Viral safety of b-domain deleted recombinant factor VIII

Seminars in Hematology

Volumn 38, Issue 2 SUPPL. 4, 2001, Pages 32-39

  Charlebois, T S ^a   O'Connell, B D ^a   Adamson, S R ^a   Brink Nilsson, H ^a   Jernberg, M ^a   Eriksson, B ^a   Kelley, B D ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN SERUM ALBUMIN; RECOMBINANT BLOOD CLOTTING FACTOR 8;

CELL CULTURE; CHO CELL; DRUG CONTAMINATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; HEMOPHILIA; HUMAN; MONITORING; PRIORITY JOURNAL; REVIEW; VIRUS INACTIVATION; VIRUS TRANSMISSION;

EID: 0034968338     PISSN: 00371963     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0037-1963(01)90106-4     Document Type: Review

References (37)

1. Viral safety of clotting factor concentrates
2. Clinical evaluation of viral safety of coagulation factor VIII and IX concentrates
3. Human parvovirus B19 infection in hemophiliacs first infused with two high purity, virally attenuated factor VIII concentrates
4. Transmission of human parvovirus B19 by coagulation factor concentrates
5. Removal/neutralization of hepatitis A virus during manufacture of high purity, solvent/detergent factor VIII concentrate
6. Life-threatening human parvovirus B19 infection in immunocompetent haemophilia
7. Elimination parvovirus B19 from blood products
8. Acute hepatitis A in haemophiliacs
9. Acute hepatitis A in patients with haemophilia A
10. Outbreak of hepatitis A among Italian patients with haemophilia
11. Hepatitis A among persons with hemophilia who received clotting factor concentrate - United States, September-December 1995
12. TT virus is present in a high frequency of Italian hemophiliac patients transfused with plasma-derived clotting factor concentrates
13. Recombinate: Viral safety and final product manufacturing testing and specifications
14. Virus safety considerations for recombinant factor VIII (rFVIII, Kogenate)
15. Viral safety of recombinant factor IX
16. Parvovirus B19 DNA is frequently present in recombinant coagulation factor VIII products
17. Expression and structure-function properties of recombinant factor VIII
18. Design and operation of a recombinant mammalian cell manufacturing process for rFVIII
19. Cell culture and purification process - Purity and safety testing
20. Relationships among product characterization, process validation and preclinical/clinical studies for well characterized products
21. Genetics of somatic mammalian cells, VII. Induction and isolation of nutritional mutants in Chinese hamster cells
22. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
23. Cell bank characterization for recombinant DNA mammalian cell lines
24. Endogenous origin of defective retroviruslike particles from a recombinant Chinese hamster ovary cell line
25. Transformation and oncogenesis: Retroviruses
26. A multifaceted approach to assure that recombinant rPA is free of adventitious virus
27. The purification process for recombinant factor VIII SQ
28. Viral safety of solvent-detergent treated blood products
29. Quantitative assays for evaluation of HTLV-III inactivation procedures: Tri(n-butyl)phosphate:sodium cholate and β-propiolactone
30. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations
31. Human parvovirus B19 infection in hemophiliacs first infused with two high-purity, virally attenuated factor VIII concentrates
32. Transmission of human parvovirus B19 by coagulation factor concentrates
33. Life-threatening human parvovirus B19 infection in immunocompetent haemophilia
34. Human parvovirus infection in haemophiliacs first infused with treated clotting factor concentrates
35. Transmission of symptomatic parvovirus B19 infection by clotting factor concentrate