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    • 1. 发明申请
    • 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
    • 用于大规模生产Gc球蛋白的纯化方法,由此产生的Gc-球蛋白,使用G球蛋白和Gc-球蛋白药用产品
    • US20030036638A1
    • 2003-02-20
    • US10217787
    • 2002-08-13
    • Statens Serum Institute
    • Charlotte Svaerke JoergensenInga LaursenGunnar Houen
    • C07K016/00
    • A61K38/1709C07K14/47
    • 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 said patients would benefit from the administration of Gc-globulin.
    • 描述了用于大规模生产Gc球蛋白的纯化方法。 Gc-球蛋白的来源优选是粗血浆级分,但可以是含有Gc-球蛋白的任何溶液,悬浮液或上清液,例如乳制品,初乳或发酵液。 Gc-球蛋白可以是血浆衍生的或由遗传修饰的生物体产生的。 该方法包括两个关键要素:通过一系列离子交换色谱步骤纯化,并进行至少两个病毒还原步骤。 还提供了测量患者血液样品中游离Gc-球蛋白的诊断方法,Gc-球蛋白在药物中的用途以及Gc-球蛋白药用产品的制备。 该产品可用于治疗患有循环系统疾病和并发症的患者,即预期所述患者可从Gc-球蛋白的给药中受益。