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, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 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 http://www.fda.gov/cber/biodev...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true 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, 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...

  5. 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...

  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, 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,...

  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, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Reporting of product deviations by licensed... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports §...

  10. FDA 101: Regulating Biological Products

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA 101: Regulating Biological Products Share Tweet Linkedin Pin it More sharing ... and highly important field. back to top What biological products does FDA regulate? The Center for Biologics ...

  11. 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.

  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, 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 runs...

  14. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  15. 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

    ... the experimental production run. (2) Identification of the affected line. (3) An explanation of how... 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...

  16. 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...

  17. 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...

  18. Plankton Production Biology

    DTIC Science & Technology

    2005-09-30

    information if it does not display a currently valid OMB control number. 1. REPORT DATE 30 SEP 2005 2. REPORT TYPE 3. DATES COVERED 00-00-2005 to 00-00... Crustacea ), the group that contributes the major part of the biomass of zooplankton collected with plankton nets in salt- and freshwater. The basis of...windows to the large Russian-language marine- biological literature by publishing this translation. The observations are not subject to becoming outdated

  19. Plankton Production Biology

    DTIC Science & Technology

    2010-09-30

    studied. The book by Sazhina provides illustrated keys for all stages of the nauplii ( copepod larvae) of 85 species common in the oceans and is the...has to take precedence. 6 3. Sazhina’s (1985) keys for copepod nauplii still are the only ones anywhere. They will permit the study of stage...specific population dynamics (growth rate, production, mortality) of copepod larvae in mixed populations. TRANSITIONS The world’s oceanographic

  20. Biological Processes for Hydrogen Production.

    PubMed

    van Niel, Ed W J

    Methane is produced usually from organic waste in a straightforward anaerobic digestion process. However, hydrogen production is technically more challenging as more stages are needed to convert all biomass to hydrogen because of thermodynamic constraints. Nevertheless, the benefit of hydrogen is that it can be produced, both biologically and thermochemically, in more than one way from either organic compounds or water. Research in biological hydrogen production is booming, as reflected by the myriad of recently published reviews on the topic. This overview is written from the perspective of how to transfer as much energy as possible from the feedstock into the gaseous products hydrogen, and to a lesser extent, methane. The status and remaining challenges of all the biological processes are concisely discussed.

  1. 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.

  2. A Methyl-Deviator Epigenotype of Estrogen Receptor–Positive Breast Carcinoma Is Associated with Malignant Biology

    PubMed Central

    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.

    2011-01-01

    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. PMID:21641572

  3. Heterogeneity-induced large deviations in activity and (in some cases) entropy production

    NASA Astrophysics Data System (ADS)

    Gingrich, Todd R.; Vaikuntanathan, Suriyanarayanan; Geissler, Phillip L.

    2014-10-01

    We solve a simple model that supports a dynamic phase transition and show conditions for the existence of the transition. Using methods of large deviation theory we analytically compute the probability distribution for activity and entropy production rates of the trajectories on a large ring with a single heterogeneous link. The corresponding joint rate function demonstrates two dynamical phases—one localized and the other delocalized, but the marginal rate functions do not always exhibit the underlying transition. Symmetries in dynamic order parameters influence the observation of a transition, such that distributions for certain dynamic order parameters need not reveal an underlying dynamical bistability. Solution of our model system furthermore yields the form of the effective Markov transition matrices that generate dynamics in which the two dynamical phases are at coexistence. We discuss the implications of the transition for the response of bacterial cells to antibiotic treatment, arguing that even simple models of a cell cycle lacking an explicit bistability in configuration space will exhibit a bistability of dynamical phases.

  4. 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

  5. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...; 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...

  6. 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...

  7. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...; 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...

  8. 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

    ...; 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...

  9. 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 with...

  10. Transfer of myelin-specific cells deviated in vitro towards IL-4 production ameliorates ongoing experimental allergic neuritis

    PubMed Central

    Ekerfelt, C; Dahle, C; Weissert, R; Kvarnström, M; Olsson, T; Ernerudh, J

    2001-01-01

    A causal role of IL-4 (Th2) production for recovery in experimental allergic neuritis (EAN) was indicated by experiments where Th1-like autoreactive cell populations, taken from the induction phase of the disease, were deviated to extensive secretion of IL-4 in a selective fashion, by ex vivo stimulation with autoantigen in the presence of IL-4. The deviated cells were adoptively transferred to EAN rats at a time just prior to the onset of clinical signs. This treatment ameliorated EAN compared with sham treatment. This therapeutic approach, with generation of autoreactive IL-4-secreting cells ex vivo followed by subsequent adoptive transfer, may become a new selective treatment of organ-specific autoimmune diseases since, in contrast to previous attempts, it is done in a physiological and technically easy way. PMID:11168007

  11. 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 products...

  12. 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... 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 products...

  13. Cyanobacterial ent-Sterol-Like Natural Products from a Deviated Ubiquinone Pathway.

    PubMed

    Moosmann, Philipp; Ueoka, Reiko; Grauso, Laura; Mangoni, Alfonso; Morinaka, Brandon I; Gugger, Muriel; Piel, Jörn

    2017-04-24

    Natural products from marine animals show high potential for the development of new medicines, but drug development based on these compounds is commonly hampered by their low natural abundance. Since many of these metabolites are suspected or known to be produced by uncultivated bacterial symbionts, the rapidly growing diversity of sequenced prokaryotic genomes offers the opportunity to identify alternative, culturable sources of natural products computationally. In this work, we investigated the potential of using this sequenced resource to facilitate the production of meroterpenoid-like compounds related to those from marine sources. This genome-mining strategy revealed a biosynthetic gene cluster for highly modified cytotoxic meroterpenoids related to pelorol and other compounds isolated from sponges. Functional characterization of the terpene cyclase MstE showed that it generates an ent-sterol-like skeleton fused to an aryl moiety from an open-chain precursor and is therefore a promising tool for the chemoenzymatic preparation of synthetically challenging chemical scaffolds. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. 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.

  15. Electrophilic natural products and their biological targets.

    PubMed

    Gersch, Malte; Kreuzer, Johannes; Sieber, Stephan A

    2012-06-01

    The study of biologically active natural products has resulted in seminal contributions to our understanding of living systems. In the case of electrophilic natural products, the covalent nature of their interaction has largely facilitated the identification of their biological binding partners. In this review, we provide a comprehensive compilation of electrophilic natural products from all major chemical classes together with their biological targets. Covering Michael acceptor systems, ring-strained compounds and other electrophiles, such as esters or carbamates, we highlight representative and instructive examples for over 20 electrophilic moieties. The fruitful cooperation of natural product chemistry, medicinal chemistry and chemical biology has produced a collection of well-studied examples for how electrophilic natural products exert their biological functions that range from antibiotic to antitumor effects. Special emphasis is put on the elucidation of their respective biological targets via activity-based protein profiling, which together with the recent advancements in mass spectrometry has been crucial to the success of the field. The wealth of naturally occurring electrophilic moieties and their chemical complexity enables binding of a large variety of biological targets, such as enzymes of all classes, nonenzymatic proteins, DNA and other cellular compounds. With approximately 30,000 genes in the human genome but only 266 confirmed protein drug targets, the study of biologically active, electrophilic natural products has the potential to provide insights into fundamental biological processes and to greatly aid the discovery of new drug targets.

  16. 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

  17. Biologically active proteins from natural product extracts.

    PubMed

    O'Keefe, B R

    2001-10-01

    The term "biologically active proteins" is almost redundant. All proteins produced by living creatures are, by their very nature, biologically active to some extent in their homologous species. In this review, a subset of these proteins will be discussed that are biologically active in heterologous systems. The isolation and characterization of novel proteins from natural product extracts including those derived from microorganisms, plants, insects, terrestrial vertebrates, and marine organisms will be reviewed and grouped into several distinct classes based on their biological activity and their structure.

  18. 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.

  19. 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.

  20. 9 CFR 114.6 - Mixing biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 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, shall...

  1. Synthetic biology advances for pharmaceutical production.

    PubMed

    Breitling, Rainer; Takano, Eriko

    2015-12-01

    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. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. 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... § 112.6 Packaging biological products. (a) Each multiple-dose final container of a biological product... equipment. (e) Final containers of biological product prepared at a licensed establishment, or imported, in...

  3. Biological engineering for sustainable biomass production

    SciTech Connect

    Shen, S.

    1986-09-01

    A new discipline has evolved in efforts to engineer photosynthetic production systems that produce biomass feedstocks efficiently, economically and with minimal adverse environmental impact. In this talk an overview is given of how biological engineering systems are designed to produce energy and novel material products within the framework of existing market infrastructure. Practical examples of biological engineering systems which employ components based on genetic engineering, species propagation, modern agricultural techniques, chemical engineering, and mechanical engineering are analyzed for worldwide materials application and environmental conservation. 9 refs., 6 figs.

  4. 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... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation of experimental biological products. Except as otherwise provided in this section, experimental biological...

  5. Systems biology solutions for biochemical production challenges.

    PubMed

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

    2017-06-01

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

  6. 9 CFR 106.1 - Biological products; exemption.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Biological products; exemption. 106.1... 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...

  7. 9 CFR 114.17 - Rebottling 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 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 may...

  8. 9 CFR 114.18 - Reprocessing 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 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 may...

  9. 9 CFR 114.18 - Reprocessing 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 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 may...

  10. 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 sufficiently...

  11. 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 sufficiently...

  12. 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

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL... products which are neither composed of nor prepared with organisms or antigens used in biologicals...

  14. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... spray) and products used in automatic vaccinating systems (including but not limited to pneumatic beak... apply to licensed veterinary practitioners administering or dispensing biological products in the course...

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. Biological response modifiers: interferons, interleukins, recombinant products, liposomal products.

    PubMed

    Kruth, S A

    1998-03-01

    The concept of enhancing the normal immune response against infections and neoplasms has been considered for decades. The administration of various natural and synthetic products to simulate systemic infections has largely given over to the idea that specific cytokines can be used effectively when administered systemically. Interferons, interleukins, and hematopoietic growth factors may offer substantial clinical benefit in chronic viral infections, and cancers such as osteosarcoma, melanoma, and lymphosarcoma. Erythropoietin has been shown to have great utility in the management of chronic renal failure. At this point in time, only recombinant products derived from humans are commercially available, and they are expensive and not licensed for use in companion animals. Nevertheless, these products may have significant clinical impact on several highly fatal disorders of dogs and cats. When administered systemically, cytokines perturb complex regulatory pathways, and serious side effects may occur. Innovative delivery methods, such as liposomes, gene therapy, and even oral administration may increase the therapeutic index of these molecules. Biological response modification, cytokine biology, and associated delivery systems are rapidly changing fields, and the small animal veterinarian will need to watch for significant advances in these areas over the next several years.

  20. 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 BIOLOGICAL...

  1. 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 BIOLOGICAL...

  2. Regulatory considerations for raw materials used in biological products.

    PubMed

    Khan, A S

    2010-01-01

    Raw materials are critical components of product manufacture; these include source materials such as cell substrates, tissues, and biological fluids required for product manufacture, as well as biological materials required for cell growth, propagation, differentiation, and selection. Adventitious viruses are a major safety concern in biological raw materials. This paper discusses the specific concerns related to different types of biological materials and presents the Center for Biologics Evaluation and Research's perspective on the qualification and management of raw materials for purposes of developing a safety program for the manufacture of biological products.

  3. 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.

  4. Biological treatment of shrimp production wastewater.

    PubMed

    Boopathy, Raj

    2009-07-01

    Over the last few decades, there has been an increase in consumer demand for shrimp, which has resulted in its worldwide aquaculture production. In the United States, the stringent enforcement of environmental regulations encourages shrimp farmers to develop new technologies, such as recirculating raceway systems. This is a zero-water exchange system capable of producing high-density shrimp yields. The system also produces wastewater characterized by high levels of ammonia, nitrate, nitrite, and organic carbon, which make waste management costs prohibitive. Shrimp farmers have a great need for a waste management method that is effective and economical. One such method is the sequencing batch reactor (SBR). A SBR is a variation of the activated sludge biological treatment process. This process uses multiple steps in the same reactor to take the place of multiple reactors in a conventional treatment system. The SBR accomplishes equalization, aeration, and clarification in a timed sequence in a single reactor system. This is achieved through reactor operation in sequences, which includes fill, react, settle, decant, and idle. A laboratory scale SBR was successfully operated using shrimp aquaculture wastewater. The wastewater contained high concentrations of carbon and nitrogen. By operating the reactors sequentially, namely, aerobic and anoxic modes, nitrification and denitrification were achieved as well as removal of carbon. Ammonia in the waste was nitrified within 4 days. The denitrification of nitrate was achieved by the anoxic process, and 100% removal of nitrate was observed within 15 days of reactor operation.

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

    SciTech Connect

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

    2016-07-15

    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.

  6. Biosynthesis of therapeutic natural products using synthetic biology.

    PubMed

    Awan, Ali R; Shaw, William M; Ellis, Tom

    2016-10-01

    Natural products are a group of bioactive structurally diverse chemicals produced by microorganisms and plants. These molecules and their derivatives have contributed to over a third of the therapeutic drugs produced in the last century. However, over the last few decades traditional drug discovery pipelines from natural products have become far less productive and far more expensive. One recent development with promise to combat this trend is the application of synthetic biology to therapeutic natural product biosynthesis. Synthetic biology is a young discipline with roots in systems biology, genetic engineering, and metabolic engineering. In this review, we discuss the use of synthetic biology to engineer improved yields of existing therapeutic natural products. We further describe the use of synthetic biology to combine and express natural product biosynthetic genes in unprecedented ways, and how this holds promise for opening up completely new avenues for drug discovery and production.

  7. Biology and technology for photochemical fuel production.

    PubMed

    Hambourger, Michael; Moore, Gary F; Kramer, David M; Gust, Devens; Moore, Ana L; Moore, Thomas A

    2009-01-01

    Sunlight is the ultimate energy source for the vast majority of life on Earth, and organisms have evolved elegant machinery for energy capture and utilization. Solar energy, whether converted to wind, rain, biomass or fossil fuels, is also the primary energy source for human-engineered energy transduction systems. This tutorial review draws parallels between biological and technological energy systems. Aspects of biology that might be advantageously incorporated into emerging technologies are highlighted, as well as ways in which technology might improve upon the principles found in biological systems. Emphasis is placed upon artificial photosynthesis, as well as the use of protonmotive force in biology.

  8. [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.

  9. 9 CFR 114.17 - Rebottling 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 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...

  10. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... name and address; number, species, class and location of animals involved; date shipment is anticipated... biological products for the purpose of evaluating such experimental products by treating limited numbers of...

  11. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... name and address; number, species, class and location of animals involved; date shipment is anticipated... biological products for the purpose of evaluating such experimental products by treating limited numbers of...

  12. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... name and address; number, species, class and location of animals involved; date shipment is anticipated... biological products for the purpose of evaluating such experimental products by treating limited numbers of...

  13. 9 CFR 103.3 - Shipment of experimental biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... name and address; number, species, class and location of animals involved; date shipment is anticipated... biological products for the purpose of evaluating such experimental products by treating limited numbers of...

  14. Design control considerations for biologic-device combination products.

    PubMed

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

    2017-01-11

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

  15. 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... be mixed thoroughly in a single container. During bottling operations, the product shall be...

  16. 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... be mixed thoroughly in a single container. During bottling operations, the product shall be...

  17. 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 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...

  18. 9 CFR 115.2 - Inspections 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 Inspections of biological products. 115.2 Section 115.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  19. 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 EXPERIMENTAL...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products and related terms. 101.3 Section 101.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS...

  1. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Biological products and related terms. 101.3 Section 101.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS...

  2. 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 EXPERIMENTAL...

  3. 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...

  4. 9 CFR 101.3 - Biological products and related terms.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Biological products and related terms. 101.3 Section 101.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT...) Product Code Number. A number assigned by Animal and Plant Health Inspection Service to each type of...

  5. Biological control and sustainable food production.

    PubMed

    Bale, J S; van Lenteren, J C; Bigler, F

    2008-02-27

    The use of biological control for the management of pest insects pre-dates the modern pesticide era. The first major successes in biological control occurred with exotic pests controlled by natural enemy species collected from the country or area of origin of the pest (classical control). Augmentative control has been successfully applied against a range of open-field and greenhouse pests, and conservation biological control schemes have been developed with indigenous predators and parasitoids. The cost-benefit ratio for classical biological control is highly favourable (1:250) and for augmentative control is similar to that of insecticides (1:2-1:5), with much lower development costs. Over the past 120 years, more than 5000 introductions of approximately 2000 non-native control agents have been made against arthropod pests in 196 countries or islands with remarkably few environmental problems. Biological control is a key component of a 'systems approach' to integrated pest management, to counteract insecticide-resistant pests, withdrawal of chemicals and minimize the usage of pesticides. Current studies indicate that genetically modified insect-resistant Bt crops may have no adverse effects on the activity or function of predators or parasitoids used in biological control. The introduction of rational approaches for the environmental risk assessment of non-native control agents is an essential step in the wider application of biological control, but future success is strongly dependent on a greater level of investment in research and development by governments and related organizations that are committed to a reduced reliance on chemical control.

  6. 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... 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...

  7. 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 the...

  8. 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... submitted to the Administrator. Research facilities that are entirely separate and apart from facilities...

  9. 9 CFR 113.3 - Sampling 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 Sampling of biological products. 113.3 Section 113.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... market by a Animal and Plant Health Inspection Service representative. (a) Either an employee of the...

  10. 9 CFR 113.3 - Sampling 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 Sampling of biological products. 113.3 Section 113.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... market by a Animal and Plant Health Inspection Service representative. (a) Either an employee of the...

