Risk Assessment of Cell Culture Procedures

Medicines from Animal Cell Culture

Volumn , Issue , 2007, Pages 567-587

  Stacey, Glyn ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

Biological medicines, risk assessment and risk management; Cell culture risk assessment procedures; Cell substrate tumorigenicity testing; Hazard Analysis Critical Control Point (HACCP); Hazard identification evaluation and control

Indexed keywords

EID: 84889273587     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470723791.ch31     Document Type: Chapter

References (90)

1. ACDP (1995) Categorisation of Biological Agents According to Hazard and Categories of Containment. HSE Books, Sudbury, UK (www.tso.co.uk); fourth edition.
2. ACDP (2005) Biological Agents: Managing the Risks in Laboratories and Healthcare Premises. Advisory Committee on Dangerous Pathogens, Health and Safety Executive, TSO, Sudbury, UK (www.hse.gov.uk).
3. Adamson SR (1998) Dev. Biol. Stand.; 93: 89-96.
4. Advisory Committee on Microbiological Safety of Blood, Tissues and Cells (MSBT) (2000) Guidance on the Microbiological Safety of Human Organs, Tissues and Cells Used in Transplantation. Medical and Healthcare products Regulatory Agency, London, UK.
5. Biwer A, Griffith S, Cooney, C (2005) Biotech. Bioeng.; 20: 167-179.
6. Bolin SR, Matthews PJ, Ridpath JF (1991) J. Vet. Diagn. Invest.; 3: 199-203.
7. British Standards Institute (2004) General Metrology. Part 4: Practical Guide to Measurement Uncertainty. British Standards Institute, London.
8. Burnouf T, Griffiths E, Padilla A, Seddik S, Stephano MA, Guttierrez J-M (2004) Biologicals; 32: 115-128.
9. Burgmeier J (2002) Jt. Comm. J. Qual. Improv.; 28: 331-339.
10. Canivet M, Hofman AD, Hardy D et al. (1990) Virol.; 178: 543-541.
11. Chen KA, Laywell ED, Marshall G, Walton N, Zheng T, Steindler DA (2006) Exp. Neurol.; 198: 129-35.
12. CHIP (2002) Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP). Health and Safety Executive, UK (see web list for H&SE Books and also the CHIP (Amendment) Regulations 2005 (CHIP 3.1)).
13. Cobo F, Stacey GN, Hunt C et al. (2005) Appl. Micro. Biotechnol.; 68: 456-466.
14. Coecke S, Balls M, Bowe G et al. (2005) ATLA; 33: 261-287.
15. Committee for Proprietary Medicinal Products (1995) Production and Quality Control of Monoclonal Antibodies (3AB4a) European Agency for the Evaluation of Medicinal Products, London, UK, October 1997. http://www.emea.europa.eu.
16. Committee for Proprietary Medicinal Products (1997) Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. (CPMP/ICH/295/95).
17. Committee for Proprietary Medicinal Products (1999) Concept Paper on Xenogeneic Cell Therapy (draft 1), 8.2 CPMP Guidelines. European Agency for the Evaluation of Medicinal Products, London, UK.
18. Committee for Proprietary Medicinal Products (2000) Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products. European Agency for the Evaluation of Medicinal Products, London, UK.
19. Committee for Proprietary Medicinal Products (2001a) Points to Consider on Human Somatic Cell Therapy (CPMP/BWP/41450/98). The European Agency for the Evaluation of Medicinal Products, London, UK.
20. Committee for Proprietary Medicinal Products (2001b) Position Statement on the use of Tumourigenic Cells of Human Origin for the Production of Biological and Biotechnological Medicinal Products (CPMP/ BWP/1143/00). The European Agency for the Evaluation of Medicinal Products, London, UK.
21. Committee for Proprietary Medicinal Products (2003) Note for Guidance on the use of Bovine Serum in the Manufacture of Human Biological Medicinal Products (CPMP/BWP/1793/02). The European Agency for the Evaluation of Medicinal Products, London, UK.
