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Safety Of Biological Products Prepared From Mammalian Cell Culture
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Book Synopsis Safety of Biological Products Prepared from Mammalian Cell Culture by : Fred Brown
Download or read book Safety of Biological Products Prepared from Mammalian Cell Culture written by Fred Brown and published by S. Karger AG (Switzerland). This book was released on 1998 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume reflects the proceedings of the WHO Consultation on the Safety of Biological Products Prepared from Mammalian Cell Substrates, and forms the basis upon which the revised WHO requirements were formulated and accepted by the 1996 Expert Committee on Biological Standardization (ECBS). Primary cells, diploid cells, and continuous cell lines (CCLs) are considered both in terms of potential risks and as appropriate methods to reduce and control those risks during the manufacturing process. Also discussed is the past clinical experience with products derived from these three types of cell substrates. Bringing together contributions by international experts in the field, this volume is important reading for cell and molecular biologists, and all those concerned with the development and manufacture of biological products.
Book Synopsis Developments in Biological Standardization by :
Download or read book Developments in Biological Standardization written by and published by . This book was released on 1998 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Handbook of Pharmaceutical Biotechnology by : Shayne Cox Gad
Download or read book Handbook of Pharmaceutical Biotechnology written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2007-05-23 with total page 1681 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.
Book Synopsis FDA Biotechnology Inspection Guide by : United States. Food and Drug Administration
Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Division on Engineering and Physical Sciences Publisher :National Academies Press ISBN 13 :0309039754 Total Pages :237 pages Book Rating :4.3/5 (9 download)
Book Synopsis Biosafety in the Laboratory by : Division on Engineering and Physical Sciences
Download or read book Biosafety in the Laboratory written by Division on Engineering and Physical Sciences and published by National Academies Press. This book was released on 1989-01-01 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safetyâ€"and more.
Book Synopsis Manual of Industrial Microbiology and Biotechnology by : Arnold L. Demain
Download or read book Manual of Industrial Microbiology and Biotechnology written by Arnold L. Demain and published by . This book was released on 1999 with total page 854 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors have enlisted a broad range of experts, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers, who offer practical experience not found in texts and journals. This comprehensive perspective makes MIMB a valuable "how to" resource, the structure of which resembles the sequence of operation involved in the development of a commercial biological process and product.
Book Synopsis Emerging Swine Viruses by : Zhenhai Chen
Download or read book Emerging Swine Viruses written by Zhenhai Chen and published by Frontiers Media SA. This book was released on 2020-05-13 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Resource Sharing in Biomedical Research by : Institute of Medicine
Download or read book Resource Sharing in Biomedical Research written by Institute of Medicine and published by National Academies Press. This book was released on 1996-12-29 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States is entering an era when, more than ever, the sharing of resources and information might be critical to scientific progress. Every dollar saved by avoiding duplication of efforts and by producing economies of scale will become increasingly important as federal funding enters an era of fiscal restraint. This book focuses on six diverse case studies that share materials or equipment with the scientific community at large: the American Type Culture Collection, the multinational coordinated Arabidopsis thaliana Genome Research Project, the Jackson Laboratory, the Washington Regional Primate Research Center, the Macromolecular Crystallography Resource at the Cornell High-Energy Synchrotron Source, and the Human Genome Center at Lawrence Livermore National Laboratory. The book also identifies common strengths and problems faced in the six cases, and presents a series of recommendations aimed at facilitating resource sharing in biomedical research.
