STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES
    10.
    发明公开
    STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES 审中-公开
    STERILES CHROMATOGRAPHIEHARZ UND VERWENDUNG DAVON IN HERSTELLUNGSPROZESSEN

    公开(公告)号:EP3094392A1

    公开(公告)日:2016-11-23

    申请号:EP15702074.4

    申请日:2015-01-16

    IPC分类号: B01D15/18 B01D15/20 A61L2/08

    摘要: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.

    摘要翻译: 本文提供了降低色谱树脂的生物负载(例如灭菌)的方法,其包括将包含包含色谱树脂和至少一种抗氧化剂和/或螯合剂的组合物的容器暴露于足以减少生物负载的γ射线剂量 的容器和色谱树脂,其中至少一种抗氧化剂和/或螯合剂的存在量足以改善在暴露于γ-照射剂量之后/之后色谱树脂的结合能力的损失。 还提供了减少的生物负载层析柱,包括还原的生物负载层析树脂,包含色谱树脂和至少一种螯合剂和/或抗氧化剂的组合物,使用这些还原的生物负载层析色谱柱之一进行减少的生物负载层析色谱的方法,以及整合的封闭 以及用于减少生物负载生产纯化的重组蛋白质的连续方法。