Establishment and qualification of a GMP-compliant induced pluripotent stem cell master cell bank for clinical applications under the Korean MFDS framework

Abstract

Background: Human induced pluripotent stem cells (iPSCs) are a promising starting material that can be differentiated into therapeutic cell products for clinical trials. The production of clinically applicable drug products requires good manufacturing practice (GMP)-compliant iPSCs as the initial starting material. Under the framework of the Korean Ministry of Food and Drug Safety, we generated a master cell bank (MCB) of a human iPSC line, KNIH01-MCB, from peripheral blood mononuclear cells obtained from a healthy female donor under a GMP system. Material and methods: To verify cell identity and quality, we performed a risk assessment of genetic stability, pluripotency, cell line identity, and sterility. For this purpose, we used validated methods, including polymerase chain reaction, karyotyping, short tandem repeat analysis, ABO/human leukocyte antigen (HLA) typing, and bacterial growth testing. After material qualification, the cells underwent comprehensive quality testing, including viral screening, ABO/HLA typing, and sterility testing. Results: We successfully established an MCB of the iPSC line, enabling clinical readiness, including full traceability and donor eligibility for clinical applications. The MCB met the quality control criteria of our in-house GMP system. Conclusion: These iPSCs provide a GMP-compliant and clinically applicable starting material for therapeutic cell manufacturing intended for human use.