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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 ; Bantounas, Ioannis ; Baptista, Ricardo ; Barker, Roger LU ; Barry, Jacqueline ; Bietrix, Florence ; Blair, Nicholas and Braybrook, Julian , et al. (2016) In Regenerative Medicine 11(5). p.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... (More)

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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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Advice, Comparability, Human pluripotent stem cell derived, Manufacturing, Quality, Regulatory
in
Regenerative Medicine
volume
11
issue
5
pages
10 pages
publisher
Future Medicine Ltd.
external identifiers
  • pmid:27404768
  • wos:000379834000010
  • scopus:84979021495
ISSN
1746-0751
DOI
10.2217/rme-2016-0053
language
English
LU publication?
yes
id
cbf3789e-65e8-47c6-928f-60a52f1a923a
date added to LUP
2016-09-08 14:57:42
date last changed
2025-01-12 11:05:36
@article{cbf3789e-65e8-47c6-928f-60a52f1a923a,
  abstract     = {{<p>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.</p>}},
  author       = {{Williams, David J. and Archer, Richard and Archibald, Peter and Bantounas, Ioannis and Baptista, Ricardo and Barker, Roger and Barry, Jacqueline and Bietrix, Florence and Blair, Nicholas and Braybrook, Julian and Campbell, Jonathan and Canham, Maurice and Chandra, Amit and Foldes, Gabor and Gilmanshin, Rudy and Girard, Mathilde and Gorjup, Erwin and Hewitt, Zöe and Hourd, Paul and Hyllner, Johan and Jesson, Helen and Kee, Jasmin and Kerby, Julie and Kotsopoulou, Nina and Kowalski, Stanley and Leidel, Chris and Marshall, Damian and Masi, Louis and McCall, Mark and McCann, Conor and Medcalf, Nicholas and Moore, Harry and Ozawa, Hiroki and Pan, David and Parmar, Malin and Plant, Anne L. and Reinwald, Yvonne and Sebastian, Sujith and Stacey, Glyn and Thomas, Robert J. and Thomas, Dave and Thurman-Newell, Jamie and Turner, Marc and Vitillio, Loriana and Wall, Ivan and Wilson, Alison and Wolfrum, Jacqueline and Yang, Ying and Zimmerman, Heiko}},
  issn         = {{1746-0751}},
  keywords     = {{Advice; Comparability; Human pluripotent stem cell derived; Manufacturing; Quality; Regulatory}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{5}},
  pages        = {{483--492}},
  publisher    = {{Future Medicine Ltd.}},
  series       = {{Regenerative Medicine}},
  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}},
  url          = {{http://dx.doi.org/10.2217/rme-2016-0053}},
  doi          = {{10.2217/rme-2016-0053}},
  volume       = {{11}},
  year         = {{2016}},
}