  11. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1990-01-01

    Previous results have shown that the medium pH, the composition of the medium and concentration of medium constituents significantly affect the ratio of ethanol to acetate in the product stream when fermenting CO, CO{sub 2} and H{sub 2} in synthesis gas to products by Clostridium ljungdahlii. An additional batch study was carried out varying the agitation rate at pH 4, 4.5 and 5.0. It was speculated that increased agitation rates in combination with low pH might result in increased ethanol production while, at the same time, yielding higher cell concentrations which could eventually result in higher ethanol concentrations.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 9 CFR 115.2 - Inspections of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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...

  17. 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

  18. Production of hydrogen using an anaerobic biological process

    DOEpatents

    Kramer, Robert; Pelter, Libbie S.; Patterson, John A.

    2016-11-29

    Various embodiments of the present invention pertain to methods for biological production of hydrogen. More specifically, embodiments of the present invention pertain to a modular energy system and related methods for producing hydrogen using organic waste as a feed stock.

  19. Retention of Preservative Levels of Formaldehyde in Desiccated Biological Products

    PubMed Central

    Pemberton, John R.

    1975-01-01

    Concentrations ranging from 8 to 100% of the preservative level of formalin (37% formaldehyde solution) were retained by desiccated biologics, with most products retaining about 50% regardless of the amount originally present. PMID:972183

  20. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1990-01-01

    Previous results have shown that the yeast extract concentration and the medium pH significantly affect the ratio of ethanol to acetate in the product stream when fermenting CO, CO{sub 2} and H{sub 2} in synthesis gas to products by Clostridium ljungdahlii. Further experimentation has demonstrated the impact of eliminating yeast extract from the medium (except for the slight quantity transferred with the inoculm), especially when coupled with low pH. An ethanol to acetate product ratio of 4.0 was obtained at pH 4.5 without yeast extract present in the medium when using culture previously exposed to growth-limiting H{sub 2}S. The product ratio was 2.0 at pH 4.0 (nearly three times the value of pH 4.5 and nine times the value of pH 5.0) without yeast extract present in the media when using the standard (unexposed) culture.

  1. Biological production of ethanol from coal

    SciTech Connect

    Not Available

    1990-01-01

    The fermentation pH has been observed to be the key parameter affecting the ratio of ethanol to acetate produced by Clostridium ljungdahlii. The effects of controlled pH on cell growth and product formation by C. ljungdahlii were measured. It was found that cell concentration and acetate concentration increased with pH, while the ethanol concentration was highest at the lower pH. The molar product ratio of ethanol to acetate was 0.74 at pH 4.0, 0.39 at pH 4.5 and 0.12 at pH 5.0. Future experiments will concentrate on studying other important parameters such as agitation rate and nutrients concentrations with controlled pH as a preclude to continuous reactor studies.

  2. 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.

  3. 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.

  4. Recent advances in biological production of erythritol.

    PubMed

    Rzechonek, Dorota A; Dobrowolski, Adam; Rymowicz, Waldemar; Mirończuk, Aleksandra M

    2017-09-27

    Erythritol is a natural sweetener commonly used in the food and pharmaceutical industries. Produced by microorganisms as an osmoprotectant, it is an ideal sucrose substitute for diabetics or overweight persons due to its almost zero calorie content. Currently, erythritol is produced on an industrial scale through the fermentation of sugars by some yeasts, such as Moniliella sp. However, the popularity of erythritol as a sweetener is still small because of its high retail price. This creates an opportunity for further process improvement. Recent years have brought the rapid development of erythritol biosynthesis methods from the low-cost substrates, and a better understanding of the metabolic pathways leading to erythritol synthesis. The yeast Yarrowia lipolytica emerges as an organism effectively producing erythritol from pure or crude glycerol. Moreover, novel erythritol producing organisms and substrates may be taken into considerations due to metabolic engineering. This review focuses on the modification of erythritol production to use low-cost substrates and metabolic engineering of the microorganisms in order to improve yield and productivity.

  5. 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

  6. Role of natural product diversity in chemical biology.

    PubMed

    Hong, Jiyong

    2011-06-01

    Through the natural selection process, natural products possess a unique and vast chemical diversity and have been evolved for optimal interactions with biological macromolecules. Owing to their diversity, target affinity, and specificity, natural products have demonstrated enormous potential as modulators of biomolecular function, been an essential source for drug discovery, and provided design principles for combinatorial library development.

  7. Improvement of FK506 production by synthetic biology approaches.

    PubMed

    Fu, Li-Feng; Tao, Yang; Jin, Mei-Ying; Jiang, Hui

    2016-12-01

    Synthetic biology has been applied to direct improvement of valuable metabolite productions. Tacrolimus (FK506), a clinically used immunosuppressive agent isolated from many Streptomyces, is produced by fermentation in industry. Here we chose FK506 as an example to review recent progress in improving FK506 production, including enhancing transcription levels of biosynthetic genes, accelerating post-translational modification levels of biosynthetic enzymes, increasing activities of rate limiting enzymes, and rational supplement of limited precursors. FK506 production was increased from 25 % to sevenfold by these synthetic biology approaches.

  8. 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.

  9. Effect of biological pretreatments in enhancing corn straw biogas production.

    PubMed

    Zhong, Weizhang; Zhang, Zhongzhi; Luo, Yijing; Sun, Shanshan; Qiao, Wei; Xiao, Meng

    2011-12-01

    A biological pretreatment with new complex microbial agents was used to pretreat corn straw at ambient temperature (about 20°C) to improve its biodegradability and anaerobic biogas production. A complex microbial agent dose of 0.01% (w/w) and pretreatment time of 15 days were appropriate for biological pretreatment. These treatment conditions resulted in 33.07% more total biogas yield, 75.57% more methane yield, and 34.6% shorter technical digestion time compared with the untreated sample. Analyses of chemical compositions showed 5.81-25.10% reductions in total lignin, cellulose, and hemicellulose contents, and 27.19-80.71% increases in hot-water extractives; these changes contributed to the enhancement of biogas production. Biological pretreatment could be an effective method for improving biodegradability and enhancing the highly efficient biological conversion of corn straw into bioenergy. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. 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.

  11. Knowledge of food and drug administration reportable deviations.

    PubMed

    Lam, Rebecca; Bryant, Barbara J

    2011-07-01

    As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations. Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service. There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization. This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations. © 2011 American Association of Blood Banks.

  12. The generation of "unnatural" products: synthetic biology meets synthetic chemistry.

    PubMed

    Goss, Rebecca J M; Shankar, Sreejith; Fayad, Antoine Abou

    2012-08-01

    Natural product analogue generation is important, providing tools for chemical biology, enabling structure activity relationship determination and insight into the way in which natural products interact with their target biomolecules. The generation of analogues is also often necessary in order to improve bioavailability and to fine tune compounds' activity. This review provides an overview of the catalogue of approaches available for accessing series of analogues. Over the last few years there have been major advances in genome sequencing and the development of tools for biosynthetic pathway engineering; it is therefore becoming increasingly easy to combine molecular biology and synthetic organic chemistry in order to enable expeditious access to series of natural products. This review outlines the various ways of combining biology and chemistry that have been applied to analogue generation, drawing upon a series of examples to illustrate each approach.

  13. 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

  14. 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.

  15. 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.

  16. Yeast synthetic biology toolbox and applications for biofuel production.

    PubMed

    Tsai, Ching-Sung; Kwak, Suryang; Turner, Timothy L; Jin, Yong-Su

    2015-02-01

    Yeasts are efficient biofuel producers with numerous advantages outcompeting bacterial counterparts. While most synthetic biology tools have been developed and customized for bacteria especially for Escherichia coli, yeast synthetic biological tools have been exploited for improving yeast to produce fuels and chemicals from renewable biomass. Here we review the current status of synthetic biological tools and their applications for biofuel production, focusing on the model strain Saccharomyces cerevisiae We describe assembly techniques that have been developed for constructing genes, pathways, and genomes in yeast. Moreover, we discuss synthetic parts for allowing precise control of gene expression at both transcriptional and translational levels. Applications of these synthetic biological approaches have led to identification of effective gene targets that are responsible for desirable traits, such as cellulosic sugar utilization, advanced biofuel production, and enhanced tolerance against toxic products for biofuel production from renewable biomass. Although an array of synthetic biology tools and devices are available, we observed some gaps existing in tool development to achieve industrial utilization. Looking forward, future tool development should focus on industrial cultivation conditions utilizing industrial strains.

  17. 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

  18. 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. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  19. Caudal septal deviation.

    PubMed

    Haack, Jason; Papel, Ira D

    2009-06-01

    The nasal septum is a structure poorly understood and appreciated by the lay public and the nonotolaryngologist--head and neck surgeon alike. Deviation of the caudal portion of the nasal septum may result in nasal obstruction, a crooked nose, and columellar irregularities. The correction of a severely deviated caudal septum is one of the most difficult challenges of the otolaryngologist and facial plastic surgeon. A variety of options are available for correction of mild, to the most severe, deflections. This condition, as with all challenges in medicine, should not be a one size fits all or one surgery fits all situation. The skilled surgeon should understand the multiple options available for surgical correction and tailor fit the procedure to the deformity.

  20. Analyzing Vehicle Operator Deviations

    DTIC Science & Technology

    2008-07-01

    related to vehicle operator deviations ( VODs ). VODs occur when a vehicle enters the airport movement area without ATC approval. We developed a VOD ...prediction model to help understand the human factors causes associated with different types of VODs . We then examined the validity of the model, using...the data that we needed was missing due to incomplete reporting of the human factors associated with a given VOD . To aid in the development of a

  1. 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.

  2. Synthetic biology of avermectin for production improvement and structure diversification.

    PubMed

    Zhuo, Ying; Zhang, Tao; Wang, Qi; Cruz-Morales, Pablo; Zhang, Buchang; Liu, Mei; Barona-Gómez, Francisco; Zhang, Lixin

    2014-03-01

    Natural products are still key sources of current clinical drugs and innovative therapeutic agents. Since wild-type microorganisms only produce natural products in very small quantities, yields of production strains need to be improved by breaking down the precise genetic and biochemical circuitry. Herein, we use avermectins as an example of production improvement and chemical structure diversification by synthetic biology. Avermectins are macrocyclic lactones produced by Streptomyces avermitilis and are well known and widely used for antiparasitic therapy. Given the importance of this molecule and its derivatives, many efforts and strategies were employed to improve avermectin production and generate new active analogues. This review describes the current status of synthetic strategies successfully applied for developing natural-product-producing strains and discusses future prospects for the application of enhanced avermectin production. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  3. Synthetic and systems biology for microbial production of commodity chemicals.

    PubMed

    Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J; Keasling, Jay D; Martín, Héctor García

    2016-01-01

    The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges start at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.

  4. Synthetic and systems biology for microbial production of commodity chemicals

    SciTech Connect

    Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J.; Keasling, Jay D.; Martín, Héctor Garcia

    2016-04-07

    The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges start at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.

  5. Synthetic and systems biology for microbial production of commodity chemicals

    PubMed Central

    Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J; Keasling, Jay D; Martín, Héctor García

    2016-01-01

    The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges start at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering. PMID:28725470

  6. Irradiation of advanced health care products - Tissues and biologics

    NASA Astrophysics Data System (ADS)

    Winters, Martell

    2014-12-01

    Radiation sterilization of tissues and biologics has become more common in recent years. As a result it has become critical to understand how to adapt the typical test methods and validation approaches to a tissue or biological product scenario. Also data evaluation sometimes becomes more critical than with traditional medical devices because for many tissues and biologics a low radiation dose is required. It is the intent behind this paper to provide information on adapting bioburden tests used in radiation validations such that the data can be most effectively used on tissues and biologics. In addition challenges with data evaluation are discussed, particularly the use of less-than values for bioburden results in radiation validation studies.

  7. 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... 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...

  8. 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...

  9. Natural products with health benefits from marine biological resources

    USDA-ARS?s Scientific Manuscript database

    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...

  10. 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...

  11. Biological cleaning of soil and reservoirs from oil products

    SciTech Connect

    Zinberg, M.B.; Ivanovskaya, I.B.; Gafarov, N.A.

    1996-12-31

    The production of oil and gas condensate invariably involves environmental hazards: water and soil contamination due to miscellaneous breakdowns of technological equipment and pipeline damage. Among many existing contamination methods biological cleaning has become more popular lately. It took us some years to make investigations and to carry out a number of field tests in order to develop biological methods of cleaning soil and reservoirs from oil and gas condensate products. Our method is based on the use of special biological agents containing various active hydrocarbon oxidizing bacteria. It has been experimentally proved that biological agents of {open_quotes}Devouroil{close_quotes} possess the greatest oxidizing properties. {open_quotes}Devouroil{close_quotes} contains five kinds of hydrocarbon oxidizing bacteria of Pseudomonas, Rodococcus, Candida genera. These bacteria are extracted from natural ecosystems: underground waters, soils, reservoirs. As the agents are grown on oil distillate, they are very destructive to different oil products. We also proved the described microorganisms ability to oxidize sulfate oil and hydrocarbon condensate, which are the most toxic components. For four years our colleagues have been cleaning soil and reservoirs contaminated with oil, black oil, gas condensate and other products of hydrocarbon origin. This method was used to treat different kinds of soil and ground (grass and arable land, swamp and forest) in actual hazardous situations involving oil and gas condensate spills. Besides it was successfully applied to clean sludge storage which had been filled with oil process sewage for several years.

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. 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

  17. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... holders of an approved drug or biological product to change the product labeling to reflect certain types... biological product to change the product labeling to reflect certain types of newly acquired information in... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of...

  18. Synthetic and systems biology for microbial production of commodity chemicals

    DOE PAGES

    Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J.; ...

    2016-04-07

    The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges startmore » at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.« less

  19. 21 CFR 601.26 - Reclassification procedures to determine that licensed biological products are safe, effective...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... shall provide that the biologics license application for that biological product will not be revoked... licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or... OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.26...

  20. 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

  1. PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

    PubMed

    Krause, Stephan O

    2015-01-01

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

  2. Current advances in biological production of propionic acid.

    PubMed

    Eş, Ismail; Khaneghah, Amin Mousavi; Hashemi, Seyed Mohammad Bagher; Koubaa, Mohamed

    2017-02-01

    Propionic acid and its derivatives are considered "Generally Recognized As Safe" food additives and are generally used as an anti-microbial and anti-inflammatory agent, herbicide, and artificial flavor in diverse industrial applications. It is produced via biological pathways using Propionibacterium and some anaerobic bacteria. However, its commercial chemical synthesis from the petroleum-based feedstock is the conventional production process bit results in some environmental issues. Novel biological approaches using microorganisms and renewable biomass have attracted considerable recent attention due to economic advantages as well as great adaptation with the green technology. This review provides a comprehensive overview of important biotechnological aspects of propionic acid production using recent technologies such as employment of co-culture, genetic and metabolic engineering, immobilization technique and efficient bioreactor systems.

  3. 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

  4. 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.

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Indexing Structured Product Labeling for Human Prescription... Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are indexing certain... class as a top priority for indexing of product labeling information. FDA is now announcing that medical...

  6. Evolution of approaches to viral safety issues for biological products.

    PubMed

    Lubiniecki, Anthony S

    2011-01-01

    CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Approaches to viral safety issues for biological products have evolved during the past 50+ years. The first cell culture products (viral vaccines) relied largely on the use of in vitro and in vivo virus screening assays that were based upon infectivity of adventitious viral agents. The use of Cohn fractionation and pasteurization by manufacturers of plasma derivatives introduced the concepts that purification and treatment with physical and chemical agents could greatly reduce the risk of viral contamination of human albumin and immunoglobulin products. But the limitations of such approaches became clear for thermolabile products that were removed early in fractionation such as antihemophilic factors, which transmitted hepatitis viruses and HIV-1 to some product recipients. These successes and limitations were taken into account by the early developers of recombinant DNA (rDNA)-derived cell culture products and by regulatory agencies, leading to the utilization of cloning technology to reduce/eliminate contamination due to human viruses and purification technologies to physically remove and inactivate adventitious and endogenous viruses, along with cell banking and cell bank characterization for adventitious and endogenous viruses, viral screening of biological raw materials, and testing of cell culture harvests, to ensure virus safety. Later development and incorporation of nanofiltration technology in the manufacturing process provided additional assurance of viral clearance for safety of biotechnology products. These measures have proven very effective at preventing iatrogenic infection of recipients of biotechnology products; however, viral contamination of production cell cultures has

  7. [Key technologies in synthetic biology of natural products].

    PubMed

    Kuang, Xue-Jun; Zou, Li-Qiu; Li, Ying; Sun, Chao; Chen, Shi-Lin

    2016-11-01

    Natural products with complex and diverse structures are the major sources of new drugs. The biosynthesis of natural products is considered to be one of the best ways to solve the problems of complex and scarce natural products. DNA assembly technology and genome editing technology are two key technologies in the emerging interdisciplinary field of synthetic biology. A number of novel DNA assembly methods developed in the last few years have paved the way for the engineering of high molecular weight DNA molecules, including whole genomes, hence, it can realize the reconstruction of the metabolic pathways and speed up optimization process. A wide variety of new tools for microbial genome editing will be applied widely to modify the chassis genome to increase its adaptation with the exogenetic pathways. This article summarized the latest advance with respect to DNA assembly and genome editing, which aims to provide help for reconstruction and optimization of the synthetic biological systems of natural products. Copyright© by the Chinese Pharmaceutical Association.

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

    NASA Astrophysics Data System (ADS)

    Chikamoto, M. O.; Timmermann, A.; Yoshimori, M.; Lehner, F.; Laurian, A.; Abe-Ouchi, A.; Mouchet, A.; Joos, F.; Raible, C.; Cobb, K. M.

    2016-12-01

    Major volcanic eruptions generate widespread ocean cooling and thus reduce upper ocean stratification. Through this ocean dynamic response, volcanic strong eruptions further have the potential to increase nutrient delivery into the euphotic zone and boost biological productivity. Using 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 whether large volcanic eruptions intensify nutrient-driven export production. In the historical last millennium simulations in CESM and LOVECLIM, strong volcanic radiative forcing enhances the likelihood of eastern Pacific El Nino-like warming, thereby reducing nutrients and export production in the eastern equatorial Pacific for the first two years. This initial response, however, reverses after about 3 years in associated with the following La Nina onset. The resulting delayed enhancement of biological production resembles the multiyear response in MIROC. In this study, volcanic impacts on tropical Pacific dynamics and biogeochemistry persist for several years, thus providing a new source for potential multiyear ecosystem predictability.

