Optimizing the Banking and Releasing Strategies of Clinical‐Grade HLA‐Homozygous Human iPSCs for Regenerative Medicine

Since their initial generation, induced pluripotent stem cells (iPSCs) have attracted considerable attention and undergone rapid development. iPSC‐derived cell therapies show great promise in the field of regenerative medicine. However, their clinical translation faces two major challenges: the limited availability of good manufacturing practice (GMP)‐compliant human iPSC (hiPSC) lines, and the high costs and prolonged timelines associated with autologous hiPSC‐based therapies. Allogeneic therapies based on rigorously quality‐controlled, GMP‐compliant, human leukocyte antigen (HLA)‐homozygous hiPSCs thus represent a promising alternative. In this study, we established and validated a GMP‐compliant platform for iPSCs production, complete with a comprehensive set of standard operating procedures (SOPs) and recommended release criteria for the iPSC master cell bank (MCB). Using frozen umbilical cord blood (UCB) from donors with high‐frequency HLA homozygosity as starting material, we generated five monoclonal iPSC MCB lines and performed full release testing. Among the five iPSC lines, three demonstrated high post‐thaw survival rates, met all release criteria, and exhibited strong potential for multilineage differentiation and clinical application in cell therapy.