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Planning a Manufacturing Change to your Cell and Gene Therapy Process? The New FDA Draft Guidance Has Answers to Your Comparability Questions
September 6, 2023ArticlePlanning a Manufacturing Change to your Cell and Gene Therapy Process? The New FDA Draft Guidance Has Answers to Your Comparability Questions
September 6, 2023The process defines the product. How then does a company approach making changes to a CGT manufacturing process without altering the product? A new FDA draft guidance, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (July 2023), provides a road map.
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