study on the application efficacy of solvent-detergent [S/D] treatment in the process of purifying factor VII from prothrombin complex

ABSTRACT

The risks of transmitting viral infection by blood and plasma-derived products have long been known and still remain an area of concern. In this study, in the process of purifying human factor VII from prothrombin complex, S/D treatment using tri-n-butyl phosphate and Tween 80 was employed and its capability and efficacy was studied. The results indicated that the process did not affect the biological function of the essential coagulation factors studied. In addition, the process was shown to be effective on enveloped viruses, where its inactivation factor for the model used, Herpes Simplex type I, was 5.5 logs. However, the procedure was not effective on poliovirus which was used as a model for non-enveloped viruses. It is therefore concluded that for increasing viral safety it is best to apply at least one more inactivating procedure which will be effective on non-enveloped viruses as well