Navigating Quality Control and Release Testing in Cell and Gene Therapy Development

Like traditional biologics, cell and gene therapies (CGTs) must meet safety and efficacy standards before they can be administered to human patients. But the manufacturing processes used for this new therapy modality are markedly different from those used to make traditional biologics like monoclonal antibodies. And that raises important questions about the appropriate quality control and GMP release testing procedures for these products. Furthermore, because cell and gene therapies are often first-in-class products, there may be no regulatory precedent in place to guide their manufacturing.

In this GEN webinar, our speakers will present important considerations for quality control testing for biosafety and product characterization in GMP release and stability studies of novel cell and gene therapies. During the webinar, they will highlight the value of QC assays in both process and product development as well as for demonstrating comparability. Key learnings from the webinar include:

• Strategies for handling lot release testing and preclinical/clinical testing for CGT products

• Tools for product characterization testing for CGT products

• The utility of quality control assays for release and product/process comparability

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.