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Last Updated: April 26, 2024

Claims for Patent: 8,852,889

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Summary for Patent: 8,852,889

Title:	Cell culture process
Abstract:	Polypeptides having target levels of C-terminal variants are described.
Inventor(s):	Prentice; Holly (Carlisle, MA)
Assignee:	Momenta Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	14/149,931
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,852,889
Patent Claims:	1. A method of producing a preparation of a recombinant antibody, comprising: culturing a cell in a medium under conditions in which the cell expresses a recombinant antibody, wherein the medium comprises 1.5 g/L lysine to less than 20 g/L lysine; and isolating the recombinant antibody, thereby producing a preparation of the recombinant antibody. 2. The method of claim 1, wherein the medium comprises 2 g/L lysine to 19.5 g/L lysine. 3. The method of claim 1, wherein the medium comprises 5 g/L lysine to 15 g/L lysine. 4. The method of claim 1, wherein the medium comprises 8 g/L lysine to 12 g/L lysine. 5. The method of claim 1, wherein the medium comprises 10 g/L lysine. 6. The method of claim 1, wherein the culturing produces C-terminal variants of the recombinant antibody that differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini, and the method further comprises measuring a level of one or more C-terminal variants of the recombinant antibody in the preparation. 7. The method of claim 6, wherein the C-terminal variants of the recombinant antibody comprise one or more of a K1 lysine variant of the recombinant antibody and a K2 lysine variant of the recombinant antibody. 8. The method of claim 7, wherein the level of one or more of K1 lysine variant and K2 lysine variant in the preparation is increased relative to a preparation of the recombinant antibody produced using a medium not comprising 1.5 g/L lysine to less than 20 g/L lysine. 9. The method of claim 7, wherein the preparation comprises a target value of one or more of K1 lysine variants of the recombinant antibody and K2 lysine variants of the recombinant antibody. 10. The method of claim 9, wherein the target value of K1 lysine variants of the recombinant antibody is at least 10% of the recombinant antibody in the preparation. 11. The method of claim 9, wherein the target value of K2 lysine variants of the recombinant antibody is at least 4% of the recombinant antibody in the preparation. 12. The method of claim 1, wherein the host cell is a CHO cell. 13. The method of claim 1, wherein the antibody is adalimumab. 14. The method of claim 1, wherein the medium has a pH of about 6.7 to about 7.1. 15. The method of claim 1, wherein the host cell is cultured at a temperature of about 31.degree. C. to about 37.degree. C. 16. A method of producing a preparation of a recombinant antibody, comprising: culturing a cell in a medium under conditions in which the cell expresses a recombinant antibody, wherein the medium comprises 1.5 g/L arginine to less than 20 g/L arginine, and wherein the culturing produces C-terminal variants of the recombinant antibody that differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini; isolating the recombinant antibody, thereby producing a preparation of the recombinant antibody; and measuring a level of one or more C-terminal variants of the recombinant antibody in the preparation. 17. The method of claim 16, wherein the medium comprises 2 g/L arginine to 19.5 g/L arginine. 18. The method of claim 16, wherein the medium comprises 5 g/L arginine to 15 g/L arginine. 19. The method of claim 16, wherein the medium comprises 8 g/L arginine to 12 g/L arginine. 20. The method of claim 16, wherein the medium comprises 10 g/L arginine. 21. The method of claim 16, wherein the C-terminal variants of the recombinant antibody comprise one or more of a K1 lysine variant of the recombinant antibody and a K2 lysine variant of the recombinant antibody. 22. The method of claim 21, wherein the level of one or more of K1 lysine variant and K2 lysine variant in the preparation is increased relative to a preparation of the recombinant antibody produced using a medium not comprising 1.5 g/L to less than 20 g/L arginine. 23. The method of claim 21, wherein the preparation comprises a target value of one or more of K1 lysine variants of the recombinant antibody and K2 lysine variants of the recombinant antibody. 24. The method of claim 23, wherein the target value of K1 lysine variants of the recombinant antibody is at least 10% of the recombinant antibody in the preparation. 25. The method of claim 23, wherein the target value of K2 lysine variants of the recombinant antibody is at least 4% of the recombinant antibody in the preparation. 26. The method of claim 16, wherein the host cell is a CHO cell. 27. The method of claim 16, wherein the antibody is adalimumab. 28. The method of claim 16, wherein the medium has a pH of about 6.7 to about 7.1. 29. The method of claim 16, wherein the host cell is cultured at a temperature of about 31.degree. C. to about 37.degree. C. 30. A method of producing a preparation of adalimumab, comprising: culturing a CHO cell in a medium under conditions in which the CHO cell expresses adalimumab, wherein the medium comprises 1.5 g/L lysine to less than 20 g/L lysine, or 1.5 g/L arginine to less than 20 g/L arginine, and wherein the culturing produces C-terminal variants of adalimumab that differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini; isolating the adalimumab, thereby producing a preparation of adalimumab; and measuring a level of one or more C-terminal variants of adalimumab in the preparation.

Details for Patent 8,852,889

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2031-07-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2031-07-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2031-07-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2031-07-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015	⤷ Try a Trial	2031-07-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016	⤷ Try a Trial	2031-07-08
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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