Concurrent Session: ATMP/Cell & Gene Therapies

Aseptic manufacturing is a critical part of gene and cell therapy production, and these products are often very sensitive and require aseptic conditions throughout the manufacturing process. Many of these products are administered directly to patients, so it is important to ensure that they are free of contaminants and any baseline bioburden is not increased by the manufacturing process. This session will showcase examples that highlight the innovative approaches that were studied and implemented for operating multi-product facility, with the ability to do quick changeover between products. The case studies will span from starting/critical material through Drug Product and cover different jurisdictions .