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. |