ENGLISH

Current Trends in Monoclonal Antibody Development and Manufacturing

By Wayne R. Gombotz , Steven J. Shire (auth.) , Steven J. Shire , Wayne Gombotz , Karoline Bechtold-Peters , James Andya (eds.)

Book information

Publisher
Springer-Verlag New York
Year
2010
ISBN
0387766421, 9780387766423, 9780387766430
DOI
10.1007/978-0-387-76643-0
Open Library ID
OL25114847M
Language
english
Format
PDF
Filesize
9 MB (9210461 bytes)
Series
Biotechnology: Pharmaceutical Aspects XI
Edition
1
Pages
354\348
Time added
2011-06-04 13:46:07
Neurosciences; Pharmacology/Toxicology

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.

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