Viral safety of a new highly purified factor VIII (OCTATE)
✍ Scribed by Biesert, Lothar; Lemon, Stanley; Goudeau, Alain; Suhartono, Haryadi; Wang, Lingru; Brede, Hans-Dieter
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 666 KB
- Volume
- 48
- Category
- Article
- ISSN
- 0146-6615
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✦ Synopsis
The inactivation of both transfusion-relevant and model viruses by modified pasteurisation (10 hours at 63°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 Vlll concentrate stabilised only by von Willebrand factor, in the presence of a proprietary mixture of low molecular weight stabilisers. 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 log,,. The combination of the solvent/detergent step used in the manufacture of OCTAVI with this modified pasteurisation leads to a double virus-inactivated factor Vlll concentrate (OCTATE) with a viral safety distinctly superior to monoinactivated products.