Williams, DJ and Archer, R and Archibald, P and Bantounas, I and Baptista, R and Barker, R and Barry, J and Bietrix, F and Blair, N and Braybrook, J and Campbell, J and Canham, M and Chandra, A and Foldes, G and Gilmanshin, R and Girard, M and Gorjup, E and Hewitt, Z and Hourd, P and Hyllner, J and Jesson, H and Kee, J and Kerby, J and Kotsopoulou, N and Kowalski, S and Leidel, C and Marshall, D and Masi, L and McCall, M and McCann, C and Medcalf, N and Moore, H and Ozawa, H and Pan, D and Parmar, M and Plant, AL and Reinwald, Y and Sebastian, S and Stacey, G and Thomas, RJ and Thomas, D and Thurman-Newell, J and Turner, M and Vitillio, L and Wall, I and Wilson, A and Wolfrum, J and Yang, Y and 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. ISSN 1746-076X

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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.

Item Type: Article
Subjects: R Medicine > R Medicine (General)
?? advice ??
?? comparability ??
?? human pluripotent stem cell derived ??
?? manufacturing ??
?? quality ??
?? regulatory ??
Divisions: Faculty of Medicine and Health Sciences > Institute for Science and Technology in Medicine
Related URLs:
Depositing User: Symplectic
Date Deposited: 16 Nov 2016 14:10
Last Modified: 16 Nov 2016 14:10
URI: http://eprints.keele.ac.uk/id/eprint/2511

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