发明名称 Antibody and protein formulations
摘要 Provided are salt-free antibody and other protein formulations that are substantially isosmotic and of low viscosity. Also provided are methods for the treatment of diseases using the disclosed formulations.
申请公布号 US9592297(B2) 申请公布日期 2017.03.14
申请号 US201313843780 申请日期 2013.03.15
申请人 BAYER HEALTHCARE LLC 发明人 Xiang Jun;Ma Xinghang
分类号 A61K39/395;A61K47/26;C07K16/38;A61K47/18;A61K47/22;C07K16/18;A61K39/00 主分类号 A61K39/395
代理机构 代理人
主权项 1. A salt-free anti-TFPI antibody formulation, comprising: a. 10 mM to 30 mM histidine, b. 50 ppm to 200 ppm of a non-ionic surfactant, c. 88 mM to 292 mM of a sugar or sugar alcohol selected from mannitol, dextrose, glucose, trehalose and sucrose, d. 10 mM to 50 mM arginine, e. 0 mM to 50 mM lysine, f. 0 mM to 133 mM glycine or alanine g. 0 mM to 10 mM methionine, and h. 1 mg/ml to 150 mg/ml of anti-TFPI human IgG2 antibody having a light chain comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:2, and wherein said anti-TFPI antibody formulation has a pH of pH 4.0 to pH 6.0, and wherein said anti-TFPI antibody formulation contains substantially no inorganic salt.
地址 Whippany NJ US