Int J Stem Cells.  2024 May;17(2):102-112. 10.15283/ijsc24047.

Essential Guidelines for Manufacturing and Application of Organoids

• Ahn SJ
• Lee S
• Kwon D
• Oh S
• Park C
• Jeon S
• Lee JH
• Kim TS
• Oh IU

• KMID: 2556229
• DOI: http://doi.org/10.15283/ijsc24047

Abstract

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.

Keyword

Organoids; Stem cells; Embryonic stem cells; Induced pluripotent stem cells; Regulations; Quality

Figure

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  Fig. 1 Organoid Standards Initiative (OSI) organoid guidelines development scope (2023∼2024) (2023.09.∼2024.02.) The OSI developed the first version of the guidelines for promoting organoid practical use, which presented general requirements and considerations for organoid production and quality evaluation with extensive evidence analysis and expert consensus. These guidelines comprise two overall guidelines that consider the fabrication of organoids from human-derived cells and seven guidelines for organoid use with specific organs (liver, intestines, heart, kidney, brain, lung, skin).

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  Fig. 2 Research scope. The guidelines cover cell source, culture, organoid quality control, and storage and preservation. ASCs: adult stem cells, iPSCs: induced pluripotent stem cells, ESCs: embryonic stem cells, DMEM: Dulbecco’s modified Eagle medium, RPMI: Roswell Park Memorial Institute, IMDM: Iscove‘s modified Dulbecco‘s medium, EGF: epidermal growth factor, FGF: fibroblast growth factor, BMP: bone morphogenetic protein, ELISA: enzyme-linked immunosorbent assay, qPCR: quantitative polymerase chain reaction.

Reference

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