自 2007 年首次生产以来，人类诱导多能干细胞 (iPSC) 为开发针对一系列疾病的各种细胞疗法提供了一个新颖的平台，从罕见的遗传性眼部疾病到癌症治疗。然而，基于 iPSC 的细胞疗法要进入市场并在全球范围内获得更广泛的采用，必须解决一些挑战。本白皮书由日本再生医学会 (JSRM) - 国际细胞治疗学会 (ISCT) iPSC 委员会撰写，深入探讨了在追求安全且经济可行的基于 iPSC 的疗法中遇到的障碍，特别是从细胞治疗行业。它讨论了全球指南和监管框架的差异，概述了确保细胞疗法安全所需的一系列质量控制测试，并提供了有关商品成本 (COG) 的详细信息和重要考虑因素，包括自动化先进制造的影响。版权© 2024 国际细胞学会

Since their first production in 2007, human induced pluripotent stem cells (iPSCs) have provided a novel platform for the development of various cell therapies targeting a spectrum of diseases, ranging from rare genetic eye disorders to cancer treatment. However, several challenges must be tackled for iPSC-based cell therapy to enter the market and achieve broader global adoption. This white paper, authored by the Japanese Society for Regenerative Medicine (JSRM) - International Society for Cell Therapy (ISCT) iPSC Committee delves into the hurdles encountered in the pursuit of safe and economically viable iPSC-based therapies, particularly from the standpoint of the cell therapy industry. It discusses differences in global guidelines and regulatory frameworks, outlines a series of quality control tests required to ensure the safety of the cell therapy, and provides details and important considerations around cost of goods (COGs), including the impact of automated advanced manufacturing.Copyright © 2024 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.