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1. WO2016115475 - FORMULATIONS D'ANTICORPS ANTI-CD40

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CLAIMS

What is claimed is:

1. An anti-CD40 antibody formulation, comprising:

anti-CD40 antibody;

10 mM to 30 mM citrate; and

140 mM to 160 mM arginine, wherein the formulation in solution has a pH value of 5.0 to 6.5.

2. The anti-CD40 antibody formulation of claim 1, wherein the formulation has an anti-CD40 antibody concentration of 100 mg/ml to 300 mg/ml.

3. The anti-CD40 antibody formulation of claim 1, wherein the formulation has an anti-CD40 antibody concentration of at least 150 mg/ml.

4. The anti-CD40 antibody formulation of claim 3, wherein the formulation has an anti-CD40 antibody concentration of at least 200 mg/ml.

5. The anti-CD40 antibody formulation of claim 4, wherein the formulation has an anti-CD40 antibody concentration of at least 250 mg/ml.

6. The anti-CD40 antibody formulation of any one of claims 1-5, wherein the formulation has an anti-CD40 antibody concentration of 250 mg/ml.

7. The anti-CD40 antibody formulation of any one of claims 1-6, wherein the anti-CD40 antibody is a monoclonal antibody.

8. The anti-CD40 antibody formulation of any one of claims 1-7, wherein the formulation has a citrate concentration of 20 mM.

9. The anti-CD40 antibody formulation of any one of claims 1-8, wherein the formulation has an arginine concentration of 150 mM.

10. The anti-CD40 antibody formulation of any one of claims 1-9, wherein the formulation has a pH value of 5.5-6.0.

11. The anti-CD40 antibody formulation of claim 10, wherein the formulation has a pH value of 5.7.

12. The anti-CD40 antibody formulation of any one of claims 1-11, further comprising sucrose.

13. The anti-CD40 antibody formulation of claim 12, wherein the formulation has a sucrose concentration of 200 mM to 400 mM.

14. The anti-CD40 antibody formulation of claim 13, wherein the formulation has a sucrose concentration of 300 mM.

15. The anti-CD40 antibody formulation of any one of claims 1-14, wherein the increase in the percentage of high molecular weight species present in the formulation after storage for one month at 40 °C is less than 4.

16. The anti-CD40 antibody formulation of any one of claims 1-15, wherein the formulation has a viscosity suitable for subcutaneous injection.

17. The anti-CD40 antibody formulation of any one of claims 1-16, wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge.

18. The anti-CD40 antibody formulation of any one of claims 1-17, wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge while at a temperature in range of 25 °C to 40 °C.

19. The anti-CD40 antibody formulation of any one of claims 1-18, wherein the formulation has a viscosity of less than 40 cP at anti-CD40 antibody concentrations of up to 250 mg/ml.

20. An anti-CD40 antibody formulation, comprising:

100 mg/ml to 250 mg/ml anti-CD40 antibody; and

buffer having a pH value of 5.5 to 6.0.

21. The anti-CD40 antibody formulation of claim 20, wherein the buffer is a citrate buffer.

22. The anti-CD40 antibody formulation of claim 21, wherein the citrate buffer has a concentration of 10 mM to 30 mM.

23. The anti-CD40 antibody formulation of claim 22, wherein the citrate buffer has a concentration of 20 mM.

24. The anti-CD40 antibody formulation of any one of claims 20-23, further comprising arginine.

25. The anti-CD40 antibody formulation of claim 24, wherein the arginine is present at a concentration of 140 mM to 160 mM.

26. The anti-CD40 antibody formulation of claim 25, wherein the arginine is present at a concentration of 150 mM.

27. The anti-CD40 antibody formulation of any one of claims 20-26, further comprising sucrose.

28. The anti-CD40 antibody formulation of claim 27, wherein the sucrose is present at a concentration of 200 mM to 400 mM.

29. The anti-CD40 antibody formulation of claim 28, wherein the sucrose is present at a concentration of 300 mM.

30. An anti-CD40 antibody formulation, comprising:

at least 150 mg/ml anti-CD40 antibody;

20 mM buffer containing sodium citrate and citric acid; and

150 niM arginine, wherein the formulation has a pH value of 5.5 to 6.0.

31. The anti-CD40 antibody formulation of claim 30, further comprising 300 mM sucrose.

32. A method of producing an anti-CD40 antibody formulation, the method comprising: combining 100 mg/ml to 300 mg/ml anti-CD40 antibody in citrate buffer; and adjusting pH of the formulation to 5.0 to 6.5.

