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Method and formulation for reducing aggregation of a macromolecule under physiological conditions
专利权人:
F. Hoffmann-La Roche AG;GENENTECH, INC.; INC.;GENENTECH
发明人:
Lobo, Brian,Lo, Sabrina,Wakankar, Aditya,Wang, Yuchang John,Wong, Rita L.,Goldbach, Pierre,Mahler, Hanns-Christian
申请号:
AU2009313756
公开号:
AU2009313756B2
申请日:
2009.11.16
申请国别(地区):
AU
年份:
2015
代理人:
摘要:
The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.
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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