April 2010, Volume 46, Issue 3-4, pp 210-216
Date: 23 Feb 2010
The generation of GLP-grade human embryonic stem cell banks from four clinical-grade cell lines for preclinical research
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
The Singapore Stem Cell Bank has generated human embryonic stem cell banks from clinical-grade cell lines ESI-017, ESI-035, ESI-049, and ESI-053. All banks were prepared and characterized according to principles of Good Laboratory Practice for quality assurance. Importantly, each cell line has clearly documented and approved ethical provenance and meets recognized standards for performance and safety. The banks are intended to facilitate the translation of stem cell research to clinical medicine by enabling early phase research and development with high-quality, low-cost cells that are also available as clinical-grade stocks.
Editor: J. Denry Sato
Code of Federal Regulations (2006a). Food and Drugs, title 21, part 1270.
Code of Federal Regulations (2006b). Food and Drugs, title 21, part 1271.
Crook J. M.; Horne R.; Colman A. Standard culture of human embryonic stem cells. In: Sullivan S.; Cowan C. A.; Eggan K. (eds) Practical handbook of human embryonic stem cells. Wiley, New York, pp 53–79; 2007a.
Crook, J. M.; Kravets L. Cell Preservation method. Patent International Publications Number W02005/118785 A1; 2005.
Crook J. M.; Peura T. T.; Kravets L.; Bosman A. G.; Buzzard J. J.; Horne R.; Hentze H.; Dunn N. R.; Zweigerdt R.; Chua F.; Upshall; Colman A. The generation of six clinical-grade human embryonic stem cell lines. Cell Stem Cell 1: 490–494; 2007b.CrossRef
International Society for Stem Cell Research. Guidelines for the conduct of human embryonic stem cell research, version 1; 2006.
International Stem Cell Banking Initiative. Draft guidance for best practice for banking of human embryonic stem cell lines; 2008.
National Research Council. Guidelines for human embryonic stem cell research. The National Academies Press, Washington; 2005.
USA Food and Drug Administration (FDA) Federal Regulations CFR 58-GLPs.
USA Food and Drug Administration (FDA) Guide to the inspection of microbiological quality control laboratories; 1993.
USA Food and Drug Administration (FDA) Guide to the inspection of pharmaceutical quality control laboratories; 1993.
- The generation of GLP-grade human embryonic stem cell banks from four clinical-grade cell lines for preclinical research
In Vitro Cellular & Developmental Biology - Animal
Volume 46, Issue 3-4 , pp 210-216
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- Human embryonic stem cells
- Good laboratory practice
- Clinical grade
- Research grade
- Industry Sectors
- Author Affiliations
- 1. Singapore Stem Cell Bank, Singapore Stem Cell Consortium, A*STAR, Singapore, Singapore
- 5. Cytentia - Australian Stem Cell Bank, Melbourne, Australia
- 3. Histopathology, Kandang Kerbau Hospital, Singapore, Singapore
- 2. Stem Cell Disease Models Laboratory, Institute of Medical Biology, A*STAR, Singapore, Singapore
- 4. Stem Cell Medicine, O’Brien Institute, 42 Fitzroy Street, Melbourne, Victoria, 3065, Australia