33. The method of claim 32, wherein the citrate buffer has a concentration of 10 mM to 30 mM.

34. The method of claim 33, wherein the citrate buffer has a concentration of 20 mM.

35. An anti-CD40 antibody formulation, comprising:

anti-CD40 antibody;

10 mM to 30 mM histidine; and

140 mM to 160 mM arginine, wherein the formulation in solution has a pH value of

5.0-6.5.

36. The anti-CD40 antibody formulation of claim 35, wherein the formulation has an anti-CD40 antibody concentration of 100 mg/ml to 300 mg/ml.

37. The anti-CD40 antibody formulation of claim 35, wherein the formulation has an anti-CD40 antibody concentration of at least 150 mg/ml.

38. The anti-CD40 antibody formulation of claim 37, wherein the formulation has an anti-CD40 antibody concentration of at least 200 mg/ml.

39. The anti-CD40 antibody formulation of claim 38, wherein the formulation has an anti-CD40 antibody concentration of at least 250 mg/ml.

40. The anti-CD40 antibody formulation of any one of claims 35-39, wherein the formulation has an anti-CD40 antibody concentration of 250 mg/ml.

41. The anti-CD40 antibody formulation of any one of claims 35-40, wherein the anti-CD40 antibody is a monoclonal antibody.

42. The anti-CD40 antibody formulation of any one of claims 35-41, wherein the formulation has a histidine concentration of 20 mM.

43. The anti-CD40 antibody formulation of any one of claims 35-42, wherein the formulation has an arginine concentration of 150 mM.

44. The anti-CD40 antibody formulation of any one of claims 35-43, wherein the formulation has a pH value of 5.5-6.0.

45. The anti-CD40 antibody formulation of claim 44, wherein the formulation has a pH value of 5.7.

46. The anti-CD40 antibody formulation of any one of claims 35-45, further comprising sucrose.

47. The anti-CD40 antibody formulation of claim 46, wherein the formulation has a sucrose concentration of 200 mM to 400 mM.

48. The anti-CD40 antibody formulation of claim 47, wherein the formulation has a sucrose concentration of 300 mM.

49. The anti-CD40 antibody formulation of any one of claims 35-48, wherein the increase in the percentage of high molecular weight species present in the formulation after storage for one month at 40 °C is less than 4.

50. The anti-CD40 antibody formulation of any one of claims 35-49, wherein the formulation has a viscosity suitable for subcutaneous injection.

51. The anti-CD40 antibody formulation of any one of claims 35-50, wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge.

52 The anti-CD40 antibody formulation of any one of claims 35-51, wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge while at a temperature in range of 25 °C to 40 °C.

53. The anti-CD40 antibody formulation of any one of claims 35-52, wherein the formulation has a viscosity of less than 40 cP at anti-CD40 antibody concentrations of up to 250 mg/ml.

54. An anti-CD40 antibody formulation, comprising:

100 mg/ml to 250 mg/ml anti-CD40 antibody; and

buffer having a pH value of 5.5 to 6.0.

55. The anti-CD40 antibody formulation of claim 54, wherein the buffer is a histidine buffer.

56. The anti-CD40 antibody formulation of claim 55, wherein the histidine buffer has a concentration of 10 mM to 30 mM.

57. The anti-CD40 antibody formulation of claim 56, wherein the histidine buffer has a concentration of 20 mM.

58. The anti-CD40 antibody formulation of any one of claims 54-57, further comprising arginine.

59. The anti-CD40 antibody formulation of claim 58, wherein the arginine is present at a concentration of 140 mM to 160 mM.

60. The anti-CD40 antibody formulation of claim 59, wherein the arginine is present at a concentration of 150 mM.

61. The anti-CD40 antibody formulation of any one of claims 54-60, further comprising sucrose.

62. The anti-CD40 antibody formulation of claim 61, wherein the sucrose is present at a concentration of 200 mM to 400 mM.

63. The anti-CD40 antibody formulation of claim 62, wherein the sucrose is present at a concentration of 300 mM.

64. An anti-CD40 antibody formulation, comprising:

at least 150 mg/ml anti-CD40 antibody;

20 mM buffer containing histidine; and

150 mM arginine, wherein the formulation has a pH value of 5.5 to 6.0.

65. The anti-CD40 antibody formulation of claim 64, further comprising 300 mM sucrose.

66. A method of producing an anti-CD40 antibody formulation, the method comprising: combining 100 mg/ml to 300 mg/ml anti-CD40 antibody in histidine buffer; and adjusting pH of the formulation to 5.5 to 6.5.

67. The method of claim 66, wherein the histidine buffer has a concentration of 10 mM to 30 mM.

68. The method of claim 67, wherein the histidine buffer has a concentration of 20 mM.