Regulatory agency concerns in the manufacturing and testing of monoclonal antibodies for therapeutic use.

Abstract

Monoclonal antibody-based therapeutic products are subject to the same regulatory review procedures and submissions requirements as more traditional pharmaceutical agents. In addition, the FDA often asks for specific information on the unique aspects of the manufacture, characterization, and testing of these products. Agency concern begins with the origin of the hybridoma cell line and continues through preclinical safety testing and clinical trials. Specific regulatory issues are often decided on a case-by-case basis with the FDA reviewers. Implementing an effective strategy for identifying and addressing these issues and concerns is a critical part of the development process.