USA FDA – Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (Catapult’s regulatory round-up – July)
Manufacturing and control of CGT products can often be affected by unique factors such as limited knowledge of product quality attributes, limited manufacturing experience, limited variable starting materials, limited amount of product, complex manufacturing processes, as well as limited product shelf life. Therefore, the management of manufacturing changes presents more challenges for human cell or gene therapy than for other biological products.
The FDA published a draft guidance on ‘Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products’ to provide recommendations for management and reporting of manufacturing changes for CGT products based on a lifecycle approach, as well as for comparability studies to assess the effect of manufacturing changes on product quality. Comments can be submitted until 13 September 2023.
Published on the 7th of August 2023. Read the Regulatory Round-up – July 2023 (catapult.org.uk) following this link.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 février 2024). USA FDA – Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (Catapult’s regulatory round-up – July). ELSIBI. Consulté le 12 octobre 2026 à l’adresse https://doi.org/10.58079/vvnj
