducts are, for the most part, well known, the "diversity" of terran biology arises (as far as we know) from a single common ancestor, represents only a small fraction of possible chemical difersity, and may reflect only a fraction of the possible chemical diversity that might support Darwinian evolution [1]. This talk will consider laboratory experiments on origins [2] and synthetic biology [3], asking how they might inform us about alternative biochemistries, and whether we have any chance of observing remotely their by-products, recognizing the uncertanties in both our models for "weird life" and our models of abiotic processes in incompletely defined planetary environments.

  2. Innovation in biological production and upgrading of methane and hydrogen for use as gaseous transport biofuel.

    PubMed

    Xia, Ao; Cheng, Jun; Murphy, Jerry D

    2016-01-01

    Biofuels derived from biomass will play a major role in future renewable energy supplies in transport. Gaseous biofuels have superior energy balances, offer greater greenhouse gas emission reductions and produce lower pollutant emissions than liquid biofuels. Biogas derived through fermentation of wet organic substrates will play a major role in future transport systems. Biogas (which is composed of approximately 60% methane/hydrogen and 40% carbon dioxide) requires an upgrading process to reduce the carbon dioxide content to less than 3% before it is used as compressed gas in transport. This paper reviews recent developments in fermentative biogas production and upgrading as a transport fuel. Third generation gaseous biofuels may be generated using marine-based algae via two-stage fermentation, cogenerating hydrogen and methane. Alternative biological upgrading techniques, such as biological methanation and microalgal biogas upgrading, have the potential to simultaneously upgrade biogas, increase gaseous biofuel yield and reduce carbon dioxide emission. PMID:26724182

  3. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

    PubMed

    Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

    2013-08-01

    The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines.

  4. Biologically active amines in fermented and non-fermented commercial soybean products from the Spanish market.

    PubMed

    Toro-Funes, N; Bosch-Fuste, J; Latorre-Moratalla, M L; Veciana-Nogués, M T; Vidal-Carou, M C

    2015-04-15

    Biologically active amines were determined in commercial soybean products. The antioxidant polyamines were found in both non-fermented and fermented soybean products. Natto and tempeh showed the highest content of polyamines (75-124 and 11-24 mg/kg of spermidine and spermine, respectively). On the other hand, the bacterial-related biogenic amines, tyramine, histamine, tryptamine and β-phenylethylamine, were detected in practically all fermented products with a high variability. The highest contents were found in sufu, tamari and soybean paste. Extremely high tyramine and histamine contents, 1700 and 700 mg/kg, respectively, found in some sufu samples could be unhealthy. However, biogenic amines observed in the other soybean products should not be a risk for healthy consumers. However, individuals who take monoamine and diamine oxidase inhibitors drugs should be strongly recommended to avoid this kind of products in order to suffer no adverse health effects. These biogenic amines were not detected in non-fermented soybean products.

  5. A cell-free expression and purification process for rapid production of protein biologics.

    PubMed

    Sullivan, Challise J; Pendleton, Erik D; Sasmor, Henri H; Hicks, William L; Farnum, John B; Muto, Machiko; Amendt, Eric M; Schoborg, Jennifer A; Martin, Rey W; Clark, Lauren G; Anderson, Mark J; Choudhury, Alaksh; Fior, Raffaella; Lo, Yu-Hwa; Griffey, Richard H; Chappell, Stephen A; Jewett, Michael C; Mauro, Vincent P; Dresios, John

    2016-02-01

    Cell-free protein synthesis has emerged as a powerful technology for rapid and efficient protein production. Cell-free methods are also amenable to automation and such systems have been extensively used for high-throughput protein production and screening; however, current fluidic systems are not adequate for manufacturing protein biopharmaceuticals. In this work, we report on the initial development of a fluidic process for rapid end-to-end production of recombinant protein biologics. This process incorporates a bioreactor module that can be used with eukaryotic or prokaryotic lysates that are programmed for combined transcription/translation of an engineered DNA template encoding for specific protein targets. Purification of the cell-free expressed product occurs through a series of protein separation modules that are configurable for process-specific isolation of different proteins. Using this approach, we demonstrate production of two bioactive human protein therapeutics, erythropoietin and granulocyte-macrophage colony-stimulating factor, in yeast and bacterial extracts, respectively, each within 24 hours. This process is flexible, scalable and amenable to automation for rapid production at the point-of-need of proteins with significant pharmaceutical, medical, or biotechnological value.

  6. [Molecular biological detection of tissues of central nervous system in meat products].

    PubMed

    Lange, Bianca; Alter, Thomas; Froeb, Annekathrin; Lücker, Ernst

    2003-01-01

    In principle, molecular biological methods can be used for the detection of specified risk material (SRM) in meat products. We were able to identify suitable target mRNAs for the marker proteins glial fibrillary acidic protein (GFAP) and myelin basic protein (MBP) of tissues of the central nervous system (CNS). The selected primers for GFAP ("GFAP87") and MBP ("MBP51") facilitated the detection of CNS in non-heated and heated standards of emulsion type (and raw) sausages with defined addition of brain by reverse transcription and polymerase chain reaction (RT-PCR). Stability of the mRNA proved to be given over a minimum of 48 hours. First results indicate an even higher stability of the target mRNAs over time and an ample stability against meat technological influences such as storage, temperature, and ripening. RT-PCR with GFAP87 facilitates the detection of CNS of all relevant slaughter animals in meat products. Thus it can be applied in food labeling control. Using RT-PCR and MBP51 as primer we were able to detect selectively the CNS of bovines, ovines and caprines but not CNS of porcines and poultry. Thus we have a second RT-PCR detection procedure for CNS in meat products which, however, yields results equivalent to the legal definition of SRM. The further development of these molecular biological methods would be of considerable importance for routine food control and reduction of human TSE-exposure risk.

  7. Static ocular counterroll reflex in skew deviation

    PubMed Central

    Chandrakumar, M.; Blakeman, A.; Goltz, H.C.; Sharpe, J.A.

    2011-01-01

    Objective: The static ocular counterroll (OCR) reflex generates partially compensatory torsional eye movements during head roll. It is mediated by the utricle in the inner ear. Skew deviation is a vertical strabismus thought to be caused by imbalance in the utriculo-ocular pathway. We hypothesized that if skew deviation is indeed caused by damage to this reflex pathway, patients with skew deviation would show abnormal OCR. Methods: Eighteen patients with skew deviation caused by brainstem or cerebellar lesions and 18 normal participants viewed a target at 1 m. Ocular responses to static passive head roll-tilts of approximately 20° were recorded using search coils. Static OCR gain was calculated as the change in torsional eye position divided by the change in head position during sustained head roll. Perception of the subjective visual vertical (SVV) was also measured. Results: Group mean OCR gain was reduced by 45% in patients. At an individual level, OCR gains were asymmetric between eyes and between torsional directions in 90% of patients. In addition, the hypotropic eye incyclotorting gain was lower than the hypertropic eye excyclotorting gain during head roll toward the hypotropic eye in 94% of patients. No consistent pattern of gain asymmetry was found during head roll toward the hypertropic eye. The SVV was tilted toward the hypotropic eye. Conclusion: Static OCR gain is significantly reduced in skew deviation. Interocular and directional gain asymmetries are also prevalent. The asymmetries provide further evidence that disruption of the utriculo-ocular pathway is a mechanism for skew deviation. PMID:21813791

  8. YS-822A, a new polyene macrolide antibiotic. I. Production, isolation, characterization and biological properties.

    PubMed

    Itoh, A; Ido, J; Iwamoto, Y; Goshima, E; Miki, T; Hasuda, K; Hirota, H

    1990-08-01

    A new polyene macrolide antibiotic, YS-822A was isolated from the culture filtrate of a mutant strain H-8 of Streptoverticillium eurocidicum var. asterocidicus S-822. Whereas the original S-822 strain produced not only YS-822 substances but also teleocidin as by-product which is well-known as a strong carcinogenic promoter, the mutagenized H-8 strain produced the antibiotic with only a trace amount of teleocidin. Chemical and biological characterizations of the antibiotic revealed that YS-822A (molecular formula: C37H59NO14) is a new polyene macrolide with a wide antifungal spectrum and a low acute toxicity. PMID:2211361

  9. Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products. Direct final rule.

    PubMed

    2016-05-01

    The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments. PMID:27192727

  10. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS...

  11. 21 CFR 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Review procedures to determine that licensed... AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.25 Review procedures to... category of products. (a) Advisory review panels. The Commissioner of Food and Drugs shall appoint...

  12. 21 CFR 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Review procedures to determine that licensed... AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.25 Review procedures to... category of products. (a) Advisory review panels. The Commissioner of Food and Drugs shall appoint...

  13. 21 CFR 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Review procedures to determine that licensed... AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.25 Review procedures to... category of products. (a) Advisory review panels. The Commissioner of Food and Drugs shall appoint...

  14. 21 CFR 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... each individual active component. 5. Pertinent medical and scientific literature. B. Combinations of... scientific literature. C. Finished biological product. 1. Controlled studies. 2. Partially controlled or... literature. VI. Efficacy data. A. Individual active components. 1. Controlled studies. 2....

  15. [The pharmaceutical company Choay: an history linked to research and commercialization of biological products].

    PubMed

    Bonnemain, Bruno

    2015-12-01

    Eugène Choay, when he created his own company in 1911, had already a large experience in pharmaceutical industry obtained with Maison Frère where he discovered the famous Dentol, well known thank to Poulbot's publicity drawings for this product. But, convinced of the future of biological products and Opotherapy, he decided to invest himself in this area with a totally new process for cold desiccation of organs. The success will be there and several pharmacists from Choay family will take care of the company and bring it to the top of its specialty in Opotherapy. At the beginning of the 1970's, Choay in in full development and has the products, the sites and the human resources for the future. In 1975, 4 therapeutic areas are covered by Choay's products: coagulation, inflammation, dermatology and hepatology. After more than 65 years of independence, Choay group will be finally bought partially and then totally by Sanofi. With the support of Sanofi, Choay created, in 1981, their US subsidiary called Choay Laboratories Inc;, after the NDA approval of sub-cutaneous Calciparine by the FDA. In 1985 Fraxiparine, a low molecular weight heparin discovered by Jean Choay's team, is lauched on the market. All these developments represent an outstanding record a longevity which indicates how perceptive was Eugène Choay and his successors when choosing to invest totally in the therapeutic use of hormones and products acting on coagulation factors.

