The National Center for Stem Cell and Regenerative Medicine (NCSR) of the Republic of Korea plays a crucial role in advancing stem cell research and clinical applications. Since its establishment, the NCSR has expanded its role not only to operate a stem cell bank but also to establish and manage facilities that comply with Good Manufacturing Practice (GMP), thereby supporting the overall development of stem cell-based therapeutics. In addition to standardizing high-quality human pluripotent stem cells for distribution to researchers, the NCSR actively engages in international collaboration to enhance the reliability of research resources. Furthermore, through the implementation of laws regarding advanced regenerative medicine and the safety and support of advanced biopharmaceuticals, the Republic of Korea has secured a leading position in the global regenerative medicine field. This paper highlights the operational achievements of the NCSR, its role in supporting clinical research, and future strategies to strengthen the development of stem cell therapeutics. The NCSR aims to promote the commercialization of advanced regenerative medicine therapeutics by enhancing GMP infrastructure and facilitating international cooperation, thereby contributing to the advancement of precision medicine and innovative healthcare solutions.

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Current Status and Future Prospects for Cell Therapy Manufacturing at KNIH

  • Hyunyoung Kim,
  • Jung-Hyun Kim,
  • Yong-Ou Kim

摘要

The National Center for Stem Cell and Regenerative Medicine (NCSR) of the Republic of Korea plays a crucial role in advancing stem cell research and clinical applications. Since its establishment, the NCSR has expanded its role not only to operate a stem cell bank but also to establish and manage facilities that comply with Good Manufacturing Practice (GMP), thereby supporting the overall development of stem cell-based therapeutics. In addition to standardizing high-quality human pluripotent stem cells for distribution to researchers, the NCSR actively engages in international collaboration to enhance the reliability of research resources. Furthermore, through the implementation of laws regarding advanced regenerative medicine and the safety and support of advanced biopharmaceuticals, the Republic of Korea has secured a leading position in the global regenerative medicine field. This paper highlights the operational achievements of the NCSR, its role in supporting clinical research, and future strategies to strengthen the development of stem cell therapeutics. The NCSR aims to promote the commercialization of advanced regenerative medicine therapeutics by enhancing GMP infrastructure and facilitating international cooperation, thereby contributing to the advancement of precision medicine and innovative healthcare solutions.