Standardized iPSC quality assessment
exploratoryEstablish harmonized quality-control methods for iPSC-derived therapies to support interoperable iPSC banks, regulatory alignment, and scalable regenerative-therapy manufacturing.
International multi-site quality assessment rounds evaluating flow cytometry for undifferentiated-state assessment and qPCR-based genomic-integrity testing, including standardized workflows and marker benchmarking.
2026 publication reported QAR 2019 across 18 sites in 11 countries and QAR 2023 across 23 sites in 12 countries, identifying OCT3/4, TRA-1-60, and SSEA5 as robust pluripotency-associated markers.
QAR 2019 showed high consistency in genomic integrity testing but substantial variability in flow cytometry; QAR 2023 standardized workflows improved cross-site evaluation and marker reliability.