Current Challenges During CMC Development and Delivery of Novel Modalities

Cesar Calero, Ph.D., is a member of the Biologics Drug Product Development & Manufacturing group at Sanofi. He has more than 7 years of experience developing formulations and manufacturing processes for biologic modalities including polypeptides, enzymes, monoclonal antibodies, multi-specifics, fusion proteins, and viral gene therapy programs; for early- and late-stage clinical programs. He is an active contributor to the scientific literature involving protein physical stability, drug product development, AI/ML and computational modelling, and in-use clinical administration considerations and compatibility studies.