PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION
    9.
    发明申请
    PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION 审中-公开
    在药物制剂中减少可分散颗粒的方法

    公开(公告)号:US20160101181A1

    公开(公告)日:2016-04-14

    申请号:US14878079

    申请日:2015-10-08

    CPC classification number: A61K47/22 A61K39/39591 A61K47/26

    Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

    Abstract translation: 本公开内容提供了包含表面活性剂并且具有每个容器具有小于或等于10微米或更大直径的小于400个可隐形颗粒的稳定的蛋白质组合物,或每个容器具有小于10,000个2微米或更大的潜在颗粒。 公开了制备这种稳定蛋白质组合物的方法,其包括除去或降低降解表面活性剂的酯酶活性的操作单元。 操作单元可以是疏水相互作用层析或过滤,混合模式色谱法等。

Patent Agency Ranking