Development of allogeneic iPS cell‐based therapy: from bench to bedside
Open Access
- 7 December 2022
- journal article
- editorial
- Published by Springer Nature in EMBO Molecular Medicine
- Vol. 15 (2)
Abstract
This commentary provides a brief overview of the steps necessary for the generation of an induced pluripotent stem (iPS) cell‐derived clinical grade product. This process requires extensive, proper documentation as well as a thoughtful and systematic optimization of the manufacturing methods to ensure maintenance of the key biological features of the product, compliance with current good manufacturing practices (cGMP), and most importantly patient safety. The scale‐up and optimization also ideally include the identification of efficient and cost‐effective purification/isolation and expansion of the target cell population.Keywords
Funding Information
- National Institutes of Health (R01 AR071439)
- U.S. Department of War (W81XWH‐17‐1‐0659)
- Duchene UK (1147094)
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