  9. 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 biological...

  10. 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 biological...

  11. 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... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A biological...

  12. 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.

  13. 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.

  14. Isoleukotrienes are biologically active free radical products of lipid peroxidation.

    PubMed

    Harrison, K A; Murphy, R C

    1995-07-21

    The free radical oxidation of arachidonic acid esterified to glycerophospholipids is known to generate complex metabolites, termed isoprostanes, that share structural features of prostaglandins derived from prostaglandin H2 synthase. Furthermore, certain isoprostanes have been found to exert biological activity through endogenous receptors on cell surfaces. Using mass spectrometry and ancillary techniques, the free radical oxidation of 1-hexadecanoyl-2-arachidonoyl-glycerophosphocholine was studied in the search for products of arachidonic acid isomeric to the leukotrienes that are derived from 5-lipoxygenase-catalyzed metabolism of arachidonic acid. Several conjugated triene metabolites were chromatographically separated from known 5-lipoxygenase products and structures characterized as 5,12-dihydroxy-6,8,10,14-eicosatetraenoic acid esterified to the glycerophosphocholine backbone. We have termed these products as B4-isoleukotrienes. Following saponification some, but not all, B4-isoleukotrienes were found to exert biological activity in elevating intracellular calcium in Indo-1-loaded human polymorphonuclear leukocytes. This activity could be blocked by a leukotriene B4 receptor antagonist. An EC50 of approximately 30 nM was determined for one unique B4-isoleukotriene with a relative retention index of 2.54. We have shown that free radical processes can lead to the formation of biologically active isoleukotrienes in glycerophosphocholine liposomes, and we propose that B4-isoleukotrienes may also be formed in membrane glycerophospholipids as a result of lipid peroxidation during tissue injury. Such B4-isoleukotrienes could then mediate events of tissue damage through activation of leukotriene B4 receptors on target cells.

  15. 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.

  16. 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.

  17. 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.

  18. Biological standards: problems in large-scale production.

    PubMed

    Campbell, P J

    1976-10-01

    A biological standard usually consists of a batch of perhaps several thousand ampoules. In defining a batch of ampoules to be a standard, we are in essence making a number of fundamental claims: (1) That in terms of content, (mass and potency) each individual ampoule is identical to every other amoule in the batch. (2) That in the course of preparation of the standard, the contents of each ampoule have been treated in exactly the same way and held for the same length of time under the same conditions, (i.e. all the ampoules of the standard have been treated as one single batch, each stage of processing being carried out under constant conditions in one complete working session, however long). (3) That the stability or instability of the biological activity of the contents of each ampoule of the batch is identical to every other ampoule (i.e. that moisture, oxygen, light, raised temperature--all factors which cause deterioration of biological activity--have been exculuded to the same degree in each and every ampoule in the batch, so that each ampoule of the standard is equally stable or unstable). It is quite a difficult task to meet these criteria even in a small number of ampoules at the bench. It becomes a very demanding exercise to achieve the same results in 4,000 ampoules--the normal batch size at NIBSC. Details of the methods used at NIBSC for the production of large batches of ampoules of biological standards have already been published (Campbell, 1974). The author of the papers will take the opportunity to develop various aspects of the published detail.

  19. 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...

  20. 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 term...

  1. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT...; ORGANISMS AND VECTORS SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS § 105.3 Notices re: worthless, contaminated, dangerous, or harmful biological products. (a) If at any time it...

  2. 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 product...

  3. 21 CFR 601.26 - Reclassification procedures to determine that licensed biological products are safe, effective...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or... Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded... for the reclassification of all biological products that have been classified into Category IIIA....

  4. 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.

  5. 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

  6. 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

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

    PubMed

    RenNanqi; GuoWanqian; LiuBingfeng; CaoGuangli; DingJie

    2011-06-01

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

  8. 9 CFR 318.308 - Deviations in processing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY...) 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...

  9. 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.

  10. 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.

  11. Is biological productivity enhanced at the New England shelfbreak front?

    NASA Astrophysics Data System (ADS)

    Zhang, Weifeng G.; McGillicuddy, Dennis J.; Gawarkiewicz, Glen G.

    2013-01-01

    A two-dimensional (cross-shelf) numerical model of the mean seasonal circulation offshore of southern New England predicts upwelling at the shelfbreak front. Expected ramifications of this upwelling include enhancement of nutrient supply, phytoplankton biomass, and productivity. However, seasonal climatologies of chlorophyll based on both in situ data and satellite observations show no mean enhancement at the front. We investigate this apparent discrepancy with a four-component planktonic ecosystem model coupled to the two-dimensional physical model. Nutrient fields are restored to climatological values at depth, and upper ocean values evolve freely according to physical and biological forcing. Vertical diffusivity is based on seasonally averaged surface and bottom mixed layer depths compiled from in situ observations. The model reproduces the general pattern of the observed cross-shelf and seasonal variations of the chlorophyll distribution. It predicts a local enhancement of phytoplankton productivity at the shelfbreak in spring and summer as a result of the persistently upwelled nutrient-rich slope water. In the model, zooplankton grazing prevents accumulation of phytoplankton biomass at the site of the upwelling. The predicted enhancement of primary productivity (but not phytoplankton biomass) at the shelfbreak constitutes a hypothesis that could be tested in the future with suitable measurements from regional long-term observatories, such as the Ocean Observatories Initiative Pioneer Array.

  12. Production and biological activities of yellow pigments from Monascus fungi.

    PubMed

    Chen, Gong; Wu, Zhenqiang

    2016-08-01

    Monascus yellow pigments (MYPs), are azaphilone compounds and one of the three main components of total Monascus pigments (MPs). Thirty-five hydrophilic or hydrophobic MYPs have been identified, with the majority being hydrophobic. Apart from screening special Monascus strains, some advanced approaches, such as extractive and high-cell-density fermentations, have been applied for developing or producing new MYPs, especially extracellular hydrophilic MYPs. The outstanding performance of MYPs in terms of resistance to photodegradation, as well as tolerance for temperature and pH, give natural MYPs reasonable prospects, compared with the orange and red MPs, for practical use in the present and future. Meanwhile, MYPs have shown promising potential for applications in the food and pharmaceutical industries based on their described bioactivities. This review briefly summarizes the reports to date on chemical structures, biological activities, biosynthetic pathways, production technologies, and physicochemical performances of MYPs. The existing problems for MYPs are discussed and research prospects proposed.

  13. 9 CFR 113.53 - Requirements for ingredients of animal origin 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 ingredients of animal origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

  14. 9 CFR 113.53 - Requirements for ingredients of animal origin 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 ingredients of animal origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

  15. 9 CFR 113.53 - Requirements for ingredients of animal origin 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 ingredients of animal origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

  16. 9 CFR 113.53 - Requirements for ingredients of animal origin 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 ingredients of animal origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

  17. 9 CFR 113.53 - Requirements for ingredients of animal origin 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 ingredients of animal origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

  18. Giant Icebergs and Biological Productivity on Early Mars

    NASA Astrophysics Data System (ADS)

    Uceda, E.; Fairen, A. G.; Woodworth-Lynas, C.

    2016-12-01

    We have previously presented evidence for furrows, dump structures and chains of craters that we interpret as indication for giant iceberg transport and grounding on very cold oceans on early Mars, both in the northern plains and in the Hellas basin. Structures include: 1. Furrows: The furrows are located in elevated areas or on local topographic highs, particularly on the Hellas basin. We interpret these features in terms of iceberg rafting and grounding. 2. Chains of craters: High-resolution images of Utopia and Isidis Basins reveal chains of crater-like structures several hundred meters wide and 1 to 5 km long. 3. Dump structures: Dark boulder clusters are revealed at large scales by their slightly darker tonality with respect to the surrounding terrain. These clusters have sizes ranging from several hundred meters to 1-2 km. On Earth's oceans, giant icebergs release melting water containing nanoparticulate iron and other micronutrients, which support biological metabolism and growth to the near-coastal euphotic ecosystems, many of which are iron limited. This iron limitation of primary producers has been documented in large regions of the Earth's oceans, most notably in polar areas proximal to significant glacial activity, and is counterbalanced by the substantial enrichment of terrigenous material supplied by icebergs. The biological productivity extends hundreds of kilometres from the giant icebergs, and persists for over one month after the iceberg passes. Here we propose that giant iceberg activity on early Mars could have promoted a similar enhancing of biological productivity on the planet's oceans. The identification of specific biosignatures in icebergs trails on Earth could give clues as to what kind of biosignatures could be expected on the ancient Mars ocean floors, and where to look for them. In particular, assuming that life existed on Mars coeval to glacial activity, enhanced concentrations of organic carbon could be anticipated near giant iceberg

  19. 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

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

    PubMed

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

    2015-06-01

    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 that JAR

  1. Hormones in international meat production: biological, sociological and consumer issues.

    PubMed

    Galbraith, Hugh

    2002-12-01

    Beef and its products are an important source of nutrition in many human societies. Methods of production vary and include the use of hormonal compounds ('hormones') to increase growth and lean tissue with reduced fat deposition in cattle. The hormonal compounds are naturally occurring in animals or are synthetically produced xenobiotics and have oestrogenic (oestradiol-17beta and its esters; zeranol), androgenic (testosterone and esters; trenbolone acetate) or progestogenic (progesterone; melengestrol acetate) activity. The use of hormones as production aids is permitted in North American countries but is no longer allowed in the European Union (EU), which also prohibits the importation of beef and its products derived from hormone-treated cattle. These actions have resulted in a trade dispute between the two trading blocs. The major concern for EU authorities is the possibility of adverse effects on human consumers of residues of hormones and metabolites. Methods used to assess possible adverse effects are typical of those used by international agencies to assess acceptability of chemicals in human food. These include analysis of quantities present in the context of known biological activity and digestive, absorptive, post-absorptive and excretory processes. Particular considerations include the low quantities of hormonal compounds consumed in meat products and their relationships to endogenous production particularly in prepubertal children, enterohepatic inactivation, cellular receptor- and non-receptor-mediated effects and potential for interference with growth, development and physiological function in consumers. There is particular concern about the role of oestradiol-17beta as a carcinogen in certain tissues. Now subject to a 'permanent' EU ban, current evidence suggests that certain catechol metabolites may induce free-radical damage of DNA in cell and laboratory animal test systems. Classical oestrogen-receptor mediation is considered to stimulate

  2. Review: production, characterization, and testing of banked mammalian cell substrates used to produce biological products.

    PubMed

    Schiff, Leonard J

    2005-01-01

    A critical component in controlling the production of biological products derived from human and animal cell lines is the characterization and testing of banked cell substrates. The objective is to confirm the identity, purity, and suitability of these cells for manufacturing use. Quality concerns for biological products derived from cell lines originate from the presence of cellular and adventitious contaminants. Well-characterized cell banks not only permit a consistent source of production cells throughout the life of a product but also decrease the likelihood of contamination by other cell lines and adventitious agents. An important part of qualifying a cell line is choosing the appropriate testing for the presence of adventitious contaminants. The qualification of cell banks includes tests for cell identity and endogenous and adventitious microbial contaminants (bacteria, fungi, mycoplasmas, and viruses). For cells producing recombinant deoxyribonucleic acid-derived products, analysis of the expression construct at the nucleic acid level (genetic stability) is also a primary concern. The strategy for designing a safety-testing program for banked cells should be based on sound scientific principles and current regulatory guidance.

  3. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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...

  4. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological... announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on...

  5. 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 the...

  6. 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.

  7. Biological removal of cationic fission products from nuclear wastewater.

    PubMed

    Ngwenya, N; Chirwa, E M N

    2011-01-01

    Nuclear energy is becoming a preferred energy source amidst rising concerns over the impacts of fossil fuel based energy on global warming and climate change. However, the radioactive waste generated during nuclear power generation contains harmful long-lived fission products such as strontium (Sr). In this study, cationic strontium uptake from solution by microbial cultures obtained from mine wastewater is evaluated. A high strontium removal capacity (q(max)) with maximum loading of 444 mg/g biomass was achieved by a mixed sulphate reducing bacteria (SRB) culture. Sr removal in SRB was facilitated by cell surface based electrostatic interactions with the formation of weak ionic bonds, as 68% of the adsorbed Sr(2+) was easily desorbed from the biomass in an ion exchange reaction with MgCl₂. To a lesser extent, precipitation reactions were also found to account for the removal of Sr from aqueous solution as about 3% of the sorbed Sr was precipitated due to the presence of chemical ligands while the remainder occurred as an immobile fraction. Further analysis of the Sr-loaded SRB biomass by scanning electron microscopy (SEM) coupled to energy dispersive X-ray (EDX) confirmed extracellular Sr(2+) precipitation as a result of chemical interaction. In summary, the obtained results demonstrate the prospects of using biological technologies for the remediation of industrial wastewaters contaminated by fission products.

  8. 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.

  9. Fundamental hair follicle biology and fine fibre production in animals.

    PubMed

    Galbraith, H

    2010-09-01

    Hair 'fine' fibre is an important commercial product of farmed and certain wild animal species. The fibre is produced in follicles embedded in skin. These have properties in common with other tissues of the integument and have importance in determining yield and quality of fibre. Means of understanding and improving these characteristics are informed by knowledge of integumental and follicle biology. This paper reviews contemporary information that identifies the major fibre-producing species and their production characteristic. It surveys knowledge describing fundamental biology of the integument and considers information derived for the hair follicle from studies on a number of species including genetically modified mice. It identifies the composition of the follicle and describes components and interrelationships between epidermal hair-fibre producing epidermis and fibroblast- and connective tissue-containing dermis. The structure of different primary and secondary follicle types, and associated structures, are described. Focus is given to the alterations in anatomy and in behaviour from active to inactive state, which occurs during the hair follicle cycle. Information is provided on the anatomical substructures (hair medulla, cortex, cuticles and supporting sheaths and dermal papilla), cellular and extracellular composition, and adhesion and chemical signalling systems, which regulate development from the early embryo to post-natal state and subsequent cycling. Such signalling involves the dermis and its specialist fibroblasts, which secrete signalling molecules, which along with those from local epidermis and systemic sources, largely determine structure and function of epidermal cells. Such chemical signalling typically includes endocrine-, paracrine-, autocrine- and juxtacrine-acting molecules and interactions with their receptors located on cell membranes or intracellularly with transduction of message mediated by transcription factors at gene level

  10. 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

  11. 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. Copyright © 2013 Elsevier B.V. All rights reserved.

  12. Presence and biological activity of antibiotics used in fuel ethanol and corn co-product production.

    PubMed

    Compart, D M Paulus; Carlson, A M; Crawford, G I; Fink, R C; Diez-Gonzalez, F; Dicostanzo, A; Shurson, G C

    2013-05-01

    Antibiotics are used in ethanol production to control bacteria from competing with yeast for nutrients during starch fermentation. However, there is no published scientific information on whether antibiotic residues are present in distillers grains (DG), co-products from ethanol production, or whether they retain their biological activity. Therefore, the objectives of this study were to quantify concentrations of various antibiotic residues in DG and determine whether residues were biologically active. Twenty distillers wet grains and 20 distillers dried grains samples were collected quarterly from 9 states and 43 ethanol plants in the United States. Samples were analyzed for DM, CP, NDF, crude fat, S, P, and pH to describe the nutritional characteristics of the samples evaluated. Samples were also analyzed for the presence of erythromycin, penicillin G, tetracycline, tylosin, and virginiamycin M1, using liquid chromatography and mass spectrometry. Additionally, virginiamycin residues were determined, using a U.S. Food and Drug Administration-approved bioassay method. Samples were extracted and further analyzed for biological activity by exposing the sample extracts to 10(4) to 10(7) CFU/mL concentrations of sentinel bacterial strains Escherichia coli ATCC 8739 and Listeria monocytogenes ATCC 19115. Extracts that inhibited bacterial growth were considered to have biological activity. Physiochemical characteristics varied among samples but were consistent with previous findings. Thirteen percent of all samples contained low (≤1.12 mg/kg) antibiotic concentrations. Only 1 sample extract inhibited growth of Escherichia coli at 10(4) CFU/mL, but this sample contained no detectable concentrations of antibiotic residues. No extracts inhibited Listeria monocytogenes growth. These data indicate that the likelihood of detectable concentrations of antibiotic residues in DG is low; and if detected, they are found in very low concentrations. The inhibition in only 1 DG

  13. 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...

  14. 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...

  15. 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... be mixed thoroughly in a single container. During bottling operations, the product shall...

  16. 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 deviate...

  17. 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 deviate...

  18. 48 CFR 401.404 - Class deviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 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 deviate...

  19. 48 CFR 401.404 - Class deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 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 deviate...

  20. 48 CFR 401.404 - Class deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 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 deviate...

  1. 9 CFR 318.308 - Deviations in processing.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... deviation file. The establishment shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description... establishment shall: (i) Immediately reprocess the product using the full process schedule; or (ii) Use...

  2. 9 CFR 318.308 - Deviations in processing.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... deviation file. The establishment shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description... establishment shall: (i) Immediately reprocess the product using the full process schedule; or (ii) Use...

  3. 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

  4. 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 to...

  5. 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 in...

  6. 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 in...

  7. 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 in...

  8. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  9. Large deviations in Taylor dispersion

    NASA Astrophysics Data System (ADS)

    Kahlen, Marcel; Engel, Andreas; Van den Broeck, Christian

    2017-01-01

    We establish a link between the phenomenon of Taylor dispersion and the theory of empirical distributions. Using this connection, we derive, upon applying the theory of large deviations, an alternative and much more precise description of the long-time regime for Taylor dispersion.

  10. 78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The......

