Cell, Gene Manufacturing Changes, Comparability

FDA has published a draft guidance, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products, to give sponsors of INDs and applicants of BLAs for cellular and gene therapy (CGT) products recommendations about product comparability and the management of manufacturing changes for investigational and licensed CGT products. The document’s purpose is to share the agency’s current thinking on (1) management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and (2) comparability studies to assess the effect of manufacturing changes on product quality.

The guidance contains an Introduction, Background, Considerations for the Management of Manufacturing Changes, Regulatory Reporting of Manufacturing Changes, Comparability Assessment and Report, Special Considerations for Tissue-Engineered Medical Products, Communications with FDA, and References.