A PURIFICATION PROCESS FOR LARGE SCALE PRODUCTION OF GC-GLOBULIN, PRODUCT OBTAINED THEREBY AND THEIR USE IN MEDICINE

摘要

The present invention discloses a novel purification process for large scale production of Gc-globulin. The source of Gc-globulin is preferably a crude plasma fraction but can be any solution, suspension or supernatant containin g Gc-globulin, e.g. a milk product, colostrum or a fermentation broth. The Gc- globulin can be plasma-derived or produced by a genetic modified organism. T he process of the invention includes two key elements: purification by series o f ionexchange chromatography steps, and performing at least two virus-reductio n steps. The present invention also discloses a diagnostic method to measure t he free Gc-globulin in a patient blood sample, a use of Gc-globulin in medicine and the preparation of a Gc-globulin medicinal product. The product can be used in therapy for patients with circulatory disorders and complications, i.e. where it is contemplated that said patients would benefit from the administration of Gc-globulin.