Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14-15 September 2015
File(s)rme-2016-0053.pdf (795.85 KB)
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Author(s)
Type
Journal Article
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.
Date Issued
2016-07-12
Date Acceptance
2016-05-17
Citation
Regenerative Medicine, 2016, 11 (5), pp.483-492
ISSN
1746-076X
Publisher
Future Medicine
Start Page
483
End Page
492
Journal / Book Title
Regenerative Medicine
Volume
11
Issue
5
Copyright Statement
This work is licensed under a Creative Commons Attribution 4.0 License.
License URL
Subjects
advice
comparability
human pluripotent stem cell derived
manufacturing
quality
regulatory
Developmental Biology
Publication Status
Published