FDA Hosts Third Installment of CGT Science Series on CMC Guidance

The third installment of the Cell + Gene Therapy Science Series was hosted by FDA and led by Andrew Byrnes, PhD. This presentation focused on recent CMC guidance for cell and gene therapies, specifically the Manufacturing Changes and Comparability and Potency Assurance guidance documents. Dr. Byrnes discussed CMC as a facet of risk management, and encouraged a robust understanding of product MOA/CQAs when making manufacturing changes.  

Dr. Byrnes is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing products, and other products. Dr. Byrnes has over 20 years of experience at FDA in CMC review and regulatory policy for cellular and gene therapy products. Dr. Byrnes has a background in virology and gene therapy, and his laboratory at FDA studies gene therapy with adenovirus vectors. Dr. Byrnes received his undergraduate degree from Yale University, earned his Ph.D. from the University of Oxford, and then conducted postdoctoral research at Johns Hopkins University before joining FDA in 2000.

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