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Does the factor IXa content of factor IX products impact function, safety and efficacy?

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Does the factor IXa content of factor IX products impact function, safety and efficacy

Gerald Schrenk, Werner Hoellriegl, Alexandra Schiviz, Hanspeter Rottensteiner, Friedrich Scheiflinger, Hans Peter Schwarz, Peter L. Turecek, Eva-Maria Muchitsch

Baxter Innovations GmbH, Vienna, Austria

Introduction

Human coagulation factor IX (FIX) is a vitamin-K-dependent coagulation factor whose absence or  dysfunction causes hemophilia B. Treatment of hemophilia B is based on replacement therapy using highly purified FIX concentrates. Baxter has developed RIXUBIS, a recombinant factor IX (rFIX) for treating hemophilia B patients that is produced in a CHO cell line using a serum and protein-free fermentation technology. Baxter’s rFIX resembles commercially available rFIX except that it has a significantly lower FIXa content, which might improve standardization compared with commercial rFIX products. The aim of this study was to evaluate the function, safety and efficacy of RIXUBIS compared with a commercially available rFIX regarding activated FIX (FIXa) content.

Summary & Conclusions

•The FIXa content of rFIX preparations
-affected FIX potency determination
-influenced the thrombogenic potential of rFIX
-did not affect the hemostatic effect of rFIX in hemophilia B mouse models
•Published and our new experimental data indicate that a low FIXa content of rFIX products is desirable (Grey et al., Thromb Haemost. 1995 Apr;73(4):675)