Int J Stem Cells.  2024 May;17(2):113-119. 10.15283/ijsc24042.

Guidelines for Packaging, Transport, and Storage of Source Cells for Organoids

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

• KMID: 2556230
• DOI: http://doi.org/10.15283/ijsc24042

Abstract

This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss–threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.

Keyword

Organoids; Guideline; Stem cells; Packaging; Transportation

Reference

References

1. Lee H, Son MY. 2021; Current challenges associated with the use of human induced pluripotent stem cell-derived organoids in regenerative medicine. Int J Stem Cells. 14:9–20. DOI: 10.15283/ijsc20140. PMID: 33632980. PMCID: PMC7904522.

2. Suhito IR, Kim TH. 2022; Recent advances and challenges in organoid-on-a-chip technology. Organoid. 2:e4. DOI: 10.51335/organoid.2022.2.e4.

3. Sekine K. 2021; Human organoid and supporting technologies for cancer and toxicological research. Front Genet. 12:759366. DOI: 10.3389/fgene.2021.759366. PMID: 34745227. PMCID: PMC8569236.

4. Clevers H. 2016; Modeling development and disease with organoids. Cell. 165:1586–1597. DOI: 10.1016/j.cell.2016.05.082. PMID: 27315476.

5. Schutgens F, Clevers H. 2020; Human organoids: tools for understanding biology and treating diseases. Annu Rev Pathol. 15:211–234. DOI: 10.1146/annurev-pathmechdis-012419-032611. PMID: 31550983.

6. Xu H, Lyu X, Yi M, Zhao W, Song Y, Wu K. 2018; Organoid technology and applications in cancer research. J Hematol Oncol. 11:116. DOI: 10.1186/s13045-018-0662-9. PMID: 30219074. PMCID: PMC6139148.

7. Kim H, Cho M. 2015. Apr. Safety Strategies through the Establishment of Management and Utilization System for Human-derived Materials [Internet]. KISTEP;Umseong: Available from: https://www.kistep.re.kr/boardDownload.es?bid=0031&list_no=35280&seq=5069. cited 2024 Mar 5.

8. Zhou C, Wu Y, Wang Z, et al. 2023; Standardization of organoid culture in cancer research. Cancer Med. 12:14375–14386. DOI: 10.1002/cam4.5943. PMID: 37081739. PMCID: PMC10358246.

9. ISO 20404. 2023. Apr. 2023 Biotechnology - Bioprocessing - General Requirements for the Design of Packaging to Contain Cells for Therapeutic Use [Internet]. ISO;Geneva: Available from: https://www.iso.org/standard/81477.html. cited 2024 Mar 1.

10. 2015. Dec. 31. Guidelines for the Evaluation of Suitability of Pharmaceutical Containers and Packaging [Internet]. Ministry of Food and Drug Safety;Cheongju: Available from: https://www.mfds.go.kr/brd/m_1060/view.do?seq=12256&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=99. cited 2024 Feb 20.

11. Chang IY, Kim KS. 2012; Developmental strategy for stem cell therapy products in regulatory considerations. Hanyang Med Rev. 32:163–169. DOI: 10.7599/hmr.2012.32.3.163.

12. 2022. Guidelines for the Storage and Transportation Management of Biological Products and Others [Internet]. Ministry of Food and Drug Safety;Cheongju: Available from: https://www.mfds.go.kr/brd/m_218/view.do?seq=33472&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1. cited 2024 Feb 20.

13. 2020. ISO 21973:2020 Biotechnology - General Requirements for Transportation of Cells for Therapeutic Use [Internet]. ISO;Geneva: Available from: https://www.iso.org/standard/72326.html. cited 2024 Mar 1.

14. 2006. Oct. 24. Commission Directive 2006/86/EC Implementing - Directive 2004/23/EC of the European Parliament and of the Council as Regards Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements for the Coding, Processing, Preservation, Storage and Distribution of Human Tissues and Cells [Internet]. legislation.gov.uk;Norwich: Available from: https://www.legislation.gov.uk/eudr/2006/86/contents. updated 2020 Dec 31 cited 2024 Feb 8.

15. 2001. Jan. 19. PART 1271- Human Cells, Tissues, and Cellular and Tissue-based Products [Internet]. National Archives;Washington, D.C.: Available from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271. cited 2024 Jan 23.