Plant, A.
(2016),
Comparability: Manufacturing, Characterisation and Controls Report of a UKRMP Pluripotent Stem Cell Platform Workshop, Regenerative Medicine, [online], https://doi.org/10.2217/rme-2016-0053
(Accessed September 9, 2024)
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Comparability: Manufacturing, Characterisation and Controls Report of a UKRMP Pluripotent Stem Cell Platform Workshop
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Author(s)
Abstract
This paper summarises the proceedings of a workshop held at Trinity Hall, Cambridge to discuss comparability and includes additional information and references to related information added subsequent to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication [1] 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 summarise the key issues and the consensus reached on each of these by the expert delegates.Citation
Regenerative Medicine
Volume
11
Pub Type
Journals
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Keywords
human pluripotent stem cell (PSC), biomanufacturing, cell therapies, quality attributes, regulatory
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Created July 10, 2016, Updated November 10, 2018