Stabilized Formulations Containing Anti-Interleukin-4 Receptor (IL-4R) Antibodies

1 - 29 . (canceled)

30 . A stable pharmaceutical formulation comprising:

(i) a human antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4Rα) and comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:1 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:5;

(ii) acetate at a concentration of from 10 mM to 15 mM;

(iii) histidine at a concentration of from 15 mM to 25 mM;

(iv) sucrose at a concentration of from 2.5% w/v to 10% w/v;

(v) polysorbate at a concentration of from 0.1% w/v to 0.3% w/v; and

(vi) arginine at a concentration of from 20 mM to 100 mM,

wherein the formulation has a pH of from 5.6 to 6.2.

31 . The pharmaceutical formulation of claim 30 , wherein the acetate is present at a concentration of 12.5 mM±1.85 mM and the histidine is present at a concentration of 20 mM±0.3 mM.

32 . The pharmaceutical formulation of claim 30 , wherein the polysorbate is polysorbate 20, or polysorbate 80.

33 . The pharmaceutical formulation of claim 32 , wherein the polysorbate is polysorbate 20 at a concentration of 0.2%±0.03% w/v.

34 . The pharmaceutical formulation of claim 32 , wherein the polysorbate is polysorbate 80 at a concentration of 0.2%±0.03% w/v.

35 . The pharmaceutical formulation of claim 30 , wherein the sucrose is present at a concentration of 5%±0.75% w/v.

36 . The pharmaceutical formulation of claim 30 , wherein the arginine is present at a concentration of 25 mM±3.75 mM.

37 . The pharmaceutical formulation of claim 30 , wherein the arginine is present at a concentration of 50 mM±7.5 mM.

38 . The pharmaceutical formulation of claim 30 , wherein the viscosity of the liquid is 11±1.1 cPoise or 8.5±0.85 cPoise.

39 . The pharmaceutical formulation of claim 30 , wherein the osmolality of the liquid is 290±20 mOsm/kg.

40 . The pharmaceutical formulation of claim 30 , wherein:

(a) at least about 98% of the native form of the antibody is recovered after about six months of storage at about 5° C., as determined by size exclusion chromatography;

(b) at least about 90% of the native form of the antibody is recovered after about eight weeks of storage at about 45° C., as determined by size exclusion chromatography;

(c) less than about 45% of the antibody recovered after about eight weeks of storage at about 45° C. is an acidic form, as determined by cation exchange chromatography; or

(d) less than about 4% of the antibody recovered after six months of storage at 25° C. is aggregated, as determined by size exclusion exchange chromatography.

41 . The pharmaceutical formulation of claim 30 , wherein the pharmaceutical formulation is contained in a glass vial.

42 . The pharmaceutical formulation of claim 30 , wherein the pharmaceutical formulation is contained in a syringe.

43 . The pharmaceutical composition of claim 30 , wherein the pharmaceutical composition is contained in a prefilled syringe.

44 . The pharmaceutical composition of claim 30 , wherein the pharmaceutical composition is contained in an autoinjector.

45 . The pharmaceutical formulation of claim 30 , wherein the pharmaceutical formulation is contained in a microinfusor.

46 . The pharmaceutical formulation of claim 42 , wherein the syringe comprises a fluorocarbon-coated plunger.

47 . The pharmaceutical formulation of claim 42 , wherein the syringe is a low tungsten syringe.

48 . A stable pharmaceutical formulation comprising:

(i) a human antibody that specifically binds to hIL-4Rα, wherein the antibody comprises a heavy chain and light chain variable region (HCVR/LCVR) amino acid sequence pair of SEQ ID NOs:1/5;

(ii) 12.5 mM±2 mM acetate;

(iii) 20 mM±3 mM histidine;

(iv) 5%±0.75% sucrose;

(v) 0.2%±0.03% polysorbate 20; and

(vi) 25 mM±3.75 mM arginine,

at a pH of 5.9±0.5.

49 . The pharmaceutical formulation of claim 48 , wherein the viscosity of the liquid is 11±1.1 cPoise or 8.5±0.85 cPoise, and the osmolality of the liquid is 290±20 mOsm/kg.

50 . The pharmaceutical formulation of claim 48 , wherein:

(a) at least about 98% of the native form of the antibody is recovered after six months of storage at 5° C., as determined by size exclusion chromatography;

(b) at least about 90% of the native form of the antibody is recovered after eight weeks of storage at 45° C., as determined by size exclusion chromatography;

(c) less than about 45% of the antibody recovered after eight weeks of storage at 45° C. is an acidic form, as determined by cation exchange chromatography; or

(d) less than about 4% of the antibody recovered after six months of storage at 25° C. is aggregated, as determined by size exclusion exchange chromatography.

51 . A stable pharmaceutical formulation comprising:

(i) a human antibody that specifically binds to hIL-4Rα, wherein the antibody comprises a heavy chain and light chain variable region (HCVR/LCVR) amino acid sequence pair of SEQ ID NOs:1/5;

(ii) 12.5 mM±2 mM acetate;

(iii) 20 mM±3 mM histidine;

(iv) 5%±0.75% sucrose;

(v) 0.2%±0.03% polysorbate 80; and

(vi) 50 mM±3.75 mM arginine,

at a pH of 5.9±0.5.