Production processes of licensed recombinant factor VIII preparations

Seminars in Thrombosis and Hemostasis

Volumn 27, Issue 4, 2001, Pages 385-394

  Boedeker, B G D ^a  

^a BAYER AG   (Germany)

Author keywords

Bayer Kogenate ; FS; Helixate ; Kogenate ; KOGENATE ; Mammalian cell culture; Recombinate ; ReFacto ; Virus safety

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 8;

ANIMAL CELL; CELL CULTURE; CULTURE MEDIUM; DRUG APPROVAL; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; GENETIC ENGINEERING; HEMOPHILIA A; HUMAN; HUMAN CELL; MAMMAL CELL; NONHUMAN; PRIORITY JOURNAL; REVIEW;

ANIMALS; CELL LINE; FACTOR VIII; HUMANS; INDUSTRIAL MICROBIOLOGY; PROTEIN ENGINEERING; RECOMBINANT PROTEINS; TRANSFORMATION, GENETIC;

EID: 0034869020     PISSN: 00946176     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2001-16891     Document Type: Review

References (27)

1. Structure of human factor VIII
2. Molecular cloning of a cDNA encoding human anithemophilic factor
3. Factor VIII gene and hemophilia A
4. Expression of active human factor VIII from recombinant DNA clones
5. The manufacturing of recombinant factor VIII, Kogenate®
6. The manufacturing of recombinant factor VIII, Recombinate®
7. Production of recombinant factor VIII from perfusion cultures: I. Large scale fermentation
8. Production of recombinant factor VIII from perfusion cultures: II. Large scale purification
9. Inactivation of viruses in labile blood derivatives: Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combination
10. Virus safety considerations for recombinant factor VIII (rFVIII, Kogenate®)
11. Insight into the structure, function and biosynthesis of factor VIII through recombinant DNA technology
12. Design and operation of a recombinant mammalian cell manufacturing process
13. Effect of von Willebrand factor coexpression on the synthesis and secretion of factor VIII in CHO cells
14. Cell culture and purification process - Purity and safety testing
15. Recombinate®: Viral safety and final product manufacturing testing and specifications
16. Novel forms of B-domain-deleted recombinant factor VIII molecules. Construction and biochemical characterization
17. Second generation, B-domain deleted recombinant factor VIII
18. Development of a freeze-dried albumin-free formulation for recombinant factor VIII SQ
19. Albumin-free formulated recombinant factor VIII preparations - How big a step forward?
20. New manufacturing process for recombinant antihemophilic factor (rFVIII)
21. Recombinate Kogenate® formulation development
22. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy