Claims for Patent: 9,926,583

Summary for Patent: 9,926,583

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:	15/285,707
Patent Claims:	1. A method of producing an adalimumab preparation, comprising: (a) providing a cell genetically engineered to express adalimumab; and (b) culturing the cell in a culture medium comprising dimethylsulfoxide (DMSO) under conditions in which the cell expresses adalimumab, to produce a preparation of adalimumab having a target value of one or more of high mannose and fucosylated glycans, wherein the target value of the high mannose glycans is 5% to 20% high mannose glycans and the target value of the fucosylated glycans is 70% to 100% fucosylated glycans. 2. The method of claim 1, further comprising harvesting the preparation of adalimumab. 3. The method of claim 2, further comprising formulating the preparation into a drug product. 4. The method of claim 1, wherein the target value is a predetermined pharmaceutical product specification. 5. The method of claim 1, further comprising evaluating the level of one or more of high mannose glycans and fucosylated glycans in the adalimumab preparation. 6. The method of claim 1, wherein the culture medium comprises 0.5% to 5% DMSO. 7. The method of claim 6, wherein the culture medium comprises 1% to 2% DMSO. 8. The method of claim 6, wherein the culture medium comprises 2% to 3% DMSO. 9. The method of claim 6, wherein the culture medium comprises 3% to 4% DMSO. 10. The method of claim 6, wherein the culture medium comprises 2% to 5% DMSO. 11. The method of claim 1, wherein the target value is 5% to 10% high mannose glycans. 12. The method of claim 1, wherein the target value is 10% to 20% high mannose glycans. 13. The method of claim 1, wherein the culturing step comprises a first stage and a second stage. 14. The method of claim 13, wherein the first stage comprises culturing the cell in the culture medium comprising a first level of DMSO, and the second stage comprises culturing the cell in the culture medium comprising a second level of DMSO. 15. The method of claim 14, wherein the first level of DMSO is no DMSO and the second level of DMSO is 1% to 5% DMSO. 16. The method of claim 15, wherein the first stage comprises culturing the cell in the first level of DMSO for 1 to 8 days. 17. The method of claim 16, wherein the second stage comprises culturing the cell in the second level of DMSO for 1 to 12 days. 18. The method of claim 1, wherein the cell is a CHO cell. 19. The method of claim 18, wherein the CHO cell is a CHO-K1 or CHO-DG44 cell. 20. A method of producing an adalimumab preparation, comprising: (a) providing a target value of one or more of high mannose glycans and fucosylated glycans; (b) culturing a cell genetically engineered to express adalimumab in a culture medium comprising DMSO, under conditions in which the cell expresses the adalimumab; (c) harvesting a preparation of the adalimumab produced by the cell; and (d) formulating the preparation into a drug product if the preparation meets the target value of the one or more of high mannose glycans and fucosylated glycans, wherein the target value of the high mannose glycans is 5% to 20% high mannose glycans and the target value of the fucosylated glycans is 70% to 100% fucosylated glycans. 21. The method of claim 20, further comprising evaluating the level of the one or more of high mannose glycans and fucosylated glycans in the adalimumab preparation. 22. The method of claim 20, wherein the target value is a predetermined pharmaceutical product specification. 23. The method of claim 20, wherein the culture medium comprises 0.5% to 5% DMSO. 24. The method of claim 23, wherein the culture medium comprises 1% to 2% DMSO. 25. The method of claim 23, wherein the culture medium comprises 2% to 3% DMSO. 26. The method of claim 23, wherein the culture medium comprises 3% to 4% DMSO. 27. The method of claim 23, wherein the culture medium comprises 2% to 5% DMSO. 28. The method of claim 20, wherein the target value is 5% to 10% high mannose glycans. 29. The method of claim 20, wherein the target value is 10% to 20% high mannose glycans. 30. The method of claim 20, wherein the culturing step comprises a first stage and a second stage. 31. The method of claim 30, wherein the first stage comprises culturing the cell in the culture medium comprising a first level of DMSO, and the second stage comprises culturing the cell in the culture medium comprising a second level of DMSO. 32. The method of claim 31, wherein the first level of DMSO is no DMSO and the second level of DMSO is 1% to 5% DMSO. 33. The method of claim 32, wherein the first stage comprises culturing the cell in the first level of DMSO for 1 to 8 days. 34. The method of claim 33, wherein the second stage comprises culturing the cell in the second level of DMSO for 1 to 12 days. 35. The method of claim 20, wherein the cell is a CHO cell. 36. The method of claim 35, wherein the CHO cell is a CHO-K1 or CHO-DG44 cell.

Details for Patent 9,926,583

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2033-03-14