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Characterization of high-purity, double virus inactivated and stable plasma-derived anti-haemophilic clotting factor-VIII/vWF complex

Background: The success in the management of haemophilia in the last two decades has been predominantly due to the availability of sufficient quantities of safe anti-haemophilic factor concentrates. Unfortunately, the prohibitive cost of these products has prevented this benefit from being available to the vast majority (~80%) of haemophiliacs living in the developing world. Methods: With this background, the article aims at demonstrating the development and characterization of a safe, economically viable, highly pure and efficient plasma-derived Factor-VIII/von Willebrand Factor complex concentrate (pdF-VIII/vWF) prepared from freshly frozen recovered plasma collected from approved blood banks across India, which is comparable to other commercially available products. This complex was subjected to solvent detergent and dry heat treatment for virus inactivation and further, characterized by various physicochemical and functional assays along with other marketed products. Results: The indigenously manufactured pdF-VIII/vWF drug product yielded ~150 IU of F-VIII/L of plasma with specific activity of 60±20 IU F-VIII/mg of total protein and functional vWF demonstrating F-VIIIC : F-VIII:Ag ratio ≈1 which is also optimum in managing vWF deficient patients, in addition to its ability to treat F-VIII deficient population. Identity of pdF-VIII/vWF was confirmed by Western blot. The high order secondary structure was confirmed using Far UV Circular Dichroism (CD) in accordance with different marketed products. pdF-VIII/vWF was proved to be stable for 24 months at 5±3 ℃. Conclusions: The present study is a milestone as it demonstrates highly pure, safe, low-cost and stable pdF-VIII/vWF complex that will be able to cater to the clinical demands of both Haemophilia A and vWF deficient patients in India as well as other developing countries of similar origin.