Innovating Biologies Regulation:Insights from the Founding Director of the US FDA’s Division of Monoclonal Antibodies

摘要

Biopharmaceutical researchers, manufacturers, and regulators converged on Washington, DC, in January 2023 to attend CASSS’s 26th annual Well-Characterized Biological Products (WCBP) meeting. Among the opening festivities at each such event is conferral of the prestigious William S. Hancock Award for Outstanding Achievements in Chemistry, Manufacturing, and Controls (CMC) Regulatory Science. The prize honors people who have spurred on significant advances in scientific principles, applied technologies, and science-based regulations for biomanufacturing process development, characterization, analysis, and quality assessment. The 2023 recipient of the prize is Kathryn Stein, who served as founding director of the Division of Monoclonal Antibodies (DMA) in the US Food and Drug Administration Center for Biologies Evaluation and Research (FDA CBER).