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Sterile chromatography resin and use thereof in manufacturing processes
专利权人:
Genzyme Corporation
发明人:
Godawat, Rahul,Warikoo, Veena,Patil, Rohan,Konstantinov, Konstantin,Ryakala, Venkat Kishore
申请号:
AU2015206341
公开号:
AU2015206341B2
申请日:
2015.01.16
申请国别(地区):
AU
年份:
2019
代理人:
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.
来源网站:
中国工程科技知识中心
来源网址:
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