Validated GMP banking of a new set of genomically stable induced pluripotent stem cell lines using single-cell...

Single-cell passaging of induced pluripotent stem cells (iPSCs) has historically been discredited, as it may risk mutations. Here, however, in combination with Rho kinase inhibition and based on stringent quality control, we successfully validate a corresponding iPSC banking process under Good Manufacturing Practice (GMP) conditions. The underlying culture system features enhanced consistency, sustains genomic integrity in the resulting cell lines, and enables excellent priming for gene editing and directed differentiation. The process, as well as the resulting GMP iPSC lines, will provide a robust foundation for clinical manufacturing.