Download PDF
Thromb Haemost 2003; 90(06): 968-970
DOI: 10.1055/s-0037-1613421
Editorial Focus
Schattauer GmbH

Potency assessment of the new generation of coagulation factor concentrates – time for a new paradigm?

Albert Farrugia
1   Blood and Tissues Unit, Office of Devices, Blood and Tissues, Australian Therapeutic Goods Administration, Australia
› Author Affiliations
Further Information

Publication History

Received 16 September 2003

Accepted after revision 25 September 2003

Publication Date:
09 December 2017 (online)

Also available at
    Permissions and Reprints

 

 

  • References

  • 1 Klinge J, Ananyeva NM, Hauser CA. et al. Hemophilia A – from basic science to clinical practice. Semin Thromb Hemost 2002; 28: 309-22.
    Thieme ConnectPubMedSearch in Google Scholar
  • 2 Kreuz W, Ettingshausen CE, Zyschka A. et al. Inhibitor development in previously untreated patients with hemophilia A: a prospective long-term follow-up comparing plasma-derived and recombinant products. Semin Thromb Hemost 2002; 28: 285-90.
    Thieme ConnectPubMedSearch in Google Scholar
  • 3 Warrier I, Ewenstein BM, Koerper MA. et al. Factor IX inhibitors and anaphylaxis in hemophilia B. J Pediatr Hematol Oncol 1997; 19: 23-7.
    CrossrefPubMedSearch in Google Scholar
  • 4 Ingerslev J, Christiansen K, Ravn HB. et al. and the Recombinate Study Group. Antibodies to heterologous proteins in hemophilia A patients receiving recombinant factor VIII (Recombinate). Thromb Haemost 2002; 87: 626-34.
    Thieme ConnectPubMedSearch in Google Scholar
  • 5 Esmon PC, Kuo HS. MA Fournel Characterization of recombinant factor VIII and a recombinant factor VIII deletion mutant using a rabbit immunogenicity model system. Blood 1990; 76: 1593-600.
    PubMedSearch in Google Scholar
  • 6 White 2nd GC, Beebe A, Nielsen B. Recombinant factor IX. Thromb Haemost 1997; 78: 261-5.
    Thieme ConnectPubMedSearch in Google Scholar
  • 7 Eriksson RK, Fenge C, Lindner-Olsson E, Ljungqvist C, Rosenquist J, Smeds AL, ostlin A, Charlebois T, Leonard M, Kelley BD, Ljungqvist A. The manufacturing process for B-domain deleted recombinant factor VIII. Semin Hematol 2001; 38 2 Suppl 4 24-31.
    CrossrefPubMedSearch in Google Scholar
  • 8 European Public Assessment Report for Re-Facto. European Medicines Evaluation Agency. 2003 On http://www.eudra.org/human docs/Humans/EPAR/Refacto/Refacto.htm.
    PubMedSearch in Google Scholar
  • 9 Sandberg H, Almstedt A, Brandt J. et al. Structural and functional characteristics of the B-domain-deleted recombinant factor VIII protein, r-VIII SQ.Thromb Haemost. 2001 85. 93-100.
    PubMedSearch in Google Scholar
  • 10 Hubbard AR, Sands D, Sandberg E. et al. A multi-centre collaborative study on the potency estmation of Refacto. Thromb Haemost 2003; 90: 1118-23.
    PubMedSearch in Google Scholar
  • 11 Gruppo RA, Brown D, Wiles MM, Navickis RJ. Comparative effectiveness of full-length and B-domain deleted factor VIII for prophy- laxis – a meta-analysis. Hamophilia 2003; 9: 251-60.
    PubMedSearch in Google Scholar
  • 12 Hubbard AR, Weller LJ, Bevan SA. Activation profiles of factor VIII in concentrates reflect one-stage/chromogenic potency discrepancies. Br J Haematol 2002; 117: 957-60.
    CrossrefPubMedSearch in Google Scholar
  • 13 European Medicines Evaluation Agency 2003. Introduction of a change to Refacto drug product specific activity. Specification increase of 20% in the amount of Refacto protein in each vial..
    PubMed
  • 14 Mattes R. The production of improved tissue-type plasminogen activator in Escherichia coli. Semin Thromb Hemost 2001; 27: 325-36.
    Thieme ConnectPubMedSearch in Google Scholar
  • 15 Negrier C, Lienhart A. Overall experience with NovoSeven. Blood Coagul Fibrinolysis 2000; 11 (Suppl. 01) Suppl S19-24.
    CrossrefPubMedSearch in Google Scholar