Williams, D.J., Archer, R., Archibald, P. et al. (46 more authors) (2016) Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14-15 September 2015. Regenerative Medicine, 11 (5). pp. 483-492. ISSN 1746-0751
Abstract
This paper summarizes the proceedings of a workshop held at Trinity Hall, Cambridge to discuss comparability and includes additional information and references to related information added subsequently to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication states that this 'may be difficult for cell-based medicinal products'. Therefore a well-managed change process is required which needs access to good science and regulatory advice and developers are encouraged to seek help early. The workshop shared current thinking and best practice and allowed the definition of key research questions. The intent of this report is to summarize the key issues and the consensus reached on each of these by the expert delegates.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 David Williams. This article is distributed under the terms of the Creative Commons Attribution License 4.0 which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. To view a copy of the license, visit http://creativecommons.org/licenses/by/4.0/ |
Keywords: | advice; comparability; human pluripotent stem cell derived; manufacturing; quality; regulatory |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Science (Sheffield) > School of Biosciences (Sheffield) > Department of Biomedical Science (Sheffield) |
Funding Information: | Funder Grant number MEDICAL RESEARCH COUNCIL MR/L012537/1 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 27 Jul 2016 08:42 |
Last Modified: | 27 Jul 2016 08:42 |
Published Version: | http://dx.doi.org/10.2217/rme-2016-0053 |
Status: | Published |
Publisher: | Future Medicine |
Refereed: | Yes |
Identification Number: | 10.2217/rme-2016-0053 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:102943 |