Safety of Biological Products Prepared from Mammalian Cell Culture

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Author :
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 260 pages
Book Rating : 4.3/5 (91 download)

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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.

Biosafety in the Laboratory

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Publisher : National Academies Press
ISBN 13 : 0309039754
Total Pages : 237 pages
Book Rating : 4.3/5 (9 download)

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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.

Handbook of Pharmaceutical Biotechnology

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Publisher : John Wiley & Sons
ISBN 13 : 0470117109
Total Pages : 1681 pages
Book Rating : 4.4/5 (71 download)

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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.

Animal Cell Culture

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Author :
Publisher : Springer
ISBN 13 : 3319103202
Total Pages : 766 pages
Book Rating : 4.3/5 (191 download)

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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.

FDA Biotechnology Inspection Guide

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Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.3/5 (91 download)

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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:

Resource Sharing in Biomedical Research

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Publisher : National Academies Press
ISBN 13 : 0309055822
Total Pages : 105 pages
Book Rating : 4.3/5 (9 download)

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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.

Emerging Swine Viruses

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Publisher : Frontiers Media SA
ISBN 13 : 2889637220
Total Pages : 134 pages
Book Rating : 4.8/5 (896 download)

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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:

Manual of Industrial Microbiology and Biotechnology

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Publisher :
ISBN 13 :
Total Pages : 854 pages
Book Rating : 4.3/5 (91 download)

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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.

Cell Culture Bioprocess Engineering, Second Edition

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Publisher : CRC Press
ISBN 13 : 0429531893
Total Pages : 567 pages
Book Rating : 4.4/5 (295 download)

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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 567 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.

Medicines from Animal Cell Culture

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Publisher : John Wiley & Sons
ISBN 13 : 9780470723784
Total Pages : 696 pages
Book Rating : 4.7/5 (237 download)

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Book Synopsis Medicines from Animal Cell Culture by : Glyn N. Stacey

Download or read book Medicines from Animal Cell Culture written by Glyn N. Stacey and published by John Wiley & Sons. This book was released on 2007-06-29 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.

Vaccines and Diagnostics for Transboundary Animal Diseases

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Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318023663
Total Pages : 231 pages
Book Rating : 4.3/5 (18 download)

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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.

Therapeutic Antibody Engineering

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Publisher : Elsevier
ISBN 13 : 1908818093
Total Pages : 697 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Therapeutic Antibody Engineering by : William R Strohl

Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

Animal Genomics for Animal Health

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Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805586191
Total Pages : 455 pages
Book Rating : 4.8/5 (55 download)

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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.

Basic Cell Culture Protocols

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Publisher : Humana Press
ISBN 13 : 9781627031271
Total Pages : 550 pages
Book Rating : 4.0/5 (312 download)

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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 2012-11-20 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.

Animal Cell Technology

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Publisher : Taylor & Francis
ISBN 13 : 113409972X
Total Pages : 506 pages
Book Rating : 4.1/5 (34 download)

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Book Synopsis Animal Cell Technology by : Leda Castilho

Download or read book Animal Cell Technology written by Leda Castilho and published by Taylor & Francis. This book was released on 2008-03-01 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal Cell Technology: from Biopharmaceuticals to Gene Therapy provides a comprehensive insight into biological and engineering concepts related to mammalian and insect cell technology, as well as an overview of the applications of animal cell technology. Part 1 of the book covers the Fundamentals upon which this technology is based and covers the science underpinning the technology. Part 2 covers the Applications from the production of therapeutic proteins to gene therapy. The authors of the chapters are internationally-recognized in the field of animal cell culture research and have extensive experience in the areas covered in their respective chapters.

Immunogenicity of Therapeutic Biological Products

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Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 196 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Immunogenicity of Therapeutic Biological Products by : Fred Brown

Download or read book Immunogenicity of Therapeutic Biological Products written by Fred Brown and published by S. Karger AG (Switzerland). This book was released on 2003 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Immune responses to biological products have occurred with many approved therapeutics. The proportion of patients mounting an immune response is product dependent and the clinical significance of the immune response also varies with the nature of the product. Some products can induce production of significant levels of antibodies without any detectable effect on the activity of the product. However, neutralizing antibodies can attenuate the efficacy of the treatment and significant adverse clinical events can be seen if neutralizing antibodies cross-react with patients' endogenous proteins. Prediction of immunogenicity includes the use of bio-informatics to predict T-cell epitopes, T-cell stimulation assays and in vivo transgenic animal models. Approaches to prevent immunogenicity involve methods to design out immunogenic sequences, protein pegylation and inducing tolerance. Current methods for assessing and detecting immunogenicity include in vivo animal models, antibody assays and biological assays. The advantages and disadvantages of the various methods illustrate that a battery of tests is required to appropriately monitor patients' immune responses during clinical trials.

Cumulated Index Medicus

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Publisher :
ISBN 13 :
Total Pages : 1156 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Cumulated Index Medicus by :

Download or read book Cumulated Index Medicus written by and published by . This book was released on 1985 with total page 1156 pages. Available in PDF, EPUB and Kindle. Book excerpt: