use of a formulation, pharmaceutical formulation, uses of a humanized 2h7 antibody, method of enhancing or maintaining solubilization, method of increasing antibody bioavailability and in vitro dialysis method
GENENTECH, INC., EMPRESA AMERICANA;F. HOFFMANN-LA ROCHE AG.
发明人:
ADITYA WAKANKAR,BRIAN LOBO,HANNS-CHRISTIAN MAHLER,PIERRE GOLDBACH,RITA L. WONG,SABRINA LO,YUCHANG JOHN WANG
申请号：
BRPI0916042
公开号：
BRPI0916042A2
申请日:
2009.11.16
申请国别(地区):
BR
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.
