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Last Updated: December 15, 2024

Claims for Patent: 9,334,319


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Summary for Patent: 9,334,319
Title:Low acidic species compositions
Abstract: The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the amount of charge variants, aggregates, and fragments of a protein of interest, as well as host cell proteins, present in purified preparations by applying particular chromatography conditions during such protein purification.
Inventor(s): Ramasubramanyan; Natarajan (Westborough, MA), Yang; Lihua (Westborough, MA), Herigstad; Matthew Omon (Charlestown, MA), Yang; Hong (Worcester, MA), Chumsae; Christopher (North Andover, MA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:13/829,989
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,334,319
Patent Claims:1. A composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab correspond to the peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab, wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5), and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm.

2. The composition of claim 1, wherein the acidic species of adalimumab comprise a first acidic region (AR1) and a second acidic region (AR2).

3. The composition of claim 1, wherein the composition comprises less than 3.8% total acidic species of adalimumab.

4. The composition of claim 2, wherein the composition comprises 0.8% AR1 and 3.0% AR2.

5. The composition of claim 1, wherein the composition comprises less than 2.4% total acidic species of adalimumab.

6. The composition of claim 2, wherein the composition comprises 0.2% AR1 and 2.2% AR2.

7. The composition of claim 1, wherein the composition comprises 4.7%-8.3% total acidic species of adalimumab.

8. The composition of claim 7, wherein the composition comprises 4.7% total acidic species of adalimumab.

9. The composition of claim 7, wherein the composition comprises 5.0% total acidic species of adalimumab.

10. The composition of claim 7, wherein the composition comprises 5.8% total acidic species of adalimumab.

11. The composition of claim 7, wherein the composition comprises 6.1% total acidic species of adalimumab.

12. The composition of claim 7, wherein the composition comprises 6.4% total acidic species of adalimumab.

13. The composition of claim 7, wherein the composition comprises 8.1% total acidic species of adalimumab.

14. The composition of claim 7, wherein the composition comprises 8.3% total acidic species of adalimumab.

15. The composition of claim 2, wherein the composition comprises 0.8%-1.4% AR1.

16. The composition of claim 2, wherein the composition comprises 3%-9% AR2.

17. The composition of claim 2, wherein the composition comprises 0.8% AR1 and 6.4% AR2.

18. The composition of claim 2, wherein the composition comprises 0.9% AR1 and 9% AR2.

19. The composition of claim 2, wherein the composition comprises 1.2% AR1 and 7.7% AR2.

20. The composition of claim 2, wherein the composition comprises 1.2% AR1 and 8.2% AR2.

21. The composition of claim 2, wherein the composition comprises 1.4% AR1 and 8.4% AR2.

22. The composition of claim 2, wherein the composition comprises 1.4% AR1 and 8.6% AR2.

23. The composition of claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier.

24. A pharmaceutical composition suitable for administration to a human subject, comprising a composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab correspond to the peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab, wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5), and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm; and a pharmaceutically acceptable carrier.

25. The pharmaceutical composition of claim 24, wherein the acidic species of adalimumab comprise a first acidic region (AR1) and a second acidic region (AR2).

26. The pharmaceutical composition of claim 24, wherein the composition comprises less than 3.8% total acidic species of adalimumab.

27. The pharmaceutical composition of claim 25, wherein the composition comprises 0.8% AR1 and 3.0% AR2.

28. The pharmaceutical composition of claim 24, wherein the composition comprises less than 2.4% total acidic species of adalimumab.

29. The pharmaceutical composition of claim 25, wherein the composition comprises 0.2% AR1 and 2.2% AR2.

30. The pharmaceutical composition of claim 24, wherein the composition comprises 4.7%-8.3% total acidic species of adalimumab.

31. The pharmaceutical composition of claim 30, wherein the composition comprises 4.7% total acidic species of adalimumab.

32. The pharmaceutical composition of claim 30, wherein the composition comprises 5.0% total acidic species of adalimumab.

33. The pharmaceutical composition of claim 30, wherein the composition comprises 5.8% total acidic species of adalimumab.

34. The pharmaceutical composition of claim 30, wherein the composition comprises 6.1% total acidic species of adalimumab.

35. The pharmaceutical composition of claim 30, wherein the composition comprises 6.4% total acidic species of adalimumab.

36. The pharmaceutical composition of claim 30, wherein the composition comprises 8.1% total acidic species of adalimumab.

37. The pharmaceutical composition of claim 30, wherein the composition comprises 8.3% total acidic species of adalimumab.

38. The pharmaceutical composition of claim 25, wherein the composition comprises 0.8%-1.4% AR1.

39. The pharmaceutical composition of claim 25, wherein the composition comprises 3%-9% AR2.

40. The pharmaceutical composition of claim 25, wherein the composition comprises 0.8% AR1 and 6.4% AR2.

41. The pharmaceutical composition of claim 25, wherein the composition comprises 0.9% AR1 and 9% AR2.

42. The pharmaceutical composition of claim 25, wherein the composition comprises 1.2% AR1 and 7.7% AR2.

43. The pharmaceutical composition of claim 25, wherein the composition comprises 1.2% AR1 and 8.2% AR2.

44. The pharmaceutical composition of claim 25, wherein the composition comprises 1.4% AR1 and 8.4% AR2.

45. The pharmaceutical composition of claim 25, wherein the composition comprises 1.4% AR1 and 8.6% AR2.

46. The composition of any one of claims 1-23, wherein the composition is a lyophilized composition.

47. The pharmaceutical composition of any one of claims 24-45, wherein the composition is a lyophilized composition.

48. The composition of any one of claims 1-23, wherein the adalimumab is produced in a mammalian host cell grown in cell culture.

49. The composition of claim 48, wherein the mammalian host cell is selected from the group consisting of a CHO cell, an NSO cell, a COS cell, and an SP2 cell.

50. The composition of claim 49, wherein the mammalian host cell is a CHO cell.

51. The pharmaceutical composition of any one of claims 24-45, wherein the adalimumab is produced in a mammalian host cell grown in cell culture.

52. The pharmaceutical composition of claim 51, wherein the mammalian host cell is selected from the group consisting of a CHO cell, an NSO cell, a COS cell, and an SP2 cell.

53. The pharmaceutical composition of claim 52, wherein the mammalian host cell is a CHO cell.

54. The pharmaceutical composition of any one of claims 24-45, wherein adalimumab is present in the pharmaceutical composition at a concentration of 0.1-250 mg/mL.

55. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises mannitol.

56. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises sodium chloride.

57. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises polysorbate 80.

58. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises a buffer.

59. The pharmaceutical composition of claim 58, wherein the buffer is sodium citrate.

60. The pharmaceutical composition of claim 58, wherein the buffer is histidine.

61. A pre-filled syringe which contains the pharmaceutical composition of any one of claims 24-45.

Details for Patent 9,334,319

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 ⤷  Subscribe 2032-04-20
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 ⤷  Subscribe 2032-04-20
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 ⤷  Subscribe 2032-04-20
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 ⤷  Subscribe 2032-04-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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