Cost-effective master cell bank validation of multiple clinical-grade human pluripotent stem cell lines from a single donor

Stem Cells Translational Medicine

Volumn 3, Issue 10, 2014, Pages 1116-1124

  Devito, Liani ^a   Petrova, Anastasia ^a   Miere, Cristian ^a   Codognotto, Stefano ^a,b   Blakely, Nicola ^c   Lovatt, Archie ^c   Ogilvie, Caroline ^d   Khalaf, Yacoub ^a,d   Ilic, Dusko ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b ST8Biologics   (United Kingdom)

^c Vitrology   (United Kingdom)

^d GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Clinical grade human embryonic stem cell lines; Clinical grade iPS cell lines; Current good manufacturing practice; Human viral pathogens; Master cell bank; Validation

Indexed keywords

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; CYTOPATHOGENIC EFFECT; EMBRYONIC STEM CELL; FLUORESCENT PRODUCT ENHANCED REVERSE TRANSCRIPTASE ASSAY; GOOD MANUFACTURING PRACTICE; HEMADSORPTION; HUMAN; HUMAN CELL; NONHUMAN; PLURIPOTENT STEM CELL; REAL TIME POLYMERASE CHAIN REACTION; TRANSMISSION ELECTRON MICROSCOPY; VALIDATION STUDY; VIRAL CONTAMINATION; CELL LINE; HEALTH CARE FACILITY; STANDARDS;

IPS;

CELL LINE; HUMANS; PLURIPOTENT STEM CELLS; REAL-TIME POLYMERASE CHAIN REACTION; TISSUE BANKS;

EID: 84908042899     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2014-0015     Document Type: Article

References (26)

1. Thomson JA, Itskovitz-Eldor J, Shapiro SS et al. Embryonic stem cell lines derived from human blastocysts. Science 1998;282:1145- 1147.
2. Stephenson EL, Braude PR,MasonC. International community consensus standard for reporting derivation of human embryonic stem cell lines. Regen Med 2007;2:349-362.
3. Available at http://www.advisorybodies. doh.gov.uk/genetics/gtac/InterimUKSCroutemap 120309.pdf.
4. Löser P, Schirm J, Guhr A et al. Human embryonic stem cell lines and their use in international research. STEM CELLS 2010;28:240- 246.
5. Strulovici Y, Leopold PL, O'Connor TP et al. Human embryonic stem cells and gene therapy. Mol Ther 2007;15:850-866.
6. Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 2006;126:663-676.
7. Schwartz SD, Hubschman JP, Heilwell G et al. Embryonic stem cell trials for macular degeneration: A preliminary report. Lancet 2012; 379:713-720.
8. Klimanskaya I, Chung Y, Becker S et al. Human embryonic stem cell lines derived from single blastomeres. Nature 2006;444:481-485.
9. Crook JM, Peura TT, Kravets L et al. The generation of six clinical-grade human embryonic stemcell lines. Cell StemCell 2007; 1:490-494.
10. Funk WD, Labat I, Sampathkumar J et al. Evaluating the genomic and sequence integrity of human ES cell lines: Comparison to normal genomes. Stem Cell Res (Amst) 2012;8:154- 164.
11. Ilic D, Stephenson E, Wood V et al. Derivation and feeder-free propagation of human embryonic stem cells under xeno-free conditions. Cytotherapy 2012;14:122-128.
12. Stephenson E, Jacquet L, Miere C et al. Derivation and propagation of human embryonic stem cell lines from frozen embryos in an animal product-free environment. Nat Protoc 2012;7:1366-1381.
13. Jacquet L, Stephenson E, Collins R et al. Strategy for the creation of clinical grade hESC line banks that HLA-match a target population. EMBO Mol Med 2013;5:10-17.
14. Health Explained: How to make stem cells. BBC News. Available at http://www.bbc. co.uk/news/health-18496355.
15. NIH Human Embryonic Stem Cell Registry. NIH. Available at http://stemcells.nih. gov/research/registry/Pages/Default.aspx.
16. Directive 2002/94/EC of the European Parliament and of the Council of October 08, 2003 laying down the principles and guidelines of good manufacturing practice in respect of medical products for human use and investigational medicinal products for human use. Official Journal of the European Union October 14, 2003;L262:22-26. Available at http://ec. europa.eu/health/files/eudralex/vol-1/dir_2003_ 94/dir_2003_94_en.pdf.
17. Commission Directive 91/412/EEC of July 23, 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Official Journal of the European Union August 17, 1991; L228:70-73. http://ec.europa.eu/health/files/ eudralex/vol-5/dir_1991_412/dir_1991_412_ en.pdf.
18. Lovatt A, Black J, Galbraith D et al. High throughput detection of retrovirus-associated reverse transcriptase using an improved fluorescent product enhanced reverse transcriptase assay and its comparison to conventional detection methods. J Virol Methods 1999;82: 185-200.
19. Brorson K, Swann PG, Lizzio E et al. Use of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus levels in mAb cell-culture and downstream processing. Biotechnol Prog 2001;17:188-196.
20. Lovatt A. Applications of quantitative PCR in the biosafety and genetic stability assessment of biotechnology products. J Biotechnol 2002;82:279-300.
21. Xu Y, Brorson K. An overview of quantitative PCR assays for biologicals: Quality and safety evaluation. Dev Biol (Basel) 2003;113: 89-98.
22. Directive 2004/23/EC of the European Parliament and of the Council of March 31, 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Available at http:// eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2004:102:0048:0058:EN:PDF.
23. Commission Directive 2006/17/EC of February 8, 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for thedonation, procurementandtesting of human tissues and cells. Available at http:// eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2006:038:0040:0052:EN:PDF.
24. Commission Directive 2006/86/EC of October 24, 2006 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. Available at http://eurlex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2006:294:0032:0050:EN: PDF. Accessed.
25. Cytomegalovirus (CMV) and congenital CMV infection. U.S. Centers for Disease Control and Prevention. Available at http://www.cdc. gov/cmv/overview.html.
26. Epstein-Barr virus and infectious mononucleosis. U.S. Centers for Disease Control and Prevention. Available at http://www.cdc. gov/epstein-barr/index.html.