| Literature DB >> 30205750 |
Stephen Sullivan1, Glyn N Stacey2, Chihiro Akazawa3, Naoki Aoyama4, Ricardo Baptista5, Patrick Bedford6, Annelise Bennaceur Griscelli7, Amit Chandra8, Ngaire Elwood9,10, Mathilde Girard11, Shin Kawamata12, Tadaaki Hanatani13, Theodoros Latsis7, Stephen Lin14, Tenneille E Ludwig15, Tamara Malygina16, Amanda Mack17, Joanne C Mountford18, Scott Noggle19, Lygia V Pereira20, Jack Price21, Michael Sheldon22, Alok Srivastava23,24, Harald Stachelscheid25, Shaji R Velayudhan23,24, Natalie J Ward5, Marc L Turner1,5,18, Jacqueline Barry1,5, Jihwan Song1,26.
Abstract
Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities. This requires agreement on the critical quality attributes of such lines and the assays that should be used. Working from established recommendations and guidance from the International Stem Cell Banking Initiative for human embryonic stem cell banking, and concentrating on those issues more relevant to iPSCs, a series of consensus workshops has made initial recommendations on the minimum dataset required to consider an iPSC line of clinical grade, which are outlined in this report. Continued evolution of this field will likely lead to revision of these guidelines on a regular basis.Entities:
Keywords: clinical-grade induced pluripotent stem cells; good manufacturing practice; minimum testing requirements; quality control; quality control attributes
Mesh：
Year: 2018 PMID： 30205750 DOI： 10.2217/rme-2018-0095
Source DB: PubMed Journal: Regen Med ISSN： 1746-0751 Impact factor: 3.806