  11. 77 FR 30887 - Amendments to Sterility Test Requirements for Biological Products; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ...The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an......

  12. 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 to...

  13. 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 Vaccines...

  14. 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 indicated...

  15. 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. FDA...

  16. 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, Center...

  17. 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...

  18. 21 CFR 310.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN.... (b) To obtain marketing approval for radioactive biological products for human use, as defined...

  19. 21 CFR 310.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN.... (b) To obtain marketing approval for radioactive biological products for human use, as defined...

  20. 21 CFR 310.4 - Biologics; products subject to license control.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN.... (b) To obtain marketing approval for radioactive biological products for human use, as defined...

  1. Chemistry and biology of bengamides and bengazoles, bioactive natural products from Jaspis sponges.

    PubMed

    García-Ruiz, Cristina; Sarabia, Francisco

    2014-03-18

    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.

  2. 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...

  3. 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 FOR...

  4. 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 production of biologics. 113.52 Section 113.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production...

  5. 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 production of biologics. 113.52 Section 113.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production...

  6. 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 production of biologics. 113.52 Section 113.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production...

  7. 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 FOR...

  8. 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 FOR...

  9. 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...

  10. Metabolic engineering with systems biology tools to optimize production of prokaryotic secondary metabolites.

    PubMed

    Kim, Hyun Uk; Charusanti, Pep; Lee, Sang Yup; Weber, Tilmann

    2016-08-27

    Covering: 2012 to 2016Metabolic engineering using systems biology tools is increasingly applied to overproduce secondary metabolites for their potential industrial production. In this Highlight, recent relevant metabolic engineering studies are analyzed with emphasis on host selection and engineering approaches for the optimal production of various prokaryotic secondary metabolites: native versus heterologous hosts (e.g., Escherichia coli) and rational versus random approaches. This comparative analysis is followed by discussions on systems biology tools deployed in optimizing the production of secondary metabolites. The potential contributions of additional systems biology tools are also discussed in the context of current challenges encountered during optimization of secondary metabolite production.

  11. Advancement in bioprocess technology: parallels between microbial natural products and cell culture biologics.

    PubMed

    Bandyopadhyay, Arpan A; Khetan, Anurag; Malmberg, Li-Hong; Zhou, Weichang; Hu, Wei-Shou

    2017-02-09

    The emergence of natural products and industrial microbiology nearly eight decades ago propelled an era of bioprocess innovation. Half a century later, recombinant protein technology spurred the tremendous growth of biologics and added mammalian cells to the forefront of industrial producing cells in terms of the value of products generated. This review highlights the process technology of natural products and protein biologics. Despite the separation in time, there is a remarkable similarity in their progression. As the new generation of therapeutics for gene and cell therapy emerges, its process technology development can take inspiration from that of natural products and biologics.

  12. 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.

  13. Large Deviations for Random Trees

    PubMed Central

    Heitsch, Christine

    2010-01-01

    We consider large random trees under Gibbs distributions and prove a Large Deviation Principle (LDP) for the distribution of degrees of vertices of the tree. The LDP rate function is given explicitly. An immediate consequence is a Law of Large Numbers for the distribution of vertex degrees in a large random tree. Our motivation for this study comes from the analysis of RNA secondary structures. PMID:20216937

  14. Management of paretic vertical deviations.

    PubMed

    Archer, Steven M

    2011-01-01

    Paretic vertical deviations are characterized by complex patterns of incomitance that make them some of the most challenging strabismus problems to treat. Optimum results are obtained by performing surgery on those muscles, selected from among the eight cyclovertical muscles in the two eyes, that minimize the incomitance. In superior oblique paresis the additional factors of torticollis and torsion need to be addressed and aberrant regeneration can alter the surgical plan in third nerve paresis.

  15. 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... if seal is broken.” (d) Diluent for the following products need not be packaged with the...

  16. 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.

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...) Product Code Number. A number assigned by Animal and Plant Health Inspection Service to each type of..., the harvest date shall be the date blood or tissues are collected for production or the date cultures... cellular antigens and shall stimulate the development of antitoxin; or (2) A combination product in...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...) Product Code Number. A number assigned by Animal and Plant Health Inspection Service to each type of..., the harvest date shall be the date blood or tissues are collected for production or the date cultures... cellular antigens and shall stimulate the development of antitoxin; or (2) A combination product in...

  19. International reference preparations for standardization of biological medicinal products.

    PubMed

    Minor, P

    2014-10-01

    International standards are prepared as materials assigned an arbitrary unitage for a biological activity by the Expert Committee on Biological Standardization of the World Health Organization. Working reference materials are calibrated against international standards giving a common unit of measurement between laboratories. The references are assessed by a collaborative study including all relevant assays rather than by a single reference method as in the SI (Le Système international d'unités) system and the unitage assigned is an arbitrary value derived from a consensus of all valid methods. The process has proved valuable in assaying the activity of therapeutic biological medicines and in standardizing certain types of diagnostics. Issues arise with maintaining the unit when the primary reference must be replaced and to some extent in assessing the commutability of the reference with real life analytes.

  20. 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.

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

    SciTech Connect

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

    2015-10-23

    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 in this paper we review synthetic metabolic pathways based on fatty acid and isoprenoid metabolism to produce alkanes and other molecules suitable as biofuels. Lastly, we further discuss engineering strategies to optimize engineered biosynthetic routes, as well as the potential of synthetic biology for sustainable manufacturing.

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

    PubMed

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

    2008-06-01

    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.

  3. 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.

  4. The chemistry and biology of guanidine natural products.

    PubMed

    Berlinck, Roberto G S; Bertonha, Ariane F; Takaki, Mirelle; Rodriguez, Julie P G

    2017-10-02

    Covering: 2015 and 2016The chemistry and biology of natural guanidines isolated from microbial culture media, from marine invertebrates, as well as from terrestrial plants and animals, are reviewed. Emphasis is directed to the biosynthesis, total synthesis, ecological roles as well as on the evolution of guanidines isolated from natural sources.

  5. The chemistry and biology of guanidine natural products.

    PubMed

    Berlinck, Roberto G S; Romminger, Stelamar

    2016-03-01

    The present review discusses the isolation, structure determination, synthesis, biosynthesis and biological activities of secondary metabolites bearing a guanidine group. Topics include non-ribosomal peptides, alkaloids, guanidine-bearing terpenes, polyketides and shikimic acid derivatives from natural sources. A critical analysis of some yet underdeveloped aspects of guanidine metabolites is also presented.

  6. Exploitation of biological wastes for the production of value-added products under solid-state fermentation conditions.

    PubMed

    Rodríguez Couto, Susana

    2008-07-01

    Biological wastes contain several reusable substances of high value such as soluble sugars and fibre. Direct disposal of such wastes to soil or landfill causes serious environmental problems. Thus, the development of potential value-added processes for these wastes is highly attractive. These biological wastes can be used as support-substrates in solid-state fermentation (SSF) to produce industrially relevant metabolites with great economical advantage. In addition, it is an environmentally friendly method of waste management. This paper reviews the reutilization of biological wastes for the production of value-added products using the SSF technique.

  7. 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…

  8. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ....17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT...) Required purity tests for final container samples of the product shall be conducted on new samples selected... tests shall not be released. (d) New test samples from each serial or subserial and copies of test...

  9. 9 CFR 114.17 - Rebottling of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ....17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT...) Required purity tests for final container samples of the product shall be conducted on new samples selected... tests shall not be released. (d) New test samples from each serial or subserial and copies of test...

  10. 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.

  11. 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…

  12. Recombinant biologic products versus nutraceuticals from plants - a regulatory choice?

    PubMed

    Drake, Pascal M W; Szeto, Tim H; Paul, Mathew J; Teh, Audrey Y-H; Ma, Julian K-C

    2017-01-01

    Biotechnology has transformed the potential for plants to be a manufacturing source of pharmaceutical compounds. Now, with transgenic and transient expression techniques, virtually any biologic, including vaccines and therapeutics, could be manufactured in plants. However, uncertainty over the regulatory path for such new pharmaceuticals has been a deterrent. Consideration has been given to using alternative regulatory paths, including those for nutraceuticals or cosmetic agents. This review will consider these possibilities, and discuss the difficulties in establishing regulatory guidelines for new pharmaceutical manufacturing technologies.

  13. 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...

  14. 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...

  15. 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 for production of biologics. 113.51 Section 113.51 Animals and Animal Products ANIMAL AND PLANT HEALTH... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used...

  16. 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 for production of biologics. 113.51 Section 113.51 Animals and Animal Products ANIMAL AND PLANT HEALTH... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used...

  17. 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 for production of biologics. 113.51 Section 113.51 Animals and Animal Products ANIMAL AND PLANT HEALTH... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used...

  18. 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.

  19. 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

  20. 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 Management...

  1. 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 Management...

  2. 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 Management...

  3. Retention of Mercurial Preservatives in Desiccated Biological Products

    PubMed Central

    Pemberton, John R.

    1975-01-01

    A variety of bacterins, vaccines, and antisera retained greater than 90% of their original level of mercurial preservative after lyophilization, and this might influence certain uses of these products. PMID:1420

  4. Strategies for optimizing algal biology for enhanced biomass production

    DOE PAGES

    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

  5. Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars).

    PubMed

    Thorpe, Robin; Wadhwa, Meenu

    2011-09-01

    Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of these materials and their limitations are considered in this paper.

  6. 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

    ... biological product. IV. Animal safety data. A. Individual active components. 1. Controlled studies. 2. Partially controlled or uncontrolled studies. B. Combinations of the individual active components. 1. Controlled studies. 2. Partially controlled or uncontrolled studies. C. Finished biological product....

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics... evidence or arguments they wish to present, the names and addresses of proposed participants, and...

  8. 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.

  9. 48 CFR 3401.404 - Class deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Class deviations. 3401.404 Section 3401.404 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.404 Class deviations. A class deviation from...

  10. 48 CFR 3401.404 - Class deviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Class deviations. 3401.404 Section 3401.404 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.404 Class deviations. A class deviation from...

  11. 48 CFR 3401.404 - Class deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Class deviations. 3401.404 Section 3401.404 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.404 Class deviations. A class deviation from...

  12. 48 CFR 3401.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Class deviations. 3401.404 Section 3401.404 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.404 Class deviations. A class deviation from...

  13. 48 CFR 3401.404 - Class deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Class deviations. 3401.404 Section 3401.404 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.404 Class deviations. A class deviation from...

  14. 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 may...

  15. 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 may...

  16. 48 CFR 401.403 - Individual deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 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 may...

  17. 48 CFR 401.403 - Individual deviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 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 may...

  18. 48 CFR 401.403 - Individual deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 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 may...

  19. Inspired Biological Engineering: Detection and Production of Polarized Light by Animals

    DTIC Science & Technology

    2009-05-26

    02-28- 2009) 4. TITLE AND SUBTITLE Inspired Biological Engineering: Detection and Production of Polarized Light by Animals 5a CONTRACT NUMBER...Number F49550-06-1-0117 "Inspired Biological Engineering: Detection and Production of Polarized Light by Animals" Thomas W. Cronin Department of...dichroic transmission using oriented carotenoid molecules. Virtually all the work in this area was the responsibility of "Short" (Tsyr-Huei) Chiou, and the

  20. 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.

  1. 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.

  2. 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.

  3. Perspectives and advances of biological H2 production in microorganisms.

    PubMed

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

    2006-09-01

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

  4. Similar biological medicinal products containing recombinant human growth hormone: European regulation.

    PubMed

    Pavlovic, Mira; Girardin, Elizabeth; Kapetanovic, Liliana; Ho, Kowid; Trouvin, Jean-Hugues

    2008-01-01

    The concept of similar biological medicinal products ('biosimilar' medicinal products) allows pharmaceutical companies to develop products based on an abridged dossier once the marketing protection of the 'reference' biological medicinal product has expired. A biosimilar medicinal product can be granted a marketing authorization provided that its similarity to a reference product is established in terms of quality, safety and efficacy (step-wise comparability exercise). A decision to launch a biosimilar medicinal product on the market is taken if it has a similar efficacy and comparable or better (less) immunogenicity than the chosen reference biological medicinal product. However, this decision is based on limited data and the comparability program may detect substantial differences in immunogenicity profiles but is likely incapable of detecting rare events. This is why clinical experience, through clinical trials and extensive pharmacovigilance programs, remains the most reliable way to assess the immunogenicity and tolerance profile of recombinant therapeutic proteins. Substitution of one biological medicinal product by a biosimilar medicinal product is not currently recommended before long-term clinical efficacy and safety have been acquired in all relevant populations. Here we review recent regulatory guidelines provided by EMEA and comment on the marketing authorizations and risk management plans of two recently approved biosimilar somatropins.

  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. Bovine mammary stem cells: Cell biology meets production agriculture

    USDA-ARS?s Scientific Manuscript database

    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 ...

  7. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... shall accurately reflect the action taken. (d) Test samples of the reprocessed serial and test reports for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee...

  8. 9 CFR 114.18 - Reprocessing of biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... shall accurately reflect the action taken. (d) Test samples of the reprocessed serial and test reports for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee...

  9. 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...

  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

    ... for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and Drugs... 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 Center...

  11. 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.

  12. Chemical biology--identification of small molecule modulators of cellular activity by natural product inspired synthesis.

    PubMed

    Hübel, Katja; Lessmann, Torben; Waldmann, Herbert

    2008-07-01

    The aim of this tutorial review is to introduce the reader to the concept, synthesis and application of natural product-inspired compound collections as an important field in chemical biology. This review will discuss how potentially interesting scaffolds can be identified (structural classification of natural products), synthesized in an appropriate manner (including stereoselective transformations for solid phase-bound compounds) and tested in biological assays (cell-based screening as well as biochemical in vitro assays). These approaches will provide the opportunity to identify new and interesting compounds as well as new targets for chemical biology and medicinal chemistry research.

  13. 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

  14. Improvements in fermentative biological hydrogen production through metabolic engineering.

    PubMed

    Hallenbeck, Patrick C; Ghosh, Dipankar

    2012-03-01

    Replacement of fossil fuels with alternative energies is increasingly imperative in light of impending climate change and fossil fuel shortages. Biohydrogen has several potential advantages over other biofuels. Dark fermentation as a means of producing biohydrogen is attractive since a variety of readily available waste streams can be used. However, at present its practical application is prevented by the low yields obtained. Here the basic metabolisms leading to hydrogen production are outlined and current research to increase yields, either through modification of existing pathways, or by metabolic engineering to create new, higher yielding, pathways, is discussed. Inactivation of competing reactions and manipulation of culture conditions has lead to higher hydrogen yields, near those predicted by metabolic schemes. However, to be useful, hydrogen production must be increased beyond present limits. Several possibilities for surpassing those limits using metabolic engineering are presented.

  15. Time-ordered product expansions for computational stochastic system biology.

    PubMed

    Mjolsness, Eric

    2013-06-01

    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 differential equations evolve the parameters of objects that can also undergo stochastic reactions. Thus, the time-ordered product expansion can be used systematically to derive simulation and parameter-fitting algorithms for stochastic systems.

  16. Time-ordered product expansions for computational stochastic system biology

    NASA Astrophysics Data System (ADS)

    Mjolsness, Eric

    2013-06-01

    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 differential equations evolve the parameters of objects that can also undergo stochastic reactions. Thus, the time-ordered product expansion can be used systematically to derive simulation and parameter-fitting algorithms for stochastic systems.

  17. 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.

  18. Process development for biological production of butanol from Eastern redcedar.

    PubMed

    Liu, Kan; Atiyeh, Hasan K; Pardo-Planas, Oscar; Ramachandriya, Karthikeyan D; Wilkins, Mark R; Ezeji, Thaddeus C; Ujor, Victor; Tanner, Ralph S

    2015-01-01

    Eastern redcedar is an invasive softwood species in Oklahoma and across grasslands in the Central Plains of the United States and potential feedstock for butanol production. Butanol has higher energy content than ethanol and can be upgraded to jet and diesel fuels. The objective of this study was to develop a process for production of butanol from redcedar. Results showed that Clostridium acetobutylicum ATCC 824 and Clostridium beijerinckii NCIMB 8052 did not grow in fermentation medium with citrate buffer. However, both strains grew in the medium with acetate buffer, resulting in 3-4g/L greater butanol than without acetate. Detoxification of redcedar hydrolyzate was required to increase butanol concentration from 1 to 13g/L. Hydrolyzate was detoxified by activated carbon to remove inhibitors. Fermentations in detoxified redcedar hydrolyzate reached 13g/L butanol and 19g/L total ABE, comparable to glucose control. This shows the potential for redcedar use in butanol production. Copyright © 2014 Elsevier Ltd. All rights reserved.

  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. 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.

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General Provisions § 510.4 Biologics; products subject to license control. An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. )...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General Provisions § 510.4 Biologics; products subject to license control. An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. )...

  3. 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.

  4. Metabolic engineering for production of biorenewable fuels and chemicals: contributions of synthetic biology.

    PubMed

    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.

  5. 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

  6. Fermentative production of butanol: Perspectives on synthetic biology.

    PubMed

    Nanda, Sonil; Golemi-Kotra, Dasantila; McDermott, John C; Dalai, Ajay K; Gökalp, Iskender; Kozinski, Janusz A

    2017-03-09

    Apprehensions relating to global warming, climate change, pollution, rising energy demands as well as fluctuating crude oil prices and supply are leading to a shift in global interest to find suitable alternatives to fossil fuels. This review aims to highlight the many different facets of butanol as an advanced next-generation transportation biofuel. Butanol has fuel properties almost on a par with gasoline, such as high energy content, low vapor pressure, non-hygroscopic nature, less volatility, flexible fuel blends and high octane number. The paper reviews some recent advances in acetone-butanol-ethanol fermentation with special emphasis on the primary challenges encountered in butanol fermentation, including butanol toxicity, solvent intolerance and bacteriophage contamination. The mechanisms for butanol recovery techniques have been covered along with their benefits and limitations. A comprehensive discussion of genetic and metabolic engineering of butanol-producing microorganisms is made for the prospective development of industrially-relevant strains that can overcome the technical challenges involved in efficient butanol production.

