Alliance for Regenerative Medicine and the National Institute for Innovation in Manufacturing Biopharmaceuticals. Project A-Gene: A case study-based approach to integrating QbD principles in gene therapy CMC programs. Published June24, 2021. Accessed December 1, 2022. https://alliancerm.org/manufacturing/a-gene-2021.
2.
MeneghelJ, KilbrideP, MorrisGJ. Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review. Front. Med. (Lausanne), 2020; 7: 592242. DOI: 10.3389/fmed.2020.592242.
3.
U.S. Food and Drug Administration. Long Term Follow-Up After Administration of Human Gene Therapy Products. Guidance for Industry. Published January30, 2020. Accessed December 1, 2022. https://www.fda.gov/media/113768/download.
LindgrenC, LeinbachA, AnnisJ, et al.Processing laboratory considerations for multi-center cellular therapy clinical trials: A report from the Consortium for Pediatric Cellular Immunotherapy. Cytotherapy, 2021; 23(2): 157–164. DOI: 10.1016/j.jcyt.2020.09.013.
7.
HarrisonRP, RafiqQA, MedcalfN. Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar. Cytotherapy, 2018; 20(6): 873–890. DOI: 10.1016/j.jcyt.2018.05.003.