This paper reviews and identifies gaps in existing guidelines on APS for ATMPs; outlines technical limitations and challenges; and provides recommendations on design and how some of the existing challenges may be addressed through risk-based approaches.
Commercialization
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Container closure integrity testing in CGT benchmark survey
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A focused short supplementary member only survey to help them resolve a few remaining questions for an article which is in the final stages of writing focusing on container closure integrity testing in CGT.
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The BioPhorum Gene-Editing subteam have produced a member only tool enabling the end-user to determine comparisons between different gene-editing techniques and delivery methods which can be used in cell and gene therapy drug product development and manufacture. The tool allows the user to form individual conclusions based on the users' requirements.
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Mar 2022 | Cell & Gene Therapy, Commercialization, Deliverable, Deliverables Report, POI - Cell and Gene Therapy, Publication
This paper is part of a series of papers being produced by the CGT Commercialization workstream. It will be available during Q2 2023.