Book Synopsis Animal Cell Culture by : Mohamed Al-Rubeai
Download or read book Animal Cell Culture written by Mohamed Al-Rubeai and published by Springer. This book was released on 2014-11-28 with total page 766 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal cells are the preferred “cell factories” for the production of complex molecules and antibodies for use as prophylactics, therapeutics or diagnostics. Animal cells are required for the correct post-translational processing (including glycosylation) of biopharmaceutical protein products. They are used for the production of viral vectors for gene therapy. Major targets for this therapy include cancer, HIV, arthritis, cardiovascular and CNS diseases and cystic fibrosis. Animal cells are used as in vitro substrates in pharmacological and toxicological studies. This book is designed to serve as a comprehensive review of animal cell culture, covering the current status of both research and applications. For the student or R&D scientist or new researcher the protocols are central to the performance of cell culture work, yet a broad understanding is essential for translation of laboratory findings into the industrial production. Within the broad scope of the book, each topic is reviewed authoritatively by experts in the field to produce state-of-the-art collection of current research. A major reference volume on cell culture research and how it impacts on production of biopharmaceutical proteins worldwide, the book is essential reading for everyone working in cell culture and is a recommended volume for all biotechnology libraries.
Book Synopsis Cell Culture Engineering by : Wei-Shu Hu
Download or read book Cell Culture Engineering written by Wei-Shu Hu and published by Springer. This book was released on 2006-08-16 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.
Book Synopsis Basic Cell Culture Protocols by : Cheryl D. Helgason
Download or read book Basic Cell Culture Protocols written by Cheryl D. Helgason and published by Humana Press. This book was released on 2016-08-23 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt: At some point in their careers, virtually every scientist and technician, as well as many medical professionals, regardless of their area of specialization have a need to utilize cell culture systems. Updating and significantly expanding upon the previous editions, Basic Cell Culture Protocols, Fourth Edition provides the novice cell culturist with sufficient information to perform the basic techniques, to ensure the health and identity of their cell lines, and to be able to isolate and culture specialized primary cell types. The intent of this extensive volume is to generate a valuable resource containing clear methodologies pertinent to current areas of investigation, rather than attempting to educate cell culturists on specific cell types or organ systems. Written in the highly successful Methods in Molecular BiologyTM, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and up-to-date, Basic Cell Culture Protocols, Fourth Edition compiles the essential techniques needed to approach this vital laboratory activity with full success.
Book Synopsis Cell Line Development by : Mohamed Al-Rubeai
Download or read book Cell Line Development written by Mohamed Al-Rubeai and published by Springer Science & Business Media. This book was released on 2009-08-11 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mammalian cell lines command an effective monopoly for the production of therapeutic proteins that require post-translational modifications. This unique advantage outweighs the costs associated with mammalian cell culture, which are far grater in terms of development time and manufacturing when compared to microbial culture. The development of cell lines has undergone several advances over the years, essentially to meet the requirement to cut the time and costs associated with using such a complex hosts as production platforms. This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout.
Author :Marie-Hélène Pinard Publisher :Karger Medical and Scientific Publishers ISBN 13 :3805586191 Total Pages :455 pages Book Rating :4.8/5 (55 download)
Book Synopsis Animal Genomics for Animal Health by : Marie-Hélène Pinard
Download or read book Animal Genomics for Animal Health written by Marie-Hélène Pinard and published by Karger Medical and Scientific Publishers. This book was released on 2008-01-01 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: "It includes a review of the state of the art in animal genomics and its applications to animal health. The contributions describe the new tools available, such as HapMaps for chicken and cattle, and show how the understanding of gene structure and function can be successfully applied to delineate the molecular mechanisms of disease and determine complex phenotypes associated with health traits. A critical evaluation of future needs and future applications of animal genomics is also presented. The integration of animal genomics in animal health research is likely to revolutionize the way scientists approach the challenges of discovering highly effective drugs and vaccines for animal diseases."--BOOK JACKET.
