Method for the production of human gammaglobulin G and virus-inactivated human gammaglobulin G

摘要

Gamma-Globulin is extracting from a fraction isolated by fractionation with ethanol in the presence of carbohydrate. After reducing the contaminants with PEG is a column with an anionic exchange resin used and in an effluent from the column is the content of PEG and a solution volume reduced by ultrafiltration for sequentially an optional treatment. The solution is brought to an acid pH and at least one of the following viral inactivation steps, namely pasteurisation and a treatment with solvent/detergent. The product afterwards being precipitated and washed with PEG to eliminate any chemical viral inactivation reagents, then by solubilisation and change of pH, the protein contaminants being eliminated, and final purifying being made by ultrafiltration in order to reduce the volume and PEG content. Finally follows an optional virus filtration and subsequent concentration of the protein to a value thereof in solution to the required value of 5 % or 10 %.