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STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES
专利权人:
Genzyme Corporation
发明人:
Rohan Patil,Chad Varner
申请号:
US16543247
公开号:
US20200069822A1
申请日:
2019.08.16
申请国别(地区):
US
年份:
2020
代理人:
摘要:
Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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.
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