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Last Updated: March 29, 2024

Claims for Patent: 9,487,810


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Summary for Patent: 9,487,810
Title:Methods of cell culture
Abstract: Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using DMSO, are described.
Inventor(s): Prentice; Holly (Carlisle, MA), Tijani; Rasheed (Haverhill, MA), Belongia; Brett (North Andover, MA)
Assignee: Momenta Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:14/587,340
Patent Claims:1. A method of producing a recombinant protein preparation having a target value of high mannose glycans, the method comprising: (a) providing a mammalian cell genetically engineered to express a recombinant protein; (b) culturing the cell in a culture medium comprising dimethylsulfoxide (DMSO) under conditions in which the cell expresses the recombinant protein; and (c) harvesting a preparation of the recombinant protein produced by the cell that meets the target value, wherein the target value is 0.1% to 20% high mannose glycans.

2. A method of producing a recombinant protein preparation, the method comprising: (a) providing a mammalian cell genetically engineered to express a recombinant protein; (b) culturing the cell in a culture medium comprising DMSO under conditions in which the cell expresses the recombinant protein; (c) harvesting a preparation of the recombinant protein produced by the cell; and (d) formulating the preparation into a drug product if the preparation comprises 0.1% to 20% high mannose glycans.

3. The method of claim 1 or 2, wherein the mammalian cell is a Chinese Hamster Ovary (CHO) cell.

4. The method of claim 1 or 2, wherein the CHO cell is a CHO-K1 or CHO-DG44 cell.

5. The method of claim 1 or 2, wherein the mammalian cell is a murine myeloma cell.

6. The method of claim 5, wherein the murine myeloma cell is an NS0 or Sp2/0 cell.

7. The method of claim 1 or 2, wherein the culture medium comprises 0.5% to 5% DMSO.

8. The method of claim 1 or 2, wherein the culture medium comprises 1% to 2% DMSO.

9. The method of claim 1 or 2, wherein the culture medium comprises 2% to 3% DMSO.

10. The method of claim 1 or 2, wherein the culture medium comprises 3% to 4% DMSO.

11. The method of claim 1 or 2, wherein the culture medium comprises 2% to 5% DMSO.

12. The method of claim 1, wherein the target value is 5% to 10% high mannose glycans.

13. The method of claim 1, wherein the target value is 10% to 20% high mannose glycans.

14. The method of claim 2, wherein the preparation is formulated into a drug product if the preparation comprises 5% to 10% high mannose glycans.

15. The method of claim 2, wherein the preparation is formulated into a drug product if the preparation comprises 10% to 20% high mannose glycans.

16. The method of claim 2, wherein the recombinant protein is abatacept.

17. The method of claim 2, wherein the recombinant protein is abciximab.

18. The method of claim 2, wherein the recombinant protein is adalimumab.

19. The method of claim 2, wherein the recombinant protein is aflibercept.

20. The method of claim 2, wherein the recombinant protein is alefacept.

21. The method of claim 2, wherein the recombinant protein is alemtuzumab.

22. The method of claim 2, wherein the recombinant protein is basiliximab.

23. The method of claim 2, wherein the recombinant protein is bevacizumab.

24. The method of claim 2, wherein the recombinant protein is belatacept.

25. The method of claim 2, wherein the recombinant protein is certolizumab.

26. The method of claim 2, wherein the recombinant protein is cetuximab.

27. The method of claim 2, wherein the recombinant protein is daclizumab.

28. The method of claim 2, wherein the recombinant protein is eculizumab.

29. The method of claim 2, wherein the recombinant protein is efalizumab.

30. The method of claim 2, wherein the recombinant protein is entanercept.

31. The method of claim 2, wherein the recombinant protein is gemtuzumab.

32. The method of claim 2, wherein the recombinant protein is ibritumomab.

33. The method of claim 2, wherein the recombinant protein is infliximab.

34. The method of claim 2, wherein the recombinant protein is muromonab-CD3.

35. The method of claim 2, wherein the recombinant protein is natalizumab.

36. The method of claim 2, wherein the recombinant protein is omalizumab.

37. The method of claim 2, wherein the recombinant protein is palivizumab.

38. The method of claim 2, wherein the recombinant protein is panitumumab.

39. The method of claim 2, wherein the recombinant protein is ranibizumab.

40. The method of claim 2, wherein the recombinant protein is rilonacept.

41. The method of claim 2, wherein the recombinant protein is rituximab.

42. The method of claim 2, wherein the recombinant protein is tositumomab.

43. The method of claim 2, wherein the recombinant protein is trastuzumab.

44. The method of claim 1 or 2, further comprising evaluating a level of high mannose glycans in the recombinant protein preparation.

45. A method of producing an adalimumab preparation having a target value of high mannose glycans, the method comprising: (a) providing a CHO cell genetically engineered to express adalimumab; (b) culturing the CHO cell in a culture medium comprising 0.5% to 5% DMSO under conditions in which the CHO cell expresses adalimumab; and (c) harvesting a preparation of adalimumab produced by the CHO cell that meets the target value, wherein the target value is a level of high mannose glycans at least 20% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the CHO cell in the medium not comprising DMSO.

