Comparability:Manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14-15 September 2015

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.

Publication DOI: https://doi.org/10.2217/rme-2016-0053
Divisions: Life & Health Sciences > Biosciences
Life & Health Sciences
Additional Information: 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/
Uncontrolled Keywords: Advice,Comparability,Human pluripotent stem cell derived,Manufacturing,Quality,Regulatory,Biomedical Engineering,Embryology
Full Text Link:
Related URLs: http://www.scop ... tnerID=8YFLogxK (Scopus URL)
https://www.fut ... 7/rme-2016-0053 (Publisher URL)
PURE Output Type: Article
Published Date: 2016-07-12
Accepted Date: 2016-05-17
Authors: Williams, David J.
Archer, Richard
Archibald, Peter
Bantounas, Ioannis
Baptista, Ricardo
Barker, Roger
Barry, Jacqueline
Bietrix, Florence
Blair, Nicholas
Braybrook, Julian
Campbell, Jonathan
Canham, Maurice
Chandra, Amit
Foldes, Gabor
Gilmanshin, Rudy
Girard, Mathilde
Gorjup, Erwin
Hewitt, Zöe
Hourd, Paul
Hyllner, Johan
Jesson, Helen
Kee, Jasmin
Kerby, Julie
Kotsopoulou, Nina
Kowalski, Stanley
Leidel, Chris
Marshall, Damian
Masi, Louis
McCall, Mark
McCann, Conor
Medcalf, Nicholas
Moore, Harry
Ozawa, Hiroki
Pan, David
Parmar, Malin
Plant, Anne L.
Reinwald, Yvonne
Sebastian, Sujith
Stacey, Glyn
Thomas, Robert J.
Thomas, Dave
Thurman-Newell, Jamie
Turner, Marc
Vitillio, Loriana
Wall, Ivan ( 0000-0001-6294-8348)
Wilson, Alison
Wolfrum, Jacqueline
Yang, Ying
Zimmerman, Heiko

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