Editors:
- Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry and monoclonal antibodies products will become increasingly prevalent over the next decade
- Provides 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
- Includes supplementary material: sn.pub/extras
Part of the book series: Biotechnology: Pharmaceutical Aspects (PHARMASP, volume XI)
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Table of contents (19 chapters)
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Front Matter
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Design Of Therapeutic MABS
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Front Matter
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Recovery and Purification
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Front Matter
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Analytics and Specification Setting for MABS
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Front Matter
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About this book
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.
Editors and Affiliations
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Genentech Inc., San Francisco, U.S.A.
Steven J. Shire
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Omeros Corporation, Seattle, U.S.A.
Wayne Gombotz
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Boehringer Ingelheim Pharma KG, Biberach, Germany
Karoline Bechtold-Peters
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Genentech, Inc., South San Francisco, U.S.A.
James Andya
Bibliographic Information
Book Title: Current Trends in Monoclonal Antibody Development and Manufacturing
Editors: Steven J. Shire, Wayne Gombotz, Karoline Bechtold-Peters, James Andya
Series Title: Biotechnology: Pharmaceutical Aspects
DOI: https://doi.org/10.1007/978-0-387-76643-0
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: Springer-Verlag New York 2010
Hardcover ISBN: 978-0-387-76642-3Published: 12 November 2009
Softcover ISBN: 978-1-4614-2491-8Published: 25 February 2012
eBook ISBN: 978-0-387-76643-0Published: 11 November 2009
Edition Number: 1
Number of Pages: XIV, 354
Topics: Neurosciences, Pharmacology/Toxicology
