Stabilized formulations containing anti-Ang2 antibodies

摘要

The present invention provides pharmaceutical formulations comprising an antibody that specifically binds to angiopoietin 2 (Ang-2). The formulations may contain, in addition to an anti-Ang-2 antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months and after being subjected to thermal and other physical stress.

主权项

1. A stable pharmaceutical formulation comprising:
(i) an antibody at a concentration of from 20±3 mg/ml to 60±9 mg/ml that binds specifically to human angiopoietin 2 (human Ang-2), wherein the antibody comprises a heavy chain variable domain (HCVD) having the amino acid sequence of SEQ ID NO:18 and a light chain variable domain (LCVD) having the amino acid sequence of SEQ ID NO:20; (ii) histidine at a concentration of 10±1.5 mM; (iii) polysorbate 20 in an amount of 0.2% w/v±0.03% w/v; and (iv) sucrose in an amount of 10% w/v±1.5% w/v, wherein the formulation has a pH of 6±0.3, and at least 92% of the antibody has native conformation when the formulation is kept at about 45° C. for up to about 28 days.