Despite rapid clinical translation, induced pluripotent stem cell (iPSC)-derived therapies face limited global adoption.Harmonized quality control (QC) remains absent, with even fundamental parameters evaluated inconsistently across laboratories.To address this, we conducted two international Quality Assessment Rounds (QARs): QAR 2019 (18 sites, 11 countries) and QAR 2023 (23 sites, 12 countries), evaluating flow cytometry-based assessment of the undifferentiated state and qPCR-based genomic integrity testing.QAR 2019 showed high consistency in genomic integrity testing, while uncovering substantial variability in flow cytometry, prompting QAR 2023 to introduce standardized workflows.These improvements enabled systematic, cross-site evaluation of marker performance across cell states, identifying OCT3/4, TRA-1-60, and SSEA5 as consistently robust pluripotency-associated markers.This global benchmarking effort provides the first empirical multi-site evidence for reproducible iPSC QC and marker-level reliability.Together, these findings establish a foundation for harmonized QC supporting interoperable iPSC banks, regulatory alignment, and scalable manufacturing of globally accessible regenerative therapies.
Hägg et al. (Sun,) studied this question.