  16. Suppressing and enhancing effects of mesoscale dynamics on biological production in the Mozambique Channel

    NASA Astrophysics Data System (ADS)

    José, Y. S.; Penven, P.; Aumont, O.; Machu, E.; Moloney, C. L.; Shillington, F.; Maury, O.

    2016-06-01

    We used a coupled physical-biogeochemical model to investigate how the strong eddy activity typical of the Mozambique Channel affects biological production. A numerical experiment was carried out, in which mesoscale dynamics were suppressed by cancelling the nonlinear terms for horizontal momentum in the Naviers-Stokes equation. Mesoscale dynamics were found to be responsible for (1) increased offshore production in the Mozambique Channel as a result of net eddy-induced offshore transport of nutrient-rich coastal waters; (2) decreased shelf production along the central Mozambican and south-west Madagascar coast caused by a reduction in nutrient availability related to the net eddy-induced lateral transport of nutrients; (3) increased coastal production along the northern Mozambican coast caused by eddy-induced nutrient supply. The model results also showed an intensification and shallowing of the subsurface production, related to increased upper layer nutrient concentrations caused by eddy activity. In addition, by driving the detachment of the East Madagascar Current at the southern tip of the island, inertial processes intensify the southern Madagascar upwelling and causes offshore diffusion of the upwelled waters. These results emphasize the complex role played by eddy activity and, more generally, inertial processes on marine ecosystems in this region.

  17. Biological Targets and Mechanisms of Action of Natural Products from Marine Cyanobacteria

    PubMed Central

    Salvador-Reyes, Lilibeth A.

    2015-01-01

    Marine cyanobacteria are an ancient group of organisms and prolific producers of bioactive secondary metabolites. These compounds are presumably optimized by evolution over billions of years to exert high affinity for their intended biological target in the ecologically relevant organism but likely also possess activity in different biological contexts such as human cells. Screening of marine cyanobacterial extracts for bioactive natural products has largely focused on cancer cell viability; however, diversification of the screening platform led to the characterization of many new bioactive compounds. Targets of compounds have oftentimes been elusive if the compounds were discovered through phenotypic assays. Over the past few years, technology has advanced to determine mechanism of action (MOA) and targets through reverse chemical genetic and proteomic approaches, which has been applied to certain cyanobacterial compounds and will be discussed in this review. Some cyanobacterial molecules are the most-potent-in-class inhibitors and therefore may become valuable tools for chemical biology to probe protein function but also be templates for novel drugs, assuming in vitro potency translates into cellular and in vivo activity. Our review will focus on compounds for which the direct targets have been deciphered or which were found to target a novel pathway, and link them to disease states where target modulation may be beneficial. PMID:25571978

  18. 14 CFR 125.3 - Deviation authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... data recorder requirements of this part will be granted. Any previously issued deviation from the flight data recorder requirements of this part is no longer valid. ... nearest Flight Standards District Office, not less than 60 days prior to the date of intended...

  19. 14 CFR 125.3 - Deviation authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... data recorder requirements of this part will be granted. Any previously issued deviation from the flight data recorder requirements of this part is no longer valid. ... nearest Flight Standards District Office, not less than 60 days prior to the date of intended...

  20. 14 CFR 125.3 - Deviation authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... data recorder requirements of this part will be granted. Any previously issued deviation from the flight data recorder requirements of this part is no longer valid. ... nearest Flight Standards District Office, not less than 60 days prior to the date of intended...

  1. 14 CFR 125.3 - Deviation authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... data recorder requirements of this part will be granted. Any previously issued deviation from the flight data recorder requirements of this part is no longer valid. ... nearest Flight Standards District Office, not less than 60 days prior to the date of intended...

  2. 14 CFR 125.3 - Deviation authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... data recorder requirements of this part will be granted. Any previously issued deviation from the flight data recorder requirements of this part is no longer valid. ... nearest Flight Standards District Office, not less than 60 days prior to the date of intended...

  3. 41 CFR 115-1.110 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Deviations. 115-1.110 Section 115-1.110 Public Contracts and Property Management Federal Property Management Regulations System (Continued) ENVIRONMENTAL PROTECTION AGENCY 1-INTRODUCTION 1.1-Regulation System § 115-1.110...

  4. 41 CFR 101-1.110 - Deviation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Deviation. 101-1.110 Section 101-1.110 Public Contracts and Property Management Federal Property Management Regulations System FEDERAL PROPERTY MANAGEMENT REGULATIONS GENERAL 1-INTRODUCTION 1.1-Regulation System § 101-1.110...

  5. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...” within the meaning of the Paperwork Reduction Act (44 U.S.C. 35) and its implementation in 5 CFR part... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Deviations. 1260.7 Section 1260.7 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS...

  6. 14 CFR § 1260.7 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...” within the meaning of the Paperwork Reduction Act (44 U.S.C. 35) and its implementation in 5 CFR part... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Deviations. § 1260.7 Section § 1260.7 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS...

  7. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...” within the meaning of the Paperwork Reduction Act (44 U.S.C. 35) and its implementation in 5 CFR part... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Deviations. 1260.7 Section 1260.7 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS...

  8. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...” within the meaning of the Paperwork Reduction Act (44 U.S.C. 35) and its implementation in 5 CFR part... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Deviations. 1260.7 Section 1260.7 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS...

  9. 7 CFR 2502.3 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 15 2014-01-01 2014-01-01 false Deviations. 2502.3 Section 2502.3 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ADVOCACY AND OUTREACH, DEPARTMENT OF AGRICULTURE AGRICULTURAL CAREER AND EMPLOYMENT (ACE) GRANTS PROGRAM General Information § 2502.3...

  10. 7 CFR 2502.3 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 15 2013-01-01 2013-01-01 false Deviations. 2502.3 Section 2502.3 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ADVOCACY AND OUTREACH, DEPARTMENT OF AGRICULTURE AGRICULTURAL CAREER AND EMPLOYMENT (ACE) GRANTS PROGRAM General Information § 2502.3...

  11. 7 CFR 2502.3 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 15 2012-01-01 2012-01-01 false Deviations. 2502.3 Section 2502.3 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ADVOCACY AND OUTREACH, DEPARTMENT OF AGRICULTURE AGRICULTURAL CAREER AND EMPLOYMENT (ACE) GRANTS PROGRAM General Information § 2502.3...

  12. 24 CFR 84.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Deviations. 84.4 Section 84.4 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND...

  13. 24 CFR 84.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Deviations. 84.4 Section 84.4 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND...

  14. 24 CFR 84.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 1 2013-04-01 2013-04-01 false Deviations. 84.4 Section 84.4 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND...

  15. 24 CFR 84.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Deviations. 84.4 Section 84.4 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND...

  16. 24 CFR 84.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 1 2014-04-01 2014-04-01 false Deviations. 84.4 Section 84.4 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND...

  17. 41 CFR 115-1.110 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Section 115-1.110 Public Contracts and Property Management Federal Property Management Regulations System (Continued) ENVIRONMENTAL PROTECTION AGENCY 1-INTRODUCTION 1.1-Regulation System § 115-1.110 Deviations. Where deemed necessary that regulations set forth in the FPMR or EPPMR be changed in the interest...

  18. 41 CFR 115-1.110 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Section 115-1.110 Public Contracts and Property Management Federal Property Management Regulations System (Continued) ENVIRONMENTAL PROTECTION AGENCY 1-INTRODUCTION 1.1-Regulation System § 115-1.110 Deviations. Where deemed necessary that regulations set forth in the FPMR or EPPMR be changed in the interest...

  19. 14 CFR 1260.104 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Deviations. 1260.104 Section 1260.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS Uniform Administrative Requirements for Grants and Cooperative Agreements With Institutions of Higher...

  20. 14 CFR 1260.104 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Deviations. 1260.104 Section 1260.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS Uniform Administrative Requirements for Grants and Cooperative Agreements With Institutions of Higher...

  1. 14 CFR 1260.104 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Deviations. 1260.104 Section 1260.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS Uniform Administrative Requirements for Grants and Cooperative Agreements With Institutions of Higher...

  2. 14 CFR 1260.104 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Deviations. 1260.104 Section 1260.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS Uniform Administrative Requirements for Grants and Cooperative Agreements With Institutions of Higher...

  3. 14 CFR § 1260.104 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Deviations. § 1260.104 Section § 1260.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS Uniform Administrative Requirements for Grants and Cooperative Agreements With Institutions of Higher...

  4. Manifestations of Deviation in the Adolescent Subculture

    ERIC Educational Resources Information Center

    Sobkin, V. S.; Abrosimova, Z. B.; Adamchuk, D. V.; Baranova, E. V.

    2005-01-01

    In this article the authors look at questions relating to school students' attitudes toward types of deviation such as smoking and the use of alcohol and narcotics. The empirical material is divided into the following topics: how widespread these forms of behavior are; motives that cause adolescents to start smoking, using alcohol, and taking…

  5. 48 CFR 201.404 - Class deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Air Force, and the Directors of the Defense Commissary Agency, the Defense Contract Management Agency, and the Defense Logistics Agency, may approve any class deviation, other than those described in 201... department or agency; (B) Have a significant cost or administrative impact on contractors or offerors;...

  6. 48 CFR 201.404 - Class deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Air Force, and the Directors of the Defense Commissary Agency, the Defense Contract Management Agency, and the Defense Logistics Agency, may approve any class deviation, other than those described in 201... department or agency; (B) Have a significant cost or administrative impact on contractors or offerors;...

  7. 41 CFR 109-1.5304 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle...

  8. 41 CFR 109-1.5304 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle...

  9. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...” within the meaning of the Paperwork Reduction Act (44 U.S.C. 35) and its implementation in 5 CFR part... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Deviations. 1260.7 Section 1260.7 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS...

  10. Bodily Deviations and Body Image in Adolescence

    ERIC Educational Resources Information Center

    Vilhjalmsson, Runar; Kristjansdottir, Gudrun; Ward, Dianne S.

    2012-01-01

    Adolescents with unusually sized or shaped bodies may experience ridicule, rejection, or exclusion based on their negatively valued bodily characteristics. Such experiences can have negative consequences for a person's image and evaluation of self. This study focuses on the relationship between bodily deviations and body image and is based on a…

  11. Voice Deviations and Coexisting Communication Disorders.

    ERIC Educational Resources Information Center

    St. Louis, Kenneth O.; And Others

    1992-01-01

    This study examined the coexistence of other communicative disorders with voice disorders in about 3,400 children in grades 1-12 at 100 sites throughout the United States. The majority of voice-disordered children had coexisting articulation deviations and also differed from controls on two language measures and mean pure-tone hearing thresholds.…

  12. 32 CFR 32.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... award may be approved by DoD Components in accordance with procedures stated in 32 CFR 21.335(a) and 21.340. (b) Small awards. DoD Components may apply less restrictive requirements than the provisions of... Components shall request approval for such deviations in accordance with 32 CFR 21.335(b) and 21.340....

