International Journal of Stem Cells

  • 제17권2호
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  • Pages.102-112
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  • 2024
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  • 2005-3606(pISSN)
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  • 2005-5447(eISSN)
한국줄기세포학회 (Korean Society for Stem Cell Research)
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Essential Guidelines for Manufacturing and Application of Organoids

  • Sun-Ju Ahn (Department of Biophysics, Sungkyunkwan University) ;
  • Sungin Lee (Institute of Quantum Biophysics, Sungkyunkwan University) ;
  • Dayeon Kwon (Institute of Quantum Biophysics, Sungkyunkwan University) ;
  • Sejeong Oh (Institute of Quantum Biophysics, Sungkyunkwan University) ;
  • Chihye Park (Institute of Quantum Biophysics, Sungkyunkwan University) ;
  • Sooyeon Jeon (Institute of Quantum Biophysics, Sungkyunkwan University) ;
  • Jin Hee Lee (Organoid Standards Initiative) ;
  • Tae Sung Kim (Organoid Standards Initiative) ;
  • Il Ung Oh (Organoid Standards Initiative)
  • 투고 : 2024.04.08
  • 심사 : 2024.05.08
  • 발행 : 2024.05.30
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초록

An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

키워드

과제정보

We thank those who contributed to the successful completion of this manuscript. We would like to thank first the Ministry of Food and Drug Safety, OSI committee chairs and members, and the Institute of Quantum Biophysics, especially, Professor Luke Lee for his invaluable insights.

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