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Regen Med. 2018 Oct;13(7):859-866. doi: 10.2217/rme-2018-0095. Epub 2018 Sep 12.

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

Author information

1
Global Alliance for iPSC Therapies (GAiT), The Jack Copland Centre, Edinburgh, UK.
2
International Stem Cell Banking Initiative, 2 High St, Barley, Hertfordshire, UK.
3
Department of Biochemistry and Biophysics, Graduate School of Health Care Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.
4
Japan Agency for Medical Research and Development (AMED), Chiyoda-ku, Tokyo, Japan.
5
Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, London, UK.
6
Centre for Commercialization of Regenerative Medicine (CCRM), Toronto, ON, Canada.
7
APHP-Hopital Paul Brousse Université Paris Sud/ESteam Paris Inserm UMR 935, Villejuif, France.
8
Centre for Biological Engineering, Loughborough University, Holywell Park, Loughborough, UK.
9
Cord Blood Research, Murdoch Children's Research Institute, Melbourne, VIC 3052, Australia.
10
Department of Paediatrics, University of Melbourne, Parkville, Victoria 3052, Australia.
11
Yposkesi, 2 Rue Henri Auguste Desbruères, 91100 Corbeil-Essonnes, France.
12
Foundation Biomedical Research and Innovation (FBRI), Research and Development Center for Cell Therapy, Chuo-ku, Kobe, Japan.
13
Center for iPS Cell Research and Application (CiRA), Kyoto University, Kyoto, Japan.
14
California Institute for Regenerative Medicine (CIRM), Lake Merritt Plaza, 1999 Harrison Street STE 1650, Oakland, CA, USA.
15
WiCell Research Institute (WiCell Stem Cell Bank), Madison, WI 53719, USA.
16
Optec LLC, Inzhenernaya Str., 28 Novosibirsk, 630090, Russia.
17
Fujifilm Cellular Dynamics International, 525 Science Dr., Madison, WI 53711, USA.
18
Advanced Therapeutics, Scottish National Blood Transfusion Service, Edinburgh, UK.
19
New York Stem Cell Foundation Laboratories, New York, NY 10032, USA.
20
Department of Genetics and Evolutionary Biology, Institute of Biosciences, University of São Paulo, São Paulo, Brazil.
21
UK Stem Cell Bank, National Institute for Biological Standards and Control, Hertfordshire, UK.
22
Department of Genetics, Rutgers, The State University of New Jersey, Piscataway, NJ 08854-8009, USA.
23
Department of Haematology, Christian Medical College, Vellore- 632004, Tamil Nadu, India.
24
Centre for Stem Cell Research, Christian Medical College, Vellore- 632004, Tamil Nadu, India.
25
Charité - Universita¨tsmedizin Berlin, Berlin Institute of Health and Berlin-Brandenburg Center for Regenerative Therapies, Berlin 13353, Germany.
26
Department of Biomedical Science, CHA Stem Cell Institute, CHA University, Seongnam-si, Gyeonggi-do, Republic of Korea.

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.

KEYWORDS:

clinical-grade induced pluripotent stem cells; good manufacturing practice; minimum testing requirements; quality control; quality control attributes

PMID:
30205750
DOI:
10.2217/rme-2018-0095
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