  7. 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

  8. 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.

  9. 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.

  10. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 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 General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing...

  11. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 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 General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing...

  12. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 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 General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing...

  13. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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 General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing...

  14. 10 CFR 961.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 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 General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing...

  15. 48 CFR 3401.403 - Individual deviations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true 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...

  16. 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...

  17. 48 CFR 3401.403 - Individual deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 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...

  18. 48 CFR 3401.403 - Individual deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 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...

  19. 48 CFR 3401.403 - Individual deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 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...

  20. 10 CFR 600.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ENERGY (CONTINUED) ASSISTANCE REGULATIONS FINANCIAL ASSISTANCE RULES General § 600.4 Deviations. (a... to one financial assistance transaction and one applicant, recipient, or subrecipient only. (3) A class deviation is a deviation which applies to more than one financial assistance transaction...

  1. 10 CFR 600.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ENERGY (CONTINUED) ASSISTANCE REGULATIONS FINANCIAL ASSISTANCE RULES General § 600.4 Deviations. (a... to one financial assistance transaction and one applicant, recipient, or subrecipient only. (3) A class deviation is a deviation which applies to more than one financial assistance transaction...

  2. 10 CFR 600.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ENERGY (CONTINUED) ASSISTANCE REGULATIONS FINANCIAL ASSISTANCE RULES General § 600.4 Deviations. (a... to one financial assistance transaction and one applicant, recipient, or subrecipient only. (3) A class deviation is a deviation which applies to more than one financial assistance transaction...

  3. 10 CFR 600.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ENERGY (CONTINUED) ASSISTANCE REGULATIONS FINANCIAL ASSISTANCE RULES General § 600.4 Deviations. (a... to one financial assistance transaction and one applicant, recipient, or subrecipient only. (3) A class deviation is a deviation which applies to more than one financial assistance transaction...

  4. 10 CFR 602.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by...

  5. 10 CFR 602.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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 ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by...

  6. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 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 General § 1260.7 Deviations. (a) A deviation is required for any of the following: (1) When a...

  7. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 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 General § 1260.7 Deviations. (a) A deviation is required for any of the following: (1) When a...

  8. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 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 General § 1260.7 Deviations. (a) A deviation is required for any of the following: (1) When a...

  9. 14 CFR § 1260.7 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 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 General § 1260.7 Deviations. (a) A deviation is required for any of the following: (1) When a...

  10. 14 CFR 1260.7 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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 General § 1260.7 Deviations. (a) A deviation is required for any of the following: (1) When a...

  11. 10 CFR 602.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

  12. 10 CFR 602.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

  13. 10 CFR 602.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

  14. 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…

  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. 48 CFR 2801.404 - 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. 2801.404 Section 2801.404 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE General DEPARTMENT OF JUSTICE ACQUISITION REGULATIONS SYSTEM Deviations From the FAR and JAR 2801.404 Class deviations....

  17. 48 CFR 2901.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Class deviations. 2901.404 Section 2901.404 Federal Acquisition Regulations System DEPARTMENT OF LABOR GENERAL DEPARTMENT OF LABOR ACQUISITION REGULATION SYSTEM Deviations From the FAR and DOLAR 2901.404 Class deviations. (a) The...

  18. Modeling Shrimp Biomass and Viral Infection for Production of Biological Countermeasures

    DTIC Science & Technology

    2005-12-09

    Modeling Shrimp Biomass and Viral Infection for Production of Biological Countermeasures H. T. Banksa, V. A. Bokilb, S. Huc, A. K. Dhard, R. A...penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 09 DEC 2005... Biological Countermeasures 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f

  19. Interventions for dissociated vertical deviation

    PubMed Central

    Hatt, Sarah R; Wang, Xue; Holmes, Jonathan M

    2015-01-01

    Background The term “strabismus” describes misalignment of the eyes. One or both eyes may deviate inward, outward, upward, or downward. Dissociated vertical deviation (DVD) is a well-recognized type of upward drifting of one or both eyes, which can occur in children or adults. DVD often develops in the context of infantile- or childhood-onset horizontal strabismus, either esotropia (inward-turning) or exotropia (outward-turning). For some individuals, DVD remains controlled and can only be detected during clinical testing. For others, DVD becomes spontaneously “manifest” and the eye drifts up of its own accord. Spontaneously manifest DVD can be difficult to control and often causes psychosocial concerns. Traditionally, DVD has been thought to be asymptomatic, although some individuals have double vision. More recently it has been suggested that individuals with DVD may also suffer from eyestrain. Treatment for DVD may be sought either due to psychosocial concerns or because of these symptoms. The standard treatment for DVD is a surgical procedure; non-surgical treatments are offered less commonly. Although there are many studies evaluating different management options for the correction of DVD, a lack of clarity remains regarding which treatments are most effective. Objectives The objective of this review was to determine the effectiveness and safety of various surgical and non-surgical interventions in randomized controlled trials of participants with DVD. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2015), EMBASE (January 1980 to August 2015), PubMed (1948 to August 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to August 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 3

  20. 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 Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling...

  1. Recent advances in endophytic exopolysaccharides: Production, structural characterization, physiological role and biological activity.

    PubMed

    Liu, Jun; Wang, Xingchi; Pu, Huimin; Liu, Shuang; Kan, Juan; Jin, Changhai

    2017-02-10

    Endophytes are microorganisms that colonize living, internal tissues of plants without causing any immediate, overt negative effects. In recent years, both endophytic bacteria and fungi have been demonstrated to be excellent exopolysaccharides (EPS) producers. This review focuses on the recent advances in EPS produced by endophytes, including its production, isolation and purification, structural characterization, physiological role and biological activity. In general, EPS production is influenced by media components and cultivation conditions. The structures of purified EPS range from linear homopolysaccharides to highly branched heteropolysaccharides. These structurally novel EPS not only play important roles in plant-endophyte interactions; but also exhibit several biological functions, such as antioxidant, antitumor, anti-inflammatory, anti-allergic and prebiotic activities. In order to utilize endophytic EPS on an industrial scale, both yield and productivity enhancement strategies are required at several levels. Besides, the exact mechanisms on the physiological roles and biological functions of EPS should be elucidated in future.

  2. Effects of variable winds on biological productivity on continental shelves in coastal upwelling systems

    NASA Astrophysics Data System (ADS)

    Botsford, Louis W.; Lawrence, Cathryn A.; Dever, Edward P.; Hastings, Alan; Largier, John

    2006-12-01

    The production and distribution of biological material in wind-driven coastal upwelling systems are of global importance, yet they remain poorly understood. Production is frequently presumed to be proportional to upwelling rate, yet high winds can lead to advective losses from continental shelves, where many species at higher trophic levels reside. An idealized mixed-layer conveyor (MLC) model of biological production from constant upwelling winds demonstrated previously that the amount of new production available to shelf species increased with upwelling at low winds, but declined at high winds [Botsford, L.W., Lawrence, C.A., Dever, E.P., Hastings, A., Largier, J., 2003. Wind strength and biological productivity in upwelling systems: an idealized study. Fisheries Oceanography 12, 245-259]. Here we analyze the response of this model to time-varying winds for parameter values and observed winds from the Wind Events and Shelf Transport (WEST) study region. We compare this response to the conventional view that the results of upwelling are proportional to upwelled volume. Most new production per volume upwelled available to shelf species occurs following rapid increases in shelf transit time due to decreases in wind (i.e. relaxations). However, on synoptic, event time-scales shelf production is positively correlated with upwelling rate. This is primarily due to the effect of synchronous periods of low values in these time series, paradoxically due to wind relaxations. On inter-annual time-scales, computing model production from wind forcing from 20 previous years shows that these synchronous periods of low values have little effect on correlations between upwelling and production. Comparison of model production from 20 years of wind data over a range of shelf widths shows that upwelling rate will predict biological production well only in locations where cross-shelf transit times are greater than the time required for phytoplankton or zooplankton production. For

  3. 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.

  4. 9 CFR 381.308 - Deviations in processing.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description of the corrective actions... establishment shall: (i) Immediately reprocess the product using the full process schedule; or, (ii) Use...

  5. 9 CFR 381.308 - Deviations in processing.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description of the corrective actions... establishment shall: (i) Immediately reprocess the product using the full process schedule; or, (ii) Use...

  6. 9 CFR 381.308 - Deviations in processing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY...) must be handled according to: (1)(i) A HACCP plan for canned product that addresses hazards associated... (d) of this section. (c) (d) Procedures for handling process deviations where the HACCP plan...

  7. 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

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

    PubMed Central

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

    2013-01-01

    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

  9. A probabilistic model for risk assessment of residual host cell DNA in biological products.

    PubMed

    Yang, Harry; Zhang, Lanju; Galinski, Mark

    2010-04-26

    Biological products such as viral vaccines manufactured in cells contain residual DNA derived from host cell substrates used in production. It is theoretically possible that the residual DNA could transmit activated oncogenes and/or latent infectious viral genomes to subjects receiving the product, and induce oncogenic or infective events. A probabilistic model to estimate the risks due to residual DNA is proposed. The model takes account of enzyme inactivation process. It allows for more accurate risk assessment when compared to methods currently in use. An application of the method to determine safety factor of a vaccine product is provided.

  10. 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

  11. Biological activities of Agave by-products and their possible applications in food and pharmaceuticals.

    PubMed

    López-Romero, Julio Cesar; Ayala-Zavala, Jesús Fernando; González-Aguilar, Gustavo Adolfo; Peña-Ramos, Etna Aida; González-Ríos, Humberto

    2017-10-11

    Agave leaves are considered a by-product of alcoholic beverage production (tequila, mezcal and bacanora) because they are discarded during the production process, despite accounting for approximately 50 % of the total plant weight. These by-products constitute a potential source of Agave extracts rich in bioactive compounds, such as saponins, phenolic compounds and terpenes, and possess different biological effects, as demonstrated by in vitro and in vivo tests (e.g., antimicrobial, antifungal, antioxidant, anti-inflammatory, antihypertensive, immunomodulatory, antiparasitic, and anticancer activity). Despite their positive results in biological assays, Agave extracts have not been widely evaluated in food systems and pharmaceutical areas, and these fields represent a potential route to improve the usage of Agave plants as food additives and agents for treating medical diseases. This article is protected by copyright. All rights reserved.

  12. Ocean glider observations of iceberg-enhanced biological production in the northwestern Weddell Sea

    NASA Astrophysics Data System (ADS)

    Biddle, Louise C.; Kaiser, Jan; Heywood, Karen J.; Thompson, Andrew F.; Jenkins, Adrian

    2015-01-01

    Icebergs affect local biological production around Antarctica. We used an ocean glider to observe the effects of a large iceberg that was advected by the Antarctic Slope Current along the continental slope in the northwestern Weddell Sea in early 2012. The high-resolution glider data reveal a pronounced effect of the iceberg on ocean properties, with oxygen concentrations of (13 ± 4) μmol kg-1 higher than levels in surrounding waters, which are most likely due to positive net community production. This response was confined to three areas of water in the direct vicinity of the iceberg track, each no larger than 2 km2. Our findings suggest that icebergs have an impact on Antarctic production presumably through local micronutrient injections, on a scale smaller than typical satellite observations of biological production in the Southern Ocean.

  13. 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).

  14. 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.

  15. Synthetic biology: tools to design microbes for the production of chemicals and fuels.

    PubMed

    Seo, Sang Woo; Yang, Jina; Min, Byung Eun; Jang, Sungho; Lim, Jae Hyung; Lim, Hyun Gyu; Kim, Seong Cheol; Kim, Se Yeon; Jeong, Jun Hong; Jung, Gyoo Yeol

    2013-11-01

    The engineering of biological systems to achieve specific purposes requires design tools that function in a predictable and quantitative manner. Recent advances in the field of synthetic biology, particularly in the programmable control of gene expression at multiple levels of regulation, have increased our ability to efficiently design and optimize biological systems to perform designed tasks. Furthermore, implementation of these designs in biological systems highlights the potential of using these tools to build microbial cell factories for the production of chemicals and fuels. In this paper, we review current developments in the design of tools for controlling gene expression at transcriptional, post-transcriptional and post-translational levels, and consider potential applications of these tools.

  16. Production, Isotopic Composition, and Atmospheric Fate of Biologically Produced Nitrous Oxide

    NASA Astrophysics Data System (ADS)

    Stein, Lisa Y.

    The anthropogenic production of greenhouse gases and their consequent effects on global climate have garnered international attention for years. A remaining challenge facing scientists is to unambiguously quantify both sources and sinks of targeted gases. Microbiological metabolism accounts for the largest source of nitrous oxide (N2O), mostly due to global conversion of land for agriculture and massive usage of nitrogen-based fertilizers. A most powerful method for characterizing the sources of N2O lies in its multi-isotope signature. This review summarizes mechanisms that lead to biological N2O production and how discriminate placement of 15N into molecules of N2O occurs. Through direct measurements and atmospheric modeling, we can now place a constraint on the isotopic composition of biological sources of N2O and trace its fate in the atmosphere. This powerful interdisciplinary combination of biology and atmospheric chemistry is rapidly advancing the closure of the global N2O budget.

  17. 76 FR 66235 - Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 610 Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug...

  18. 37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Calculation of patent term extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent Term...

  19. 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.

  20. 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.... Most biological products are produced in a living system such as a microorganism, or plant or animal cells, whereas small molecule drugs are typically manufactured through chemical synthesis. Section 351(k...

  1. Statistical and regulatory considerations in assessments of interchangeability of biological drug products.

    PubMed

    Tóthfalusi, Lászlo; Endrényi, László; Chow, Shein-Chung

    2014-05-01

    When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectation that the 90% confidence interval for the ratio of geometric means of some pharmacokinetic parameters be between 0.80 and 1.25. When such criteria are satisfied, the drug products are generally considered to exhibit therapeutic equivalence. They are then usually interchanged freely within individual patients. Biological drugs are complex proteins, for instance, because of their large size, intricate structure, sensitivity to environmental conditions, difficult manufacturing procedures, and the possibility of immunogenicity. Generic and brand-name biologic products can be expected to show only similarity but not identity in their various features and clinical effects. Consequently, the determination of biosimilarity is also a complicated process which involves assessment of the totality of the evidence for the close similarity of the two products. Moreover, even when biosimilarity has been established, it may not be assumed that the two biosimilar products can be automatically substituted by pharmacists. This generally requires additional, careful considerations. Without declaring interchangeability, a new product could be prescribed, i.e. it is prescribable. However, two products can be automatically substituted only if they are interchangeable. Interchangeability is a statistical term and it means that products can be used in any order in the same patient without considering the treatment history. The concepts of interchangeability and prescribability have been widely discussed in the past but only in relation to small molecule generics. In this paper we apply these concepts to biosimilars and we discuss: definitions of prescribability and interchangeability and

  2. A downstream process for production of a viable and stable Bacillus cereus aquaculture biological agent.

    PubMed

    Lalloo, Rajesh; Maharajh, Dheepak; Görgens, Johann; Gardiner, Neil

    2010-03-01

    Biological products offer advantages over chemotherapeutics in aquaculture. Adoption in commercial application is lacking due to limitations in process and product development that address key end user product requirements such as cost, efficacy, shelf life and convenience. In previous studies, we have reported on the efficacy, physiological robustness and low-cost spore production of a Bacillus cereus isolate (NRRL 100132). This study examines the development of suitable spore recovery, drying, formulation and tablet production from the fermentation product. Key criteria used for such downstream process unit evaluation included spore viability, recovery, spore balance, spore re-germination, product intermediate stability, end product stability and efficacy. A process flow sheet comprising vertical tube centrifugation, fluidised bed agglomeration and tablet pressing yielded a suitable product. The formulation included corn steep liquor and glucose to enhance subsequent spore regermination. Viable spore recovery and spore balance closure across each of the process units was high (>70% and >99% respectively), with improvement in recovery possible by adoption of continuous processing at large scale. Spore regermination was 97%, whilst a product half-life in excess of 5 years was estimated based on thermal resistance curves. The process resulted in a commercially attractive product and suitable variable cost of production.

  3. 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.

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

    PubMed Central

    Turner, David P.

    2015-01-01

    Low income, poor diet, obesity and a lack of exercise are inter-related lifestyle factors that can profoundly alter our biological 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 biological consequence of lifestyle that can directly impact tumor biology. Advanced glycation end-products (AGEs) 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 biological links with the socioeconomic and environmental risk factors that drive cancer disparity. Given the potential benefits of lifestyle changes and the potential biological role of AGEs in promoting cancer, opportunities exist for collaborations impacting basic, translational, epidemiological and cancer prevention initiatives. PMID:25920350

  5. 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. ©2015 American Association for Cancer Research.

  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. New synthetic strategies towards psammaplin A, access to natural product analogues for biological evaluation.

    PubMed

    Baud, Matthias G J; Leiser, Thomas; Meyer-Almes, Franz-Josef; Fuchter, Matthew J

    2011-02-07

    New synthetic routes towards the natural product psammaplin A were developed with the particular view to preparing diverse analogues for biological assessment. These routes utilize cheap and commercially available starting materials, and allowed access to psammaplin A analogues not accessible via currently reported methods. Preliminary biological studies revealed these compounds to be the most potent non peptidic inhibitors of the enzyme histone deacetylase 1 (HDAC1, class I) discovered so far. Interestingly, psammaplin A and our synthetic analogues show class I selectivity in vitro, an important feature for the design and synthesis of future isoform selective inhibitors.

  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.

  9. 20 CFR 435.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Deviations. 435.4 Section 435.4 Employees' Benefits SOCIAL SECURITY ADMINISTRATION UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH... General § 435.4 Deviations. The Office of Management and Budget (OMB) may grant exceptions for classes of...

  10. 20 CFR 435.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Deviations. 435.4 Section 435.4 Employees' Benefits SOCIAL SECURITY ADMINISTRATION UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH... General § 435.4 Deviations. The Office of Management and Budget (OMB) may grant exceptions for classes of...

