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Grifols’ factor IX concentrates: new findings in biochemical characteristics and safety profiles

The control of bleeding in patients with haemophilia B requires replacement of the deficient coagulation protein, factor IX (FIX). From the late 1950s to the early 1970s, fresh frozen plasma (FFP) was used as a source of FIX [1]. The main drawback to this treatment strategy was the low quantity of FIX contained in FFP. Large intravenous infusions were needed to adequately raise FIX levels, frequently leading to fluid overload. In 1972, the use of FFP was superseded by prothrombin complex concentrates (PCCs) and activated PCCs (aPCCs), intermediatepurity pooled plasma products containing FIX and varying amounts of the other vitamin K-dependent clotting factors II, VII and X. Although highly effective haemostatic agents, PCCs and, particularly, aPCCs have been associated with thrombotic complications, including disseminated intravascular coagulopathy and myocardial infarction [2,3]. The introduction of highly purified plasma-derived FIX (pdFIX) concentrates to the US market in 1991 represented a tremendous advance in haemophilia B therapy. Grifols manufactures two ultrapurified pdFIX products: US-manufactured AlphaNine SD (Los Angeles, California, USA) and Factor IX Grifols (Parets del Vallés, Spain) manufactured in Spain. To safeguard the health of persons with haemophilia B who receive Grifols pdFIX products, Grifols employs a number of safety measures that begin with plasma donation and continue throughout the manufacturing process.