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Recent advances in clustered regularly interspaced short palindromic repeats (CRISPR)-based editing have enabled targeted correction of nonsense mutations [184, 185]

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doi: 10.1038/s41392-024-01911-3

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These include extractable and leachable studies, stability testing under ICH recommended conditions, sorption studies, evaluation of barrier properties of packaging film, and toxicological risk assessment for any leachables detected.The selection of the container closure system should be made early in development and materials must be evaluated not only for inertness but also for their mechanical integrity, heat sealability and performance under manufacturing conditions including fill temperature and cooling rates