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. 1996 Apr;48(4):360-6.
doi: 10.1002/(SICI)1096-9071(199604)48:4<360::AID-JMV10>3.0.CO;2-F.

Viral safety of a new highly purified factor VIII (OCTATE)

L Biesert  1 , S Lemon, A Goudeau, H Suhartono, L Wang, H D Brede
Affiliations

Viral safety of a new highly purified factor VIII (OCTATE)

L Biesert et al. J Med Virol. 1996 Apr.

Abstract

The inactivation of both transfusion-relevant and model viruses by modified pasteurisation (10 hours at 63 degrees C in solution) has been evaluated following the established guidelines of the EU CPMP Ad Hoc Working Party on Biotechnology/Pharmacy. This heat treatment was introduced into the manufacturing process of OCTAVI, a very high purity factor VIII concentrate stabilized only by von Willebrand factor, in the presence of a proprietary mixture of low molecular weight stabilizers. Both enveloped (human immunodeficiency virus, Sindbis virus, herpes simplex virus, pseudorabies virus) and nonenveloped viruses (poliovirus, Coxsackievirus, hepatitis A virus) were inactivated by this heating step by more than 4.7 log10. The combination of the solvent/detergent step used in the manufacture of OCTAVI with this modified pasteurization leads to a double virus-inactivated factor VIII concentrate (OCTATE) with a viral safety distinctly superior to monoinactivated products.

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