Estimation of efficiency of solvent-detergent method for virus inactivation in the technology of immunoglobulin production on the model of duck hepatitis B virus.

The virucidal action of solvent tributyl phosphate and detergent sodium cholate used in the production of immunoglobulin for inactivation of viruses with lipid envelope was studied on the model of duck hepatitis B virus. PCR analysis revealed no significant decrease in duck hepatitis B virus DNA concentrations after treatment with solvent/detergent. At the same time, in vivo experiments showed that treatment of duck hepatitis B virus with tributyl phosphate (concentration >0.15%) and sodium cholate (concentration >0.1%) at 37°C for 6 h or longer completely inactivated this model virus added to immunoglobulin solution in concentration 5 log ID50. Duck hepatitis B virus appears to be one of the most acceptable model viruses for validation of virus inactivating technologies in manufacturing human plasma preparations.