Current Trends in Monoclonal Antibody Development and Manufacturing by Steven J Shire

Current Trends in Monoclonal Antibody Development and Manufacturing by Steven J Shire

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.

SKU	Unavailable
ISBN 13	9781461424918
ISBN 10	1461424917
Title	Current Trends in Monoclonal Antibody Development and Manufacturing
Author	Steven J Shire
Series	Biotechnology: Pharmaceutical Aspects
Condition	Unavailable
Binding Type	Paperback
Publisher	Springer-Verlag New York Inc.
Year published	2012-02-25
Number of pages	354
Cover note	Book picture is for illustrative purposes only, actual binding, cover or edition may vary.