A METHOD TO PRODUCE A MEDICINAL PRODUCT COMPRISING A BIOLOGICALLY ACTIVE PROTEIN AND THE RESULTING PRODUCT
    1.
    发明申请
    A METHOD TO PRODUCE A MEDICINAL PRODUCT COMPRISING A BIOLOGICALLY ACTIVE PROTEIN AND THE RESULTING PRODUCT 审中-公开
    生产包含生物活性蛋白质和结果产品的药物产品的方法

    公开(公告)号:WO2014009328A1

    公开(公告)日:2014-01-16

    申请号:PCT/EP2013/064422

    申请日:2013-07-09

    Abstract: The present invention pertains to a method for producing a medicinal product comprising a biologically active protein comprising the steps of providing an aqueous composition comprising a solvent, the biologically active protein and between 20% w/w and 60% w/w of a non-polymeric sugar, freezing the composition, thereby forming at least one frozen body comprising the solvent in frozen form, putting the frozen body in a drying apparatus while being carried by a support, the support comprising one or more restraining elements that define one or more boundaries of the support, wherein at most 30% of the surface of the body is contiguous with the one or more restraining elements, reducing the pressure in the drying apparatus below atmospheric pressure, providing heat to the body in order to sublimate the frozen solvent of the body and obtain a dried body. The invention also pertains to a product obtainable by this method.

    Abstract translation: 本发明涉及一种生产包含生物活性蛋白质的药用产品的方法,包括以下步骤:提供包含溶剂,生物活性蛋白质和20%w / w至60%w / w的非水性组合物的水性组合物, 聚合糖,冷冻组合物,从而形成至少一个包含冷冻形式的溶剂的冷冻体,将冷冻的身体放在干燥装置中同时被支撑物携带,所述支撑体包括限定一个或多个边界的一个或多个约束元件 的载体,其中至少30%的身体表面与一个或多个限制元件邻接,将干燥装置中的压力降低到大气压力以下,为身体提供热量,以便使冷冻溶剂升华 身体并获得干燥的身体。 本发明还涉及通过该方法可获得的产品。

Patent Agency Ranking