To Improve Stability of Factor VIII Using Minipool Cryoprecipitate Lyophilized for Hemophilia a Treatment in Indonesia

Abstract

Hemophilia is the most common hereditary bleeding disorder. Across Indonesia were around 2000 people suffering hemophilia. Replacement therapy to treat bleeding with F VIII concentrate, but still imported, expensive and not always available. As a substitute it can give Minipool Cryoprecipitate (MC), but it is liquid, must be stored at -30°C. To improve that MC stability, lyophilization was carried out to become dry MC. The aim of this research is To compare the stability and safety of dry MC and liquid MC. Made of liquid MC from 70 fresh frozen plasma. Then lyophilization was carried out to make MC dry, partly with the addition of excipients and some without excipients. The content of F VIII was checked on days 0, 7, 30 and 240 at 4°C and room temperature. Safety is assessed from hemagglutinin titers and bacterial contamination. The results shows that the content of F VIII in dry MC with excipients was lower than dry MC without excipients. F VIII on dry MC without excipients remained stable until day 30 at 4°C and room temperature. Addition of excipients caused lower F VIII content. Dry MC without excipients remained stable until day 30 at 4°C and room temperature.