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치료용 면역글로불린 제제 제조에 사용되는 산성 완충액, 이를 이용한 치료용 면역글로불린 제제 제조방법 및 이 제조방법으로 제조된 치료용 면역글로불린 제제
专利权人:
NAHM; Dong-ho
发明人:
NAHM, Dong-ho,남동호,JEON, Sook-yeong,전숙영
申请号:
KRKR2015/003148
公开号:
WO2015/152598A1
申请日:
2015.03.31
申请国别(地区):
WO
年份:
2015
代理人:
摘要:
The present invention relates to: an acidic buffer used for preparing a therapeutic immunoglobulin preparation a method for preparing a therapeutic immunoglobulin preparation by using the same and an immunoglobulin preparation prepared by the preparation method. The present invention provides an acidic buffer used for preparing a therapeutic immunoglobulin preparation, comprising a 5-50 mM acidic sodium citrate solution, which is used as an acidic buffer for eluting immunoglobulin proteins from an immunoglobulin adsorption resin, and provides, as a preparation method, a method for preparing a therapeutic immunoglobulin preparation, comprising three steps of: a) an adsorption step of allowing immunoglobulin proteins to be adsorbed into an immunoglobulin adsorption resin by making a cell culture medium, which contains the blood plasma or immunoglobulin proteins of a mammal, come into contact with the immunoglobulin adsorption resin b) a washing step of removing, through washing, other materials other than the immunoglobulin proteins adsorbed into the immunoglobulin adsorption resin by allowing a washing solution to pass through the immunoglobulin adsorption resin after the adsorption step is completed and c) an elution step of preparing a final therapeutic immunoglobulin preparation by allowing an acidic buffer, comprising the 5-50 mM sodium citrate solution, to pass through the immunoglobulin adsorption resin so as to elute the immunoglobulin proteins adsorbed into the immunoglobulin adsorption resin after the washing step is completed. In addition, the present invention provides a therapeutic immunoglobulin preparation comprising immunoglobulin proteins and the 5-50 mM sodium citrate solution.La présente invention concerne : un tampon acide utilisé pour préparer une préparation dimmunoglobuline thérapeutique un procédé de préparation dune préparation dimmunoglobuline thérapeutique à laide de ce dernier et une préparation dimmunoglobuline préparée par le procédé de
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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