22. Copeland NG, Cooper GM (1979) Cell; 16: 347-356.
23. COSHH (2002) Control of Substances Hazardous to Health (fifth edition). The Control of Substances Hazardous to Health Regulations 2002 (as amended). Approved code of practice and guidance. Health and Safety Executive, UK, ISBN 0717629813. (see also the COSHH general guidance document in website list).
24. DoH (2002) Code of Practice for Production of Human-derived Therapeutic Products, UK Department of Health, TSO Sudbury, UK. www.mhra.gov.uk/home (see "How We Regulate-Tissue Engineered Products") Draper JS, Smith K, Gokhale P et al. (2004) Nat. Biotechnol.; 22: 53-54.
25. Elmishad AG, Bocchetta M, Pass HI, Carbone M (2006) Dev. Biol. (Basel); 123: 109-117.
26. Eloit M (1999) Dev. Biol. Stand.; 99: 9-16.
27. Erickson GA, Bolin SR, Landgraf JG (1991) Dev. Biol. Stand.; 75: 173-175.
28. European Pharmacopoeia (2005) Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (5.2.8). European Pharmacopoeia 5.0, 01/2005:50208, 463-471.
29. European Union (2004) Official J. Europ. Union; L102: 48-58.
30. Fleming DO (2006) Chapter 2, in: Biological Safety: Principles and Practice (4th edn) eds Fleming DO, Hunt DC, ASM Press, pp 19-33.
31. Food and Drug Administration (1993) Points to Consider in the Characterization of Cell Lines used to Produce Biologicals. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, USA (http://www.fda.gov/cber/).
32. Food and Drug Administration (1997) Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. Food and Drugs Administration, Rockville, MD20857, USA.
33. Food and Drug Administration (2004). 21 CFR Parts 16, 1270 and 1271. Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-based Products Establishments; Inspection and Enforcement; Final Rule. Department of Health and Human Services, November 24.
34. Frommer W, Archer L, Boon B, Brunuis G, Collins CH, Crooy P et al. (1993) Appl. Microbiol. Biotechnol.; 39: 141-147.
35. Froude SJ (1999) Dev. Biol. Stand.; 99: 157-166.
36. Gearing AJ, Cartwright JE, Bird CR, Wadhwa M, Priest R, Thorpe R (1989) Lancet; 2(8670): 1011-1012.
37. Hallauer C, Kronauer G, Seigl G (1971) Arch. Gesamte Virusforsch.; 35: 80-90.
38. Harasawa R, Mizusawa H (1995) Microbiol. Immunol.; 39: 979-985.
39. Harris R (1998) Bioessays; 20: 307-316.
40. Healy L, Hunt C, Young L, Stacey G (2005) Adv. Drug Del. Rev.; 57: 1981-1988.
41. Hummeler K, Davidson WL, Henle W, Laboccetta AC, Ruch HG (1959) N. Eng. J. Med.; 261: 64-68.
42. IEC (2001) Hazard and Operability Studies (HAZOP Studies) Application Guide. International Eletrotechnical Commission, Geneva, Switzerland.
43. International Conference on Harmonization (1997) 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). ICH Technical Coordination, European Medicines Evaluation Agency, London.
44. International Conference on Harmonization (2005) ICH Topic Q9 Quality Risk Management (Current Step 4 Version). ICH, ICH Technical Coordination, European Medicines Evaluation Agency, London. See also website for ICH Q9 Quality Risk Management.
45. Ishikawa F, Shimazu H, Shultz LD et al. FASEB J.; 20: 950-952.
46. Ishikawa F, Shimazu H, Shultz LD et al. (in press). FASEB J. (E-publication ahead of print April 2006).
47. Kappeler A, Lutz-Wallace C, Sapp T, Sidhu M (1996) Biologicals; 24: 131-135.
48. Kraft V, Meyer B (1990) Z. Versuchstierkd.; 33: 29-35.
49. Kraus H, Weber A, Appel M et al. (2003) Zoonoses: Infectious Diseases Transmissble from Animals to Humans (3rd edn) ASM Press; Washington DC.
