Process for preparing immunoglobulins for intravenous administration and other immunoglobulin products

摘要

A method for purifying immunoglobulin G from a crude fraction of immunoglobulin-containing plasma proteins is described. This method comprises a series of steps from which the anion-exchange and cation-exchange chromatography involved in series is preferably performed. During the process of purification, an acetate buffer having a pH of 5.0 to 6.0 and a molarity of 5 to 25 mM is preferably used. Further disclosed is an immunoglobulin product obtainable by this process and having a purity greater than 98%, an IgG monomer and dimer content greater than 98.5%, an IgA content less than 4 mg IgA / L and containing less than 0, 5% polymer and aggregate. This product does not include detergent, PEG or albumin as a stabilizer. The product is stable, virus-free, liquid and intended for immediate intravenous administration.