Current Trends in Monoclonal Antibody Development and Manufacturing

Monoclonal antibodies are rapidly emerging as a key area for new drug development in the pharmaceutical industry. In recent years, we have seen the approval of several blockbuster products such as Rituxan, Remicade, Avastin, Humira, and Herceptin. Additionally, there are over 300 new drugs in various stages of clinical trials. Both established biotechnology companies and smaller start-ups are actively involved in the development of these important molecules, indicating that monoclonal antibody products will continue to be a significant presence in the market in the coming years.

The regulatory review process for monoclonal antibodies has recently shifted from the Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. CDER is now requiring a certain minimum amount of data to be provided for these products as they progress through the regulatory pipeline. To stay informed about the current developments in monoclonal antibody development and manufacturing, readers can turn to Current Trends in Monoclonal Antibody Development and Manufacturing. This resource offers insight into the industry's efforts to develop, manufacture, and release monoclonal antibody products, as well as what is necessary for a successful regulatory submission.

Overall, the future of monoclonal antibodies looks promising as advancements continue to be made in their development and approval processes. Stay informed about the latest trends in this field to ensure you are up-to-date on the latest developments in monoclonal antibody products.

product information: