Virus validation experiments on the production process of OCTAVI SDPlus

The inactivation of both transfusion-relevant and model viruses by modified pasteurization has been evaluated following the established guidelines of the European Union Committee for Proprietary Medical Products Ad Hoc Working Party on Biotechnology/Pharmacy. This heat treatment in solution for 10 h at 63 degrees C was introduced into the manufacturing process of OCTAVI, a very high purity factor VIII concentrate stabilized by von Willebrand factor. It could be demonstrated that both enveloped (human immunodeficiency virus, herpes simplex virus, pseudorabies virus) and non-enveloped viruses (poliovirus, coxsackievirus, hepatitis A virus) were inactivated by this heating step with an efficacy of greater than 4.5 log10 TCID50. The combination of the solvent/detergent step already used in the manufacture with this modified pasteurization leads to a double virus-inactivated factor VIII concentrate (OCTAVI SDPlus) with a viral safety distinctly superior to monoinactivated products.