50. Krontiris TG, Cooper GM (1981) Proc. Natl. Acad. Sci. USA; 78: 1181-1184.
51. Lewis AM, Krause P, Peden K (2001) Dev. Biol. Stand.; 106: 513-535.
52. Lim AC, Zhou Y, Washbrook J (2005) Biotechnol. Prog.; 21: 1231-1242.
53. Lloyd G, Jones N (1984) J. Inf.; 12: 117-125.
54. Lower R (1999) Trends Microbiol.; 7: 350-356.
55. Magnani C (2005) Med. Law; 96: 347-353.
56. Mahy BW, Dykewicz C, Fischer-Hoch S, Ostroff S, Tipple M, Sanchez A (1991) Dev. Biol. Stand.; 75: 183-189.
57. Merten O-W (1999) Dev. Biol. Stand.; 99: 167-180.
58. MHSWR (2000) Management of Health and Safety at Work Regulations (1999) Approved Code of Practice L21. HSE books.
59. Minor PD, Will RG, Salisbury D (2001) Vaccine; 19: 3607.
60. Miyata H, Kanazawa T, Shibuya K, Hino S (2005) J. Gen. Virol.; 86: 733-741.
61. Nakamura S, Shimazaki T, Sakamoto K, Fukusho Y, Ogawa N (1995) J. Vet. Med. Sci.; 57: 677-681.
62. Nicklas W, Kraft V, Meyer B (1993) Lab. Anim. Sci.; 43: 296-300.
63. Noguchi PD (1992) Dev. Biol. Stand.; 76: 47-50.
64. Oie S, Oomaki M, Yorioka K et al. (1998) J. Hosp. Infection; 38: 61-65.
65. Onions D (2001) In Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development. Eds Brown F, Lewis A, Peden K, Krause P. Karger, Basel; Vol. 106: 135-142.
66. Patzke S, Lindeskog M, Munthe E, Aasheim H-C (2002) Virology; 303: 164-173.
67. Perl A (2003) Rheum. Dis. Clin. N. Am.; 29: 123-143.
68. Pocchiari M (1991) Dev. Biol. Stand.; 75: 87-95.
69. Rabenau H, Ohlinger V, Anderson J et al. (1993) Biologicals; 21: 207-214.
70. Reinmuller B, Ljungqvist B (1999) Nordic J. Contam. Cont. Cleanroom Technol.; 28: 9-12.
71. Rollinson DE, Page WF, Crawford H et al. (2004) Am. J. Epidemiol.; 160: 317-324.
72. Schuurman R, van Steenis B, van Strien A, van der Noorda J, Sol C (1991) J. Gen. Virol.; 72: 2739-2745.
73. Sheeley H (1998) In Safety in Cell and Tissue Culture. Eds Stacey GN, Doyle A, Hambleton P. Kluwer Academic Publishers, Dordrecht, Netherlands: 173-188.
74. Simon M, Domok I, Pinter A (1982) Acta Microbiol. Acad. Sci. Hung.; 29: 201-208.
75. Sistare FD (2001) In Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development. Eds Brown F, Lewis A, Peden K, Krause P. Dev. Biol. Stand. Karger, Basel; Vol. 106: 123-132.
76. Stacey GN (2002) Dev. Biologicals; 111: 259-272.
77. Stacey GN (2004) Human Fertility; 7: 113-118.
78. Stacey G (2005) Eur. Biopharm. Rev. winter edn: 112-115.
79. Stacey GN, Hartung T (in press) In Drug Testing in vitro: Breakthroughs and Trends in Cell Culture Technology. Eds Marx U, Sandig V. Wiley-VCH.
80. Stacey GN, Possee R (1996) Cytotechnology; 20: 299-304.
81. Sweet BH, Hilleman MR, (1960) Proc. Soc. Exp. Med.; 105: 420-427.
82. Sun R, Grogan E, Shedd D et al. (1995) Virology; 209: 374-383.
83. Tedder RS, Zuckerman MA, Goldstone AH et al. (1995) Lancet; 346.
84. Uckert W, Fleischhacker M, Kettmann R (1986) Virology; 155: 742-746.
85. Vaughn JL (1991) Dev. Biol. Stand.; 76: 319-214.
86. World Health Organization (1993) Laboratory Biosafety Manual. World Health Organization, Geneva; second edition.
87. World Health Organization (1998) Requirements for the Use of Animal Cells as in vitro Substrates for the Production of Biologicals. Requirements for Biological Substances No. 50. WHO Technical Report Series No. 878. World Health Organization, Geneva.
88. World Health Organization (2003) Technical Report Series No. 908, Appendix 7: Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals, WHO, Geneva.
89. Weiss RA (2001) Emerging Infect. Dis.; 7: 153-154.
90. Xue W, Minocha HC (1996) Vet. Microbiol.; 49: 67-79.