Stacey, G., Andrews, P.W. orcid.org/0000-0001-7215-4410, Asante, C. et al. (41 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. ISSN 1746-0751
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.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2018 Future Medicine Ltd. This is an author produced version of a paper subsequently published in Regenerative Medicine. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Ancillary materials; cell-based medicines; cell therapy; characterization regulatory science; efficacy; raw materials; regenerative medicine; safety; starting materials |
Dates: |
|
Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Science (Sheffield) > School of Biosciences (Sheffield) > Department of Biomedical Science (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 06 Feb 2019 10:47 |
Last Modified: | 26 Feb 2019 10:06 |
Published Version: | https://doi.org/10.2217/rme-2018-0120 |
Status: | Published |
Publisher: | Future Medicine |
Refereed: | Yes |
Identification Number: | 10.2217/rme-2018-0120 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:142142 |