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Title: Comparability: Manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14-15 September 2015
Authors: Williams, David J.
Archer, J. Richard
Archibald, Peter R.T.
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, Zoe
Hourd, Paul C.
Hyllner, Johan
Jesson, Helen
Kee, Jasmin
Kerby, Julie
Kotsopoulou, Nina
Kowalski, Stanley
Leidel, Chris
Marshall, Damian
Masi, Louis
McCall, Mark J.S.
McCann, Conor
Medcalf, Nick
Moore, Harry
Ozawa, Hiroki
Pan, David
Parmar, Malin
Plant, Anne L.
Reinwald, Yvonne
Sebastian, Sujith
Stacey, Glyn
Thomas, Robert James
Thomas, Dave
Thurman-Newell, Jamie A.
Turner, Marc
Vitillio, Loriana
Wall, Ivan
Wilson, Alison
Wolfrum, Jacqueline
Yang, Ying
Zimmerman, Heiko
Issue Date: 2016
Publisher: ©The Authors. Published by Future Medicine
Citation: WILSON, D.J. ...et al., 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: © 2016 Future Medicine Ltd.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.
Description: This is an Open Access Article. It is published by Future Medicine Ltd under the Creative Commons Attribution 4.0 Unported Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/
Version: Published
DOI: 10.2217/rme-2016-0053
URI: https://dspace.lboro.ac.uk/2134/22197
Publisher Link: http://dx.doi.org/10.2217/rme-2016-0053
ISSN: 1746-0751
Appears in Collections:Published Articles (Mechanical, Electrical and Manufacturing Engineering)

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