Determination of the clearance factor for transmissible spongiform encephalopathy agents during the manufacturing process of polygeline

Intensive Care Medicine

Volumn 26, Issue 5, 2000, Pages 608-612

  Peano, P ^a   Reiner, G ^b   Carbonatto, M ^a   Bodenbender, L ^b   Boland, P ^b   Abel, K J ^b  

^a LCG RBM   (Italy)

^b SANOFI   (France)

Author keywords

263K Scrapie agent; Bovine spongiform encephalopathy; Gelatine safety; Hamster model; Polygeline; Transmissible spongiform encephalopathy

Indexed keywords

GELATIN; POLYGELINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BOVINE SPONGIFORM ENCEPHALOPATHY; DISEASE TRANSMISSION; DRUG MANUFACTURE; DRUG SAFETY; FEMALE; MATERIALS TESTING; NONHUMAN; QUALITY CONTROL; RISK MANAGEMENT; SCRAPIE AGENT; SYRIAN HAMSTER; VIRUS INACTIVATION;

ANIMALS; BRAIN; CATTLE; CRICETINAE; DRUG COMPOUNDING; DRUG CONTAMINATION; ENCEPHALOPATHY, BOVINE SPONGIFORM; FEMALE; LETHAL DOSE 50; MESOCRICETUS; PLASMA SUBSTITUTES; POLYGELINE; SCRAPIE; STERILIZATION;

EID: 0034039155     PISSN: 03424642     EISSN: None     Source Type: Journal    
DOI: 10.1007/s001340051211     Document Type: Article

References (22)

1. 1. Brown P, Rohwer RG, Gajdusek DC (1986) Newer data on the inactivation of scrapie virus of Creutzfeldt-Jakob disease in brain tissue. J Infect Dis 153: 1145-1148
2. 2. Brown P, Wolff A, Gajdusek DC (1990) A simple and effective method for inactivating virus infectivity in formalin-fixed tissue samples from patients with Creutzfeldt-Jakob disease. Neurology 40: 887-890
3. 3. Committee for Proprietary Medicinal Products (1991) Guidelines for minimising the risk of transmission of agents causing spongiform encephalopathies via medicinal products. III/3298/91-EN, final
4. 4. Committee for Proprietary Medicinal Products (1996) Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95,14 February
5. 5. Committee for Proprietary Medicinal Products (1998) Note for guidance for minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products. CPMP/BWP/ 1230/98 corr
6. 6. Committee for Proprietary Medicinal Products (1998) Opinion on the safety of gelatine adopted at the Scientific Steering Committee at the Plenary Meeting of 26-27 March 1998, version updated 3 April 1998
7. 7. Di Martino A, Safar J, Cerani M, Gibbs CJ, Jr (1993) Inactivation of the scrapie agent in a scaled-down procedure for the purification of gangliosides from the brain tissue. Dev Biol Stand 80: 187-194
8. 8. Ernst DR, Race RE (1993) Comparative analysis of scrapie agent inactivation methods. J Virol Methods 193-201
9. 9. Gölker CF, Whiteman MD, Gugel KH, Stadler P, Kovatch RM, Lister D, Whisher MH, Calcagni C, Hübner GE (1996) Reduction of the infectivity of scrapie agent as a model for BSE in the manufacturing process of Trasylol. Biologicals 24:103-111
10. 10. Kimberlin RH, Walker CA (1977) Characteristics of a short incubation model of scrapie in the golden hamster. J Gen Virol 34: 295-304
11. 11. Kimberlin RH, Walker CA (1988) Pathogenesis of experimental scrapie. In: Novel infectious agents and the central nervous system. Ciba Foundation symposium 135. Wiley, Chichester, pp 37-62
12. 12. Kimberlin RH (1996) Bovine spongiform encephalopathy and public health: some problems and solutions in assessing the risks. In: Court L, Dodet B (eds) Transmissible subacute spongiform encephalopathies: prion diseases, Elsevier, Paris
13. 13. Kozac RW, Golker CF, Stadler P (1996) Transmissible spongiform encephalopathies (TSE). Minimizing the risk of transmission by biological/biopharmaceutical products: an industrial perspective. Dev Biol Stand 88: 257-264
14. 14. Lee D, Lebing W, Stenland C, Petteway S Jr (1998) Methods of Inactivation of transmissible spongiform encephalopathies (TSEs) as applied to production chromatography processes. Downstream 27, Clayton
15. 15. Pocchiari M, Shmittinger S, Masullo C (1987) Amphotericin B delays the incubation period of scrapie in intracerebrally inoculated hamsters. J Gen Virol 68:219-223
16. 16. Pocchiari M (1991) Methodological aspects of the validation of purification procedures of human/animal-derived products to remove unconventional slow viruses. Dev Biol Stand 75: 87-95
17. 17. Pocchiari M, Peano S, Conz A, Eshkol A, Maillard F, Brown P, Gibbs CJ Jr, Xi YG, Tenham-Fisher E, Macchi G (1991) Combination ultrafiltration and 6M urea treatment of human growth hormone effectively minimizes risk from potential Creutzfeldt-Jakob disease virus contamination. Horm Res 35: 161-166
18. 18. Pocchiari M (1994) Prions and related neurological diseases. Mol Aspects Med 15: 195-291
19. 19. Prusiner SB (1993) Prion diseases of humans and animals. State of the Art Lecture given at a conference on human prion diseases held at the Royal College of Physicians of London, 17 May
20. 20. Reed LJ, Muench H (1938) A simple method of estimating fifty per cent endpoints. Am J Hyg 27: 493-497
21. 21. Taylor DM (1993) Inactivation of SE agents. Br Med Bull 49: 810-821
22. 22. Taylor Dm, Fraser H, McConnell I, Brown DA, Brown KL, Lanza KA, Smith GRA (1994) Decontamination studies with the agents of bovine spongiform encephalopathy and scrapie. Arch Virol 139: 313-326