METHOD OF PRODUCING A VIRUS-FREE HUMAN IMMUNOGLOBULIN G SOLUTION FOR INTRAMUSCULAR ADMINISTRATION Russian patent published in 2020 - IPC A61K39/395 G01N33/50 

FIELD: medicine.

SUBSTANCE: invention relates to a method for preparing a virus-free immunoglobulin G solution for intramuscular administration, involving recovering immunoglobulin fraction II Cohn (sediment B) from blood plasma of healthy donors by alcohol fractionation and additional purification from impurities and viruses, where removal of viruses is carried out by deep filtration on filter material with anion-exchange effect, at pH of solution from 6.0 to 7.0, and virus inactivation is carried out by incubation of sterile immunoglobulin solution at low pH 4.5, temperature from 36 °C for 24–38 hours, with subsequent purification by ultrafiltration with simultaneous correction of protein and pH, introduction of glycine stabilizer into solution, performing sterilizing filtration, at that, sequence of technological stages and optimal process conditions for each stage aimed at viruses reduction, during the validation tests during deliberate infection of the analyzed material, the model viruses are determined, the manufacturing process is simulated on a laboratory scale and the level of viral reduction in the logarithms is determined.

EFFECT: invention provides higher quality and safety of produced immunoglobulin preparations due to introducing into the process additional stages of virus removal and inactivation, efficiency of which is confirmed experimentally.

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