  13. 32 CFR 32.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... award may be approved by DoD Components in accordance with procedures stated in 32 CFR 21.335(a) and 21.340. (b) Small awards. DoD Components may apply less restrictive requirements than the provisions of... Components shall request approval for such deviations in accordance with 32 CFR 21.335(b) and 21.340....

  14. 43 CFR 12.904 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Deviations. 12.904 Section 12.904 Public Lands: Interior Office of the Secretary of the Interior ADMINISTRATIVE AND AUDIT REQUIREMENTS AND COST... Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations General § 12.904...

  15. 2 CFR 215.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agreements OFFICE OF MANAGEMENT AND BUDGET CIRCULARS AND GUIDANCE Reserved UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS (OMB CIRCULAR A-110) General § 215.4 Deviations. The Office of Management and Budget (OMB)...

  16. Large Deviations: Advanced Probability for Undergrads

    ERIC Educational Resources Information Center

    Rolls, David A.

    2007-01-01

    In the branch of probability called "large deviations," rates of convergence (e.g. of the sample mean) are considered. The theory makes use of the moment generating function. So, particularly for sums of independent and identically distributed random variables, the theory can be made accessible to senior undergraduates after a first course in…

  17. Production of dissolved organic carbon enriched in deoxy sugars representing an additional sink for biological C drawdown in the Amazon River plume

    NASA Astrophysics Data System (ADS)

    Meador, Travis B.; Aluwihare, Lihini I.

    2014-10-01

    In North Atlantic waters impacted by discharges from the Amazon and Orinoco Rivers, where planktonic diatom-diazotroph associations (DDA) were active, we observed that an average (± standard deviation) of 61 ± 12% of the biological drawdown of dissolved inorganic carbon (DIC) was partitioned into the accumulating total organic carbon pool, representing a flux of up to 9 ± 4 Tg C yr-1. This drawdown corresponded with chemical alteration of ultrafiltered dissolved organic matter (UDOM), including increases in stable C isotopic composition (δ13C) and C:N. The dissolved carbohydrate component of UDOM also increased with biological DIC drawdown and diatom-associated diazotroph (i.e., Richelia) abundance. New carbohydrates could be distinguished by distinctively high relative abundances of deoxy sugars (up to 55% of monosaccharides), which may promote aggregate formation and enhance vertical carbon export. The identified production of non-Redfieldian, C-enriched UDOM thus suggests a mechanism to explain enhanced C sequestration associated with DDA N2 fixation, which may be widespread in mesohaline environments.

  18. Association between septal deviation and sinonasal papilloma.

    PubMed

    Nomura, Kazuhiro; Ogawa, Takenori; Sugawara, Mitsuru; Honkura, Yohei; Oshima, Hidetoshi; Arakawa, Kazuya; Oshima, Takeshi; Katori, Yukio

    2013-01-01

    Sinonasal papilloma is a common benign epithelial tumor of the sinonasal tract and accounts for 0.5% to 4% of all nasal tumors. The etiology of sinonasal papilloma remains unclear, although human papilloma virus has been proposed as a major risk factor. Other etiological factors, such as anatomical variations of the nasal cavity, may be related to the pathogenesis of sinonasal papilloma, because deviated nasal septum is seen in patients with chronic rhinosinusitis. We, therefore, investigated the involvement of deviated nasal septum in the development of sinonasal papilloma. Preoperative computed tomography or magnetic resonance imaging findings of 83 patients with sinonasal papilloma were evaluated retrospectively. The side of papilloma and the direction of septal deviation showed a significant correlation. Septum deviated to the intact side in 51 of 83 patients (61.4%) and to the affected side in 18 of 83 patients (21.7%). Straight or S-shaped septum was observed in 14 of 83 patients (16.9%). Even after excluding 27 patients who underwent revision surgery and 15 patients in whom the papilloma touched the concave portion of the nasal septum, the concave side of septal deviation was associated with the development of sinonasal papilloma (p = 0.040). The high incidence of sinonasal papilloma in the concave side may reflect the consequences of the traumatic effects caused by wall shear stress of the high-velocity airflow and the increased chance of inhaling viruses and pollutants. The present study supports the causative role of human papilloma virus and toxic chemicals in the occurrence of sinonasal papilloma.

  19. The Pig PeptideAtlas: A resource for systems biology in animal production and biomedicine.

    PubMed

    Hesselager, Marianne O; Codrea, Marius C; Sun, Zhi; Deutsch, Eric W; Bennike, Tue B; Stensballe, Allan; Bundgaard, Louise; Moritz, Robert L; Bendixen, Emøke

    2016-02-01

    Biological research of Sus scrofa, the domestic pig, is of immediate relevance for food production sciences, and for developing pig as a model organism for human biomedical research. Publicly available data repositories play a fundamental role for all biological sciences, and protein data repositories are in particular essential for the successful development of new proteomic methods. Cumulative proteome data repositories, including the PeptideAtlas, provide the means for targeted proteomics, system-wide observations, and cross-species observational studies, but pigs have so far been underrepresented in existing repositories. We here present a significantly improved build of the Pig PeptideAtlas, which includes pig proteome data from 25 tissues and three body fluid types mapped to 7139 canonical proteins. The content of the Pig PeptideAtlas reflects actively ongoing research within the veterinary proteomics domain, and this article demonstrates how the expression of isoform-unique peptides can be observed across distinct tissues and body fluids. The Pig PeptideAtlas is a unique resource for use in animal proteome research, particularly biomarker discovery and for preliminary design of SRM assays, which are equally important for progress in research that supports farm animal production and veterinary health, as for developing pig models with relevance to human health research.

  20. Evaluation of meat products from cloned cattle: biological and biochemical properties.

    PubMed

    Takahashi, Seiya; Ito, Yoshihiko

    2004-01-01

    Agricultural utilization of cloned livestock produced by nuclear transfer and their products for food will require public and governmental acceptance. A series of studies of properties of meat derived from cloned cattle was carried out to collect data for the safety assessment of cloned cattle products. Meat samples obtained from embryonic cloned, somatic cloned and non-cloned cattle were analyzed for chemical composition, as well as amino acids and fatty acids. Digestibility, allergenicity, and mutagenicity of meat were also examined. There were no significant differences in these properties among embryonic cloned, somatic cloned and non-cloned cattle. The analyses and tests revealed that there were no significant biological differences in meat from a non-cloned, an embryonic cloned, or a somatic cloned animal. A 14-week feeding trial in rats showed there were no abnormalities in body growth, general condition, locomotor activity, reflexes, sexual cycle, urinalysis, hematology, blood biochemistry, and histology. This study showed for the first time that the biological/biochemical properties of meat of cloned cattle are similar to those of non-cloned cattle.

  1. The Pig PeptideAtlas: a resource for systems biology in animal production and biomedicine

    PubMed Central

    Hesselager, Marianne O.; Codrea, Marius C.; Sun, Zhi; Deutsch, Eric W.; Bennike, Tue B.; Stensballe, Allan; Bundgaard, Louise; Moritz, Robert L.; Bendixen, Emøke

    2016-01-01

    Biological research of Sus scrofa, the domestic pig, is of immediate relevance for food production sciences, and for developing pig as a model organism for human biomedical research. Publicly available data repositories play a fundamental role for all biological sciences, and protein data repositories are in particular essential for the successful development of new proteomic methods. Cumulative proteome data repositories, including the PeptideAtlas, provide the means for targeted proteomics, system wide observations, and cross species observational studies, but pigs have so far been underrepresented in existing repositories. We here present a significantly improved build of the Pig PeptideAtlas, which includes pig proteome data from 25 tissues and three body fluid types mapped to 7139 canonical proteins. The content of the Pig PeptideAtlas reflects actively ongoing research within the veterinary proteomics domain, and this manuscript demonstrates how the expression of isoform-unique peptides can be observed across distinct tissues and body fluids. The Pig PeptideAtlas is a unique resource for use in animal proteome research, particularly biomarker discovery and for preliminary design of SRM assays, which are equally important for progress in research that supports farm animal production and veterinary health, as for developing pig models with relevance to human health research. PMID:26699206

  2. Connecting marine productivity to sea-spray via nanoscale biological processes: Phytoplankton Dance or Death Disco?

    PubMed

    O'Dowd, Colin; Ceburnis, Darius; Ovadnevaite, Jurgita; Bialek, Jakub; Stengel, Dagmar B; Zacharias, Merry; Nitschke, Udo; Connan, Solene; Rinaldi, Matteo; Fuzzi, Sandro; Decesari, Stefano; Facchini, Maria Cristina; Marullo, Salvatore; Santoleri, Rosalia; Dell'Anno, Antonio; Corinaldesi, Cinzia; Tangherlini, Michael; Danovaro, Roberto

    2015-10-14

    Bursting bubbles at the ocean-surface produce airborne salt-water spray-droplets, in turn, forming climate-cooling marine haze and cloud layers. The reflectance and ultimate cooling effect of these layers is determined by the spray's water-uptake properties that are modified through entrainment of ocean-surface organic matter (OM) into the airborne droplets. We present new results illustrating a clear dependence of OM mass-fraction enrichment in sea spray (OMss) on both phytoplankton-biomass, determined from Chlorophyll-a (Chl-a) and Net Primary Productivity (NPP). The correlation coefficient for OMss as a function of Chl-a increased form 0.67 on a daily timescale to 0.85 on a monthly timescale. An even stronger correlation was found as a function of NPP, increasing to 0.93 on a monthly timescale. We suggest the observed dependence is through the demise of the bloom, driven by nanoscale biological processes (such as viral infections), releasing large quantities of transferable OM comprising cell debris, exudates and other colloidal materials. This OM, through aggregation processes, leads to enrichment in sea-spray, thus demonstrating an important coupling between biologically-driven plankton bloom termination, marine productivity and sea-spray modification with potentially significant climate impacts.

  3. Effect of Methanethiol Concentration on Sulfur Production in Biological Desulfurization Systems under Haloalkaline Conditions.

