Role of the mini-pool cryoprecipitate technology for cost-saving and guarantee of local Factor VIII, Von Willebrand Factor and Fibrinogen product supply: Egypt experience

Management of patients with inherited bleeding disorders (IBDs) showed remarkable advances during the last three decades. Safe plasma derived and recombinant clotting factor concentrates (CFCs) have available for prophylaxis therapy in patients with hemophilia with the aim to prevent or reduce bleeding episodes. This improved the quality of life of these patients and allowed them to be fully integrated in education and work like their non hemophiliac-peers. While this is true in the developed world, patients with IBDs living in developing world have limited access to safe CFCs. The high cost of CFCs prohibits its procurement by governments from these countries. As a consequence, patients suffer from complications of the disease as well as viral and immunological risks associated with the transfusion of fresh frozen plasma (FFP) or cryoprecipitate. Pathogen inactivation of FFP and cryoprecipitate at an affordable cost for developing countries can both increase safety of domestic plasma components as well as availability of safe treatment. A medical device for Solvent and Detergent Virus Inactivation of Cryoprecipitate was introduced into the market in 2010. The medical device was registered in Egypt in 2013. Since then, 285,250 units of cryoprecipitate were processed using these devices and helped to produce more than 32 million units of coagulation Factor VIII (FVIII) to treat more than 2000 patients with hemophilia A, von Willebrand Disease as well as other IBDs, like fibrinogen deficiency. The cost of a FVIII unit using the minipool technology was around 7 US cents which is lower than that from industrial cryoprecipitate (>14 US cents according to lowest price of FVIII concentrates in Egypt) and even much lower if compared to the mean cost of 21 US Cents for all types of CFCs according to procurement prices in Egypt as well. This supply strategy is now on going with the development of a medical device to produce local immunoglobulins for the treatment of immunodeficient patients.