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.
Introduction.- Design of Therapeutic Monoclonal Antibodies.- Manufacturing of Monoclonal Antibodies/Expression and Production of Monoclonal Antibodies.- Manufacturing of Monoclonal Antibodies/ Recovery and Purification of Bulk Drug Substance.- Formulation and Delivery Challenges.- Analytics and Specification Setting of MAbs.- Pharmacokinetics of Mabs.- Clinics and Toxicology.- Future Trends.
Series: Biotechnology: Pharmaceutical Aspects : Book 11
Number Of Pages: 354
Published: 1st November 2009
Publisher: Springer-Verlag New York Inc.
Country of Publication: US
Dimensions (cm): 25.4 x 18.42
Weight (kg): 0.97