METHOD FOR PRODUCING A STANDARD SAMPLE OF HUMAN IGG ANTIBODY CONTENT TO TICK-BORNE ENCEPHALITIS VIRUS

摘要

FIELD: biotechnology.;SUBSTANCE: invention relates to biotechnology, specifically to obtaining a standard sample of human IgG antibodies to tick-borne encephalitis virus. Method involves selection of donor plasma substance tested for absence of surface antigen of hepatitis B virus (HBsAg), antigen p24 HIV-1, antibodies to human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus, with activity 1:10 and higher; isolation of a specific immunoglobulin fraction by an alcoholic method at low temperatures with subsequent stages of ultrafiltration and concentration until obtaining solution of immunoglobulin G (not less than 95 % of total protein fraction) with content of human antibodies to TBE virus in titre from 1:80 to 1:320; introduction of stabilizers to final concentrations of glycine – 12.5 g/l, L-proline – 12.5 g/l; correcting the pH value to 5.0±0.5; sterile bottling; lyophilic drying till residual moisture content is no more than 1 %.;EFFECT: identity of the standard sample by composition and properties of the analyzed material – preparations of human immunoglobulins against TBE, and improved safety of IgG antibodies to TBE virus during storage, transportation and use of a standard sample.;1 cl, 6 ex, 4 tbl