Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes
- The International Stem Cell Banking Initiative
- … show all 1 hide
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
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 effect ...
- 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.
- ISBER. (2007). Best practices for repositories I: collection, storage, and retrieval of human biological materials for research. Cell Preservation Technology, 3, 5–48.
- OECD (2007) Best Practice Guidelines for Biological Resource Centres; OECD, Paris. http://www.oecd.org/document/50/0,3343,en_2649_201185_1911986_1_1_ 1_1,00.html
- 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. http://www.olis.oecd.org/olis/2004doc.nsf/linkTo/nT00008FEE/$FIlE/JT00174939.PdF
- 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.
- 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.
- Chatterjee, R. (2007). Cell biology: cases of mistaken identity. Science, 315, 928–931. CrossRef
- NIH (2007) Notice regarding authentication of cultured cell lines, NOTod-08-017, Nov 28, NiH. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-017.html
- Editorial (2007). Nature Biotechnology, 1211–1212.
- 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.
- Sikkema-Raddatz, B., Castedo, B., & Meerman, G. T. (1997). Probability tables for exclusion of mosaicism in prenatal diagnosis. Prenatal Diagnosis, 17, 115–118. CrossRef
- 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.
- Association of Clinical Cytogenetics General Best Practice Guidelines. 2007; v10.01, ACC Professional Standards Committee.
- 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.
- Bolske, G. (1988). Survey of mycoplasma infections in cell cultures and a comparison of detection methods. Zbl Bakt Nug, A269, 331–340.
- Rottem, S., & Naot, Y. (1998). Subversion and exploitation of host cells by mycoplasma. Trends in Microbiology, 6, 436–440. CrossRef
- 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. CrossRef
- 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.
- 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.
- 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.
- Uphoff, C. C., & Drexler, H. G. (2005). Detection of mycoplasma contaminations. Methods in Molecular Biology, 290, 13–23.
- 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. CrossRef
- Healy, L. E., Ludwig, T. E., & Choo, A. (2008). International banking: checks, deposits and withdrawals. Cell Stem Cell, 2(4), 305–306. CrossRef
- 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).
- Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes
Stem Cell Reviews and Reports
Volume 5, Issue 4 , pp 301-314
- Cover Date
- Print ISSN
- Online ISSN
- Humana Press Inc
- Additional Links
- Human embryonic stem cells
- Cell banking
- Microbiological testing
- Quality control
- Industry Sectors
- Author Affiliations
- 1. Blanche Lane, Ridge, Herts, UK