Composition of intravenous immune globulin

Claim 1

A process for the preparation of an unmodified, native gamma immune globulin for intravenous administration comprising the steps of: a., suspending of IgG Cohn Fraction II in an aqueous solution of about 2 to 10% w/v ethanol at a protein concentration of about 1 to 4% w/v at a temperature of 2°-5° C.; b., adjusting the pH of the suspension to about 7.6±0.2; c., adding NaCl to the suspension to obtain salt concentration of 0 to 2 mM NaCl; d., allowing the suspension to stand for 6 to 18 hrs. to precipitate IgM, IgA, enzymes, polymeric forms of IgG impurities and to obtain equilibrium between precipitated impurities and dissolved IgG; e., removing the precipitated impurites to obtain a dilute IgG solution; f., stabilizing the dilute IgG solution by adding Human Serum Albumin to obtain an IgG/albumin ratio of 1/1 to 2/1; g., adjusting NaCl concentration of the solution to 0 to 0.9% w/v NaCl; h., adjusting the pH of the solution to about 6.9±0.4; i., concentrating the solution by ultrafiltration to obtain a concentration of about 4% w/v IgG; j., removing the ethanol and concentrating the solution to about 4 to 6% w/v IgG by diafiltration; and k., formulating the solution with the addition of sodium chloride, carbohydrates or combinations thereof.