Recombinant blood components: clinical administration today and tomorrow

Improvements in the technology of whole blood fractionation have resulted in the development of many subfractions that allow more specific management of clotting deficiencies, such as the hemophilias. Infective disasters have occurred in recent years, which has led to concern regarding the use of human blood components. There has been great interest in the search for alternatives, such as synthetic volume expanders, antifibrinolytic drugs, and hormones to stimulate bone marrow production. Recombinant technology has developed rapidly over the past 15 years, and several products are now available for use, including recombinant factor VIII and recombinant factor VIIa for the treatment of hemophilia and recombinant erythropoietin to stimulate red blood cell production. As these recombinant proteins are complex, they require mammalian cell lines as their substrate. Recombinant processes have the potential to produce sufficient quantities of these products for the treatment of patients around the world independent of a human plasma source. The introduction of all of the new recombinant products has been done in an orderly fashion through clinical trials. Erythropoietin was extensively reviewed initially for its effect in chronic renal failure patients and appears to have other applications. Recombinant factor VIII has now become a mainstay of treatment for many patients with hemophilia A, and recombinant factor VIIa has a major role to play in the management of patients with inhibitors to factors VIII and IX. We anticipate the availability of other recombinant blood proteins soon.