  11. 20 CFR 435.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Deviations. 435.4 Section 435.4 Employees' Benefits SOCIAL SECURITY ADMINISTRATION UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH... General § 435.4 Deviations. The Office of Management and Budget (OMB) may grant exceptions for classes of...

  12. 20 CFR 435.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Deviations. 435.4 Section 435.4 Employees' Benefits SOCIAL SECURITY ADMINISTRATION UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH... General § 435.4 Deviations. The Office of Management and Budget (OMB) may grant exceptions for classes of...

  13. 20 CFR 435.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Deviations. 435.4 Section 435.4 Employees' Benefits SOCIAL SECURITY ADMINISTRATION UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH... General § 435.4 Deviations. The Office of Management and Budget (OMB) may grant exceptions for classes of...

  14. 48 CFR 2001.403 - 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. 2001.403 Section 2001.403 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR...

  15. 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. 2001.403 Section 2001.403 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR...

  16. 48 CFR 2001.403 - Individual deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Individual deviations. 2001.403 Section 2001.403 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR...

  17. 48 CFR 2001.404 - 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. 2001.404 Section 2001.404 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.404...

  18. 48 CFR 2001.403 - Individual deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Individual deviations. 2001.403 Section 2001.403 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR...

  19. 48 CFR 2001.404 - Class deviations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Class deviations. 2001.404 Section 2001.404 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.404...

  20. 48 CFR 2001.404 - 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. 2001.404 Section 2001.404 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.404...

  1. 48 CFR 2001.403 - 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. 2001.403 Section 2001.403 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR...

  2. 48 CFR 2001.404 - 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. 2001.404 Section 2001.404 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.404...

  3. 48 CFR 2001.404 - Class deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Class deviations. 2001.404 Section 2001.404 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.404...

  4. 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...

  5. 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...

  6. 10 CFR 800.204 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 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...

  7. 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...

  8. 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...

  9. 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 Deviations...

  10. 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. (a...

  11. 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 Deviation...

  12. 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, after...

  13. 34 CFR 74.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 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...

  14. 48 CFR 1201.404 - Class deviations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Class deviations. 1201.404... in writing class deviations from the (FAR) 48 CFR chapter 1 and (TAR) 48 CFR chapter 12, unless (FAR) 48 CFR 1.405(e) applies. ...

  15. 48 CFR 501.403 - Individual deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... authority to grant an individual deviation may be re-delegated to the Contracting Director. (b) If GSA delegates authority to another agency and requires compliance with the GSAR as a condition of the delegation... Contracting Activity (HCA) must approve an individual deviation to the FAR. The authority to grant an...

  16. Comparing Standard Deviation Effects across Contexts

    ERIC Educational Resources Information Center

    Ost, Ben; Gangopadhyaya, Anuj; Schiman, Jeffrey C.

    2017-01-01

    Studies using tests scores as the dependent variable often report point estimates in student standard deviation units. We note that a standard deviation is not a standard unit of measurement since the distribution of test scores can vary across contexts. As such, researchers should be cautious when interpreting differences in the numerical size of…

  17. 22 CFR 518.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 2 2013-04-01 2009-04-01 true Deviations. 518.4 Section 518.4 Foreign Relations BROADCASTING BOARD OF GOVERNORS UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 518.4 Deviations....

  18. 22 CFR 518.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Deviations. 518.4 Section 518.4 Foreign Relations BROADCASTING BOARD OF GOVERNORS UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 518.4 Deviations....

  19. 22 CFR 145.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 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...

  20. 22 CFR 145.4 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 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...

  1. 22 CFR 145.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 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...

  2. 22 CFR 518.4 - Deviations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 2 2012-04-01 2009-04-01 true Deviations. 518.4 Section 518.4 Foreign Relations BROADCASTING BOARD OF GOVERNORS UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 518.4 Deviations....

  3. 22 CFR 518.4 - Deviations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Deviations. 518.4 Section 518.4 Foreign Relations BROADCASTING BOARD OF GOVERNORS UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 518.4 Deviations....

  4. 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...

  5. 48 CFR 1201.403 - 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. 1201.403 Section 1201.403 Federal Acquisition Regulations System DEPARTMENT OF TRANSPORTATION GENERAL... Executive Service (SES) official or that of a Flag Officer, may authorize individual deviations (unless (FAR...

  6. 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 other...

  7. Alternating Skew Deviation from Traumatic Intracranial Hypotension

    PubMed Central

    Moster, Stephen J.; Moster, Mark L.

    2014-01-01

    Abstract A 56-year-old woman developed progressive headache, mental status changes, and diplopia after trauma. She was diagnosed with alternating skew deviation caused by intracranial hypotension. This is the first case of alternating skew deviation reported from intracranial hypotension and perhaps a differential pressure between intracranial and intraspinal spaces plays a role in the development of these findings. PMID:27928294

  8. 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 Deviations...

  9. 12 CFR 1808.104 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 10 2014-01-01 2014-01-01 false Deviations. 1808.104 Section 1808.104 Banks and Banking COMMUNITY DEVELOPMENT FINANCIAL INSTITUTIONS FUND, DEPARTMENT OF THE TREASURY COMMUNITY DEVELOPMENT FINANCIAL INSTITUTIONS BOND GUARANTEE PROGRAM General Provisions § 1808.104 Deviations. To the...

  10. 48 CFR 1401.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Class deviations. 1401.404 Section 1401.404 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR GENERAL DEPARTMENT OF THE INTERIOR ACQUISITION REGULATION SYSTEM Deviations from the FAR and DIAR 1401.404 Class...

  11. 48 CFR 3001.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Class deviations. 3001.404 Section 3001.404 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND SECURITY ACQUISITION REGULATION (HSAR) GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations from the FAR and...

  12. 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...

  13. 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, after...

  14. 34 CFR 74.4 - Deviations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 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...

  15. 48 CFR 1480.403 - Deviations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... authorize a deviation for an IA acquisition: For a proposed contract action . . . The following official may authorize a deviation . . . Exceeding $25,000 but not exceeding $550,000 The CCO (or the IA Procurement Chief, absent a CCO). Exceeding $550,000 but not exceeding $11.5 million IA Competition...

  16. Penile deviation--our therapeutic concept.

    PubMed

    Lenk, S; Schönberger, B

    1994-01-01

    Penile deviations can be congenital or acquired, e.g. Peyronie's disease, and--depending on the degree of curvature--can impede cohabitation or make it completely impossible. 53 patients (17 congenital, 36 acquired) with penile curvature were examined as to anamnesis, clinical state, autophotography or artificial erection with the help of vasoactive drugs or a vacuum device. A pharmacocavernosography was performed in patients with erectile problems. In cases of congenital deviation, surgical correction was carried out according to the Nesbit procedure, and in 2 patients with hypoplastic urethra after penile straightening a urethroplasty was performed. Twenty-eight patients with Peyronie's disease were treated with superoxide dismutase. Seven of them had to be operated on, and in 8 patients with severe deviation surgical therapy was primary. In conclusion, the management of penile deviation should be differentiated depending on the cause and degree of deviation as well as discomfort and erectile potency.

  17. 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.

  18. 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.

  19. Charting biologically relevant chemical space: A structural classification of natural products (SCONP)

    PubMed Central

    Koch, Marcus A.; Schuffenhauer, Ansgar; Scheck, Michael; Wetzel, Stefan; Casaulta, Marco; Odermatt, Alex; Ertl, Peter; Waldmann, Herbert

    2005-01-01

    The identification of small molecules that fall within the biologically relevant subfraction of vast chemical space is of utmost importance to chemical biology and medicinal chemistry research. The prerequirement of biological relevance to be met by such molecules is fulfilled by natural product-derived compound collections. We report a structural classification of natural products (SCONP) as organizing principle for charting the known chemical space explored by nature. SCONP arranges the scaffolds of the natural products in a tree-like fashion and provides a viable analysis- and hypothesis-generating tool for the design of natural product-derived compound collections. The validity of the approach is demonstrated in the development of a previously undescribed class of selective and potent inhibitors of 11β-hydroxysteroid dehydrogenase type 1 with activity in cells guided by SCONP and protein structure similarity clustering. 11β-hydroxysteroid dehydrogenase type 1 is a target in the development of new therapies for the treatment of diabetes, the metabolic syndrome, and obesity. PMID:16301544

  20. Meiosis and its deviations in polyploid animals.

    PubMed

    Stenberg, P; Saura, A

    2013-01-01

    We review the different modes of meiosis and its deviations encountered in polyploid animals. Bisexual reproduction involving normal meiosis occurs in some allopolyploid frogs with variable degrees of polyploidy. Aberrant modes of bisexual reproduction include gynogenesis, where a sperm stimulates the egg to develop. The sperm may enter the egg but there is no fertilization and syngamy. In hybridogenesis, a genome is eliminated to produce haploid or diploid eggs or sperm. Ploidy can be elevated by fertilization with a haploid sperm in meiotic hybridogenesis, which elevates the ploidy of hybrid offspring such that they produce diploid gametes. Polyploids are then produced in the next generation. In kleptogenesis, females acquire full or partial genomes from their partners. In pre-equalizing hybrid meiosis, one genome is transmitted in the Mendelian fashion, while the other is transmitted clonally. Parthenogenetic animals have a very wide range of mechanisms for restoring or maintaining the mother's ploidy level, including gamete duplication, terminal fusion, central fusion, fusion of the first polar nucleus with the product of the first division, and premeiotic duplication followed by a normal meiosis. In apomictic parthenogenesis, meiosis is replaced by what is effectively mitotic cell division. The above modes have different evolutionary consequences, which are discussed. See also the sister article by Grandont et al. in this themed issue.

  1. 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...

  2. 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...

  3. 21 CFR 114.89 - Deviations from scheduled processes.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 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...

  4. 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...

  5. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 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...

  6. 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...

  7. 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 and...

  8. 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.

  9. Biological production, export efficiency, and phytoplankton communities across 8000 km of the South Atlantic

    NASA Astrophysics Data System (ADS)

    Howard, E. M.; Durkin, C. A.; Hennon, G. M. M.; Ribalet, F.; Stanley, R. H. R.

    2017-07-01

    In situ oxygen tracers (triple oxygen isotope and oxygen/argon ratios) were used to evaluate meridional trends in surface biological production and export efficiency across 8000 km of the tropical and subtropical South Atlantic in March-May 2013. We used observations of picophytoplankton, nanophytoplankton, and microphytoplankton to evaluate community structure and diversity and assessed the relationships of these characteristics with production, export efficiency, and particulate organic carbon (POC) fluxes. Rates of productivity were relatively uniform along most of the transect with net community production (NCP) between 0 and 10 mmol O2 m-2 d-1, gross primary production (GPP) between 40 and 100 mmol O2 m-2 d-1, and NCP/GPP, a measure of export efficiency, ranging from 0.1 to 0.2 (0.05-0.1 in carbon units). However, notable exceptions to this basin-scale homogeneity included two locations with highly enhanced NCP and export efficiency compared to surrounding regions. Export of POC and particulate nitrogen, derived from sediment traps, correlated with GPP across the transect, over which the surface community was dominated numerically by picophytoplankton. NCP, however, did not correlate with POC flux; the mean difference between NCP and POC flux was similar to published estimates of dissolved organic carbon export from the surface ocean. The interrelated rates of production presented in this work contribute to the understanding, building on the framework of better-studied ocean basins, of how carbon is biologically transported between the atmosphere and the deep ocean.

  10. A PCR detection method for testing Mycoplasma contamination of veterinary vaccines and biological products.

    PubMed

    Ingebritson, A L; Gibbs, C P; Tong, C; Srinivas, G B

    2015-02-01

    A rapid test method was developed for detecting mycoplasma contamination in veterinary biological products. The method reduces testing time by 2 weeks and shows comparable sensitivity to the current agar-based detection model. The primary goals for the development of the test were to reduce the testing time, incorporate a method that was easily adaptable across the veterinary biologics industry and reduce the subjective interpretation of results. We found that biological enrichment is necessary to maintain sensitivity of the detection method when compared to the standard culture-based test and that periodic sampling of enrichment cultures is essential to detect a wide variety of mycoplasma species that may be present as contaminants. The PCR detection method is comparable to the agar-based model and can reduce the overall testing time by up to 14 days.

  11. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug labeling...

  12. 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, antibiotic...

  13. 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, antibiotic...

  14. 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, antibiotic...

  15. 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, antibiotic...

  16. 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, antibiotic...

  17. Characterization of persistent colors and decolorization of effluent from biologically treated cellulosic ethanol production wastewater.

    PubMed

    Shan, Lili; Liu, Junfeng; Yu, Yanling; Ambuchi, John J; Feng, Yujie

    2016-05-01

    The high chroma of cellulosic ethanol production wastewater poses a serious environmental concern; however, color-causing compounds are still not fully clear. The characteristics of the color compounds and decolorization of biologically treated effluent by electro-catalytic oxidation were investigated in this study. Excitation-emission matrix (EEM), fourier transform infrared spectrometer (FTIR), UV-Vis spectra, and ultrafiltration (UF) fractionation were used to analyze color compounds. High chroma of wastewater largely comes from humic materials, which exhibited great fluorescence proportion (67.1 %) in the biologically treated effluent. Additionally, the color compounds were mainly distributed in the molecular weight fractions with 3-10 and 10-30 kDa, which contributed 53.5 and 34.6 % of the wastewater color, respectively. Further decolorization of biologically treated effluent by electro-catalytic oxidation was investigated, and 98.3 % of color removal accompanied with 97.3 % reduction of humic acid-like matter was achieved after 180 min. The results presented herein will facilitate the development of a well decolorization for cellulosic ethanol production wastewater and better understanding of the biological fermentation.

  18. Application of synthetic biology for production of chemicals in yeast Saccharomyces cerevisiae.

    PubMed

    Li, Mingji; Borodina, Irina

    2015-02-01

    Synthetic biology and metabolic engineering enable generation of novel cell factories that efficiently convert renewable feedstocks into biofuels, bulk, and fine chemicals, thus creating the basis for biosustainable economy independent on fossil resources. While over a hundred proof-of-concept chemicals have been made in yeast, only a very small fraction of those has reached commercial-scale production so far. The limiting factor is the high research cost associated with the development of a robust cell factory that can produce the desired chemical at high titer, rate, and yield. Synthetic biology has the potential to bring down this cost by improving our ability to predictably engineer biological systems. This review highlights synthetic biology applications for design, assembly, and optimization of non-native biochemical pathways in baker's yeast Saccharomyces cerevisiae We describe computational tools for the prediction of biochemical pathways, molecular biology methods for assembly of DNA parts into pathways, and for introducing the pathways into the host, and finally approaches for optimizing performance of the introduced pathways.

  19. Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective.

    PubMed

    Wang, Yow-Ming C; Wang, Jie; Hon, Yuen Yi; Zhou, Lin; Fang, Lanyan; Ahn, Hae Young

    2016-03-01

    Immunogenicity assessment is important for biological products due to potential impacts of immunogenicity on safety and efficacy. We reviewed the prescribing information and the FDA's clinical pharmacology review of 121 approved biological products for evaluating and reporting of immunogenicity data. Of the 121 products, 89% (n = 108) reported the incidence of immunogenicity and 49% (n = 59) reported immunogenicity impact on efficacy. However, only 26% (n = 31) reported whether the immunogenicity affected pharmacokinetics. A subset of 16 products reported effects of anti-drug antibodies (ADA) on both systemic clearance and efficacy; 8 of 16 products had increased systemic clearance coinciding with reduced efficacy, and 6 of 16 products had no changes in either clearance or efficacy. Factors contributing to infrequent reporting of the ADA effect on exposure and methods for determining the effect of ADA on exposure are summarized. Measuring ADA and drug concentrations concurrently over time enables the evaluation of ADA impact on pharmacokinetics. Within-subject comparison of concentration data (before vs. after ADA formation) is a useful alternative to between-subject (ADA+ vs. ADA-) comparison when sample size is limited or when the majority of subjects developed ADA. The biological complexity of immune responses presents challenges to quantifying the ADA impact on pharmacokinetics using model-based methods. Our findings support that pharmacokinetic exposure is more sensitive than efficacy endpoints for evaluating ADA effects. A decrease in drug concentration due to formation of ADA during treatment can serve as an early indicator for potential reduced efficacy occurring at a later time.

  20. 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.

  1. Total synthesis of biologically active natural products based on highly selective synthetic methodologies.

    PubMed

    Hatakeyama, Susumi

    2014-01-01

    Total syntheses of structurally and biologically intriguing natural products relying on new synthetic methodologies are described. This article features cinchona alkaloid-catalyzed asymmetric Morita-Baylis-Hillman reactions, heterocycle syntheses based on rhodium-catalyzed C-H amination and indium-catalyzed Conia-ene reactions, and their utilization for the syntheses of the phoslactomycin family of antibiotics, glutamate receptor agonists and antagonists, and alkaloids with characteristic highly substituted pyrrolidinone core structures.

  2. Path Deviation Equations in AP-Geometry

    NASA Astrophysics Data System (ADS)

    Wanas, M. I.; Kahil, M. E.

    2006-02-01

    Recently, it has been shown that Absolute Parallelism (AP) geometry admits paths that are naturally quantized. These paths have been used to describe the motion of spinning particles in a background gravitational field. In case of a weak static gravitational field limits, the paths are applied successfully to interpret the discrepancy in the motion of thermal neutrons in the Earth's gravitational field (COW-experiment). The aim of the present work is to explore the properties of the deviation equations corresponding to these paths. In the present work the deviation equations are derived and compared to the geodesic deviation equation of the Riemannian geometry.

  3. 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.

  4. Biological Productivity from an Oxygen Mass Balance in the subarctic North Pacific

    NASA Astrophysics Data System (ADS)

    Giesbrecht, K. E.; Hamme, R. C.

