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 journalArticle

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 languageEnglish
Pages (from-to)483-492
Number of pages10
JournalRegenerative medicine
Volume11
Issue number5
DOIs
Publication statusPublished - 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

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    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