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

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 c...

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Published in:	Regenerative medicine Vol. 11; no. 5; pp. 483 - 492
Main Authors:	Williams, David J, Archer, Richard, Archibald, Peter, 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, Zöe, Hourd, Paul, Hyllner, Johan, Jesson, Helen, Kee, Jasmin, Kerby, Julie, Kotsopoulou, Nina, Kowalski, Stanley, Leidel, Chris, Marshall, Damian, Masi, Louis, McCall, Mark, McCann, Conor, Medcalf, Nicholas, Moore, Harry, Ozawa, Hiroki, Pan, David, Parmar, Malin, Plant, Anne L, Reinwald, Yvonne, Sebastian, Sujith, Stacey, Glyn, Thomas, Robert J, Thomas, Dave, Thurman-Newell, Jamie, Turner, Marc, Vitillo, Loriana, Wall, Ivan, Wilson, Alison, Wolfrum, Jacqueline, Yang, Ying, Zimmerman, Heiko
Format:	Journal Article Conference Proceeding
Language:	English
Published:	England Future Medicine Ltd 01-07-2016
Subjects:	Advice Basic Medicine Biotechnology - methods Biotechnology - trends Comparability Human pluripotent stem cell derived Humans Manufacturing Manufacturing and Industrial Facilities Medical and Health Sciences Medicin och hälsovetenskap Medicinska och farmaceutiska grundvetenskaper Neurosciences Neurovetenskaper Pluripotent Stem Cells - transplantation Quality Regenerative Medicine - legislation & jurisprudence Regenerative Medicine - methods Regenerative Medicine - trends Regulatory United Kingdom White Paper human pluripotent stem cell derived manufacturing comparability advice regulatory quality
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Summary:	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.
Bibliography:	ObjectType-Article-2 content type line 25 ObjectType-Conference-1 SourceType-Conference Papers & Proceedings-1
ISSN:	1746-0751 1746-076X
DOI:	10.2217/rme-2016-0053