TY - JOUR
T1 - Quality control guidelines for clinical-grade human induced pluripotent stem cell lines
AU - Sullivan, Stephen
AU - Stacey, Glyn N.
AU - Akazawa, Chihiro
AU - Aoyama, Naoki
AU - Baptista, Ricardo
AU - Bedford, Patrick
AU - Bennaceur Griscelli, Annelise
AU - Chandra, Amit
AU - Elwood, Ngaire
AU - Girard, Mathilde
AU - Kawamata, Shin
AU - Hanatani, Tadaaki
AU - Latsis, Theodoros
AU - Lin, Stephen
AU - Ludwig, Tenneille E.
AU - Malygina, Tamara
AU - Mack, Amanda
AU - Mountford, Joanne C.
AU - Noggle, Scott
AU - Pereira, Lygia V.
AU - Price, Jack
AU - Sheldon, Michael
AU - Srivastava, Alok
AU - Stachelscheid, Harald
AU - Velayudhan, Shaji R.
AU - Ward, Natalie J.
AU - Turner, Marc L.
AU - Barry, Jacqueline
AU - Song, Jihwan
N1 - Funding Information:
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. No writing assistance was utilized in the production of this manuscript.
Publisher Copyright:
© 2018 2018 Global Alliance for iPSC Therapies (GAiT).
PY - 2018/10
Y1 - 2018/10
N2 - 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.
AB - 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.
KW - clinical-grade induced pluripotent stem cells
KW - good manufacturing practice
KW - minimum testing requirements
KW - quality control
KW - quality control attributes
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U2 - 10.2217/rme-2018-0095
DO - 10.2217/rme-2018-0095
M3 - Article
C2 - 30205750
AN - SCOPUS:85054977128
SN - 1746-0751
VL - 13
SP - 859
EP - 866
JO - Regenerative Medicine
JF - Regenerative Medicine
IS - 7
ER -