coagulation factor IX (Kedrion Biopharma)

Nanofiltered factor IX (brand name: AIMAFIX) is a human plasma-derived coagulation factor IX concentrate developed by Kedrion S.p.A. for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). The manufacturing process includes a double virus inactivation strategy—solvent/detergent treatment and heat treatment—complemented by a dedicated 15 nm nanofiltration step to enhance the viral safety profile by removing both enveloped and non-enveloped viruses. As a replacement therapy, it restores the activity of factor IX in the intrinsic coagulation pathway. Once activated to factor IXa, it forms a complex with activated factor VIII to activate factor X, which subsequently facilitates the conversion of prothrombin to thrombin, leading to the formation of a stable fibrin clot and the cessation of bleeding.

Brand names

AIMAFIX

Other names

nanofiltered factor IXhuman plasma-derived coagulation factor IX concentratenanofiltered plasma-derived factor IX