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Updated: May 27, 2026

Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay
Published on: September 9, 2012
Room-temperature-stable recombinant activated coagulation factor VII recombinant: chemical and microbiologic
Abeline Christensen1, Jane T Jensen, Anne Mette Nøhr
1Novo Nordisk A/S, Gentofte, Denmark.
Abstract:
rFVIIa-25C is a recombinant coagulation factor VIIa (rFVIIa) formulated to remain stable at room temperature (up to 25°C) for up to 2 hours. The bolus injection of rFVIIa-25C has been reported to be bioequivalent to that of rFVIIa. With alternative administration by continuous infusion (50 μg/kg/h) for surgical hemostatic coverage in hemophilia patients with inhibitors, rFVIIa has been reported to be stable. This research letter presents data from an in vitro study of the activity and chemical stability (rFVIIa content, clot activity, and degradation products), physical stability, and microbiologic stability of rFVIIa-25C administered as a continuous infusion. The findings suggest that rFVIIa-25C remained biochemically stable and aseptic during 24-hour continuous infusion in vitro at 19.3°C to 20.7°C, with no clinically significant changes in clot activity, solution constituents, or concentrations.
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