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Virus removal method in high concentration monoclonal antibody solution
专利权人:
旭化成メディカル株式会社
发明人:
本郷 智子,小室 雅廉
申请号:
JP2011505900
公开号:
JP5755136B2
申请日:
2010.03.26
申请国别(地区):
JP
年份:
2015
代理人:
摘要:
An object of the present invention is to provide a method for removing even small viruses from a high concentration monoclonal antibody solution using a membrane, and thus for recovering the antibody within a short time at high yield in the form of a filtrate. The present invention provides a method for producing a preparation containing a monoclonal antibody, which comprises a step of removing viruses by filtering viruses in a monoclonal antibody solution using a virus-removing membrane, wherein (1) the monomer content of the monoclonal antibody accounts for 90% or more; (2) the monoclonal antibody concentration in the monoclonal antibody solution ranges from 20 mg/ml to 100 mg/ml; (3) the monoclonal antibody solution contains at least a basic amino acid; and (4) the parvovirus removal rate of the virus-removing membrane satisfies the following conditions: LRV (Log Reduction Value: logarithmic reduction value) ‰§ 4.
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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