| abstract |
The invention relates to a method for producing a virus-safe, storage-stable and intravenously tolerable immunoglobulin G preparation, in which the precipitant is removed from a plasma freed of coagulation factors or an IgG-containing plasma or serum fraction using diafiltration or gel filtration sets the desired ion composition, subjects the protein solution obtained to separate the IgG from the remaining proteins to fractionation on an ion exchanger, removes the proteolytic enzymes in the resulting IgG solution by affinity chromatography on a sorbent coupled with a dye and / or inhibits them by adding antithrombin III , the IgG solution stabilized in this way at a protein concentration of 20 to 60 g / l and a pH of 6.0 to 8.0 treated with 0.03 to 0.07% β-propiolactone and after dilution to a protein concentration of 5 to 20 g / l of irradiation with UV light throws, the sterilized, diluted IgG solution to remove low-molecular substances again diafiltered or gel filtered and the stabilized and sterilized solution is adjusted to the desired protein content and sterile filtered. |