    PubMed

    Roman, Pawel; Veltman, René; Bijmans, Martijn F M; Keesman, Karel J; Janssen, Albert J H

    2015-08-01

    Bioremoval of H2S from gas streams became popular in recent years because of high process efficiency and low operational costs. To expand the scope of these processes to gas streams containing volatile organic sulfur compounds, like thiols, it is necessary to provide new insights into their impact on overall biodesulfurization process. Published data on the effect of thiols on biodesulfurization processes are scarce. In this study, we investigated the effect of methanethiol on the selectivity for sulfur production in a bioreactor integrated with a gas absorber. This is the first time that the inhibition of biological sulfur formation by methanethiol is investigated. In our reactor system, inhibition of sulfur production started to occur at a methanethiol loading rate of 0.3 mmol L(-1) d(-1). The experimental results were also described by a mathematical model that includes recent findings on the mode of biomass inhibition by methanethiol. We also found that the negative effect of methanethiol can be mitigated by lowering the salinity of the bioreactor medium. Furthermore, we developed a novel approach to measure the biological activity by sulfide measurements using UV-spectrophotometry. On the basis of this measurement method, it is possible to accurately estimate the unknown kinetic parameters in the mathematical model.

  4. Connecting marine productivity to sea-spray via nanoscale biological processes: Phytoplankton Dance or Death Disco?

    NASA Astrophysics Data System (ADS)

    O'Dowd, Colin; Ceburnis, Darius; Ovadnevaite, Jurgita; Bialek, Jakub; Stengel, Dagmar B.; Zacharias, Merry; Nitschke, Udo; Connan, Solene; Rinaldi, Matteo; Fuzzi, Sandro; Decesari, Stefano; Cristina Facchini, Maria; Marullo, Salvatore; Santoleri, Rosalia; Dell'Anno, Antonio; Corinaldesi, Cinzia; Tangherlini, Michael; Danovaro, Roberto

    2015-10-01

    Bursting bubbles at the ocean-surface produce airborne salt-water spray-droplets, in turn, forming climate-cooling marine haze and cloud layers. The reflectance and ultimate cooling effect of these layers is determined by the spray’s water-uptake properties that are modified through entrainment of ocean-surface organic matter (OM) into the airborne droplets. We present new results illustrating a clear dependence of OM mass-fraction enrichment in sea spray (OMss) on both phytoplankton-biomass, determined from Chlorophyll-a (Chl-a) and Net Primary Productivity (NPP). The correlation coefficient for OMss as a function of Chl-a increased form 0.67 on a daily timescale to 0.85 on a monthly timescale. An even stronger correlation was found as a function of NPP, increasing to 0.93 on a monthly timescale. We suggest the observed dependence is through the demise of the bloom, driven by nanoscale biological processes (such as viral infections), releasing large quantities of transferable OM comprising cell debris, exudates and other colloidal materials. This OM, through aggregation processes, leads to enrichment in sea-spray, thus demonstrating an important coupling between biologically-driven plankton bloom termination, marine productivity and sea-spray modification with potentially significant climate impacts.

  5. Connecting marine productivity to sea-spray via nanoscale biological processes: Phytoplankton Dance or Death Disco?

    PubMed Central

    O’Dowd, Colin; Ceburnis, Darius; Ovadnevaite, Jurgita; Bialek, Jakub; Stengel, Dagmar B.; Zacharias, Merry; Nitschke, Udo; Connan, Solene; Rinaldi, Matteo; Fuzzi, Sandro; Decesari, Stefano; Cristina Facchini, Maria; Marullo, Salvatore; Santoleri, Rosalia; Dell’Anno, Antonio; Corinaldesi, Cinzia; Tangherlini, Michael; Danovaro, Roberto

    2015-01-01

    Bursting bubbles at the ocean-surface produce airborne salt-water spray-droplets, in turn, forming climate-cooling marine haze and cloud layers. The reflectance and ultimate cooling effect of these layers is determined by the spray’s water-uptake properties that are modified through entrainment of ocean-surface organic matter (OM) into the airborne droplets. We present new results illustrating a clear dependence of OM mass-fraction enrichment in sea spray (OMss) on both phytoplankton-biomass, determined from Chlorophyll-a (Chl-a) and Net Primary Productivity (NPP). The correlation coefficient for OMss as a function of Chl-a increased form 0.67 on a daily timescale to 0.85 on a monthly timescale. An even stronger correlation was found as a function of NPP, increasing to 0.93 on a monthly timescale. We suggest the observed dependence is through the demise of the bloom, driven by nanoscale biological processes (such as viral infections), releasing large quantities of transferable OM comprising cell debris, exudates and other colloidal materials. This OM, through aggregation processes, leads to enrichment in sea-spray, thus demonstrating an important coupling between biologically-driven plankton bloom termination, marine productivity and sea-spray modification with potentially significant climate impacts. PMID:26464099

  6. The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves

    NASA Astrophysics Data System (ADS)

    Zhang, Jinlun; Ashjian, Carin; Campbell, Robert; Hill, Victoria; Spitz, Yvette H.; Steele, Michael

    2014-01-01

    A coupled biophysical model is used to examine the impact of the great Arctic cyclone of early August 2012 on the marine planktonic ecosystem in the Pacific sector of the Arctic Ocean (PSA). Model results indicate that the cyclone influences the marine planktonic ecosystem by enhancing productivity on the shelves of the Chukchi, East Siberian, and Laptev seas during the storm. Although the cyclone's passage in the PSA lasted only a few days, the simulated biological effects on the shelves last 1 month or longer. At some locations on the shelves, primary productivity (PP) increases by up to 90% and phytoplankton biomass by up to 40% in the wake of the cyclone. The increase in zooplankton biomass is up to 18% on 31 August and remains 10% on 15 September, more than 1 month after the storm. In the central PSA, however, model simulations indicate a decrease in PP and plankton biomass. The biological gain on the shelves and loss in the central PSA are linked to two factors. (1) The cyclone enhances mixing in the upper ocean, which increases nutrient availability in the surface waters of the shelves; enhanced mixing in the central PSA does not increase productivity because nutrients there are mostly depleted through summer draw down by the time of the cyclone's passage. (2) The cyclone also induces divergence, resulting from the cyclone's low-pressure system that drives cyclonic sea ice and upper ocean circulation, which transports more plankton biomass onto the shelves from the central PSA. The simulated biological gain on the shelves is greater than the loss in the central PSA, and therefore, the production on average over the entire PSA is increased by the cyclone. Because the gain on the shelves is offset by the loss in the central PSA, the average increase over the entire PSA is moderate and lasts only about 10 days. The generally positive impact of cyclones on the marine ecosystem in the Arctic, particularly on the shelves, is likely to grow with increasing summer

  7. The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves

    PubMed Central

    Zhang, Jinlun; Ashjian, Carin; Campbell, Robert; Hill, Victoria; Spitz, Yvette H; Steele, Michael

    2014-01-01

    [1] A coupled biophysical model is used to examine the impact of the great Arctic cyclone of early August 2012 on the marine planktonic ecosystem in the Pacific sector of the Arctic Ocean (PSA). Model results indicate that the cyclone influences the marine planktonic ecosystem by enhancing productivity on the shelves of the Chukchi, East Siberian, and Laptev seas during the storm. Although the cyclone's passage in the PSA lasted only a few days, the simulated biological effects on the shelves last 1 month or longer. At some locations on the shelves, primary productivity (PP) increases by up to 90% and phytoplankton biomass by up to 40% in the wake of the cyclone. The increase in zooplankton biomass is up to 18% on 31 August and remains 10% on 15 September, more than 1 month after the storm. In the central PSA, however, model simulations indicate a decrease in PP and plankton biomass. The biological gain on the shelves and loss in the central PSA are linked to two factors. (1) The cyclone enhances mixing in the upper ocean, which increases nutrient availability in the surface waters of the shelves; enhanced mixing in the central PSA does not increase productivity because nutrients there are mostly depleted through summer draw down by the time of the cyclone's passage. (2) The cyclone also induces divergence, resulting from the cyclone's low-pressure system that drives cyclonic sea ice and upper ocean circulation, which transports more plankton biomass onto the shelves from the central PSA. The simulated biological gain on the shelves is greater than the loss in the central PSA, and therefore, the production on average over the entire PSA is increased by the cyclone. Because the gain on the shelves is offset by the loss in the central PSA, the average increase over the entire PSA is moderate and lasts only about 10 days. The generally positive impact of cyclones on the marine ecosystem in the Arctic, particularly on the shelves, is likely to grow with increasing

  8. Use of biologically reclaimed minerals for continuous hydroponic potato production in a CELSS

    NASA Astrophysics Data System (ADS)

    Mackowiak, C. L.; Wheeler, R. M.; Stutte, G. W.; Yorio, N. C.; Sager, J. C.

    1997-01-01

    Plant-derived nutrients were successfully recycled in a Controlled Ecological Life Support System (CELSS) using biological methods. The majority of the essential nutrients were recovered by microbiologically treating the plant biomass in an aerobic bioreactor. Liquid effluent containing the nutrients was then returned to the biomass production component via a recirculating hydroponic system. Potato (Solanum tuberosum L.) cv. Norland plants were grown on those nutrients in either a batch production mode (same age plants on a nutrient solution) or a staggered production mode (4 different ages of plants on a nutrient solution). The study continued over a period of 418 days, within NASA Breadboard Project's Biomass Production Chamber at the Kennedy Space Center. During this period, four consecutive batch cycles (104-day harvests) and 13 consecutive staggered cycles (26-day harvests) were completed using reclaimed minerals and compared to plants grown with standard nutrient solutions. All nutrient solutions were continually recirculated during the entire 418 day study. In general, tuber yields with reclaimed minerals were within 10% of control solutions. Contaminants, such as sodium and recalcitrant organics tended to increase over time in solutions containing reclaimed minerals, however tuber composition was comparable to tubers grown in the control solutions.

  9. Use of biologically reclaimed minerals for continuous hydroponic potato production in a CELSS.

    PubMed

    Mackowiak, C L; Wheeler, R M; Stutte, G W; Yorio, N C; Sager, J C

    1997-01-01

    Plant-derived nutrients were successfully recycled in a Controlled Ecological Life Support System (CELSS) using biological methods. The majority of the essential nutrients were recovered by microbiologically treating the plant biomass in an aerobic bioreactor. Liquid effluent containing the nutrients was then returned to the biomass production component via a recirculating hydroponic system. Potato (Solanum tuberosum L.) cv. Norland plants were grown on those nutrients in either a batch production mode (same age plants on a nutrient solution) or a staggered production mode (4 different ages of plants on a nutrient solution). The study continued over a period of 418 days, within NASA Breadboard Project's Biomass Production Chamber at the Kennedy Space Center. During this period, four consecutive batch cycles (104-day harvests) and 13 consecutive staggered cycles (26-day harvests) were completed using reclaimed minerals and compared to plants grown with standard nutrient solutions. All nutrient solutions were continually recirculated during the entire 418 day study. In general, tuber yields with reclaimed minerals were within 10% of control solutions. Contaminants, such as sodium and recalcitrant organics tended to increase over time in solutions containing reclaimed minerals, however tuber composition was comparable to tubers grown in the control solutions.

