Monoclonal antibodies represent one of the fastest growing areas for the development of new drugs in the pharmaceutical industry. Many popular products have been approved over the past few years including Retoxan, Remicade, Avastin, Humira, and Herceptin.

In addition, there are currently more than 300 new drugs in clinical trials. With both large biotechnology companies and small startups involved in the development of this important class of molecules, monoclonal antibody products will become more prevalent over the next decade.

Recently, the regulatory review of monoclonal antibodies was transferred from the Center for Biological Research and Research to the Drug and Drug Evaluation Center (CDER) of the US Food and Drug Administration. CDER is expected to expect a minimum amount of data to be provided as more of these products move through the Pipeline Pipeline.

Current trends in the development and manufacture of monoclonal antibodies will provide readers with an understanding of what is currently being done in the industry to develop, manufacture and issue monoclonal antibody products and what will be required to make a successful regulatory application.