Removal of S/D virus-inactivating reagents after inactivation procedure by immunoglobulins

Different methods of virus elimination with the goal of preparing virus-safe therapeutic immunoglobulin preparations have been investigated. Virus inactivation strategies are in generally dictated by the lability of the virusand the stabilityof the biological activity of the protein in question. No single methods has proven to be optimal for this purpose. The results obtained with low pH treatment in combination with solvent-detergent (S/D) method ensure the virus safety of immunoglobulins for therapeutic use. S/D method include treatment with solvent, tri(n-butyl) phosphate, and nonionic detergent (Triton X-100), and it was shown to be effecient for lipid-enveloped viruses (HIV, hepatitis C). In present work we studied a new possibility of removing S/D reagent from immunoglobulins, using Amberlite adsorption resin. The entire procedure was done in one step. S/D antiviral treatment combined with Amberlite adsorption resulted in immunoglobulins with slightly increased percentage of polymers and dimers. The activity of specific atibides was slightly decreased. Changes in other biological properties were not observed.