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Author: National Research Council
Publisher: National Academies Press
ISBN: 0309173051
Category : Medical
Languages : en
Pages : 74
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Book Description
The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309173051
Category : Medical
Languages : en
Pages : 74
Get Book
Book Description
The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.
Author: Steven J. Shire
Publisher: Springer Science & Business Media
ISBN: 038776643X
Category : Medical
Languages : en
Pages : 348
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Book Description
Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
Author: James W. Goding
Publisher:
ISBN:
Category : Antibodies, Monoclonal
Languages : en
Pages : 344
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Book Description
This book represents the distillation and critical evaluation of many hundreds of publications relating to the production and use of antibodies. Therefore it is restricted to the "core" techniques of production and handling of antibodies, and their use in studies of antigen analysis, purification and localization.
Author: Committee on Methods of Producing Monoclonal Antibodies
Publisher: National Academies Press
ISBN: 0309519047
Category : Science
Languages : en
Pages : 74
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Book Description
The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) in early 1997 to prohibit the use of an animal in the production of mAb (monoclonal antibodies). NIH responded late in 1997, asserting that continued use of the mouse method for producing mAb was scientifically required. In a second petition, in early 1998, AAVS did not accept the NIH response. NIH asked the National Research Council to form a committee to study this issue. The Committee on Methods of Producing Monoclonal Antibodies was composed of 11 experts with extensive experience in biomedical research, laboratory animal medicine, pain research, animal welfare, and patient advocacy. The committee was asked to determine whether there is a scientific necessity for producing mAb by the mouse method and, if so, to recommend ways to minimize any pain or distress that might be associated with the method. The committee was also to determine whether there are regulatory requirements for the mouse method and to summarize the current stage of development of tissue-culture methods.
Author: Vincent Ossipow
Publisher: Humana
ISBN: 9781493963225
Category : Medical
Languages : en
Pages : 0
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Book Description
Monoclonal Antibodies: Methods and Protocols, Second Edition expands upon the previous edition with current, detailed modern approaches to isolate and characterize monoclonal antibodies against carefully selected epitopes. This edition includes new chapters covering the key steps to generate high quality monoclonals via different methods, from antigen generation to epitope mapping and quality control of the purified IgG. Chapters are divided into four parts corresponding to four distinct objectives. Part I covers monoclonal antibody generation, Part II deals with monoclonal antibody expression and purification, Part III presents methods for monoclonal antibody characterization and modification, and Part IV describes selected applications of monoclonal antibodies. Written in the highly successful Methods in Molecular Biology series format, 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. Authoritative and practical, Monoclonal Antibodies: Methods and Protocols, Second Edition provides crucial initial steps of monoclonal antibody generation and characterization with state-of-the art protocols.
Author: Uwe Gottschalk
Publisher: John Wiley & Sons
ISBN: 1119126932
Category : Medical
Languages : en
Pages : 752
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Book Description
Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing
Author: Roger H. Kennett
Publisher: Springer Science & Business Media
ISBN: 1461575052
Category : Medical
Languages : en
Pages : 423
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Book Description
On August 7, 1975, Kohler and Milstein published in Nature (256:495) a report describing "Continuous cultures of fused cells secreting antibody of predefined specificity. " Their report has become a classic and has already had a profound effect on basic and applied research in biology and medicine. By the time the first Workshop on Lymphocyte Hybridomas (Current Topics in Microbiology and Im munology 81, 1978) was held on April 3-5, 1978, in Bethesda, Maryland, investi gators from many laboratories had made hybrids between plasmacytomas and spleen cells from immunized animals and had obtained monoclonal antibodies reacting with a broad variety of antigenic determinants. At the time Kohler and Milstein introduced this new technology, the editors of this volume were involved in the production of antisera against differentiation antigens (K. B. B. ), histocompatibility antigens (T. ]. McK. ), and human tumor associated antigens (R. H. K. ). Because of the potential usefulness of monoclonal antibodies in these areas, we each began production of hybridomas and analysis of the resulting monoclonal reagents. One of the most interesting aspects of participation in the early stages of the development and application of hybrid oma technology has been observing how the implications of the initial observa tions gradually spread first among the practitioners of immunology and immu nogenetics, and then to other areas of the biological sciences, such as developmental biology, biochemistry, human genetics, and cell and tumor biology.
Author: Cheng Liu
Publisher: John Wiley & Sons
ISBN: 1118662318
Category : Medical
Languages : en
Pages : 720
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Book Description
Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs
Author: A.M. Campbell
Publisher: Elsevier
ISBN: 9780080858821
Category : Medical
Languages : en
Pages : 264
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Book Description
This volume contains detailed, comprehensive advice on rat, mouse and human hybridoma production. It begins with a general introduction, then describes the practical applications of the technology with photographs and protocols for everything from animal dissection to epitope analysis of antigens.
Author:
Publisher: Academic Press
ISBN: 0128173173
Category : Medical
Languages : en
Pages : 288
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Book Description
Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. Includes the authority and expertise of leading contributors in pharmacology Presents the latest release in the Advances in Pharmacology series
