"Boost for Domestic Cell Therapy Development"... Establishment of Clinical-Grade Induced Pluripotent Stem Cell MCB

Key Achievement in Multi-Ministerial Artificial Blood Development Project
Standard Cell Line Based on Rh(D)+ O Type Secured
Reducing Research Costs and Time, Accelerating Clinical Entry

The National Institute of Health under the Korea Disease Control and Prevention Agency announced on March 29 that it has established clinical-grade induced pluripotent stem cells to support the development of cell therapy products by domestic research institutes and biotech companies.

Clinical-grade induced pluripotent stem cells are a core achievement of the 'Development of Cell-Based Artificial Blood Manufacturing and Demonstration Platform Technology' project, which is being jointly promoted by multiple ministries (Ministry of Health and Welfare, Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Ministry of Food and Drug Safety, and Korea Disease Control and Prevention Agency). These stem cells can be utilized not only for the development of blood components such as red blood cells and platelets, but also for a wide range of other cell therapy products.

Development Process of Cell Therapy Products Derived from Induced Pluripotent Stem Cell Lines. National Institute of Health

The National Institute of Health has produced high-quality cell lines and completed quality testing in accordance with Good Manufacturing Practice (GMP) standards. This has established a foundation to reduce the costs and time required at the early stages of research.

In this study, in order to increase versatility with a focus on artificial blood development, blood was donated by four individuals with Rh(D)+ O blood type and two individuals with Rh(D)- O blood type. A total of 18 cell lines were created, with three cell lines produced for each donor. Among these, a master cell bank (MCB) was established for one Rh(D)+ O type induced pluripotent stem cell line.

This marks the first time that a master cell bank of clinical-grade induced pluripotent stem cells has been established in Korea. It is significant in that the nation has created a foundation to provide standard cells, which can be immediately used for clinical purposes, to researchers.

The National Institute of Health expects that, with the establishment of this MCB, the burden on researchers to produce their own cells will be reduced, and the costs and time will be shortened, thereby accelerating the development of cell therapy products and the entry into clinical research.

Kim Wonho, Director of the Department of Chronic Disease Convergence Research, stated, "Going forward, we will swiftly expand the distribution of clinical-grade induced pluripotent stem cells for both Rh(D)+ O and Rh(D)- O types. By doing so, we aim to help domestic researchers overcome challenges of high costs and time competition, and to provide practical support for the development and research of advanced biopharmaceuticals, including artificial blood and cell therapy products."

Im Seungkwan, Commissioner of the Korea Disease Control and Prevention Agency, said, "The establishment of a national master cell bank for induced pluripotent stem cells will rapidly lower the barriers to entry for regenerative medicine therapy development. We will continue to strengthen our clinical research and manufacturing support collaboration measures, so that it can function as a global-level, high-quality cell resource platform."

This content was produced with the assistance of AI translation services.