Publications by authors named "Shinko Hata"
Article Synopsis
- - MEASURE2 is a Japanese initiative focused on creating standardized testing methods for evaluating tumorigenicity in human pluripotent stem cell-derived cell therapy products.
- - The project included multisite studies that assessed two key areas: colony formation efficiency of human induced pluripotent stem cells under different conditions and the effectiveness of microbead sorting for enriching hiPSCs.
- - Findings revealed that a specific culture condition (CEPT) enhanced colony formation and reduced variance across labs compared to a common method, while sorting with anti-Tra-1-60 microbeads showed high efficiency, potentially leading to better tumorigenicity assessments for cell therapy products.
Introduction: Contamination of human cell-processed therapeutic products (hCTPs) with tumorigenic/immortalized cellular impurities is a major concern in the manufacturing and quality control of hCTPs. The cellular immortality test based on cell growth analysis is a method for detecting tumorigenic/immortalized cellular impurities in hCTPs. However, the performance of the cellular immortality test has not yet been well characterized.
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