Stabilized formulations containing anti-IL-33 antibodies
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsQingyan Hu, Dingjiang Liu
Life of this patent
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Abstract
The present invention provides pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-33 (hIL-33). The formulations may contain, in addition to an anti-IL-33 antibody, a buffer, 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 stresses.
Claims29
A stable liquid pharmaceutical formulation comprising:
- (i) a human antibody that specifically binds to human interleukin-33 (hIL-33), wherein the antibody comprises heavy chain complementary determining regions HCDR1, HCDR2, and HCDR3 comprising the amino acid sequences of SEQ ID NOs:
- 4, 6, and 8, respectively, and light chain complementarity determining regions LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of SEQ ID NOs:
- 12, 14, and 16, respectively, wherein the antibody is present at a concentration of from 15 mg/ml to 150 mg/ml;
- (ii) 5 mM to 15 mM acetate;
- (iii) 50 mM to 100 mM arginine hydrochloride;
- (iv) 3% w/v to 7% w/v sucrose;
- and
- (v) 0.06% w/v to 0.1% w/v polysorbate 80,
- wherein the formulation has a pH of from 5.1 to 5.5, and wherein the formulation exhibits a viscosity of less than about 15 cPoise when measured at 20° C.
A stable liquid pharmaceutical formulation comprising:
- (i) a human antibody that specifically binds to human interleukin-33 (hIL-33) at a concentration of from 15±1.5 mg/ml to 150±15 mg/ml, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 18 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 20;
- (ii) 10 mM±2 mM acetate;
- (iii) 70 mM±14 mM arginine hydrochloride;
- (iv) 5% w/v±1% w/v sucrose;
- and
- (iv) 0.08%±0.016% w/v polysorbate 80,
- wherein the formulation has a pH of from 5.1 to 5.5, and wherein the formulation exhibits a viscosity of less than about 15 cPoise when measured at 20° C.
Dependencies are inferred from the claim text.