Toward standardized iPSC testing: Insights from a multi-year international Quality Assessment Round - PubMed
5 hours ago
- #standardization
- #iPSC
- #quality control
- Two international Quality Assessment Rounds (QARs) were conducted to evaluate iPSC quality control (QC) methods.
- QAR 2019 involved 18 sites across 11 countries, while QAR 2023 expanded to 23 sites in 12 countries.
- QAR 2019 revealed high consistency in genomic integrity testing but significant variability in flow cytometry.
- QAR 2023 introduced standardized workflows to improve cross-site evaluation of marker performance.
- OCT3/4, TRA-1-60, and SSEA5 were identified as robust pluripotency-associated markers.
- The study provides empirical evidence for reproducible iPSC QC and marker reliability.
- Findings support harmonized QC for interoperable iPSC banks, regulatory alignment, and scalable manufacturing.