Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop.
journal contributionposted on 2018-12-11, 13:56 authored by Glyn Stacey, Peter W. Andrews, Curtis Asante, Ivana Barbaric, Jacqueline Barry, Louise Bisset, Julian Braybrook, Robin Buckle, Amit Chandra, Peter Coffey, Sharon Crouch, Philip Driver, Amanda Evans, John Gardner, Patrick J. Ginty, Christopher Goldring, David C. Hay, Lyn Healy, Anna Hows, Claire Hutchinson, Helen Jesson, Tammy Kalber, Sue J. Kimber, Roland Leathers, Sarah Moyle, Trish Murray, Michael Neale, David Pan, B. Kevin Park, Raul Elgueta Rebolledo, Ian Rees, Marcelo N. Rivolta, Allan Ritchie, Eric J. Roos, Kourosh Saeb-Parsy, Bernd Schroder, Sujith Sebastian, Angela Thomas, Rob ThomasRob Thomas, Marc Turner, Ludovic Vallier, Loriana Vitillo, Andrew Webster, David Williams
Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.
The workshop was funded by the Biotechnology and Biological Sciences Research Council, the Engineering and Physical Sciences Research Council and the Medical Research Council via the UK Regenerative Medicine Platform program (www.ukrmp.org.uk/) grant number MR/L012537/1
- Mechanical, Electrical and Manufacturing Engineering