Quality Control and Test Methods of Human Induced Pluripotent Stem Cells

doi:10.19803/j.1672-8629.20250265

Abstract

Abstract: Objective To explore the challenges to clinical translation of human induced pluripotent stem cell (hiPSC) therapies and define the quality control requirements in order to provide references to regulation of related products. Methods Based on literature review, the current R&D of hiPSC therapies was outlined and technical hurdles in each stage of production were identified. Quality control standards were summarized out of recent guidelines. Results While hiPSC-based therapies promised wide applications, no clinical-grade product had been approved for marketing. The major obstacles arose from technical challenges encountered in the complicated process of production. Quality control and product characterization were critical to the development and commercialization of these products. Despite the lack of a uniform standard, there was consensus regarding critical quality attributes of hiPSC-derived cell therapies. Conclusion A uniform quality control standard is essential to overcome translational barriers. Keen insights into each element of quality control during the process of production will facilitate the assessment of safety/efficacy of hiPSC-derived products, thus accelerating clinical translation and regulatory approval.

Key words: Induced Pluripotent Stem Cells, Production Process, Quality Control, Testing Methods

CLC Number:

R979.1

YANG Yifan, YANG Yanwei, ZHANG Di, XIE Yin, ZHANG Yong, CHEN Xulin, GAO Sutao, GENG Xingchao, QU Zhe. Quality Control and Test Methods of Human Induced Pluripotent Stem Cells[J]. Chinese Journal of Pharmacovigilance, 2025, 22(7): 728-734.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I7/728

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