Nice review of "The FDA's recent draft guidance on 'Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products'. The report covers manufacturing changes in investigational products, where alterations fundamentally changing the product design may need a new IND filing, while those leading to acceptable quality can be submitted as an amendment. Also, it guides on post-approval changes for licensed CGT products similar to existing biologic product protocols. The draft introduces a risk-based approach for comparability assessment, insisting on a statistical approach and a comprehensive study of quality attributes. Special considerations are highlighted for products derived from variable cellular starting material and for tissue-engineered medical products. Due to terminological gaps, the industry must still refer to previous CMC guidance for CGT products and biologics. #FDA #CGT #ManufacturingChanges"
Accenture Applied Life Sciences' Rajanikanth (Raj) Bandaru provides a detailed overview of FDA's highly anticipated draft guidance to the industry that addresses “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.” Check it out. #cellandgenetherapy #fda #draftguidance https://lnkd.in/exEkVifr
