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

David J. Williams; Richard Archer; Peter Archibald; Ioannis Bantounas; Ricardo Baptista; Roger Barker; Jacqueline Barry; Florence Bietrix; Nicholas Blair; Julian Braybrook; Jonathan Campbell; Maurice Canham; Amit Chandra; Gabor Foldes; Rudy Gilmanshin; Mathilde Girard; Erwin Gorjup; Zöe Hewitt; Paul Hourd; Johan Hyllner; Helen Jesson; Jasmin Kee; Julie Kerby; Nina Kotsopoulou; Stanley Kowalski; Chris Leidel; Damian Marshall; Louis Masi; Mark McCall; Conor McCann; Nicholas Medcalf; Harry Moore; Hiroki Ozawa; David Pan; Malin Parmar; Anne L. Plant; Yvonne Reinwald; Sujith Sebastian; Glyn Stacey; Robert J. Thomas; Dave Thomas; Jamie Thurman-Newell; Marc Turner; Loriana Vitillio; Ivan Wall; Alison Wilson; Jacqueline Wolfrum; Ying Yang; Heiko Zimmerman

doi:10.2217/rme-2016-0053

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

David J. Williams^*, Richard Archer, Peter Archibald, Ioannis Bantounas, Ricardo Baptista, Roger Barker, Jacqueline Barry, Florence Bietrix, Nicholas Blair, Julian Braybrook, Jonathan Campbell, Maurice Canham, Amit Chandra, Gabor Foldes, Rudy Gilmanshin, Mathilde Girard, Erwin Gorjup, Zöe Hewitt, Paul Hourd, Johan HyllnerHelen Jesson, Jasmin Kee, Julie Kerby, Nina Kotsopoulou, Stanley Kowalski, Chris Leidel, Damian Marshall, Louis Masi, Mark McCall, Conor McCann, Nicholas Medcalf, Harry Moore, Hiroki Ozawa, David Pan, Malin Parmar, Anne L. Plant, Yvonne Reinwald, Sujith Sebastian, Glyn Stacey, Robert J. Thomas, Dave Thomas, Jamie Thurman-Newell, Marc Turner, Loriana Vitillio, Ivan Wall, Alison Wilson, Jacqueline Wolfrum, Ying Yang, Heiko Zimmerman

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	483-492
Number of pages	10
Journal	Regenerative medicine
Volume	11
Issue number	5
DOIs	https://doi.org/10.2217/rme-2016-0053
Publication status	Published - 12 Jul 2016

Bibliographical note

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/

Keywords

Advice
Comparability
Human pluripotent stem cell derived
Manufacturing
Quality
Regulatory

Access to Document

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Cite this

Williams, D. J., Archer, R., Archibald, P., Bantounas, I., Baptista, R., Barker, R., Barry, J., Bietrix, F., Blair, N., Braybrook, J., Campbell, J., Canham, M., Chandra, A., Foldes, G., Gilmanshin, R., Girard, M., Gorjup, E., Hewitt, Z., Hourd, P., ... Zimmerman, H. (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), 483-492. https://doi.org/10.2217/rme-2016-0053

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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",

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.",

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author = "Williams, {David J.} and Richard Archer and Peter Archibald and Ioannis Bantounas and Ricardo Baptista and Roger Barker and Jacqueline Barry and Florence Bietrix and Nicholas Blair and Julian Braybrook and Jonathan Campbell and Maurice Canham and Amit Chandra and Gabor Foldes and Rudy Gilmanshin and Mathilde Girard and Erwin Gorjup and Z{\"o}e Hewitt and Paul Hourd and Johan Hyllner and Helen Jesson and Jasmin Kee and Julie Kerby and Nina Kotsopoulou and Stanley Kowalski and Chris Leidel and Damian Marshall and Louis Masi and Mark McCall and Conor McCann and Nicholas Medcalf and Harry Moore and Hiroki Ozawa and David Pan and Malin Parmar and Plant, {Anne L.} and Yvonne Reinwald and Sujith Sebastian and Glyn Stacey and Thomas, {Robert J.} and Dave Thomas and Jamie Thurman-Newell and Marc Turner and Loriana Vitillio and Ivan Wall and Alison Wilson and Jacqueline Wolfrum and Ying Yang and Heiko Zimmerman",

note = "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/",

year = "2016",

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Williams, DJ, Archer, R, Archibald, P, Bantounas, I, Baptista, R, Barker, R, Barry, J, Bietrix, F, Blair, N, Braybrook, J, Campbell, J, Canham, M, Chandra, A, Foldes, G, Gilmanshin, R, Girard, M, Gorjup, E, Hewitt, Z, Hourd, P, Hyllner, J, Jesson, H, Kee, J, Kerby, J, Kotsopoulou, N, Kowalski, S, Leidel, C, Marshall, D, Masi, L, McCall, M, McCann, C, Medcalf, N, Moore, H, Ozawa, H, Pan, D, Parmar, M, Plant, AL, Reinwald, Y, Sebastian, S, Stacey, G, Thomas, RJ, Thomas, D, Thurman-Newell, J, Turner, M, Vitillio, L, Wall, I, Wilson, A, Wolfrum, J, Yang, Y & Zimmerman, H 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, vol. 11, no. 5, pp. 483-492. https://doi.org/10.2217/rme-2016-0053

Comparability: Manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14-15 September 2015. / Williams, David J.; Archer, Richard; Archibald, Peter et al.
In: Regenerative medicine, Vol. 11, No. 5, 12.07.2016, p. 483-492.

Research output: Contribution to journal › Article › peer-review

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AU - Archer, Richard

AU - Archibald, Peter

AU - Bantounas, Ioannis

AU - Baptista, Ricardo

AU - Barker, Roger

AU - Barry, Jacqueline

AU - Bietrix, Florence

AU - Blair, Nicholas

AU - Braybrook, Julian

AU - Campbell, Jonathan

AU - Canham, Maurice

AU - Chandra, Amit

AU - Foldes, Gabor

AU - Gilmanshin, Rudy

AU - Girard, Mathilde

AU - Gorjup, Erwin

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AU - Jesson, Helen

AU - Kee, Jasmin

AU - Kerby, Julie

AU - Kotsopoulou, Nina

AU - Kowalski, Stanley

AU - Leidel, Chris

AU - Marshall, Damian

AU - Masi, Louis

AU - McCall, Mark

AU - McCann, Conor

AU - Medcalf, Nicholas

AU - Moore, Harry

AU - Ozawa, Hiroki

AU - Pan, David

AU - Parmar, Malin

AU - Plant, Anne L.

AU - Reinwald, Yvonne

AU - Sebastian, Sujith

AU - Stacey, Glyn

AU - Thomas, Robert J.

AU - Thomas, Dave

AU - Thurman-Newell, Jamie

AU - Turner, Marc

AU - Vitillio, Loriana

AU - Wall, Ivan

AU - Wilson, Alison

AU - Wolfrum, Jacqueline

AU - Yang, Ying

AU - Zimmerman, Heiko

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