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- DescriptionMoclonal 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 biotechlogy companies and small start-ups involved in the development of this important class of molecules, moclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of moclonal 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 Moclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release moclonal antibody products and what will be required for a successful regulatory submission.
- PublisherSpringer-Verlag New York Inc.
- Date of Publication25/02/2012
- SubjectLife Sciences: General
- Series TitleBiotechnology: Pharmaceutical Aspects
- Place of PublicationNew York, NY
- Country of PublicationUnited States
- ImprintSpringer-Verlag New York Inc.
- Content Note33 black & white tables, biography
- Weight699 g
- Width178 mm
- Height254 mm
- Spine19 mm
- Edited byJames Andya,Karoline Bechtold-Peters,Steve Shire,Wayne Gombotz
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