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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: Steven J. Shire
Publisher: Springer Science & Business Media
ISBN: 038776643X
Category : Medical
Languages : en
Pages : 348
Get Book Here
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: Marie A. Simmons
Publisher: Nova Publishers
ISBN: 9781594545504
Category : Medical
Languages : en
Pages : 160
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Book Description
This new and important international source of information brings together leading-edge research dedicated to monoclonal antibodies. Monoclonal antibodies (MABs) are: antibodies of exceptional purity and specificity; components of the immune system; able to recognise and bind to a specific antigen. Monoclonal antibodies are currently utilised in many diagnostic procedures, including: measuring protein and drug levels in serum; typing tissue and blood; identifying infectious agents; identifying clusters of differentiation for the classification and follow-up therapy of leukaemias and lymphomas; identifying tumour antigens and auto-antibodies; identifying the specific cells involved in the immune response; identifying and quantifying hormones. For example, monoclonal antibodies (MABs or MOABs) work on cancer cells in the same way natural antibodies work, by identifying and binding to the target cells. They then alert other cells in the immune system to the presence of the cancer cells. MABs are specific for a particular antigen-one designed for a B-cell lymphoma will not work on cells for ovarian cancer cells for example.
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: Stefan Dübel
Publisher: John Wiley & Sons
ISBN: 3527329374
Category : Science
Languages : en
Pages : 2538
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Book Description
Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
Author: James W. Goding
Publisher:
ISBN:
Category : Medical
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: Uwe Gottschalk
Publisher: John Wiley & Sons
ISBN: 1119126932
Category : Medical
Languages : en
Pages : 849
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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: William R Strohl
Publisher: Elsevier
ISBN: 1908818093
Category : Medical
Languages : en
Pages : 697
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Book Description
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
Author: Stewart Sell
Publisher: Springer Science & Business Media
ISBN: 1461251761
Category : Medical
Languages : en
Pages : 440
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Book Description
This represents the third volume in a series on cancer markers pub lished by the Humana Press. The first volume, published in 1980, stressed the relationship of development and cancer as reflected in the production of markers by cancer that are also produced by normal cells during fetal development. The concept that cancer represents a problem of differentiation was introduced by Barry Pierce in describing differenti ation of teratocarcinomas. Highlighted were lymphocyte markers, alphafetoprotein, carcinoembryonic antigen, ectopic hormones, enzymes and isozymes, pregnancy proteins, and fibronectin. The second volume, published in 1982 and coedited with Britta Wahren, focused on the diagnostic use of oncological markers in human cancers, which were systematically treated on an organ by organ basis. At that time, the application of monoclonal antibodies to the identification of cancer markers was still in a very preliminary stage. A general introduc tion to monoclonal antibodies to human tumor antigens was given there by William Raschke, and other authors included coverage of those mark ers then detectable by monoclonal antibodies in their chapters.
Author: Yuti Chernajovsky
Publisher: Springer
ISBN: 9783540732587
Category : Medical
Languages : en
Pages : 380
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Book Description
This essential work, edited by two researchers at London’s famous Queen Mary’s medical school targets one of the most important areas in medical development today. These days, antibody therapeutics are the treatment of choice for several autoimmune and oncological conditions. They are, indeed, becoming the molecules of choice for further combination therapies and cell engineering. In this timely work, a slew of expert in the field of drug development summarize all the current developments and clinical successes.
Author: John E. Schiel
Publisher: ACS Symposium
ISBN: 9780841230293
Category : Medical
Languages : en
Pages : 0
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Book Description
"Distributed in print by Oxford University Press."
