Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop



Stacey, Glyn, Andrews, Peter W, Asante, Curtis, Barbaric, Ivana, Barry, Jaqueline, Bisset, Louise, Braybrook, Julian, Buckle, Robin, Chandra, Amit, Coffey, Peter
et al (show 34 more authors) (2018) Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop. REGENERATIVE MEDICINE, 13 (8). pp. 935-944.

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Abstract

Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.

Item Type: Article
Uncontrolled Keywords: ancillary materials, cell-based medicines, cell therapy, characterization regulatory science, efficacy, raw materials, regenerative medicine, safety, starting materials
Depositing User: Symplectic Admin
Date Deposited: 21 Feb 2020 15:12
Last Modified: 19 Jan 2023 01:09
DOI: 10.2217/rme-2018-0120
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3029961