Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee.

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作者： Marinna,Madrid ^[1] ; Uma,Lakshmipathy ^[2] ; Xiaokui,Zhang ^[3] ; Kapil,Bharti ^[4] ; Dominic M,Wall ^[5] ; Yoji,Sato ^[6] ; George,Muschler ^[7] ; Anthony,Ting ^[8] ; Nathan,Smith ^[9] ; Shuhei,Deguchi ^[10] ; Shin,Kawamata ^[11] ; Jennifer C,Moore ^[12] ; Bar,Makovoz ^[1] ; Stephen,Sullivan ^[13] ; Veronica,Falco ^[14] ; Arwa Z,Al-Riyami ^[15]

作者单位： Cellino Biotech, Cambridge, USA. ^[1] Pharma Services, Thermo Fisher Scientific, Carlsbad, USA. ^[2] Aspen Neuroscience Inc., San Diego, USA. ^[3] National Eye Institute of the National Institutes of Health, Bethesda, USA. ^[4] Peter MacCallum Cancer Centre, Melbourne Australia; Cell Therapies Pty Ltd, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Australia. ^[5] National Institute of Health Sciences, Kawasaki, Japan. ^[6] Cleveland Clinic, Cleveland, USA. ^[7] BRL C&GT consulting, LLC., Cleveland, USA. ^[8] Cell Therapies Pty Ltd, Melbourne, Australia. ^[9] CIRA Foundation, Facility for iPS Cell Therapy (FiT), Kyoto, Japan. ^[10] Cyto-Facto Inc., Kobe, Japan; Kobe University, Kobe, Japan. Electronic address: kawamata.shin@cytofacto.com. ^[11] Sampled, New York City, USA. ^[12] iPSirius, Paris, France; Lindville Bio, London, UK. ^[13] Lindville Bio, London, UK. ^[14] Department of Hematology, Sultan Qaboos University Hospital, University Medical City, Muscat, Oman. ^[15]

关键词 critical quality attributes (CQAs)good manufacturing practice (cGMP)iPSC-derived cell therapies quality by design (QbD)quality control (QC)regenerative medicine the cost of goods (COGs)

主题词人类(Humans);诱导多能干细胞(Induced Pluripotent Stem Cells);再生医学(Regenerative Medicine);质量控制(Quality Control)

DOI 10.1016/j.jcyt.2024.05.022

PMID 38958627

发布时间 2024-10-14

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