  10. Linking Physical Dynamics and Biological Productivity in a Coastal Mesoscale Eddy

    NASA Astrophysics Data System (ADS)

    Simons, R. D.; Nishimoto, M. M.; Washburn, L.; Brown, K. S.; Siegel, D. A.

    2014-12-01

    The Santa Barbara Channel (SBC) eddy is a cyclonic mesoscale eddy located off the coast of Southern California, USA. In the summer of 1998 and 1999, the SBC eddy was surveyed for juvenile fishes. In 1998, very high numbers of juvenile fishes were observed within the eddy, but not in 1999. The ocean conditions that contributed to the differences in fish abundances inside the eddy were investigated with three-dimensional numerical modeling. The physical dynamics of the SBC eddy, which included eddy size, three-dimensional rotational structure, and isopycnal uplift, were evaluated using a three-dimensional Regional Ocean Modeling System (ROMS). The retention ability of the eddy was quantified using a three-dimensional particle tracking model driven by the ROMS. The physical dynamics and particle retention of the SBC eddy were found to differ significantly in 1998 and 1999. In 1998, when the SBC eddy was rotating at a steady rate spatially and temporally and cycling consistently in and out of solid-body rotation, the particle retention was high and the isopycnal uplift sustained. However in 1999, when the SBC eddy was rotating unsteadily in space and time and did not have periods of solid-body rotation, the particle retention was low and the isopycnal uplift unstable. We theorize that the steady symmetric rotation of the eddy in 1998 had two important impacts on the biological productivity inside the eddy. First, it provided a prolonged period of cold nutrient rich water uplifting into the euphotic zone, which stimulated productivity and consequently attracted zooplankton. Second, it allowed the zooplankton, prey for the juvenile fish, to be retained inside the eddy, which attracted the juvenile fish. We conclude that biological productivity inside mesoscale eddies may be linked to the stability of its three-dimensional rotational structure and consequently its ability to retain particles.

  11. Biological and functional properties of proteolytic enzyme-modified egg protein by-products

    PubMed Central

    Pokora, Marta; Eckert, Ewelina; Zambrowicz, Aleksandra; Bobak, Łukasz; Szołtysik, Marek; Dąbrowska, Anna; Chrzanowska, Józefa; Polanowski, Antoni; Trziszka, Tadeusz

    2013-01-01

    Enzymatic hydrolysis led to improve functional properties and biological activity of protein by-products, which can be further used as protein ingredients for food and feed applications. The effects of proteolytic enzyme modification of egg-yolk protein preparation (YP) and white protein preparation (WP), obtained as the by-products left during the course of lecithin, lysozyme, and cystatin isolation on their biological and functional properties, were evaluated by treating a commercial Neutrase. The antihypertensive and antioxidative properties of YP and WP hydrolysates were evaluated based on their angiotensin-converting enzyme (ACE)-inhibitory activity and radical scavenging (DPPH) capacity, ferric reducing power, and chelating of iron activity. The functionality of obtained hydrolysates was also determined. Neutrase caused a degree of hydrolysis (DH) of YP and WP by-products: 27.6% and 20.9%, respectively. In each of them, mixture of peptides with different molecular masses were also observed. YP hydrolysate showed high levels of antioxidant activity. The scavenging capacity, ferric reducing power, and chelating capacity were observed at the level: 0.44 μmol/L Trolox mg−1, 177.35 μg Fe2+ mg−1, and 549.87 μg Fe2+ mg−1, respectively. YP hydrolysate also exhibited significant ACE-inhibitory activity, in which the level was 59.2 μg. Protein solubility was significantly improved as the DH increased. WP hydrolysate showed high water-holding capacity of 43.2. This study indicated that YP and WP hydrolysates could be used in foods as natural antioxidants and functionality enhancers. PMID:24804027

  12. Determination of production biology of cladocera in a reservoir receiving hyperthermal effluents from a nuclear production reactor. [Par Pond

    SciTech Connect

    Vigerstad, T J

    1980-01-01

    The effects on zooplankton of residence in a cooling reservoir receiving hyperthermal effluents directly from a nuclear-production-reactor were studied. Rates of cladoceran population production were compared at two stations in the winter and summer of 1976 on Par Pond located on the Savannah River Plant, Aiken, SC. One station was located in an area of the reservoir directly receiving hyperthermal effluent (Station MAS) and the second was located about 4 km away in an area where surface temperatures were normal for reservoirs in the general geographical region (Station CAS). A non-parametric comparison between stations of standing stock and fecundity data for Bosmina longirostris, taken for the egg ratio model, was used to observe potential hyperthermal effluent effects. There was a statistically higher incidence of deformed eggs in the Bosmina population at Station MAS in the summer. Bosmina standing stock underwent two large oscillations in the winter and three large oscillations in the summer at Station MAS compared with two in the winter and one in the summer at Station CAS. These results are consistent with almost all other Par Pond studies which have found the two stations to be essentially similar in spectra composition but with some statistically significant differences in various aspects of the biology of the species.

  13. Biological re-cultivation of industrial technological waste banks after steel production

    NASA Astrophysics Data System (ADS)

    Sokolovska, Maria; Zhiyanski, Miglena; Bech, Jaume

    2010-05-01

    The problem of re-cultivation of disturbed lands, after the creation of waste banks, is very important and of great scientific interest. The studies on the effectiveness of biological re-cultivation are focused mainly on activities and techniques for the acceleration of soil formation processes as. The relationship between substrate and plants is also studied, in order to create modern biotechnologies and contributes to the remediation of the re-cultivated lands within the territorial system. In this work we have studied three parts of an industrial waste bank named "The 7th of September" located in the green system of Sofia - Pernik agglomeration in Bulgaria. It consists of technological wastes produced by the steel industry. Its area of 20 dca is of special local importance. The aim of this study was to propose an appropriate technology for the biological re-cultivation, which could take place after all production activities had ceased. To achieve this aim a detailed study on the characteristics of climatic elements was carried out focusing on precipitation - limiting factor for future afforestation of waste banks. Analyses on hydro-physical and chemical parameters of substrates were undertaken in order to elaborate recommendations for their improvement and utility in biological re-cultivation. Here we present the characteristics of the vegetation which existed before the production activities and the approaches for choice of tree species in afforestation with different schemes and methods applied. On the basis of this study we were able to establish that the hydrological properties of substrates are quite similar to those of natural soils in the region. The variations obtained for some soil substrate layers were not significant. In relation to this we also outlined the quantity of organic matter and nutrient elements in waste banks as determining parameters for further biological re-cultivation. The studied site is located in the lower forest zone of the country

  14. Effects of milk yield on biological efficiency and profit of beef production from birth to slaughter.

    PubMed

    Miller, S P; Wilton, J W; Pfeiffer, W C

    1999-02-01

    Effect of milk yield (MY) on biological efficiency and gross margin as an indicator of profit potential of beef production from birth to slaughter was determined. Data included 9 yr of spring-born single male calves. Biological efficiency was calculated as carcass weight/total feed energy intake, including nonlactating and lactating intakes of cow and creep and feedlot intakes of calf. Slaughter end point was finish constant at 9 mm of fat thickness. Gross margin was determined as returns minus feed costs. Three breeding systems were analyzed: purebred Hereford (HE), large rotational (LR), and small rotational (SR). Analyses were performed separately by breeding system when differences in the effect of MY among breeding systems were significant. Increased MY was associated with increased preweaning gain (P < .001), increased weight at start of feedlot trial (P < .001), and increased hot carcass weight (P < .05). No significant (P > .10) effect of MY on age at slaughter or on carcass weight per day of age at slaughter was found. Increased MY was associated with increased cow lactating energy intake (P < .10) and negatively associated with calf creep intake (P < .01). No effects of MY on intake of the cow during the nonlactating period, calf feedlot intake, or total feed intake were found. Increased MY was associated with a reduction in backfat thickness of the cow during the lactating period (P < .01) with no change in body weight. In the subsequent nonlactating period, increasing MY was associated with increased backfat thickness (P < .10) and body weight (P < .05). No effect of MY on change in backfat or weight of cow from calving to the end of the next nonlactating period was found. No effect of MY on biological efficiency to slaughter was detected. Milk yield was positively associated with gross margin from birth to slaughter (P < .05); results were similar when cow feed prices were reduced by 30%. Increased MY was associated with increased biological efficiency

  15. Deviations from LTE in a stellar atmosphere

    NASA Technical Reports Server (NTRS)

    Kalkofen, W.; Klein, R. I.; Stein, R. F.

    1979-01-01

    Deviations for LTE are investigated in an atmosphere of hydrogen atoms with one bound level, satisfying the equations of radiative, hydrostatic, and statistical equilibrium. The departure coefficient and the kinetic temperature as functions of the frequency dependence of the radiative cross section are studied analytically and numerically. Near the outer boundary of the atmosphere, the departure coefficient is smaller than unity when the radiative cross section grows with frequency faster than with the square of frequency; it exceeds unity otherwise. Far from the boundary the departure coefficient tends to exceed unity for any frequency dependence of the radiative cross section. Overpopulation always implies that the kinetic temperature in the statistical-equilibrium atmosphere is higher than the temperature in the corresponding LTE atmosphere. Upper and lower bounds on the kinetic temperature are given for an atmosphere with deviations from LTE only in the optically shallow layers when the emergent intensity can be described by a radiation temperature.

  16. On large deviations for ensembles of distributions

    SciTech Connect

    Khrychev, D A

    2013-11-30

    The paper is concerned with the large deviations problem in the Freidlin-Wentzell formulation without the assumption of the uniqueness of the solution to the equation involving white noise. In other words, it is assumed that for each ε>0 the nonempty set P{sub ε} of weak solutions is not necessarily a singleton. Analogues of a number of concepts in the theory of large deviations are introduced for the set (P{sub ε}, ε>0), hereafter referred to as an ensemble of distributions. The ensembles of weak solutions of an n-dimensional stochastic Navier-Stokes system and stochastic wave equation with power-law nonlinearity are shown to be uniformly exponentially tight. An idempotent Wiener process in a Hilbert space and idempotent partial differential equations are defined. The accumulation points in the sense of large deviations of the ensembles in question are shown to be weak solutions of the corresponding idempotent equations. Bibliography: 14 titles.

