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, Wilson, Alison, Wolfrum, Jacqueline, Yang, Ying and Zimmerman, Heiko (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.
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: | College of Health & Life Sciences > School of Biosciences College of Health & Life 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 |
| Publication ISSN: | 1746-076X |
| Last Modified: | 31 Oct 2024 08:30 |
| Date Deposited: | 30 Jul 2019 13:18 |
| 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 |
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)