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STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES
专利权人:
发明人:
GODAWAT RAHUL,WARIKOO VEENA,PATIL ROHAN,KONSTANTINOV KONSTANTIN,RYAKALA VENKAT KISHORE
申请号:
IN201637024705
公开号:
IN201637024705A
申请日:
2016.07.19
申请国别(地区):
IN
年份:
2016
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:
http://www.ckcest.cn/home/

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