Critical CMC Issues for Gene and Cell Therapy Products

December 3, 2021 | 1:00-3:00 p.m. (CT)

Chemistry, Manufacturing and Controls (CMC) issues have proven to be a significant hurdle in both early and late stages of gene and cell therapy product development and regulatory approval. This café begins with an introduction to CMC issues for gene and cell therapy products and will also help attendees understand the critical CMC development issues from a regulatory perspective. The presentation begins at a basic level but ultimately progresses to a level where mid-career professionals will feel very comfortable and early professionals will feel developmentally pushed.

Our speaker, Gautam Ranade, PhD, is a member of ASGCT, ISCT, and the gene and cell therapy products community of the American Association of Pharmaceutical Scientists. He is an active consultant to the pharmaceutical industry and a member of several technical advisory boards. Previously, he was a senior director (pharmaceutical sciences) at Pfizer Worldwide R&D, where he directed the development of multiple commercial parenteral dosage forms and managed the GMP sterile manufacturing facility for small molecules and biologics. He is well versed in aseptic processing, sterilization process validation and sterile product development, and quality control. He is the inventor for 19 U.S. patents related to pharmaceutical product development.

Agenda

Introductions 

Grant Holley, PhD.—1-1:10 p.m. (CT) 

Critical CMC Issues for Gene and Cell Therapy Products: An Introduction 

Gautam Ranade, PhD—1:10-2:30 p.m. (CT) 

Q&A Session 

Gautam Ranade PhD—2:30-3 p.m. (CT)