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    • 8. 发明申请
    • PRODUCTION OF A BIOPHARMACEUTICAL PRODUCT
    • 生产生物制品
    • US20120193264A1
    • 2012-08-02
    • US13499738
    • 2010-09-29
    • Magali BarbarouxSamuel DoreyMareva GueneronOscar Reif
    • Magali BarbarouxSamuel DoreyMareva GueneronOscar Reif
    • B65D85/84B65B1/04
    • C12M23/14C12M29/00C12M29/04
    • Process of producing a biopharmaceutical product includes providing a pouch unit including a pouch and at least one port, and optionally, a functional device; filling the pouch with the product; carrying out the production process, and at at least one stage thereof, using or generating a liquid or small solid incident body within the biopharmaceutical product; the pouch unit incorporating a support and replacement element formed by or integrated in the pouch wall, or in the port or functional device so as to be accessible from the inside space and be in direct physical contact with the contents of the pouch, arranged so as to be able to be loaded with the incident body and pass between the support and replacement element and the contents, such that the incident body is loaded on the support and replacement element when it is not or should not be within the biopharmaceutical product.
    • 生产生物药物产品的方法包括提供包括袋和至少一个端口的袋单元,以及任选的功能性装置; 用产品填充袋子; 进行生产过程,并在其至少一个阶段,在生物药物产品内使用或产生液体或小固体入口体; 所述袋单元包括由所述袋壁形成或集成在所述袋壁中的所述支撑和替换元件,或所述端口或功能装置中,以便能够从所述内部空间接近并与所述袋的内容物直接物理接触, 能够装载入射体并在支撑和更换元件与内容物之间通过,使得当不是或不应该在生物药物产品内时,入射体被装载在支撑和替换元件上。