Concentrate safety and efficacy

Haemophilia

Volumn 8, Issue 3, 2002, Pages 161-165

  Kasper, C K ^a  

^a JOINT REPLACEMENT INSTITUTE   (United States)

Author keywords

Concentrate; Factor IX; Factor VIII; Haemophilia A; Haemophilia B

Indexed keywords

ALBUMIN; BLOOD CLOTTING FACTOR; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; STABILIZING AGENT; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9;

APHERESIS; ARTICLE; BLOOD COMPONENT THERAPY; BLOOD DONOR; CONTROLLED STUDY; CREUTZFELDT JAKOB DISEASE; DISEASE TRANSMISSION; DRUG CONTAMINATION; DRUG POTENCY; DRUG SAFETY; HEPATITIS B; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IN VITRO STUDY; IN VIVO STUDY; INFECTION PREVENTION; NONHUMAN; PRIORITY JOURNAL; PROTEIN PURIFICATION; SCREENING TEST; SEROLOGY; VIRUS INACTIVATION; VIRUS INFECTION; HEMOPHILIA A; PHARMACOKINETICS; REVIEW; STANDARD;

FACTOR IX; FACTOR VIII; HEMOPHILIA A; HUMANS; THERAPEUTIC EQUIVALENCY; VIRUS DISEASES;

EID: 0036588866     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2516.2002.00601.x     Document Type: Article

References (24)

1. Kasper CK, Lusher JM and the Transfusion Practices Committee of the American Association of Blood Banks. Recent evolution of clotting factor concentrates for hemophilia A and B. Transfusion 1993; 33: 422-34.
2. Foster PR, Welch AG, McLean C, Griffin BD, Hardy JC, Bartlery A et al. Studies on the removal of abnormal prion protein by processes used in the manufacture of human plasma products. Vox Sang 2000; 78: 86-95.
3. Farrugia A. Variant Creutzfeldt-Jakob disease and haemophilia: A risk assessment of plasma-derived products. WFH Task Force on TSEs, Bulletin 2, 2001; 1-11.
4. McDougal JS, Martin LS, Cort SP, Mozen M, Heldebrand CM, Evatt BL. Thermal inactivation of the acquired immune deficiency virus, human T-lymphotropic virus-III/lymphadenopathy-associated viruses, with special reference to antihemophilic factor. J Clin Invest 1985; 76: 878-7.
5. Knevelman A, de Wit HJC, Potstra P, Does JA. Development and small-scale productions of a severely heated factor VIII concentrate. Vox Sang 1994; 66: 89-95.
6. Dichtelmuller H, Rudnick D, Breuer B, Kotitschke R, Kloft M, Darling A et al. Improvement of virus safety of a S/D-treated factor VIII concentrate by additional dry heat treatment at 100 °C. Biologicals 1996; 24: 125-30.
7. Horowitz B, Wiebe ME, Lippin A, Stryker MH. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri (n-butyl) phosphate detergent combinations. Transfusion 1985; 25: 516-22.
8. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia N et al. Transmission of hepatitis A to patients with hemophilia by factor VIII concentrates treated with organic solvent and detergent to inactivate viruses. Ann Intern Med 1994; 120: 1-7.
9. Morfini M, Azzi A, Mannucci PM. B19 parvovirus withstands 'super heating' in antihemophilic concentrates. Thromb Haemost 1996; 76: 821.
10. Fricke W, Augustyniak L, Laurence D, Brownstein A, Kramer A, Evatt BL. Human immunodeficiency virus infection due to clotting factor concentrates: Results of the Seroconversion Surveillance Project. Transfusion 1992; 32: 707-9.
11. Berntorp E, Petrini P, Dockter G, Tengborn L, Wendisch I, Eberl W et al. An approach to study the viral safety of plasma-derived products in previously treated, non-infected patients. Haemophilia 2001; 7: 360-3.
12. Peerlinck K, Arnout J, Gilles JG, Saint-Remy J-M, Vermylen J. A higher than expected incidence of factor VIII inhibitors in multitransfused haemophilia A patients treated with an intermediate purity pasteurized factor VIII concentrate. Thromb Haemost 1993; 69: 115-8.
13. Raut S, Di Giambattista M, Bevan SA, Hubbard AR, Barrowcliffe TW, Laub R. Modification of factor VIII in therapeutic concentrates after virus inactivation by solvent-detergent and pasteurization. Thromb Haemost 1998; 80: 624-31.
14. Wadhwa M, Dilger P, Tubbs J, Mire-Sluis A, Barrocliffe T, Thorpe R. Identification of transforming growth factor-beta as a contaminant in factor VIII concentrates: a possible link with immunosuppressive effects in hemophiliacs. Blood 1994; 84: 2021-30.
15. Lusher JM. Thrombogenicity associated with factor IX concentrate. Semin Hematol 1991; 28 (Suppl. 6): 3-5.
16. Thomas DP, Hampton KK, Dasani H et al. A crossover pharmacokinetic and thrombogenicity study of a prothrombin complex concentrate and a purified factor IX concentrate. Br J Haematol 1994; 87: 782-8.
17. Ragni MV. New-generation recombinant factor concentrates: Bridge to gene therapy. Haemophilia 2001; 7 (Suppl. 1): 28-35.
18. Hedner U, Ginsburg D, Lusher JM, High KA. Congenital hemorrhagic disorders: New insights into the pathophysiology and treatment of hemophilia. Hematology 2000. Education Program Book, 47th Annual Meeting, American Society of Hematology, San Francisco, 2000; 241-65.
19. White GC, Beebe A, Nielsen B. Recombinant factor IX. Thromb Haemost 1997; 78: 261-5.
20. Hubbard AR, Bevan SA, Weller LJ. Potency estimation of recombinant factor VIII. Effect of assay method and standard. Br J Haematol 2001; 113: 533-6.
21. Barrowcliffe TW. Recommendation for the assay of high-purity factor VIII concentrates. (Scientific Standardization Committee Communication.) Thromb Haemost 1993; 70: 876-7.
22. Lundblad RL, Kingdon HS, Mann KG, White GC. Issues with the assay of factor VIII activity in plasma and factor VIII concentrates. Thromb Haemost 2000; 84: 942-8.
23. Schulman S, Gitel S, Martinowitz U. Stability of factor VIII concentrates after reconstitution. Am J Hematol 1994; 45: 217-23.
24. Pollman H, Aledort L. Albumin-free formulated recombinant factor VIII preparations - How big a step forward? Thromb Haemost 1999; 82: 1370-1.