  17. Note onset deviations as musical piece signatures.

    PubMed

    Serrà, Joan; Özaslan, Tan Hakan; Arcos, Josep Lluis

    2013-01-01

    A competent interpretation of a musical composition presents several non-explicit departures from the written score. Timing variations are perhaps the most important ones: they are fundamental for expressive performance and a key ingredient for conferring a human-like quality to machine-based music renditions. However, the nature of such variations is still an open research question, with diverse theories that indicate a multi-dimensional phenomenon. In the present study, we consider event-shift timing variations and show that sequences of note onset deviations are robust and reliable predictors of the musical piece being played, irrespective of the performer. In fact, our results suggest that only a few consecutive onset deviations are already enough to identify a musical composition with statistically significant accuracy. We consider a mid-size collection of commercial recordings of classical guitar pieces and follow a quantitative approach based on the combination of standard statistical tools and machine learning techniques with the semi-automatic estimation of onset deviations. Besides the reported results, we believe that the considered materials and the methodology followed widen the testing ground for studying musical timing and could open new perspectives in related research fields.

  18. Note Onset Deviations as Musical Piece Signatures

    PubMed Central

    Serrà, Joan; Özaslan, Tan Hakan; Arcos, Josep Lluis

    2013-01-01

    A competent interpretation of a musical composition presents several non-explicit departures from the written score. Timing variations are perhaps the most important ones: they are fundamental for expressive performance and a key ingredient for conferring a human-like quality to machine-based music renditions. However, the nature of such variations is still an open research question, with diverse theories that indicate a multi-dimensional phenomenon. In the present study, we consider event-shift timing variations and show that sequences of note onset deviations are robust and reliable predictors of the musical piece being played, irrespective of the performer. In fact, our results suggest that only a few consecutive onset deviations are already enough to identify a musical composition with statistically significant accuracy. We consider a mid-size collection of commercial recordings of classical guitar pieces and follow a quantitative approach based on the combination of standard statistical tools and machine learning techniques with the semi-automatic estimation of onset deviations. Besides the reported results, we believe that the considered materials and the methodology followed widen the testing ground for studying musical timing and could open new perspectives in related research fields. PMID:23935971

  19. Note onset deviations as musical piece signatures.

    PubMed

    Serrà, Joan; Özaslan, Tan Hakan; Arcos, Josep Lluis

    2013-01-01

    A competent interpretation of a musical composition presents several non-explicit departures from the written score. Timing variations are perhaps the most important ones: they are fundamental for expressive performance and a key ingredient for conferring a human-like quality to machine-based music renditions. However, the nature of such variations is still an open research question, with diverse theories that indicate a multi-dimensional phenomenon. In the present study, we consider event-shift timing variations and show that sequences of note onset deviations are robust and reliable predictors of the musical piece being played, irrespective of the performer. In fact, our results suggest that only a few consecutive onset deviations are already enough to identify a musical composition with statistically significant accuracy. We consider a mid-size collection of commercial recordings of classical guitar pieces and follow a quantitative approach based on the combination of standard statistical tools and machine learning techniques with the semi-automatic estimation of onset deviations. Besides the reported results, we believe that the considered materials and the methodology followed widen the testing ground for studying musical timing and could open new perspectives in related research fields. PMID:23935971

  20. Variability of Ocular Deviation in Strabismus

    PubMed Central

    Economides, John R.; Adams, Daniel L.; Horton, Jonathan C.

    2015-01-01

    IMPORTANCE In strabismus, the fixating eye conveys the direction of gaze while the fellow eye points at a peripheral location in space. The stability of the eyes may be reduced by the absence of a common target. OBJECTIVE To quantify the stability of eye position in strabismus and to measure variability in the ocular deviation. DESIGN, SETTING, AND PARTICIPANTS From 2010 to 2014, a prospective comparative case study of 25 patients with alternating exotropia with normal visual acuity in each eye and 25 control individuals was conducted in a laboratory at a tertiary eye center. A video eye tracker was used to measure the position of each eye while participants alternated fixation on the center of a cross under dichoptic conditions or scanned pictures of natural scenes. MAIN OUTCOMES AND MEASURES Spatial and temporal variability in the position of the fixating eye and the nonfixating eye in patients with strabismus and control individuals, quantified by the log area of ellipses containing 95% of eye positions or mean SDs of eye position. RESULTS In the 25 patients with strabismus, the mean (SD) age was 28 (14) years (range, 8–55 years) and the mean (SD) ocular deviation was 14.2° (5.9°) (range, 4.4°–22.4°). In the patients with strabismus, the mean position variability (1.80 log units; 95% CI, 1.66–1.93) for the deviating eye was greater than for the fixating eye (1.26 log units; 95% CI, 1.17–1.35) (P < .001). The fixating eye of patients with strabismus was more variable in position than the fixating eye of individuals without strabismus (0.98 log units; 95% CI, 0.88–1.08) (P < .005). CONCLUSIONS AND RELEVANCE In patients with strabismus, even without amblyopia, the deviated eye is more variable in position than the fixating eye. Both eyes are less stable in position than the eyes of control individuals, which indicates that strabismus impairs the ability to fixate targets steadily. Saccades contribute to variability of the deviation angle because they

  1. A model of the ocean iron cycle and its influence on biological production

    NASA Astrophysics Data System (ADS)

    Dutkiewicz, S.; Parekh, P.; Follows, M.

    2003-04-01

    Biological productivity in large regions of the ocean, specifically high nutrient, low chlorophyll regions, is limited by the deficit in iron relative to other nutrients. We have developed a parameterization of the iron cycle of the world's oceans which attempts to explicitly represent the processes by which this deficit in iron occurs. We have implemented this parameterization in the context of the MIT three dimensional global ocean model and examined the consequences for nutrient distributions, new production and primary production. The iron model parameterizes the mechanisms of scavenging of iron onto sinking particles and complexation with an organic ligand and is driven by specified aeolian flux patterns. First, using an idealized representation of export production, limited by light, phosphate and iron, the model reproduces the broad features of the observed ocean phosphate and iron distributions. We replace the simplified export parameterization with an explicit, but highly idealized, ecosystem model. The model represents a simplified food web with two phytoplankton size classes and a single grazer. The base currency for this model is phosphorus, but the larger phytoplankton class (i.e. diatoms) is also limited by silica. Both classes are limited by the availability of iron. The results of this model are also generally consistent with the observed patterns of phosphate and iron. In addition, the model captures the broad features of the distributions and cycles of silica, chlorophyll and primary production. We will also explore the sensitivities of this model to the forcing fields (e.g. aeolian iron flux) and parameter choices of the ecosystem model. This model represents a step towards the explicit representation of the ocean iron cycle, and its biogeochemical influences, in global biogeochemical models.

  2. When do tissues and cells become products? Regulatory oversight of emerging biological therapies.

    PubMed

    Farrugia, Albert

    2006-01-01

    Although therapeutics derived from biological sources have been subjected to regulatory oversight for some time, the products used in transplantation procedures have historically been exempt from this oversight. These products have been viewed as being part of medical practice rather than as the result of mainstream pharmaceutical manufacture. Furthermore, their unique source makes them difficult to assess in traditional regulatory systems based on the tenets of pharmaceutical quality control. With the increasing use of transplantation therapies to both replace dysfunctional organs and to influence genetic and metabolic processes, public health concerns on these therapies have increased. In addition, it is recognized that therapeutic claims for some of these interventions need to be properly assessed. These considerations have led the established regulatory agencies of the developed world to develop new regulatory paradigms for the products of transplantation practice. While a number of concerns have driven these developments, the minimization of infectious disease risk remains the paramount driver for introducing these regulatory systems. More than the regulation of medicines and medical devices manufactured in traditional pharmaceutical modes, the regulation of cell and tissue products is intimately linked to areas of public health policy and funding. This places regulators in a challenging position as they attempt to reconcile their roles as independent assessors with the needs of the overall public health framework. This is particularly difficult when considering measures which may affect access to life saving therapies. Regulators have recognized the need to assess these therapies through systems which incorporate consideration of risk-benefit ratios and include mechanisms for transparent and accountable release of products when full compliance to traditional concepts of manufacturing practice is not possible.

  3. 9 CFR 318.308 - Deviations in processing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) Deviations in processing (or process deviations) must be handled according to: (1)(i) A HACCP plan for canned...) of this section. (c) (d) Procedures for handling process deviations where the HACCP plan...

  4. Applying complex models to poultry production in the future--economics and biology.

    PubMed

    Talpaz, H; Cohen, M; Fancher, B; Halley, J

    2013-09-01

    The ability to determine the optimal broiler feed nutrient density that maximizes margin over feeding cost (MOFC) has obvious economic value. To determine optimal feed nutrient density, one must consider ingredient prices, meat values, the product mix being marketed, and the projected biological performance. A series of 8 feeding trials was conducted to estimate biological responses to changes in ME and amino acid (AA) density. Eight different genotypes of sex-separate reared broilers were fed diets varying in ME (2,723-3,386 kcal of ME/kg) and AA (0.89-1.65% digestible lysine with all essential AA acids being indexed to lysine) levels. Broilers were processed to determine carcass component yield at many different BW (1.09-4.70 kg). Trial data generated were used in model constructed to discover the dietary levels of ME and AA that maximize MOFC on a per broiler or per broiler annualized basis (bird × number of cycles/year). The model was designed to estimate the effects of dietary nutrient concentration on broiler live weight, feed conversion, mortality, and carcass component yield. Estimated coefficients from the step-wise regression process are subsequently used to predict the optimal ME and AA concentrations that maximize MOFC. The effects of changing feed or meat prices across a wide spectrum on optimal ME and AA levels can be evaluated via parametric analysis. The model can rapidly compare both biological and economic implications of changing from current practice to the simulated optimal solution. The model can be exploited to enhance decision making under volatile market conditions.

