Pathogen safety of manufacturing processes for biological products: Special emphasis on KOGENATE® Bayer

Haemophilia

Volumn 8, Issue SUPPL. 2, 2002, Pages 6-9

  Lee, D C ^a   Miller, J L A ^a   Petteway Jr , S R ^a  

^a BAYER CORPORATION   (United States)

Author keywords

Biological products; Pathogen safety; Prion; TSE; Virus

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 8;

ARTICLE; BRAIN SPONGIOSIS; CLEARANCE; DRUG CONTAMINATION; DRUG IMPURITY; DRUG ISOLATION; DRUG MANUFACTURE; DRUG SAFETY; DRUG SCREENING; DRUG STERILITY; HUMAN; LABORATORY TEST; PATHOGENICITY; PRION DISEASE; PRIORITY JOURNAL; RISK ASSESSMENT; SIMULATION; VIRUS INACTIVATION;

BIOLOGICAL PRODUCTS; BLOOD-BORNE PATHOGENS; CONSUMER PRODUCT SAFETY; CREUTZFELDT-JAKOB SYNDROME; DRUG CONTAMINATION; FACTOR VIII; HUMANS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL; VIRUS DISEASES;

EID: 0036264630     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1351-8216.2001.00117.x     Document Type: Article

References (19)

1. Inactivation of HIV-, HBV-, HCV-related viruses and other viruses in human plasma derivatives by pasteurisation
2. Effect of terminal (dry) heat treatment on non-enveloped viruses in coagulation factor concentrates
3. Virucidal treatment of blood protein products with UVC radiation
4. Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process
5. Potential contribution of mild pepsin treatment at pH4 to the viral safety of human immunoglobulin products
6. Inactivation of viruses in labile blood derivatives. 1. Disruption of lipid-enveloped viruses by tri (n-butyl) phosphate detergent combinations
7. Inactivation of lipid-enveloped viruses in proteins by caprylate
8. Human prion disease and human prion protein disease
9. Human prion diseases
10. Prions
11. A protease-resistant protein is a structural component of the scrapie prion
12. Molecular characteristics of the major scrapie prion protein
13. Mice devoid of PrP are resistant to scrapie
14. The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy
15. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humans
16. Transmission of BSE by blood transfusion in sheep
17. Monitoring plasma processing steps with a senstitive Western blot assay for the detection of the prion protein
18. A direct relationship between partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins
19. Current approaches to the preparation of plasma fractions