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Viral safety of a new highly purified factor VIII (OCTATE)
Author(s) -
Biesert Lothar,
Lemon Stanley,
Goudeau Alain,
Suhartono Haryadi,
Wang Lingru,
Brede HansDieter
Publication year - 1996
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/(sici)1096-9071(199604)48:4<360::aid-jmv10>3.0.co;2-f
Subject(s) - virology , sindbis virus , pseudorabies , virus , poliovirus , pasteurization , viral envelope , herpes simplex virus , hepatitis c virus , biology , microbiology and biotechnology , chemistry , food science , rna , biochemistry , gene
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 VIII 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 10 . The combination of the solvent/detergent step used in the manufacture of OCTAVI with this modified pasteurisation leads to a double virus‐inactivated factor VIII concentrate (OCTATE) with a viral safety distinctly superior to monoinactivated products. © 1996 Wiley‐Liss, Inc.