  5. Production of Biologically Active Cecropin A Peptide in Rice Seed Oil Bodies

    PubMed Central

    Izquierdo, Esther; Campo, Sonia; Badosa, Esther; Rossignol, Michel; Montesinos, Emilio; San Segundo, Blanca; Coca, María

    2016-01-01

    Cecropin A is a natural antimicrobial peptide that exhibits fast and potent activity against a broad spectrum of pathogens and neoplastic cells, and that has important biotechnological applications. However, cecropin A exploitation, as for other antimicrobial peptides, is limited by their production and purification costs. Here, we report the efficient production of this bioactive peptide in rice bran using the rice oleosin 18 as a carrier protein. High cecropin A levels were reached in rice seeds driving the expression of the chimeric gene by the strong embryo-specific oleosin 18 own promoter, and targeting the peptide to the oil body organelle as an oleosin 18-cecropin A fusion protein. The accumulation of cecropin A in oil bodies had no deleterious effects on seed viability and seedling growth, as well as on seed yield. We also show that biologically active cecropin A can be easily purified from the transgenic rice seeds by homogenization and simple flotation centrifugation methods. Our results demonstrate that the oleosin fusion technology is suitable for the production of cecropin A in rice seeds, which can potentially be extended to other antimicrobial peptides to assist their exploitation. PMID:26760761

  6. In situ pneumococcal vaccine production and delivery through a hybrid biological-biomaterial vector

    PubMed Central

    Li, Yi; Beitelshees, Marie; Fang, Lei; Hill, Andrew; Ahmadi, Mahmoud Kamal; Chen, Mingfu; Davidson, Bruce A.; Knight, Paul; Smith, Randall J.; Andreadis, Stelios T.; Hakansson, Anders P.; Jones, Charles H.; Pfeifer, Blaine A.

    2016-01-01

    The type and potency of an immune response provoked during vaccination will determine ultimate success in disease prevention. The basis for this response will be the design and implementation of antigen presentation to the immune system. Whereas direct antigen administration will elicit some form of immunological response, a more sophisticated approach would couple the antigen of interest to a vector capable of broad delivery formats and designed for heightened response. New antigens associated with pneumococcal disease virulence were used to test the delivery and adjuvant capabilities of a hybrid biological-biomaterial vector consisting of a bacterial core electrostatically coated with a cationic polymer. The hybrid design provides (i) passive and active targeting of antigen-presenting cells, (ii) natural and multicomponent adjuvant properties, (iii) dual intracellular delivery mechanisms, and (iv) a simple formulation mechanism. In addition, the hybrid format enables device-specific, or in situ, antigen production and consolidation via localization within the bacterial component of the vector. This capability eliminates the need for dedicated antigen production and purification before vaccination efforts while leveraging the aforementioned features of the overall delivery device. We present the first disease-specific utilization of the vector toward pneumococcal disease highlighted by improved immune responses and protective capabilities when tested against traditional vaccine formulations and a range of clinically relevant Streptococcus pneumoniae strains. More broadly, the results point to similar levels of success with other diseases that would benefit from the production, delivery, and efficacy capabilities offered by the hybrid vector. PMID:27419235

  7. Production of Biologically Active Cecropin A Peptide in Rice Seed Oil Bodies.

    PubMed

    Montesinos, Laura; Bundó, Mireia; Izquierdo, Esther; Campo, Sonia; Badosa, Esther; Rossignol, Michel; Montesinos, Emilio; San Segundo, Blanca; Coca, María

    2016-01-01

    Cecropin A is a natural antimicrobial peptide that exhibits fast and potent activity against a broad spectrum of pathogens and neoplastic cells, and that has important biotechnological applications. However, cecropin A exploitation, as for other antimicrobial peptides, is limited by their production and purification costs. Here, we report the efficient production of this bioactive peptide in rice bran using the rice oleosin 18 as a carrier protein. High cecropin A levels were reached in rice seeds driving the expression of the chimeric gene by the strong embryo-specific oleosin 18 own promoter, and targeting the peptide to the oil body organelle as an oleosin 18-cecropin A fusion protein. The accumulation of cecropin A in oil bodies had no deleterious effects on seed viability and seedling growth, as well as on seed yield. We also show that biologically active cecropin A can be easily purified from the transgenic rice seeds by homogenization and simple flotation centrifugation methods. Our results demonstrate that the oleosin fusion technology is suitable for the production of cecropin A in rice seeds, which can potentially be extended to other antimicrobial peptides to assist their exploitation. PMID:26760761

  8. Removal of disinfection by-products formation potential by biologically intensified process.

    PubMed

    An, Dong; Li, Wei-guang; Cui, Fu-yi; He, Xin; Zhang, Jin-song

    2005-01-01

    The removal of disinfection by-products formation potential (DBPFP) in artificially intensified biological activated carbon (IBAC) process which is developed on the basis of traditional ozone granular activated carbon was evaluated. By IBAC removals of 31% and 68% for THMFP and HAAFP were obtained respectively. Under identical conditions, the removals of the same substances were 4% and 32% respectively only by the granular activated carbon (GAC) process. Compared with GAC, the high removal rates of the two formed potential substances were due to the increasing of bioactivity of the media and the synergistic capabilities of biological degradation cooperating with lactivated carbon adsorption of organic compounds. A clear linear correlation (R2 = 0.9562 and R2 = 0.9007) between DOC HAAFP removal rate and Empty Bed Contact Time (EBCT) of IBAC process was observed, while that between THMFP removal rate and EBCT of GAC was R2 = 0.9782. In addition certain linear correlations between THMFP, HAAFP and UV254 (R2 = 0.855 and R2 = 0.7702) were found for the treated water. For IBAC process there are also more advantages such as long backwashing cycle time, low backwashing intensity and prolonging activated carbon lifetime and so on. PMID:16295913

  9. A dedicated database program for cataloging recombinant clones and other laboratory products of molecular biology technology.

    PubMed

    Jenson, H B

    1989-06-01

    A novel computer database program dedicated to storing, cataloging, and accessing information about recombinant clones and libraries has been developed for the IBM (or compatible) personal computer. This program, named CLONES, also stores information about bacterial strains and plasmid and bacteriophage vectors used in molecular biology. The advantages of this method are improved organization of data, fast and easy assimilation of new data, automatic association of new data with existing data, and rapid retrieval of desired records using search criteria specified by the user. Individual records are indexed in the database using B-trees, which automatically index new entries and expedite later access. The use of multiple windows, pull-down menus, scrolling pick-lists, and field-input techniques make the program intuitive to understand and easy to use. Daughter databases can be created to include all records of a particular type, or only those records matching user-specified search criteria. Separate databases can also be merged into a larger database. This computer program provides an easy-to-use and accurate means to organize, maintain, access, and share information about recombinant clones and other laboratory products of molecular biology technology. PMID:2631777

  10. Production of feline leukemia inhibitory factor with biological activity in Escherichia coli.

    PubMed

    Kanegi, R; Hatoya, S; Tsujimoto, Y; Takenaka, S; Nishimura, T; Wijewardana, V; Sugiura, K; Takahashi, M; Kawate, N; Tamada, H; Inaba, T

    2016-07-15

    Leukemia inhibitory factor (LIF) is a cytokine which is essential for oocyte and embryo development, embryonic stem cell, and induced pluripotent stem cell maintenance. Leukemia inhibitory factor improves the maturation of oocytes in the human and the mouse. However, feline LIF (fLIF) cloning and effects on oocytes during IVM have not been reported. Thus, we cloned complete cDNA of fLIF and examined its biological activity and effects on oocytes during IVM in the domestic cat. The aminoacid sequence of fLIF revealed a homology of 81% or 92% with that of mouse or human. The fLIF produced by pCold TF DNA in Escherichia coli was readily soluble and after purification showed bioactivity in maintaining the undifferentiated state of mouse embryonic stem cells and enhancing the proliferation of human erythrocyte leukemia cells. Furthermore, 10- and 100-ng/mL fLIF induced cumulus expansion with or without FSH and EGF (P < 0.05). The rate of metaphase II oocytes was also improved with 100-ng/mL fLIF (P < 0.05). We therefore confirmed the successful production for the first time of biologically active fLIF and revealed its effects on oocytes during IVM in the domestic cat. Feline LIF will further improve reproduction and stem cell research in the feline family. PMID:27020881

  11. Optimisation of the biological pretreatment of wheat straw with white-rot fungi for ethanol production.

    PubMed

    López-Abelairas, M; Álvarez Pallín, M; Salvachúa, D; Lú-Chau, T; Martínez, M J; Lema, J M

    2013-09-01

    The biological pretreatment of lignocellulosic biomass for the production of bioethanol is an environmentally friendly alternative to the most frequently used process, steam explosion (SE). However, this pretreatment can still not be industrially implemented due to long incubation times. The main objective of this work was to test the viability of and optimise the biological pretreatment of lignocellulosic biomass, which uses ligninolytic fungi (Pleurotus eryngii and Irpex lacteus) in a solid-state fermentation of sterilised wheat straw complemented with a mild alkali treatment. In this study, the most important parameters of the mechanical and thermal substrate conditioning processes and the most important parameters of the fungal fermentation process were optimised to improve sugar recovery. The largest digestibilities were achieved with fermentation with I. lacteus under optimised conditions, under which cellulose and hemicellulose digestibility increased after 21 days of pretreatment from 16 to 100 % and 12 to 87 %, respectively. The maximum glucose yield (84 %) of cellulose available in raw material was obtained after only 14 days of pretreatment with an overall ethanol yield of 74 % of the theoretical value, which is similar to that reached with SE.

  12. Removal of anaerobic soluble microbial products in a biological activated carbon reactor.

    PubMed

    Dong, Xiaojing; Zhou, Weili; He, Shengbing

    2013-09-01

    The soluble microbial products (SMP) in the biological treatment effluent are generally of great amount and are poorly biodegradable. Focusing on the biodegradation of anaerobic SMP, the biological activated carbon (BAC) was introduced into the anaerobic system. The experiments were conducted in two identical lab-scale up-flow anaerobic sludge blanket (UASB) reactors. The high strength organics were degraded in the first UASB reactor (UASB1) and the second UASB (UASB2, i.e., BAC) functioned as a polishing step to remove SMP produced in UASB1. The results showed that 90% of the SMP could be removed before granular activated carbon was saturated. After the saturation, the SMP removal decreased to 60% on the average. Analysis of granular activated carbon adsorption revealed that the main role of SMP removal in BAC reactor was biodegradation. A strain of SMP-degrading bacteria, which was found highly similar to Klebsiella sp., was isolated, enriched and inoculated back to the BAC reactor. When the influent chemical oxygen demand (COD) was 10,000 mg/L and the organic loading rate achieved 10 kg COD/(m3 x day), the effluent from the BAC reactor could meet the discharge standard without further treatment. Anaerobic BAC reactor inoculated with the isolated Klebsiella was proved to be an effective, cheap and easy technical treatment approach for the removal of SMP in the treatment of easily-degradable wastewater with COD lower than 10,000 mg/L.

