TANG, XIAOLIN,汤 晓林,湯 曉林,LUDWIG, DAVID BRETT,路德维格 大卫,路德維格 大衛
申请号：
TW107125081
公开号：
TW201919582A
申请日:
2018.07.20
申请国别(地区):
TW
年份:
2019
代理人:
摘要：
The present invention provides drug products comprising sealed containers containing a stable liquid recombinant protein, such as an antigen-binding protein, composition and a headspace gas comprising less than 5% oxygen, and methods of producing same. As such, the present invention provides a method for controlling the oxygen levels in the headspace of a drug product in a sealed container comprising a stable liquid recombinant protein composition and a headspace gas comprising less than 21% oxygen.本發明提供包括密封容器之藥品，所述密封容器含有諸如抗原結合蛋白之穩定液體重組蛋白的組合物及包括少於5%氧氣之頂部空間氣體；及其製造方法。因此，本發明提供一種用於控制密封容器中之藥品之頂部空間中的氧含量之方法，所述密封容器包括穩定液體重組蛋白組合物及包括少於21%氧氣之頂部空間氣體。