    2008-12-01

    Biological productivity is an important process controlling the export of carbon into the deep ocean and thus influencing the earth's climate. An O2 mass balance of the upper ocean can estimate this export of organic carbon if the physical processes affecting the O2 concentrations are accounted for. This can be accomplished by measuring the dissolved O2/Ar ratio, because their similar physical properties allow us to consider Ar an 'abiotic' O2 analogue. Here we present a two-year data set of O2/N2/Ar ratio measurements collected at Station Papa and along Line P in 2007/08. Line P, situated in the subarctic North Pacific, is a series of oceanographic stations running from the southwest tip of Vancouver Island to Station Papa (50°N, 145°W), one of the oldest deep-ocean time series in existence which is located in the High-Nutrient/Low-Chlorophyll (HNLC) region of the subarctic gyre. Current cruises along Line P run three times per year, typically in February, June and August. The dissolved gas ratios are measured using a stable isotope mass spectrometer and oxygen concentrations by titration. In a simple steady state, we equate biological O2 production to diffusive gas exchange, using the O2/Ar ratio to normalize the physical component of the oxygen signal and calculate the net biological oxygen production. Diffusive gas exchange is calculated using a wind speed parameterization. Preliminary estimates of the net biological production in the mixed layer at Station Papa for 2007 are calculated at 30.9 and 14.0 mmol C m-2 d- 1 for June and August respectively, both exhibiting mixed layer O2/Ar supersaturations. The O2/Ar undersaturation in the mixed layer for February 2007 suggests net respiration at that time. The wind speed parameterization of diffusive gas exchange is the major source of error for this method. We plan to refine our productivity calculation to account for vertical mixing and also by measuring rates of production using a number of different methods

  5. 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. © 2016 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. Development of GRAS strains for nutraceutical production using systems and synthetic biology approaches: advances and prospects.

    PubMed

    Liu, Long; Guan, Ningzi; Li, Jianghua; Shin, Hyun-Dong; Du, Guocheng; Chen, Jian

    2017-03-01

    Nutraceuticals are food substances with medical and health benefits for humans. Limited by complicated procedures, high cost, low yield, insufficient raw materials, resource waste, and environment pollution, chemical synthesis and extraction are being replaced by microbial synthesis of nutraceuticals. Many microbial strains that are generally regarded as safe (GRAS) have been identified and developed for the synthesis of nutraceuticals, and significant nutraceutical production by these strains has been achieved. In this review, we systematically summarize recent advances in nutraceutical research in terms of physiological effects on health, potential applications, drawbacks of traditional production processes, characteristics of production strains, and progress in microbial fermentation. Recent advances in systems and synthetic biology techniques have enabled comprehensive understanding of GRAS strains and its wider applications. Thus, these microbial strains are promising cell factories for the commercial production of nutraceuticals.

  11. Methods for genetic optimization of biocatalysts for biofuel production from dairy waste through synthetic biology.

    PubMed

    Pasotti, Lorenzo; Zucca, Susanna; Casanova, Michela; Politi, Nicolo; Massaiu, Ilaria; Mazzini, Giuliano; Micoli, Giuseppina; Calvio, Cinzia; Cusella De Angelis, Maria Gabriella; Magni, Paolo

    2015-08-01

    Whey is an abundant by-product of cheese production process and it is considered a special waste due to its high nutritional load and hypertrophic potential. Technologies for whey valorization are available. They can convert such waste into high-value products, like whey proteins. However, the remaining liquid (called permeate) is still considered as a polluting waste due to its high lactose concentration. The alcoholic fermentation of lactose into ethanol will simultaneously achieve two important goals: safe disposal of a pollutant waste and green energy production. This methodology paper illustrates the workflow carried out to design and realize an optimized microorganism that can efficiently perform the lactose-to-ethanol conversion, engineered via synthetic biology experimental and computational approaches.

  12. 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.

  13. 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.

  14. Connecting marine productivity to sea-spray via microscale biological processes: phytoplancton demise and viral infection

    NASA Astrophysics Data System (ADS)

    Facchini, C.; O'Dowd, C. D. D.; Danovaro, R.

    2015-12-01

    The processes that link phytoplankton biomass and productivity to the organic matter enrichment in sea spray aerosol are far from being elucidated and modelling predictions remain highly uncertain at the moment. While some studies have asserted that the enrichment of OM in sea spray aerosol is independent on marine productivity, others, have shown significant correlation with phytoplankton biomass and productivity (Chl-a retrieved by satellites). We present here new results illustrating a clear link between OM mass-fraction enrichment in sea spray (OMss) and both phytoplankton-biomass and Net Primary Productivity (NPP). We suggest that the OM enrichment of sea spray through the demise of the bloom, driven by nanoscale biological processes (such as viral infections), which determine the release of celldebris, exudates and other colloidal material. This OM, through processes, leads to enrichment in sea-spray, thus demonstrating an important coupling between biologically-drive plankton bloom termination, marine productivity and sea-spraymodification with potentially significant climate impacts.

  15. 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.

  16. 48 CFR 201.404 - Class deviations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., 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; (C...

  17. 38 CFR 49.4 - Deviations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... NON-PROFIT ORGANIZATIONS General § 49.4 Deviations. The Office of Management and Budget (OMB) may..., which are statutory. Exceptions on a case-by-case basis may also be made by Federal awarding...

  18. 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...

  19. Biological Oxygen Production Across 8000 km of the South Atlantic: Basin Scale Similarity but Mesoscale Variability

    NASA Astrophysics Data System (ADS)

    Howard, E. M.; Stanley, R. H.; Hennon, G. M. M.; Durkin, C. A.

    2016-02-01

    Two important components of the biological carbon pump are (1) gross primary production (GPP), which is equal to total photosynthetic production, and (2) net community production (NCP), which expresses the net carbon drawdown or oxygen production by the biological pump. NCP should be balanced by export of carbon over sufficient scales of time and space. The ratio of net to gross production (NCP/GPP) is similar to the export ratio defined by Laws et al. (2000) and reflects how tightly carbon is being recycled in the ecosystem. We use in situ oxygen tracers (triple oxygen isotope and oxygen:argon ratios) to evaluate meridional trends in surface mixed-layer GPP and NCP across 8000 km of the tropical and subtropical South Atlantic in March-May 2013. These data encompass biogeographic provinces for which there are few published in situ estimates of phytoplankton production. NCP is surprisingly uniform along most of the cruise transect with slightly autotrophic values typically ranging from 5 to 10 mmol O2 m-2 d-1. GPP generally follows the same trends as NCP such that the NCP/GPP ratio is typically 0.1 to 0.2. However, notable exceptions to this lack of variability include two stations which have highly enhanced NCP and NCP/GPP ratio compared to the surrounding region. Additionally, the transition region between the subpolar and subtropical gyres has significantly higher NCP than elsewhere along the transect. Particulate organic carbon fluxes from the same cruise indicate that regionally, only about a third of the NCP is balanced by particulate export below the mixed layer. Overall these results highlight the large-scale similarity of rates of biological production over large regions of the Atlantic Ocean (scale of thousands of kilometers), overlain with high variability on the scale of hundreds of kilometers. This intriguing increase in variability on small scales rather than large ones supports the growing literature that mesoscale and/or submesoscale processes may be

  20. Eddy-mediated biological productivity in the Bay of Bengal during fall and spring intermonsoons

    NASA Astrophysics Data System (ADS)

    Prasanna Kumar, S.; Nuncio, M.; Ramaiah, N.; Sardesai, S.; Narvekar, Jayu; Fernandes, Veronica; Paul, Jane T.

    2007-09-01

    The signature of cold-core eddies and their role in altering the biological productivity of the Bay of Bengal was examined using two recent sets of hydrographic data collected along the central and western Bay of Bengal during fall (14 September-12 October, 2002) and spring (12 April-7 May, 2003) intermonsoons under the Bay of Bengal process studies (BOBPS) programme. Based on the thermohaline structure and the satellite-derived sea-level anomaly maps nine cyclonic eddies were identified. Out of this, four cyclonic eddies—two each along the central Bay and along the western boundary—occurred during fall intermonsoon 2002, while five occurred—three along the central Bay and two along the western boundary—during spring intermonsoon. The eddy depressed the temperature, which varied from 3 °C to 7 °C at 120 m depth. Maximum depression of temperature was associated with spring-time eddies in the northern Bay, where subsurface stability was low. The reduced water column stability in spring leads to greater eddy-pumping, thereby cooling the water to a greater extent. However, the cyclonic eddies were unable to break the stratification of the top 20 m layer, thereby curtailing their effects below this depth during both seasons. Eddy-pumping not only cooled the water column but also enhanced the nutrient concentrations. This in turn increased the biological productivity of the Bay to 1{1}/{2}-2 times. In addition, the subsurface chlorophyll maximum (SCM), which is generally located between 40 and 70 m in fall and 60 and 90 m in spring intermonsoons, shallowed under the influence of the eddies and also enhanced the chlorophyll concentration in the SCM to more than double. Thus, eddy-pumping of nutrients controls the biological productivity of the Bay of Bengal during both the seasons. In the fall intermonsoon, however, the riverine input of nutrients and sediments in the northern Bay also plays a role in altering the biological productivity. This has an overall

  1. Role of Extracorporeal Septoplasty in Deviated Noses.

    PubMed

    Ghaisas, Virendra; Parab, Sapna Ramkrishna

    2015-09-01

    Severe gross septal deviations present big surgical challenges for operating surgeon. Septal deviations has direct effect on aesthetic and functional part of nose. Correcting septal deviations during rhinoplasty is basic procedure. Extreme deviations of septum especially on dorsal and caudal end of cartilaginous septum are difficult to treat. The classical septoplasty approach becomes unsuitable for such severe deviations. Gubisch has first reported in 1995 about extracorporeal septoplasty. To report the experience of Extracorporeal septoplasty and the complication rates with the technique. Retrospective study of 112 patients who underwent extracorporeal septoplasty in primary rhinoplasty from May 2009 to June 2014. Patient's pre and postoperatively evaluation was done by photographs, nasal endoscopy and subjective by symptoms evaluation satisfaction scale 6 and 12 months postoperatively. Nasal endoscopy revealed significant improvement in nasal airway and nasal valve and subjective evaluation satisfaction score was very encouraging. Complications like septal perforation, bleeding, aesthetic complications were minimal (9 %) On basis of results obtained, shows that this technique, increases patients nasal airway and aesthetic look of the patients. Irrespective of extreme nasal deviations.

  2. 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

  3. 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.

  4. Evolution of the biological productivity during the last deglaciations using the triple isotopic composition of oxygen

    NASA Astrophysics Data System (ADS)

    Favre, Violaine; Extier, Thomas; Landais, Amaelle; Kageyama, Masa; Bopp, Laurent; Blunier, Thomas; Duchamp-Alphonse, Stéphanie; Masson-Delmotte, Valérie

    2017-04-01

    The last deglaciation is probably the best documented large climatic changes of the Quaternary. It is associated with global temperature increases of 4-5°C, significant increase of the sea level by 120 m and an increase in atmospheric CO2 concentration by 80 ppm. Understanding the combination of biochemical and physical factors responsible for this 80 ppm increase and the link with climate change is essential in the current evolution of greenhouse gases concentration. Biological productivity plays a role in the change of CO2 concentration during the last deglaciation. However, the lack of direct and global tracers of biological productivity makes it difficult to quantify and date the global change of productivity over the last deglaciation. Here, we use the triple isotopic composition of oxygen (δ17O of O2) over the last deglaciation obtained with a 300 years resolution on the NEEM ice core to depict the change of global productivity on this period. δ17O of O2 is indeed responding to the variations of O2 flux from the biosphere albeit in a complex manner. To help its interpretation, we thus combine these measurements with O2 fluxes obtained from the coupled climate model of IPSL over the last deglaciation. Finally, we compare the dynamic and amplitude of the δ17O of O2 change over the last deglaciation with variations obtained on previous deglaciations using new δ17O of O2 data obtained from the Dome C ice core.

  5. 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.

  6. 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

  7. Fate of phosphorus from biological aerobic treatment of pig slurry. By-products characterization and recovery.

    PubMed

    Daumer, M L; Beline, F; Guiziou, F

    2003-11-01

    The fate of phosphorus distribution in the products obtained from biological aerobic treatment of pig slurry, e.g. separated solids, liquid effluent and sludge, was monitored in three different farm-scale units. Samples of raw slurry, solid products, aerated slurry, liquid effluent and sludge were characterised and analysed for their concentration in total phosphorus, nitrogen content and heavy metals (Cu and Zn). At each treatment stage, nitrogen, phosphorus and heavy metals mass balance between input and output was established. Moreover, liquid products were characterised and analysed both for their total and dissolved ortho-phosphate content. Separated solids, sludge and liquid effluent represented 5%, 15-40% and 75-83% of the mass of the raw slurry, respectively. A mechanical separation step prior to aeration allowed the export of 25-30% of total phosphorus for further use as organic fertiliser. A large amount of total phosphorus (e.g. 60-70%) was located in sludge while phosphorus remaining in liquid effluent was about 15-25%. Raw slurry separation and sufficient aeration allowed phosphorus to concentrate in the sludge. Insufficient aeration resulted in the release of phosphorus as dissolved ortho-phosphate within the liquid effluent. Finally, relevance of the agronomic use of the products was discussed and improvements of biological aerobic treatment to enhance phosphorus removal and/or recovery were considered.

  8. Mass and energy balance constraints on the biological production of chemicals from coal

    SciTech Connect

    Andrews, G.

    1990-01-01

    Several organic chemicals, including methane and ethanol, may be produced by the bioprocessing of coal. This may be done either by direct microbial attack on the coal, or indirectly by the bioprocessing of solubilized coal. As in chemical liquefaction and gasification, the relative amounts of the various products that can be produced are severely constrained by mass and energy balance considerations. The main differences in biological processing are that water is a ubiquitous reactant, carbon dioxide a common product, and that some of the carbon and nitrogen in the coal may go to the synthesis of new biomass rather than products. The conventional biotechnological yield analysis applied to coal processing has several interesting consequences. The mass balance reduces to a balance of available electrons, and coal has a similar oxidation/reduction state to both carbohydrates and biomass. This makes high product yields feasible particularly under anaerobic conditions, although leaving open the question of whether the relevant hydrolase enzymes exist. Recommendations are made on products, and combinations of two products, that may be made with high yields and economic return. The energy balance provides little extra information. A general intracellular energy balance can be written in terms of the production and consumption of ATP, but much of the necessary information on the metabolic pathways is currently not available for coal processing microorganisms. 9 refs., 2 figs., 2 tabs.

  9. HPLC study of oxidation products of hydroethidine in chemical and biological systems: Ramifications in superoxide measurements

    PubMed Central

    Zielonka, Jacek; Hardy, Micael; Kalyanaraman, B.

    2012-01-01

    Methods for detection and quantitation of hydroethidine (HE) and its oxidation products by HPLC analysis are described. Synthetic methods for preparations of authentic standards (2-hydroxyethidium and diethidium) are provided. Potential applications of the HPLC methods to chemical and biological systems are discussed. Specific examples of chromatograms obtained using UV-Vis absorption, fluorescence, electrochemical and mass spectrometry detectors are provided. The development of a dual electrochemical and fluorescence detection methodology and its applications are described. The HPLC-based method enables analyses of HE and its oxidation products such as ethidium and the dimeric products of HE. Ramifications of HPLC measurements of HE and its oxidation products in the detection and quantitation of 2-hydroxyethidium, the diagnostic marker product of superoxide and HE, in the intracellular milieu are discussed. Similarly, mitochondria-targeted HE conjugated to a triphenylphosphonium group (Mito-HE or Mito-SOX) also forms oxidation products (dimers of Mito-HE and Mito-E+) that can affect the detection and quantitation of 2-hydroxy-mito-ethidium, the diagnostic marker product of Mito-HE and superoxide in mitochondria. PMID:19026738

  10. Improvements in algal lipid production: a systems biology and gene editing approach.

    PubMed

    Banerjee, Avik; Banerjee, Chiranjib; Negi, Sangeeta; Chang, Jo-Shu; Shukla, Pratyoosh

    2017-08-09

    In the wake of rising energy demands, microalgae have emerged as potential sources of sustainable and renewable carbon-neutral fuels, such as bio-hydrogen and bio-oil. For rational metabolic engineering, the elucidation of metabolic pathways in fine detail and their manipulation according to requirements is the key to exploiting the use of microalgae. Emergence of site-specific nucleases have revolutionized applied research leading to biotechnological gains. Genome engineering as well as modulation of the endogenous genome with high precision using CRISPR systems is being gradually employed in microalgal research. Further, to optimize and produce better algal platforms, use of systems biology network analysis and integration of omics data is required. This review discusses two important approaches: systems biology and gene editing strategies used on microalgal systems with a focus on biofuel production and sustainable solutions. It also emphasizes that the integration of such systems would contribute and compliment applied research on microalgae. Recent advances in microalgae are discussed, including systems biology, gene editing approaches in lipid bio-synthesis, and antenna engineering. Lastly, it has been attempted here to showcase how CRISPR/Cas systems are a better editing tool than existing techniques that can be utilized for gene modulation and engineering during biofuel production.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Extracellular production of an intact and biologically active human growth hormone by the Bacillus brevis system.

    PubMed

    Kajino, T; Saito, Y; Asami, O; Yamada, Y; Hirai, M; Udata, S

    1997-10-01

    The characteristic features of the Bacillus brevis system are very high productivity of heterologous proteins and very low extracellular protease activity. However, degradation of some heterologous proteins, especially mammalian proteins, can be observed and resulted in a lowering of protein productivity. By using a mutant expressing low levels of proteases and the addition of EDTA to the medium, intact human growth hormone (hGH) was successfully produced with the B. brevis system. Signal peptide modification with higher basicity in the amino terminal region and higher hydrophobicity in the middle region brought about a twelve-fold increase in hGH production. The hGH yield was further elevated to 240 mg L-1 by optimization of culture conditions. Thus, biologically active and mature hGH can be efficiently produced directly in the medium with the B. brevis system.

