Stacey, Glyn Andrews, Peter W. Asante, Curtis Barbaric, Ivana Barry, Jacqueline Bisset, Louise Braybrook, Julian Buckle, Robin Chandra, Amit Coffey, Peter Crouch, Sharon Driver, Philip Evans, Amanda Gardner, John Ginty, Patrick J. Goldring, Christopher Hay, David C. Healy, Lyn Hows, Anna Hutchinson, Claire Jesson, Helen Kalber, Tammy Kimber, Sue J. Leathers, Roland Moyle, Sarah Murray, Trish Neale, Michael Pan, David Park, B. Kevin Rebolledo, Raul Elgueta Rees, Ian Rivolta, Marcelo N. Ritchie, Allan Roos, Eric J. Saeb-Parsy, Kourosh Schroder, Bernd Sebastian, Sujith Thomas, Angela Thomas, Rob Turner, Marc Vallier, Ludovic Vitillo, Loriana Webster, Andrew Williams, David Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop. 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. Ancillary materials;Cell therapy;Cell-based medicines;Characterization regulatory science;Efficacy;Raw materials;Regenerative medicine;Safety;Starting materials;Mechanical Engineering not elsewhere classified 2018-12-11
    https://repository.lboro.ac.uk/articles/journal_contribution/Science-based_assessment_of_source_materials_for_cell-based_medicines_report_of_a_stakeholders_workshop_/9545849