GUIDANCE DOCUMENT
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products July 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2023-D-2436
- Docket Number:
- FDA-2023-D-2436
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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
On August 24, 2023, FDA Announced the comment period for the draft guidance, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products will be extended to November 13, 2023. For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Andrew Byrnes, Gene Transfer & Immunogenicity Branch Chief, Office of Gene Therapy CMC, Office of Therapeutic Products, CBER.
The management of manufacturing changes presents many challenges for human cellular therapy or gene therapy (CGT) products due to the complexity of these products. We, FDA, are providing you, sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products, with recommendations regarding product comparability and the management of manufacturing changes for investigational and licensed CGT products. The purpose of this guidance is to provide FDA’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.
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