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

1 - 29 . (canceled)

30 . A pharmaceutical formulation comprising:

i. an anti-human interleukin-4 receptor alpha (anti-hIL4Rα) antibody at a concentration of about 100 mg/ml to about 200 mg/ml, wherein the anti-hIL4Rα antibody is a human antibody, wherein the anti-hIL4Rα antibody is an immunoglobulin molecule comprising two heavy chains and two light chains interconnected by disulfide bonds, wherein each heavy chain comprises a heavy chain variable region (HCVR), wherein the HCVR in each heavy chain comprises the amino acid sequence of SEQ ID NO: 1, wherein each light chain comprises a light chain variable region (LCVR), wherein the LCVR in each light chain comprises the amino acid sequence of SEQ ID NO: 5;

ii. one or more buffers, comprising at least one of a histidine buffer, an acetate buffer, a succinate buffer, a phosphate buffer, or a citrate buffer;

iii. a thermal stabilizer at a concentration from about 0.9%±0.135% w/v to about 10%±1.5% w/v; and

iv. a non-ionic surfactant;

wherein the pharmaceutical formulation has a pH from about 5.6 to about 6.2;

wherein the osmolality of the pharmaceutical formulation is less than about 450 mOsm/kg; and

wherein at least 95% of the anti-hIL4Rα antibody in the pharmaceutical formulation is in its native form after 3 months of storage at about 5° C., as determined by size exclusion chromatography.

31 . The pharmaceutical formulation of claim 30 , wherein the one or more buffers comprise the histidine buffer or the succinate buffer.

32 . The pharmaceutical formulation of claim 31 , wherein the thermal stabilizer is arginine.

33 . The pharmaceutical formulation of claim 32 , wherein the pharmaceutical formulation has a pH of about 5.9.

34 . The pharmaceutical formulation of claim 32 , wherein the non-ionic surfactant is a poloxamer or a polyethylene glycol.

35 . The pharmaceutical formulation of claim 32 , wherein the non-ionic surfactant is a polysorbate.

36 . The pharmaceutical formulation of claim 35 , wherein the polysorbate is polysorbate 20 or polysorbate 80.

37 . The pharmaceutical formulation of claim 36 , wherein the polysorbate 20 or polysorbate 80 is at a concentration of about 0.2% w/v.

38 . The pharmaceutical formulation of claim 36 , wherein the anti-hIL4Rα antibody is at a concentration of about 175 mg/mL.

39 . The pharmaceutical formulation of claim 36 , wherein the anti-hIL4Rα antibody is at a concentration of about 150 mg/mL.

40 . The pharmaceutical formulation of claim 34 , wherein the non-ionic surfactant is poloxamer 188.

41 . The pharmaceutical formulation of claim 40 , wherein the anti-hIL4Rα antibody is at a concentration of about 175 mg/mL.

42 . The pharmaceutical formulation of claim 40 , wherein the anti-hIL4Rα antibody is at a concentration of about 150 mg/mL.

43 . The pharmaceutical formulation of claim 31 , wherein the pharmaceutical formulation comprises a viscosity reducer at a concentration from about 20 mM to 100 mM.

44 . The pharmaceutical formulation of claim 43 , wherein the viscosity reducer and/or thermal stabilizer is an amino acid.

45 . The pharmaceutical formulation of claim 44 , wherein the viscosity reducer is arginine.

46 . The pharmaceutical formulation of claim 45 , wherein the arginine is at a concentration of about 25 mM±3.75.

47 . The pharmaceutical formulation of claim 45 , wherein the arginine is at a concentration of about 50 mM±7.5.

48 . The pharmaceutical formulation of claim 44 , wherein the thermal stabilizer is a sugar or sugar alcohol at a concentration from about 2.5% to about 10% w/v and the viscosity reducer is an amino acid.

49 . The pharmaceutical formulation of claim 48 , wherein the thermal stabilizer is sucrose.

50 . The pharmaceutical formulation of claim 49 , wherein the sucrose is at a concentration of about 5%±0.75% w/v.

51 . The pharmaceutical formulation of claim 49 , wherein the viscosity reducer is arginine, and wherein the arginine is at a concentration of about 25 mM±3.75 mM.

52 . The pharmaceutical formulation of claim 49 , wherein the viscosity reducer is arginine, and wherein the arginine is at a concentration of about 50 mM±7.5 mM.

53 . The pharmaceutical formulation of claim 48 , wherein the thermal stabilizer is sorbitol.

54 . The pharmaceutical formulation of claim 48 , wherein the non-ionic surfactant is a polysorbate.

55 . The pharmaceutical formulation of claim 54 , wherein the polysorbate is polysorbate 20 or polysorbate 80.

56 . The pharmaceutical formulation of claim 55 , wherein the polysorbate 20 or polysorbate 80 is at a concentration of about 0.2% w/v.

57 . The pharmaceutical formulation of claim 55 , wherein the pharmaceutical formulation has a pH of about 5.9.

58 . The pharmaceutical formulation of claim 55 , wherein the anti-hIL4Ra antibody is at a concentration of about 175 mg/mL.

59 . The pharmaceutical formulation of claim 55 , wherein the anti-hIL4Ra antibody is at a concentration of about 150 mg/mL.