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Antibody formulations
专利权人:
GENENTECH INC.
发明人:
Patapoff, Thomas,Gokarn, Yatin,Zarraga, Isidro,Zarzar, Jonathan,Wurth, Christine
申请号:
NZ75145214
公开号:
NZ751452A
申请日:
2014.03.13
申请国别(地区):
NZ
年份:
2020
代理人:
摘要:
The invention provides stable aqueous pharmaceutical formulations comprising the therapeutic antibody obinutuzumab (GA101), trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. Particularly, the present invention provides antibody formulations with a higher concentration of protein relative to trehalose resulting in a decreased risk of soluble aggregate and trailing edge dimer (TED). Specifically, a weight ratio of the antibody obinutuzumab to trehalose of 1.65-4.95 is found to decrease aggregation and improve stability of the antibody formulation. The invention also provides methods for making such formulations and methods of using such formulations. In the past years, advances in biotechnology have made it possible to produce a variety of proteins for pharmaceutical applications using recombinant DNA techniques.
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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