  13. Production and Analysis of Biological Properties of Recombinant Human Apolipoprotein A-I.

    PubMed

    Ryabchenko, A V; Kotova, M V; Tverdohleb, N V; Knyazev, R A; Polyakov, L M

    2015-11-01

    Production of recombinant human apolipoprotein A-I (apoA-I) in E. coli cells is described and its biological properties are compared with those of natural protein. Recombinant apoA-I was isolated as a chimeric polypeptide and then processed to a mature form apoA-I (rapo-I). We studied the ability of the resulting protein to penetrate into hepatocyte nuclei and regulate the rate of DNA biosynthesis in complex with estriol. Penetration of rapoA-I conjugated with FITC into hepatocyte nuclei was demonstrated. rapoA-I-estriol and apoA-I-estriol complexes induced similar increase in DNA biosynthesis rate in isolated hepatocytes, which confi rms functional similarity of the obtained recombinant mature protein (rapoA-I) and native human apoA-I.

  14. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

  15. Advances in microalgae engineering and synthetic biology applications for biofuel production.

    PubMed

    Gimpel, Javier A; Specht, Elizabeth A; Georgianna, D Ryan; Mayfield, Stephen P

    2013-06-01

    Among the technologies being examined to produce renewable fuels, microalgae are viewed by many in the scientific community as having the greatest potential to become economically viable. Algae are capable of producing greater than 50,000 kg/acre/year of biomass [1]. Additionally, most algae naturally accumulate energy-dense oils that can easily be converted into transportation fuels. To reach economic parity with fossil fuels there are still several challenges. These include identifying crop protection strategies, improving harvesting and oil extraction processes, and increasing biomass productivity and oil content. All of these challenges can be impacted by genetic, molecular, and ultimately synthetic biology techniques, and all of these technologies are being deployed to enable algal biofuels to become economically competitive with fossil fuels.

  16. The biological pump: Profiles of plankton production and consumption in the upper ocean

    NASA Astrophysics Data System (ADS)

    Longhurst, Alan R.; Glen Harrison, W.

    The ‘biological pump’ mediates flux of carbon to the interior of the ocean by interctions between the components of the vertically-structured pelagic ecosystem of the photic zone. Chlorophyll profiles are not a simple indicator of autotrophic biomass or production, because of non-linearities in the physiology of cells and preferential vertical distribution of taxa. Profiles of numbers or biomass of heterotrophs do not correspond with profiles of consumption, because of depth-selection (taxa, seasons) for reasons unconnected with feeding. Depths of highest plant biomass, chlorophyll and growth rate coincide when these depths are shallow, but become progressively separated in profiles where they are deeper - so that highest growth rate lies progressively shallower than the chloropyll maximum. It is still uncertain how plant biomass is distributed in deep profiles. Depths of greatest heterotroph biomass (mesozooplankton) are usually close to depths of fastest plant growth rate, and thus lie shallower than the chlorophyll maximum in profiles where this itself is deep. This correlation is functional, and relates to the role of heterotrophs in excreting metabolic wastes (especially ammonia), which may fuel a significant component of integrated algal production, especially in the oligotrophic ocean. Some, but not all faecal material from mesozooplankton of the photic zone appears in vertical flux below the pycnocine, depending on the size of the source organisms, and the degree of vertical mixing above the pycnocline. Diel, but probably not seasonal, vertical migration is significant in the vertical flux of dissolved nitrogen. Regional generalisations of the vertical relations of the main components of the ‘biological pump’ now appear within reach, and an approach is suggested.

  17. Constraining geochemistry and biological primary productivity in hydrothermal systems via in situ mass spectrometric geochemical mapping

    NASA Astrophysics Data System (ADS)

    Vidoudez, Charles; Marcon, Yann; Bach, Wolfgang; Lebris, Nadine; Dubilier, Nicole; Girguis, Peter

    2014-05-01

    Hydrothermal vent ecosystems are biological hot spots, supported by chemoautotrophic primary productivity and achieving densities comparable to rainforests. Nevertheless, our understanding of the geochemical factors that govern the distribution of animals and microbes within vents is limited. It is well known that vent endemic organisms are found in specific vent "microenvironments", and that these microenvironments are distributed -coarsely speaking- in predictable patterns within a vent field. However, the relative differences in activity among these faunal patches, and their role in influencing geochemical flux remains largely unknown due to historical limitations in our ability to sample and quantify geochemical constituents with fine spatial resolution. In particular, the distribution of biologically important volatiles around vent fields is poorly constrained, as is the degree to which their distribution influences the destiny and distribution of organisms. To characterize the relationship between the distribution of volatiles, chemosynthetic microbes, and chemosynthetic symbioses, we generated detailed geo-referenced maps of methane, hydrogen sulfide, carbon dioxide and oxygen (four of the key volatiles that are both vent- and seawater derived) using an in situ mass spectrometer (ISMS). We characterized these concentrations in over 130 spots across three vent sites associated with the mid-Atlantic ridge in the Menez Gwen vent field. We quantified gases in sites ranging from hot fluids to mussel beds, and found notable relationships between the distribution and consumption of hydrogen sulfide and methane and the animal and microbial communities. Finally, we also developed a metabolic energy "map", which enables us to constrain both the potential energy that is available to these communities as well as the extent to which it is being used, and places constraints on the extent of primary production that can be supported by the realized use of these volatiles.

  18. Simulated influence of postweaning production system on performance of different biological types of cattle: III. Biological efficiency.

    PubMed

    Williams, C B; Bennett, G L; Keele, J W

    1995-03-01

    Methods were developed and incorporated into a previously published computer model to predict ME intake and calculate biological efficiencies in terms of grams of empty BW (EBW) and fat-free matter (FFM) gained/megacalorie of ME consumed from weaning to slaughter. Efficiencies were calculated for steers from F1 crosses of 16 sire breeds (Hereford, Angus, Jersey, South Devon, Limousin, Simmental, Charolais, Red Poll, Brown Swiss, Gelbvieh, Maine Anjou, Chianina, Brahman, Sahiwal, Pinzgauer, and Tarentaise) mated to Hereford and Angus dams, grown under nine backgrounding systems, finished at either a low (1.0 kg) or high (1.36 kg) ADG, and slaughtered at 300 kg carcass weight, small or greater degree of marbling, and 28% carcass fat. Backgrounding systems were high ADG (.9 kg) for 111, 167, or 222 d, medium ADG (.5 kg) for 200, 300, or 400 d, and low ADG (.25 kg) for 300 or 400 d, and 0 d backgrounding. The high ADG finishing system was more biologically efficient than the low ADG finishing system, and generally backgrounding systems were less biologically efficient than direct finishing after weaning (0 d backgrounding). Large-framed breeds were more efficient at the constant carcass weight and carcass fatness end point, and breeds that achieved the marbling end point at low levels of carcass fatness were more efficient at this end point. Some small-framed breeds gained EBW more efficiently but gained FFM less efficiently than some of the large-framed breeds. Variation in efficiency between genotypes was greatest with 0 d backgrounding and decreased in the other backgrounding systems. PMID:7608001

  19. Simulated influence of postweaning production system on performance of different biological types of cattle: III. Biological efficiency.

    PubMed

    Williams, C B; Bennett, G L; Keele, J W

    1995-03-01

    Methods were developed and incorporated into a previously published computer model to predict ME intake and calculate biological efficiencies in terms of grams of empty BW (EBW) and fat-free matter (FFM) gained/megacalorie of ME consumed from weaning to slaughter. Efficiencies were calculated for steers from F1 crosses of 16 sire breeds (Hereford, Angus, Jersey, South Devon, Limousin, Simmental, Charolais, Red Poll, Brown Swiss, Gelbvieh, Maine Anjou, Chianina, Brahman, Sahiwal, Pinzgauer, and Tarentaise) mated to Hereford and Angus dams, grown under nine backgrounding systems, finished at either a low (1.0 kg) or high (1.36 kg) ADG, and slaughtered at 300 kg carcass weight, small or greater degree of marbling, and 28% carcass fat. Backgrounding systems were high ADG (.9 kg) for 111, 167, or 222 d, medium ADG (.5 kg) for 200, 300, or 400 d, and low ADG (.25 kg) for 300 or 400 d, and 0 d backgrounding. The high ADG finishing system was more biologically efficient than the low ADG finishing system, and generally backgrounding systems were less biologically efficient than direct finishing after weaning (0 d backgrounding). Large-framed breeds were more efficient at the constant carcass weight and carcass fatness end point, and breeds that achieved the marbling end point at low levels of carcass fatness were more efficient at this end point. Some small-framed breeds gained EBW more efficiently but gained FFM less efficiently than some of the large-framed breeds. Variation in efficiency between genotypes was greatest with 0 d backgrounding and decreased in the other backgrounding systems.

  20. Modelling the impact of variations in ice sheet runoff on fjord and coastal biological productivity over annual to decadal timescales

    NASA Astrophysics Data System (ADS)

    Sole, A. J.; Cowton, T. R.

    2015-12-01

    Each summer, vast quantities of surface-derived ice sheet meltwater runs off from the Greenland Ice Sheet. Much of this runoff is injected into glaciated fjords at depth beneath marine-terminating glaciers. Due to its low relative density, the runoff rises as a buoyant plume up the glaciers' calving fronts, entraining deep fjord water as it does so. This deep, ambient water tends to be relatively rich in nutrients and so the runoff plumes act to fertilise the surface layers of the fjord, leading to an observed late season spike in biological productivity in the fjord's surface layers. Although surface melting and runoff from the Greenland Ice Sheet are predicted to increase significantly in the coming years and decades, the potential effect of this on fjord and coastal biological productivity is yet to be quantified. Here we present simulations of fjord circulation and biological productivity using the Massachusetts Institute of Technology general circulation model (MITgcm), and a new coupled representation of buoyant runoff plumes which enables decadal time period experiments of large three dimensional fjords. We investigate the effect on biological productivity of varying ice sheet runoff, ocean properties, near-surface winds and fjord geometry and bathymetry. We find that variations in ice sheet runoff are particularly important for biological productivity because the rate of discharge controls the depth at which the plumes reach neutral buoyancy and therefore whether the nutrient-rich deep water is delivered to the photic zone.