VIRAL SAFETY OF A NEW HIGHLY PURIFIED FACTOR-VIII (OCTATE)

The inactivation of both transfusion-relevant and model viruses by mod ified pasteurisation (10 hours at 63 degrees C in solution) has been e valuated following the established guidelines of the EU CPMP Ad Hoc Wo rking Party on Biotechnology/Pharmacy. This heat treatment was introdu ced into the manufacturing process of OCTAVI, a very high purity facto r VIII concentrate stabilised only by von Willebrand factor, in the pr esence of a proprietary mixture of low molecular weight stabilisers. B oth enveloped (human immunodeficiency virus, Sindbis virus, herpes sim plex virus, pseudorabies virus) and nonenveloped viruses (poliovirus, Coxsackievirus, hepatitis A virus) were inactivated by this heating st ep by more than 4.7 log(10). The combination of the solvent/detergent step used in the manufacture of OCTAVI with this modified pasteurisati on leads to a double virus-inactivated factor VIII concentrate (OCTATE ) with a viral safety distinctly superior to monoinactivated products. (C) 1996 Wiley-Liss, Inc.