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Thromb Haemost 2002; 87(04): 626-634
DOI: 10.1055/s-0037-1613059
Review Article
Schattauer GmbH

Antibodies to Heterologous Proteins in Hemophilia A Patients Receiving Recombinant Factor VIII (Recombinate™)

Jørgen Ingerslev
1   Center for Hemophilia and Thrombosis, Department of Clinical Immunology, University Hospital Skejby, Aarhus, Denmark
,
Kirsten Christiansen
1   Center for Hemophilia and Thrombosis, Department of Clinical Immunology, University Hospital Skejby, Aarhus, Denmark
,
Hanne B. Ravn
1   Center for Hemophilia and Thrombosis, Department of Clinical Immunology, University Hospital Skejby, Aarhus, Denmark
,
Gordon L. Bray
2   Baxter BioScience, Glendale, California, USA
,
Edward D. Gomperts
2   Baxter BioScience, Glendale, California, USA
,
The Recombinate Study Group › Author Affiliations
Further Information

Publication History

Received 26 May 2001

Accepted after resubmission 09 January 2002

Publication Date:
08 December 2017 (online)

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Summary

As a consequence of the manufacturing process, trace quantities of Chinese hamster ovary cell protein, bovine serum albumin and murine immunoglobulin G are present in Recombinate™ recombinant human factor VIII (rhFVIII). The development of antibodies (Abs) to these heterologous proteins was evaluated during long-term rhFVIII therapy of hemophilia A in 68 previously treated and 73 previously untreated patients. Ab prevalence was also assessed in 157 non-hemophilic subjects. Abs against heterologous proteins could be detected in varying percentages of patients and non-hemophilic subjects. Abs arose in patients sporadically, and levels were typically low. There were no adverse events associated with development or presence of anti-heterologous protein Abs. These data indicate that sustained immune responses to trace levels of heterologous proteins are very infrequent during long-term rhFVIII therapy.

Keywords

Factor VIII - recombinant proteins - CHO cells - antibodies - monoclonal - serum albumin - bovine
 

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