  16. The biological pump in the Costa Rica Dome: an open-ocean upwelling system with high new production and low export

    PubMed Central

    Stukel, Michael R.; Benitez-Nelson, Claudia R.; Décima, Moira; Taylor, Andrew G.; Buchwald, Carolyn; Landry, Michael R.

    2016-01-01

    The Costa Rica Dome is a picophytoplankton-dominated, open-ocean upwelling system in the Eastern Tropical Pacific that overlies the ocean's largest oxygen minimum zone. To investigate the efficiency of the biological pump in this unique area, we used shallow (90–150 m) drifting sediment traps and 234Th:238U deficiency measurements to determine export fluxes of carbon, nitrogen and phosphorus in sinking particles. Simultaneous measurements of nitrate uptake and shallow water nitrification allowed us to assess the equilibrium balance of new and export production over a monthly timescale. While f-ratios (new:total production) were reasonably high (0.36 ± 0.12, mean ± standard deviation), export efficiencies were considerably lower. Sediment traps suggested e-ratios (export/14C-primary production) at 90–100 m ranging from 0.053 to 0.067. ThE-ratios (234Th disequilibrium-derived export) ranged from 0.038 to 0.088. C:N and N:P stoichiometries of sinking material were both greater than canonical (Redfield) ratios or measured C:N of suspended particulates, and they increased with depth, suggesting that both nitrogen and phosphorus were preferentially remineralized from sinking particles. Our results are consistent with an ecosystem in which mesozooplankton play a major role in energy transfer to higher trophic levels but are relatively inefficient in mediating vertical carbon flux to depth, leading to an imbalance between new production and sinking flux. PMID:27275035

  17. Recent advances in synthetic biology for engineering isoprenoid production in yeast.

    PubMed

    Vickers, Claudia E; Williams, Thomas C; Peng, Bingyin; Cherry, Joel

    2017-06-14

    Isoprenoids (terpenes/terpenoids) have many useful industrial applications, but are often not produced at industrially viable level in their natural sources. Synthetic biology approaches have been used extensively to reconstruct metabolic pathways in tractable microbial hosts such as yeast and re-engineer pathways and networks to increase yields. Here we review recent advances in this field, focusing on central carbon metabolism engineering to increase precursor supply, re-directing carbon flux for production of C10, C15, or C20 isoprenoids, and chemical decoration of high value diterpenoids (C20). We also overview other novel synthetic biology strategies that have potential utility in yeast isoprenoid pathway engineering. Finally, we address the question of what is required in the future to move the field forwards. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. 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. Copyright © 2013 Elsevier Ltd. All rights reserved.

  19. 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.

  20. 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.

  1. 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. Copyright © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  2. Long-term biological hydrogen production by agar immobilized Rhodobacter capsulatus in a sequential batch photobioreactor.

    PubMed

    Elkahlout, Kamal; Alipour, Siamak; Eroglu, Inci; Gunduz, Ufuk; Yucel, Meral

    2017-04-01

    In this study, agar immobilization technique was employed for biological hydrogen production using Rhodobacter capsulatus DSM 1710 (wild type) and YO3 (hup-mutant) strains in sequential batch process. Different agar and glutamate concentrations were tested with defined nutrient medium. Agar concentration 4% (w/v) and 4 mM glutamate were selected for bacterial immobilization in terms of rate and longevity of hydrogen production. Acetate concentration was increased from 40 to 60-100 and 60 mM gave best results with both bacterial strains immobilized in 4% (w/v) agar. Cell concentration was increased from 2.5 to 5 mg dcw mL(-1) agar and it was found that increasing cell concentration of wild-type strain caused decrease in yield and productivity while these parameters improved by increasing cell concentration of mutant strain. Also, the hydrogen production time has extended from 17 days up to 60 days according to the process conditions and parameters. Hydrogen production by immobilized photosynthetic bacteria is a convenient technology for hydrogen production as it enables to produce hydrogen with high organic acid concentrations comparing to suspended cultures. Besides, immobilization increases the stability of the system and allowed sequential batch operation for long-term application.

  3. 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.

  4. Biological Oxygen Productivity Over The Last Glacial Termination From Triple Oxygen Isotope Measurements

    NASA Astrophysics Data System (ADS)

    Blunier, T.; Bender, M. L.; Hendricks, M. B.

    The atmospheric oxygen isotope signature of O2 is linked to the oxygen signature of seawater through photosynthesis and respiration. Fractionation during these pro- cesses is mass dependent affecting 17O about half as much as 18O. A mass indepen- dent fractionation process takes place during isotope exchange between O2 and CO2 in the stratosphere (Thiemens, 1999; Luz et al., 1999). The magnitude of the mass- independent anomaly in the triple isotope composition of O2 depends on relative rates of biological O2 cycling and photochemical reactions in the stratosphere. Variations of this anomaly thus allows us to estimate changes of mass dependent O2 production by photosynthesis versus mass independent O2-CO2 exchange in the stratosphere. We reconstruct total oxygen productivity for the past from 17O and 18O measure- ments of O2 trapped in ice cores. With a box model we estimate that the total biogenic productivity was only 76-83 % of today for the glacial and was probably still lower than today during the glacial-interglacial transition and the early Holocene. In principle we can calculate the oxygen flux from the ocean biosphere if we know the oxygen flux from the land biosphere. Calculated ocean production is very sensitive to the estimate of land biosphere production. The latter term remains uncertain, however, and we can presently only constrain glacial ocean production to 88 to 140 % of the present value.

  5. Biological Oxygen Productivity Over the Last Glacial Termination From Triple Oxygen Isotope Measurements

    NASA Astrophysics Data System (ADS)

    Blunier, T.; Bender, M. L.; Hendricks, M. B.

    2001-05-01

    The atmospheric oxygen isotope signature of O2 is linked to the oxygen signature of seawater through photosynthesis and respiration. Fractionation during these processes is mass dependent affecting δ 17O about half as much as δ 18O. A mass independent fractionation process takes place during isotope exchange between O2 and CO2 in the stratosphere (Thiemens, 1999; Luz et al., 1999). The magnitude of the mass-independent anomaly in the triple isotope composition of O2 depends on relative rates of biological O2 cycling and photochemical reactions in the stratosphere. Variations of this anomaly thus allows us to estimate changes of mass dependent O2 production by photosynthesis versus mass independent O2-CO2 exchange in the stratosphere. We reconstruct total oxygen productivity for the past from δ ^ {17}O and δ ^ {18}O measurements of O2 trapped in ice cores. With a box model we estimate that the total biogenic productivity was only ~70-80 % of today for the glacial and was probably still lower than today during the glacial-interglacial transition and the early Holocene. In principle we can calculate the oxygen flux from the ocean biosphere if we know the oxygen flux from the land biosphere. Calculated ocean production is very sensitive to the estimate of land biosphere production. The latter term remains uncertain, however, and we can presently only constrain glacial ocean production to 70 to 140 % of the present value.

  6. Anterior septal deviation and contralateral alar collapse.

    PubMed

    Schalek, P; Hahn, A

    2011-01-01

    Septal deviation is often found in conjunction with other pathological conditions that adversely affect nasal patency. Anterior septal deviation, together with contralateral alar collapse, is a relatively rare type of anatomical and functional incompetence. In our experience, it can often be resolved with septoplasty, without the necessity of surgery involving the external valve. The aim of this paper was to verify this hypothesis prospectively. Twelve patients with anterior septal deviation and simultaneous alar collapse on the opposite side were prospectively enrolled in the study. Subjective assessment of nasal patency was made on post-operative day 1, and again 6 months after surgery, using a subjective evaluation of nasal breathing. The width of the nostril (alar-columellar distance) on the side with the alar collapse was measured during inspiration pre-operatively, 1 day after surgery and again 6 months after surgery. Immediately after surgery, all patients reported improved or excellent nasal breathing on the side of the original septal deviation. On the collapsed side, one patient reported no change in condition. With the exception of one patient, all measurements showed some degree of improvement in the extension of the alar-columellar distance. The average benefit 6 months after surgery was an improvement of 4.54 mm. In our group of patients (anterior septal deviation and simultaneous contralateral alar collapse and no obvious structural changes of the alar cartilage) we found septoplasty to be entirely suitable and we recommend it as the treatment of choice in such cases.

  7. The scientific production in health and biological sciences of the top 20 Brazilian universities.

    PubMed

    Zorzetto, R; Razzouk, D; Dubugras, M T B; Gerolin, J; Schor, N; Guimarães, J A; Mari, J J

    2006-12-01

    Brazilian scientific output exhibited a 4-fold increase in the last two decades because of the stability of the investment in research and development activities and of changes in the policies of the main funding agencies. Most of this production is concentrated in public universities and research institutes located in the richest part of the country. Among all areas of knowledge, the most productive are Health and Biological Sciences. During the 1998-2002 period these areas presented heterogeneous growth ranging from 4.5% (Pharmacology) to 191% (Psychiatry), with a median growth rate of 47.2%. In order to identify and rank the 20 most prolific institutions in these areas, searches were made in three databases (DataCAPES, ISI and MEDLINE) which permitted the identification of 109,507 original articles produced by the 592 Graduate Programs in Health and Biological Sciences offered by 118 public universities and research institutes. The 20 most productive centers, ranked according to the total number of ISI-indexed articles published during the 1998-2003 period, produced 78.7% of the papers in these areas and are strongly concentrated in the Southern part of the country, mainly in São Paulo State.

  8. Online Deviation Detection for Medical Processes

    PubMed Central

    Christov, Stefan C.; Avrunin, George S.; Clarke, Lori A.

    2014-01-01

    Human errors are a major concern in many medical processes. To help address this problem, we are investigating an approach for automatically detecting when performers of a medical process deviate from the acceptable ways of performing that process as specified by a detailed process model. Such deviations could represent errors and, thus, detecting and reporting deviations as they occur could help catch errors before harm is done. In this paper, we identify important issues related to the feasibility of the proposed approach and empirically evaluate the approach for two medical procedures, chemotherapy and blood transfusion. For the evaluation, we use the process models to generate sample process executions that we then seed with synthetic errors. The process models describe the coordination of activities of different process performers in normal, as well as in exceptional situations. The evaluation results suggest that the proposed approach could be applied in clinical settings to help catch errors before harm is done. PMID:25954343

  9. Fatigue, pilot deviations and time of day

    NASA Technical Reports Server (NTRS)

    Baker, Susan P.

    1989-01-01

    The relationships between pilot fatigue, pilot deviations, reported incidents, and time of day are examined. A sample of 200 Aviation Safety Reporting System (ASRS) reports were analyzed from 1985 and 200 reports from 1987, plus 100 reports from late 1987 and early 1988 that were selected because of possible association with fatigue. The FAA pilot deviation data and incident data were analyzed in relation to denominator data that summarized the hourly operations (landings and takeoffs of scheduled flights) at major U.S. airports. Using as numerators FAA data on pilot deviations and incidents reported to the FAA, the rates by time of day were calculated. Pilot age was also analyzed in relation to the time of day, phase of flight, and type of incident.

  10. Language deviations in aphasia: a frequency analysis.

    PubMed

    Ardila, A; Rosselli, M

    1993-02-01

    Thirty right-handed left hemisphere-damaged patients were taken and divided into five groups (transcortical motor, Broca, conduction, Wernicke, and anomic aphasia). Language deviations were scored and analyzed for the Picture Description (Plate No. 1, The Cookie Theft), Repetition (Words, High and Low Probability Sentences), and Naming (Responsive Naming, Confrontation, and Body-part naming) subtests of the Boston Diagnostic Aphasia Examination--Spanish version (Goodglass & Kaplan, 1979). A classification of paraphasias is proposed. Language deviations were scores for the following groups: Literal paraphasias (phoneme omissions, additions, displacements, and substitutions), verbal paraphasias (formal, morphologic, semantic, and unrelated), syntagmatic paraphasias, circumlocutions (object description and instrumental function), indefinite anaphors, and neologisms. Frequency of different types of language deviations is presented in the five aphasia groups. It was found that some paraphasic errors appeared in several aphasia groups; others were characteristics of specific aphasic syndromes.

  11. Models for the biological production of glycerol and biosurfactants from potato-processing industry residuals

    SciTech Connect

    Polman, K.; Bala, G.A.; St. Clair, P.

    1995-12-31

    The fermentative production of valuable chemicals from biomass-derived substrates (e.g., glucose) represents the historical essence of industrial biotechnology. In the past, the capabilities of microorganisms to produce useful chemicals have been, at best, sporadically utilized. The primary products produced biotechnologically today are antibiotics and ethanol (for fuel and beverage uses). Many years ago, glycerol (also known as glycerin or glycerine) was produced at an industrial scale by fermentative means. Such production was stimulated by increased demand for glycerol and diversion of petroleum resources during wartime. Biotechnological production of glycerol ceased during peacetime, because the undeveloped and inefficient biotechnological processes that were used could not compete with inexpensive petroleum and natural feedstocks and the efficient and well developed methods by which to convert them to commodity chemicals. Industrial glycerol production by biological conversion of sugar has not occurred since that time. However, several factors, including the historical uncertainty of petroleum price and supply, the demand for environmentally safe industrial processes, and the vast development and improvement of bioprocess technology, suggest that the time for taking advantage of bioprocesses that produce marketable chemicals is near. Glycerol is a good candidate for such a chemical, because it is biologically produced from glucose in good yield (0.5 g glycerol/g glucose), the market is very large (> 140 million kg consumed/yr in the US), and future market growth is predicted to be good because of the widespread usage of glycerol and its historically strong market. Based on this, recent research has involved developing patentable technologies for the conversion of corn starch to glycerol; these efforts have progressed to the pilot plant scale.

  12. Testing the nematophagous biological control strain Paecilomyces lilacinus 251 for paecilotoxin production.

    PubMed

    Khan, Alamgir; Williams, Keith; Nevalainen, Helena

    2003-10-10

    Paecilomyces lilacinus is a nematophagous fungus currently developed as a biological control agent. In order to evaluate potential toxin production, culture extract and concentrated culture supernatant of P. lilacinus strain 251 were tested against Gram-negative and Gram-positive bacteria. High-performance liquid chromatography analysis was carried out to compare the chromatograms of P. lilacinus strain 251 with the chromatogram of known paecilotoxin. It was found that the 251 strain of P. lilacinus did not produce detectable levels of paecilotoxin or other toxins with antimicrobial activity.

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

    PubMed

    2016-05-04

    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.

  14. Strong Large Deviation and Local Limit Theorems

    DTIC Science & Technology

    1989-08-01

    Strong Large Deviation and Local Limit Theorenisi by (D -N araitia Rao Chaganty and Jayaraii Setrhurainari ____Old DoiinUnitnerity and Florida State...deviations, Local Limit Theorems. El L ,CT OCQT23 1989 u2 ’JB 169 Abstract M os t la𔃼Cd~viaio re11 t ; asym~1O 5 Iptotic expressions to log P( In > ! y...ji(S) < xandl let b",-*x Define q,,(y,; b, S) = V(b,,/p(S)) P(?),(!I, - Y) E S)]. as the pseudo-density futnction of I- . By a local limit theorem

  15. Enriching the biological space of natural products, through real time biotransformation monitoring: The NMR tube bioreactor.

    PubMed

    Chatzikonstantinou, Alexandra V; Chatziathanasiadou, Maria V; Ravera, Enrico; Fragai, Marco; Parigi, Giacomo; Gerothanassis, Ioannis P; Luchinat, Claudio; Stamatis, Haralambos L; Tzakos, Andreas G

    2017-09-30

    Natural products offer a wide range of biological activities, but they are not easily integrated in the drug discovery pipeline, beacuse of their inherent scaffold intricacy and the associated complexity in their synthetic chemistry. Enzymes may be used to perform regioselective and stereoselective incorporation of functional groups in the natural product core, avoiding harsh reaction conditions, several protection/deprotection and purification steps. Herein we developed a three step protocol carried out inside an NMR-tube. 1st-step: STD-NMR was used to predict the: i) capacity of natural products as enzyme substrates and ii) possible regioselectivity of the biotransformations. 2nd-step: The real-time formation of multiple-biotransformation products in the NMR-tube bioreactor was monitored in-situ. 3rd-step: STD-NMR was applied in the mixture of the biotransformed products to screen ligands for protein targets. Herein we developed a simple and time-effective process, the "NMR-tube bioreactor", that is able to: (i) predict which component of a mixture of natural products can be enzymatically transformed, (ii) monitor in situ the transformation efficacy and regioselectivity in crude extracts and multiple substrate biotransformations without fractionation and (iii) simultaneously screen for interactions of the biotransformation products with pharmaceutical protein targets. We have developed a green, time-, and cost-effective process that provide a simple route from natural products to lead compounds for drug discovery. This process can speed up the most crucial steps in the early drug discovery process, and reduce the chemical manipulations usually involved in the pipeline, improving the environmental compatibility. Copyright © 2017. Published by Elsevier B.V.

  16. Linking neuroethology to the chemical biology of natural products: interactions between cone snails and their fish prey, a case study.

    PubMed

    Olivera, Baldomero M; Raghuraman, Shrinivasan; Schmidt, Eric W; Safavi-Hemami, Helena

    2017-05-27

    From a biological perspective, a natural product can be defined as a compound evolved by an organism for chemical interactions with another organism including prey, predator, competitor, pathogen, symbiont or host. Natural products hold tremendous potential as drug leads and have been extensively studied by chemists and biochemists in the pharmaceutical industry. However, the biological purpose for which a natural product evolved is rarely addressed. By focusing on a well-studied group of natural products-venom components from predatory marine cone snails-this review provides a rationale for why a better understanding of the evolution, biology and biochemistry of natural products will facilitate both neuroscience and the potential for drug leads. The larger goal is to establish a new sub-discipline in the broader field of neuroethology that we refer to as "Chemical Neuroethology", linking the substantial work carried out by chemists on natural products with accelerating advances in neuroethology.

  17. 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

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false 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...

  18. 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

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false 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...

  19. 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

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false 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...

  20. [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.