The National Institute of Health (NIH) under the Korea Disease Control and Prevention Agency (KDCA) has established induced pluripotent stem cells (iPSCs) ready for immediate clinical use and will begin distributing them to outside researchers. The move is seen as laying the groundwork to accelerate therapeutic development by freeing researchers from the costly and time-consuming step of producing "source cells" on their own.
The NIH announced Thursday that it will begin distributing clinical-grade iPSC lines to domestic research institutions and biotech companies. iPSCs are cells created by reprogramming ordinary cells, such as skin cells, back to an "initial state," enabling them to be re-differentiated into various cell types. Clinical-grade cells produced under Good Manufacturing Practice (GMP) standards for pharmaceutical production have secured the quality and safety levels required for actual patient treatment research.
The achievement is a key outcome of the "Cell-Based Artificial Blood Manufacturing and Demonstration Platform" project jointly pursued by the Ministry of Health and Welfare and other related government agencies. Artificial blood, a technology that uses stem cells to produce red blood cells and platelets, is considered a promising alternative to address the shortage of blood for transfusions. It is also regarded as a foundational technology applicable to the development of various cell-based therapeutics.
Notably, the cells established this time were produced primarily from type O blood, which causes fewer rejection reactions during transfusions. The institute secured a total of 18 cell lines, and one of them has been developed into a Master Cell Bank (MCB). An MCB is a standardized raw material repository designed to supply cells of consistent quality in large volumes on a stable basis, serving as core infrastructure that can be directly utilized in clinical research. This marks the first time a clinical-grade iPSC-based MCB has been established in South Korea.
Until now, researchers had to go through the high-cost, highly complex cell production process themselves to develop cell-based therapeutics. However, with the government now providing standardized cells, the time and cost required in the early research stage can be significantly reduced. Industry officials expect the timeline to reach clinical trials will be shortened.
The government plans to use this cell line supply as an opportunity to drive a qualitative shift in the country's bio-industry structure, moving from a generics-focused model toward one centered on therapeutic development. The strategy aims to simultaneously secure competitiveness in both artificial blood and regenerative medicine based on high-quality cell resources.
"Establishing a national cell bank is core infrastructure that lowers the entry barrier for regenerative medicine research," KDCA Commissioner Lim Seung-kwan said. "We will develop it into a global-standard cell resource platform."