46. The method of claim 45, wherein the target value is a level of high mannose glycans at least 30% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

47. The method of claim 45, wherein the target value is a level of high mannose glycans at least 50% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

48. The method of claim 45, wherein the target value is a level of high mannose glycans at least 70% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

49. The method of claim 45, wherein the target value is a level of high mannose glycans at least 100% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

50. A method of producing an adalimumab preparation, the method comprising: (a) providing a CHO cell genetically engineered to express adalimumab; (b) culturing the CHO cell in a culture medium comprising 0.5% to 5% DMSO under conditions in which the CHO cell expresses adalimumab; (c) harvesting a preparation of the adalimumab produced by the CHO cell; and (d) formulating the adalimumab preparation into a drug product if the adalimumab preparation comprises a level of high mannose glycans at least 20% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the CHO cell in the medium not comprising DMSO.

51. The method of claim 50, wherein the adalimumab preparation is formulated into a drug product if the adalimumab preparation comprises a level of high mannose glycans at least 30% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

52. The method of claim 50, wherein the adalimumab preparation is formulated into a drug product if the adalimumab preparation comprises a level of high mannose glycans at least 50% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

53. The method of claim 50, wherein the adalimumab preparation is formulated into a drug product if the adalimumab preparation comprises a level of high mannose glycans at least 70% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

54. The method of claim 50, wherein the adalimumab preparation is formulated into a drug product if the adalimumab preparation comprises a level of high mannose glycans at least 100% higher than a level of high mannose glycans in an adalimumab preparation produced by culturing the cell in the medium not comprising DMSO.

55. A method of producing an adalimumab preparation having a target value of high mannose glycans, the method comprising: (a) providing a CHO cell genetically engineered to express adalimumab; (b) culturing the CHO cell in a culture medium comprising 0.5% to 5% DMSO under conditions in which the CHO cell expresses adalimumab; and (c) harvesting a preparation of the adalimumab produced by the CHO cell that meets the target value, wherein the target value is 5% to 20% high mannose glycans.

56. The method of claim 55, wherein the target value is 5% to 10% high mannose glycans.

57. The method of claim 55, wherein the target value is 10% to 20% high mannose glycans.

58. A method of producing an adalimumab preparation, the method comprising: (a) providing a CHO cell genetically engineered to express adalimumab; (b) culturing the CHO cell in a culture medium comprising 0.5% to 5% DMSO under conditions in which the CHO cell expresses adalimumab; (c) harvesting a preparation of the adalimumab produced by the CHO cell; and (d) formulating the adalimumab preparation into a drug product if the adalimumab preparation comprises 5% to 20% high mannose glycans.

59. The method of claim 58, wherein the adalimumab preparation is formulated into a drug product if the adalimumab preparation comprises 5% to 10% high mannose glycans.

60. The method of claim 58, wherein the adalimumab preparation is formulated into a drug product if the adalimumab preparation comprises 10% to 20% high mannose glycans.

61. The method of any one of claim 45, 50, 55, or 58, wherein the CHO cell is a CHO-K1 or CHO-DG44 cell.

62. The method of any one of claim 45, 50, 55, or 58, wherein the culture medium comprises 1% to 2% DMSO.

63. The method of any one of claim 45, 50, 55, or 58, wherein the culture medium comprises 2% to 3% DMSO.

64. The method of any one of claim 45, 50, 55, or 58, wherein the culture medium comprises 3% to 4% DMSO.

65. The method of any one of claim 45, 50, 55, or 58, wherein the culture medium comprises 2% to 5% DMSO.

66. The method of any one of claim 45, 50, 55, or 58, further comprising evaluating a level of high mannose glycans in the adalimumab preparation.

67. A method of producing a therapeutic recombinant antibody, the method comprising: (a) providing a CHO cell population genetically engineered to express a therapeutic recombinant antibody; (b) culturing the CHO cell population in a culture medium comprising 0.5% to 5% DMSO, under conditions in which the CHO cell population expresses the therapeutic recombinant antibody; (c) harvesting a preparation of the therapeutic recombinant antibody produced by the CHO cell population; and (d) formulating the preparation of the therapeutic recombinant antibody into a drug product if the preparation comprises a level of high mannose glycans at least 20% higher than a level of high mannose glycans present in a preparation produced by culturing the CHO cell population in the culture medium not comprising DMSO.

68. The method of claim 67, comprising (d) formulating the preparation of the therapeutic recombinant antibody into a drug product if the preparation comprises a level of high mannose glycans at least 50% higher than a level of high mannose glycans present in a preparation produced by culturing the CHO cell population in the culture medium not comprising DMSO.

69. The method of claim 67, comprising (d) formulating the preparation of the therapeutic recombinant antibody into a drug product if the preparation comprises a level of high mannose glycans at least 100% higher than a level of high mannose glycans present in a preparation produced by culturing the CHO cell population in the culture medium not comprising DMSO.

Details for Patent 9,487,810

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Centocor Ortho Biotech Products, L.p. ORTHOCLONE OKT3 muromanab-cd3 Injection 103463 09/14/1992 ⤷  Try a Trial 2033-03-14
Janssen Biotech, Inc. REOPRO abciximab Injection 103575 12/22/1994 ⤷  Try a Trial 2033-03-14
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2033-03-14
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2033-03-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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