Journal article

Quality control guidelines for clinical-grade human induced pluripotent stem cell lines

Stephen Sullivan, Glyn N Stacey, Chihiro Akazawa, Naoki Aoyama, Ricardo Baptista, Patrick Bedford, Annelise Bennaceur Griscelli, Amit Chandra, Ngaire Elwood, Mathilde Girard, Shin Kawamata, Tadaaki Hanatani, Theodoros Latsis, Stephen Lin, Tenneille E Ludwig, Tamara Malygina, Amanda Mack, Joanne C Mountford, Scott Noggle, Lygia V Pereira Show all



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 gra..

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Awarded by Korea Health Industry Development Institute (KHIDI) - Ministry of Health and Welfare, Republic of Korea

Funding Acknowledgements

This work was supported by a grant awarded to J Song from the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health and Welfare (HI15C3042), Republic of Korea. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.