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Toward standardized iPSC testing: Insights from a multi-year international Quality Assessment Round
Alice Hägg1, Rachel Wood2, Ayako L Mochizuki3
1Department of Experimental Medical Science (EMV), Lund Stem Cell Center, Science for Life Laboratory, Sölvegatan 17 A11, 221 84 Lund, Sweden.
Stem Cell Reports
|March 20, 2026
Summary
Global quality control assessments reveal inconsistencies in induced pluripotent stem cell (iPSC) manufacturing. Standardized methods improved reproducibility, identifying reliable markers for robust quality control (QC) in regenerative medicine.
Area of Science:
- Regenerative Medicine
- Stem Cell Biology
- Biotechnology Quality Control
Background:
- Induced pluripotent stem cell (iPSC)-derived therapies face limited global adoption due to inconsistent quality control (QC) standards.
- Fundamental QC parameters for iPSCs are evaluated inconsistently across different laboratories worldwide.
- Lack of harmonization hinders the scalable manufacturing and regulatory alignment of iPSC-based regenerative therapies.
Purpose of the Study:
- To establish harmonized quality control (QC) methods for induced pluripotent stem cells (iPSCs) through international quality assessment rounds.
- To evaluate the reproducibility of flow cytometry and qPCR-based QC assays across multiple global sites.
- To identify robust pluripotency markers for reliable iPSC characterization in a multi-site setting.
Main Methods:
- Conducted two international Quality Assessment Rounds (QARs) in 2019 and 2023, involving 18 and 23 sites across 12 countries, respectively.
- Assessed flow cytometry for undifferentiated state evaluation and quantitative PCR (qPCR) for genomic integrity testing.
- Introduced standardized workflows in QAR 2023 to address variability observed in QAR 2019's flow cytometry assessments.
Main Results:
- Genomic integrity testing demonstrated high consistency across sites in both QARs.
- Flow cytometry assessments showed significant variability in QAR 2019, which was reduced after implementing standardized workflows in QAR 2023.
- OCT3/4, TRA-1-60, and SSEA5 were identified as consistently robust markers for assessing pluripotency across different sites and cell states.
Conclusions:
- This global benchmarking effort provides the first empirical evidence for reproducible iPSC QC and marker reliability across multiple international sites.
- Harmonized QC protocols and standardized marker assessments are crucial for ensuring the quality and consistency of iPSC manufacturing.
- These findings lay the groundwork for interoperable iPSC banks, regulatory alignment, and the scalable production of globally accessible regenerative therapies.
