MEASURE: In vitro study for detection of residual undifferentiated pluripotent stem cells: (1) Droplet Digital PCR Assay (ddPCR)

Abstract

The cell therapy products (CTPs) derived from pluripotent stem cells (PSCs) have potentials to remain the PSCs and the residual PSCs are naturally tumorigenic, giving rise to teratoma. The droplet digital PCR (ddPCR) assay is known as in vitro assay to detect residual undifferentiated PSCs. The MEASURE project has developed ddPCR assay using LIN28 as a marker of undifferentiated PSCs and the reported detection sensitivity (0.001%) of the ddPCR assay for hiPSC was confirmed at multisite. This result indicates that ddPCR assay is rapid and robust assay for detection of residual undifferentiated PSCs in CTPs.