Stem Cell Reviews and Reports

, Volume 5, Issue 4, pp 301–314 | Cite as

Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes

  • The International Stem Cell Banking Initiative
Translational Stem Cell Studies

Background and Scope

In just a few years hundreds of human embryonic stem cell (hESC) lines have been established in laboratories around the world and many programmes of research initiated to investigate their properties and broad ranging potential in therapy and for other research applications, such as developmental biology, toxicology and drug discovery. This work is being performed with a variety of cell lines using a variety of culture conditions; a situation that makes standardisation between projects and publications very difficult and could prevent the identification of cells that have undergone permanent deleterious changes. Clearly the consequence of using such cells would be wasted time and resources but, more seriously, the generation of erroneous data in the literature which could both confuse and delay scientific progress in this area. Thus ensuring that cell lines used in this dynamic field have the correct identity and characteristics is critical to the delivery of...


Human embryonic stem cells Cell banking Standardisation Microbiological testing Pluripotency Quality control 



We would like to thank the International Stem Cell Forum for funding this initiative. Details of the ‘Forum’ can be found at Thanks also to the Jackson Laboratory (Bar Harbor, Maine, USA) who hosted meetings of the International Stem Cell Banking Initiative to establish this guidance and to Mrs Gill Cathro who assisted in the preparation of these meetings.


  1. 1.
    Coecke, S., Balls, M., Bowe, G., Davis, J., Gstraunthaler, G., Hartung, T., et al. (2005). Second ECVAM task force on Good Cell Culture practice. Guidance on good cell culture practice: a report of the second ECVAM task force on good cell culture practice. Alternatives to Laboratory Animals, 33, 261–287.PubMedGoogle Scholar
  2. 2.
    ISBER. (2007). Best practices for repositories I: collection, storage, and retrieval of human biological materials for research. Cell Preservation Technology, 3, 5–48.Google Scholar
  3. 3.
    OECD (2007) Best Practice Guidelines for Biological Resource Centres; OECD, Paris.,3343,en_2649_201185_1911986_1_1_ 1_1,00.html
  4. 4.
    OECD Advisory Document of the Working Group on Good Laboratory practice: the application of the principles of GLP to in vitro studies. OECD series on principles of Good laboratory practice and Compliance monitoring 2004; Number 14 (ENV/JM/MONO(2004)26), OECD, Paris.$FIlE/JT00174939.PdF
  5. 5.
    International Conference on Harmonisation. ICH Topic Q 5 D Quality of Biotechnological Products: derivation and characterisation of cell substrates used for production of Biotechnological/Biological Products (CPMP/ICH/294/95), 1998; ICH Technical Coordination, European Medicines Evaluation Agency, London.Google Scholar
  6. 6.
    WHO (Expert Committee on Biological Standardization and Executive Board) requirements for the use of animal Cells as in vitro substrates for the production of biologicals (requirements for Biological substances no. 50). 1998; WHO technical report series no. 878; World Health Organization, Geneva.Google Scholar
  7. 7.
    Chatterjee, R. (2007). Cell biology: cases of mistaken identity. Science, 315, 928–931.CrossRefPubMedGoogle Scholar
  8. 8.
    NIH (2007) Notice regarding authentication of cultured cell lines, NOTod-08-017, Nov 28, NiH.
  9. 9.
    Editorial (2007). Nature Biotechnology, 1211–1212.Google Scholar
  10. 10.
    International Stem Cell Initiative: Adewumi, O., Aflatoonian, B., Ahrlundrichter, L, Amit, M., Andrews, P. W., Beighton, G., et al. (2007). Characterization of human embryonic stem cell lines by the International Stem Cell Initiative. Nature Biotechnology, 25, 803–816.Google Scholar
  11. 11.
    Sikkema-Raddatz, B., Castedo, B., & Meerman, G. T. (1997). Probability tables for exclusion of mosaicism in prenatal diagnosis. Prenatal Diagnosis, 17, 115–118.CrossRefPubMedGoogle Scholar
  12. 12.
    Hook, E. B. (1977). Exclusion of chromosomal mosaicism: tables of 90%, 95% and 99% confidence limits and comments on use. American Journal of Human Genetics, 29, 94–97.PubMedGoogle Scholar
  13. 13.
    Association of Clinical Cytogenetics General Best Practice Guidelines. 2007; v10.01, ACC Professional Standards Committee.Google Scholar
  14. 14.
    An International System for Human Cytogenetic Nomenclature (2009) In L. G. Shaffer, M. L. Slovak, L. J. Campbell (Eds.), Cytogenetic and Genome Research. Switzerland: Karger.Google Scholar
  15. 15.
    Bolske, G. (1988). Survey of mycoplasma infections in cell cultures and a comparison of detection methods. Zbl Bakt Nug, A269, 331–340.Google Scholar
  16. 16.
    Rottem, S., & Naot, Y. (1998). Subversion and exploitation of host cells by mycoplasma. Trends in Microbiology, 6, 436–440.CrossRefPubMedGoogle Scholar
  17. 17.
    Timenetsky, J., Santos, L. M., Buzinhani, M., & Mettifogo, E. (2006). Detection of multiple mycoplasma infection in cell cultures by PCR. Brazilian Journal of Medical and Biological Research, 39, 907–914.CrossRefPubMedGoogle Scholar
  18. 18.
    Eldering, J. A., Felton, C., Veilleux, C. A., & Potts, B. J. (2004). Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins. Biologicals, 32, 183–193.PubMedGoogle Scholar
  19. 19.
    van Kuppeveld, F. J. M., Johansson, K.-E., Galama, J. M. D., Kissing, J., Bolske, G., van der Logt, J. T. M., et al. (1994). Detection of mycoplasma contamination in cell cultures by a mycoplasma group-specific PCR. Applied and Environmental Microbiology, 60, 149–152.PubMedGoogle Scholar
  20. 20.
    Sung, H., Kang, S. H., Bae, Y. J., Hong, J. T., Chung, Y. B., Lee, C.-K., et al. (2006). PCR-Based Detection of mycoplasma species. Journal of Microbiology, 44, 42–49.Google Scholar
  21. 21.
    Uphoff, C. C., & Drexler, H. G. (2005). Detection of mycoplasma contaminations. Methods in Molecular Biology, 290, 13–23.PubMedGoogle Scholar
  22. 22.
    Kong, H., Volokhov, D. V., George, J., Ikonomi, P., Chandler, D., Anderson, C., et al. (2007). Application of cell culture enrichment for improving the sensitivity of mycoplasma detection methods based on nucleic acid amplification technology (NAT). Applied Microbiology and Biotechnology, 77, 223–232.CrossRefPubMedGoogle Scholar
  23. 23.
    Healy, L. E., Ludwig, T. E., & Choo, A. (2008). International banking: checks, deposits and withdrawals. Cell Stem Cell, 2(4), 305–306.CrossRefPubMedGoogle Scholar
  24. 24.
    Crook, J. M., Hei, D., & Stacey, G. (2010). International Stem Cell Banking Initiative (ISCBI): Raising standards to bank on. In Vitro Cell Dev Biol-Animal, (in press).Google Scholar

Copyright information

© Humana Press 2009

Authors and Affiliations

  • The International Stem Cell Banking Initiative
    • 1
  1. 1.Blanche LaneRidgeUK

Personalised recommendations