Abstract
For clinical hepatocyte transplantation, cells need to be prepared in a sterile GMP environment. Strict regulations are in place that set the standard for this environment that cells are prepared in. These regulations control all aspects of the environment. In the United Kingdom, the laboratory must have a licence from the Human Tissue Authority to prepare cell for clinical administration. The physical parameters such as air quality, pressure, temperature and microbiology counts have to be monitored regularly usually through direct measurement. Described here are the methods for microbial monitoring of the laboratory environment and the isolated cell preparations.
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References
Lehec, S., Wade, J., Mitry, R., et al. (November 2004) Evidence of microbiological screening of human hepatocytes and islets for clinical transplantation. Abstracts of 7th International Congress of the Cell Transplant Society, p. 124, Boston, USA.
Mitry, R. R., Hughes, R. D., Aw, M. M., et al.(2003) Human hepatocyte isolation and relationship of cell viability to early graft function. Cell Transplant 12, 69–74.
Mitry, R. R. (2008) Isolation of Human Hepatocyte. In Dhawan A. and Hughes R. D., eds. Methods in Molecular Biology: Hepatocyte Transplantation, Humana Press Inc.: New Jersey [In Press].
Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Medicines Control Agency, 2007. Pharmaceutical Press. London.
Further Reading
Human Tissue Act 2004, Office of Public Sector Information.
A Code of Practice for Tissue Banks. Department of Health. 2001.
Guidance on the Microbiological Safety ofHuman Organs, Tissues and Cells used in Transplantation. Department of Health. 2000.
Alison M Beaney. (2001) Quality Assurance of Aseptic Preparation Services 3rd edition. Pharmaceutical Press.
BS 5295, Environmental Cleanliness in Enclosed Places, British Standards Institute, 1989.
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© 2009 Humana Press, a part of Springer Science+Business Media, LLC
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Lehec, S. (2009). Microbiological Monitoring of Hepatocyte Isolation in the GMP Laboratory. In: Dhawan, A., Hughes, R. (eds) Hepatocyte Transplantation. Methods in Molecular Biology, vol 481. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59745-201-4_18
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DOI: https://doi.org/10.1007/978-1-59745-201-4_18
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-60761-172-1
Online ISBN: 978-1-59745-201-4
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