METHOD OF PRODUCING ANTI-RHESUS HUMAN BLOOD PLASMA Russian patent published in 2024 - IPC A61K35/16 A61K39/395 A61P7/00 

FIELD: industrial transfusiology; pharmaceutical biotechnology.

SUBSTANCE: invention can be used to produce anti-Rhesus plasma for producing medicinal preparations of human anti-Rhesus immunoglobulin. Method involves searching for potential donors of anti-rhesus plasma using an accessible transfusion information system for given parameters (Rh-negative affiliation and withdrawal from donations due to detection of anti-erythrocytic antibodies in the blood); formation of a pool of donors with an anti-D antibody titre of 1:64 and higher; preparation of plasma by automatic plasmapheresis with an average volume of 600 ml or from a blood dose by centrifugation with an average volume of 250 ml; determining content of anti-D antibodies by indirect hemagglutination in comparison with a standard with known content of anti-D antibodies. For this purpose, serial 1.5-fold dilutions of plasma samples are prepared, starting with a dilution twice lower than the antibody titre detected in the donor's blood, and 1.5-fold dilutions of the reference in the range of content of anti-D antibodies from 0.002 to 0.020 IU/ml. Content of anti-D antibodies in the analyzed sample is determined by multiplying the amount of anti-D antibodies in the maximum dilution of the reference, at which agglutination of erythrocytes is observed, for maximum dilution of the analyzed sample with presence of hemagglutination.

EFFECT: use of the invention increases efficiency of using donor plasma, reduce labor costs associated with a technologically complex procedure for immunization of donors with human erythrocytes, due to the use of blood plasma of donors naturally immunized to D-antigen, and standardizing donor plasma by content of anti-D antibodies in international units.

2 cl, 3 tbl, 5 ex