Viral safety of a new highly purified factor VIII (OCTATE).
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.
Biesert
L
L
Octapharma AG, Ziegelbrücke, Switzerland.
Lemon
S
S
Goudeau
A
A
Suhartono
H
H
Wang
L
L
Brede
H D
HD
D000818:Animals; D002460:Cell Line; D002626:Chemistry, Pharmaceutical / Q000592:standards; D003257:Consumer Product Safety; D003902:Detergents; D004340:Drug Contamination; D005169:Factor VIII; D006361:Heating; D006801:Humans; D013242:Sterilization; D014780:Viruses
D003902:Detergents; D005169:Factor VIII