Extended Stability and Sterility of Antihemophilic Factor Human.

Abstract

Antihemophilic factor human is a factor VIII product used to supplement those with hemophilia. Recent data show treatment benefit and cost saving opportunities if factor products are administered as a continuous infusion rather than conventional bolus dose. This method has not been widely used given the lack of evidence for safe and effective use beyond 3 hours from preparation. The objectives of this study were to determine the physical and chemical stability and sterility of antihemophilic factor human over a 7-day period. Antihemophilic factor human was obtained from the manufacturer. Baseline stability and sterility were determined by factor activity levels along with bacterial and fungal cultures. These tests were also evaluated over a span of 7 days at room temperature and under refrigeration. Each sample was inspected at the time of delivery and showed no visible signs of physical changes. Factor activity levels were maintained between 88% and 102% of baseline measurements. No growth was observed for bacterial or fungal cultures in any sample after 4 weeks of incubation. Antihemophilic factor human maintained physical stability and chemical stability and remained sterile for the 7-day period, allowing extended stability and continuous infusions to be considered.