Current Trends in Monoclonal Antibody Development and Manufacturing

indgår i serie Biotechnology: Pharmaceutical Aspects


Current Trends in Monoclonal Antibody Development and Manufacturing
Format:
Bog, hæftet
Udgivelsesdato:
01-03-2012
Sprog:
Engelsk
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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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Udgivelsesdato:
01-03-2012
ISBN13:
9781461424918
Vægt:
640 g
Dybde:
19 mm
Bredde:
178 mm
Højde:
254 mm
Forlag:
Springer
Format:
Hæftet
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    Current Trends in Monoclonal Antibody Development and Manufacturing

    indgår i serie Biotechnology: Pharmaceutical Aspects

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