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npj Regen. Med., 2022 Sep 29;7(1):54 | doi: 10.1038/s41536-022-00242-7 Perspectives on the cost of goods for hPSC banks for manufacture of cell therapies

Jung-Hyun Kim ^{1 2}, Eihachiro Kawase ³, Kapil Bharti ⁴, Ohad Karnieli ⁵, Yuji Arakawa ⁶, Glyn Stacey ^{7 8 9}

¹Korea National Stem Cell Bank, Osong, Korea.
²Division of intractable diseases research, Department of chronic diseases convergence research, Korea national institute of health, Osong, Korea.
³Division of Clinical Basis for ES Cell Research, Center for Human ES Cell Research, Institute for Frontier Life and Medical Sciences, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.
⁴Ocular and Stem Cell Translational Research Section, Ophthalmic Genetics and Visual Function Branch, National Eye Institute, National Institutes of Health, Bethesda, MD, USA.
⁵Adva Biotechnology, Hadolev3, Bar Lev Industrial Park, Israel.
⁶Facility for iPS cell therapy, CiRA foundation, Kyoto, Japan.
⁷International Stem Cell Banking Initiative, Barley, Herts, SG88HZ, UK.
⁸National Stem Cell Resource Centre, Institute of Zoology, Chinese Academy of Sciences, 100190, Beijing, China.
⁹Institute for Stem Cell and Regeneration, Chinese Academy of Sciences, 100101, Beijing, China.

Corresponding author: Glyn Stacey

Abstract

This report summarizes key issues contributing to the cost of preparing human pluripotent stem cell lines for use in cell therapy manufacturing based on discussion between stem cell banking experts from ten countries at a workshop session on ‘cost of goods’ for human pluripotent stem cell banking organized by the International Stem Cell Banking Initiative (ISCBI) held at the Korea National Institutes of Health in Korea (25^th September 2019). In this report, we also build on the workshop discussion and highlight and discuss the full range of costs and unexpected challenges on resources for the delivery of stocks of hPSCs suitable for use as starting materials in the manufacture of stem cell-based medicines. The experiences of global leaders from different national resource centers highlight issues to consider in cost management and the possibilities for reducing costs while moving into the clinical application stage.

논문정보

형식Research article
게재일2022년 09월 (BRIC 등록일 2022-12-02)
연구진국내+국외 연구진
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