Purification process for large scale production of Gc-globulin, the Gc-globulin produced hereby, a use of Gc-globulin and a Gc-globulin medicinal product

摘要

A purification process for large-scale production of Gc-globulin is described. The source of Gc-globulin is preferably a crude plasma fraction but can be any solution, suspension or supernatant containing 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. The process includes two key elements: purification by series of ion exchange chromatography steps, and performing at least two virus-reduction steps. A diagnostic method to measure the free Gc-globulin in a patient blood sample, a use of Gc-globulin in medicine and the preparation of a Gc-globulin medicinal product is also provided. The product can be used in therapy for patients with circulatory disorders and complications, i.e., where it is contemplated that patients would benefit from the administration of Gc-globulin.