Kurkina O. Physiсo-chemical and biological properties of Anti-Herpes simplex virus type 1 immunoglobulin

The present study is dedicated to elaboration of the immunoglobulin medication for treatment diseases caused by Herpes simplex virus type 1 and characterization its physiсo-chemical and biological properties. The method of solvent/detergent viral inactivation in immunoglobulin preparations and conditions of chromatographic purification were developed. Optimal conditions of the elaborated method were optimized. It is ascertained, elaborated method inactivates at least four of the most dangerous viruses: HCV, HBV, HIV-1 and HIV-2; and efficiently inactivates DNA- and RNA-containing enveloped viruses. Scientific criteria for creation of specific standard immunoglobulins were developed. These include determination of anti-virus antibodies in samples of plasma of donor blood and intermediate products. The quantitative assay of anti-HSV-1 antibodies (titer) in specific immunoglobulin preparations was carried out and the activity, which is equal 1:80000 with avidity index in 99,7%, determined. Experimental series of specific anti-HSV-1 immunoglobulin preparation with the antibody titer 1:80000 and 99,7% avidity index was manufactured. Physico-chemical analysis has shown successful removal of residues of tri-n-butylphosphate and polysorbate 80, higher degree of fractional and electrophoretic homogeneity and higher content of monomers in comparison to traditional techniques of the immunoglobulin purification, that essentially improved it quality. It was demonstrated in vitro, elaborated preparation on the model of HSV-1 strain US had virus inactivating properties both for prophylaxis and treatment circuitry of studies. The IG medication in the medical scheme of treatment was active in a range of dilutions of 1:16 - 1:256, and, it should be noted, that even in the dilution of 1:1024 20% inhibition of viral replication observed. The scientific-technical documentation at the elaborated anti-herpes preparation was developed, namely: Analytical Normative Documentation on the "Human anti Herpes simplex virus type 1 immunoglobulin", Technological Regulations for drug manufacturing, "User manual of anti-HSV-1 immunoglobulin"