Book Synopsis Vaccines and Diagnostics for Transboundary Animal Diseases by : J.A. Roth
Download or read book Vaccines and Diagnostics for Transboundary Animal Diseases written by J.A. Roth and published by Karger Medical and Scientific Publishers. This book was released on 2013-04-18 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transboundary animal diseases (TADs) are a major threat to livestock. They are highly contagious or transmissible, and they have the potential to cause high morbidity and mortality in both susceptible animal populations and humans. In addition, not only are TADs detrimental to national economies, they are also a serious threat to world food security. This volume presents the proceedings of an international workshop on Vaccines and Diagnostics for Transboundary Animal Diseases that was held in Ames (Iowa, USA) in 2012. Experts and scientists from academia, industry and government reviewed the current status of vaccines and diagnostics for high priority TADs, decision-making and regulatory processes for veterinary biologics, and the roles and responsibilities of government agencies. The discussions also addressed achievements and gaps in vaccine and diagnostics development for 11 important TADs as well as the translation of research findings into licensed novel vaccines and diagnostics for high-priority TADs.
Book Synopsis Perfusion Cell Culture Processes for Biopharmaceuticals by : Moritz Wolf
Download or read book Perfusion Cell Culture Processes for Biopharmaceuticals written by Moritz Wolf and published by Cambridge University Press. This book was released on 2020-08-06 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a monography about perfusion cell cultures for the production of biopharmaceuticals, such as therapeutic proteins (i.e. biomolecules like monoclonal antibodies), and describes the fundamentals, design and operation of these processes. Context is given in the first chapters to understand the state-of-the-art of the technology. We then give an overview of the challenges and objectives in operating mammalian cell perfusion cultures and provide guidelines for the design and setup of lab-scale bioreactor systems, and the required control structure to achieve stable operation. Scale-down devices and PAT tools are described in the context of continuous manufacturing and guidelines for process optimization are given using a variety of case studies to illustrate different approaches. Scale-up is also adressed with a strong focus on bioreactor aeration and mixing, shear stress and cell retention device. Finally, a general introduction for the application of mechanistic and statistic models in bioreactor process development and optimization is given in the last chapter.
Book Synopsis Cell Culture Bioprocess Engineering, Second Edition by : Wei-Shou Hu
Download or read book Cell Culture Bioprocess Engineering, Second Edition written by Wei-Shou Hu and published by CRC Press. This book was released on 2020-03-06 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the culmination of three decades of accumulated experience in teaching biotechnology professionals. It distills the fundamental principles and essential knowledge of cell culture processes from across many different disciplines and presents them in a series of easy-to-follow, comprehensive chapters. Practicality, including technological advances and best practices, is emphasized. This second edition consists of major updates to all relevant topics contained within this work. The previous edition has been successfully used in training courses on cell culture bioprocessing over the past seven years. The format of the book is well-suited to fast-paced learning, such as is found in the intensive short course, since the key take-home messages are prominently highlighted in panels. The book is also well-suited to act as a reference guide for experienced industrial practitioners of mammalian cell cultivation for the production of biologics.
Book Synopsis Introduction to Cell and Tissue Culture by : Jennie P. Mather
Download or read book Introduction to Cell and Tissue Culture written by Jennie P. Mather and published by Springer Science & Business Media. This book was released on 2007-08-20 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is a pleasure to contribute the foreword to Introduction to Cell and Tissue Culture: The ory and Techniques by Mather and Roberts. Despite the occasional appearance of thought ful works devoted to elementary or advanced cell culture methodology, a place remains for a comprehensive and definitive volume that can be used to advantage by both the novice and the expert in the field. In this book, Mather and Roberts present the relevant method ology within a conceptual framework of cell biology, genetics, nutrition, endocrinology, and physiology that renders technical cell culture information in a comprehensive, logical for mat. This allows topics to be presented with an emphasis on troubleshooting problems from a basis of understanding the underlying theory. The material is presented in a way that is adaptable to student use in formal courses; it also should be functional when used on a daily basis by professional cell culturists in a- demia and industry. The volume includes references to relevant Internet sites and other use ful sources of information. In addition to the fundamentals, attention is also given to mod ern applications and approaches to cell culture derivation, medium formulation, culture scale-up, and biotechnology, presented by scientists who are pioneers in these areas. With this volume, it should be possible to establish and maintain a cell culture laboratory devot ed to any of the many disciplines to which cell culture methodology is applicable.
