Extended Stability and Sterility of Antihemophilic Factor Human.

OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.