Claims for Patent: 9,073,988

Summary for Patent: 9,073,988

Title:	Fed batch method of making anti-TNF-alpha antibodies
Abstract:	The invention describes improved methods and compositions for producing a recombinant protein, e.g., an antibody, in mammalian cell culture. In addition, the invention provides improved cell culture media, including improved production media, feed solutions, and combination feeds, which may be used to improve protein productivity in mammalian cell culture.
Inventor(s):	Pla; Itzcoatl A. (Worcester, MA), Matuck; Joseph G. (Worcester, MA), Fann; John C. (Shrewsbury, MA), Schulz; Christof (Ayer, MA), Roy; Nichole A. (Worcester, MA), Bruton; David F. (Enfield, CT), McIntire; James (Castro Valley, CA), Chang; Yu-hsiang D. (Solana Beach, CA), Seewoester; Thomas (Simi Valley, CA)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	14/563,993
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,073,988
Patent Claims:	1. A fed batch method for making an anti-TNF.alpha. antibody comprising a light chain variable region (LCVR) comprising the sequence of SEQ ID NO:1 and a heavy chain variable region (HCVR) comprising the sequence of SEQ ID NO:2, said method comprising culturing mammalian cells comprising a nucleic acid encoding said anti-TNF.alpha. antibody in a cell culture production medium in large scale, wherein the pH of the cell culture production medium is adjusted according to a pH linear ramp comprising beginning at a starting pH and ending at a final pH that is less than the starting pH, such that said anti-TNF.alpha. antibody is produced, and wherein said produced anti-TNF.alpha. antibody is further affinity purified using a Protein A resin. 2. The fed batch method according to claim 1, wherein the starting pH is 8 or less. 3. The fed batch method according to claim 1, wherein the final pH is 6.5 to 7.0. 4. The fed batch method according to claim 3, wherein the starting pH is 8 or less. 5. The fed batch method according to claim 1, wherein the starting pH is 7.1 to 7.2. 6. The fed batch method according to claim 1, wherein the final pH is 6.9. 7. The fed batch method according to claim 1, wherein the starting pH is 6.5 to 8 and the final pH is 6.5 to 7. 8. The fed batch method according to claim 1, wherein the starting pH is 7.1 and the final pH is 6.9. 9. The fed batch method according to claim 1, wherein the pH is adjusted over a period of at least 24 hours. 10. The fed batch method according to claim 1, wherein the pH is adjusted within the first 72 hours of the culturing. 11. The fed batch method according to claim 1, further comprising supplementing the cell culture production medium, wherein the pH is adjusted prior to the supplementing. 12. The fed batch method according to claim 1, wherein the mammalian cells are Chinese Hamster Ovary (CHO) cells. 13. The fed batch method according to claim 1, wherein the pH is adjusted over a period of at least 48 hours. 14. The fed batch method according to claim 1, wherein the pH is adjusted over a period of at least 72 hours. 15. A fed batch method for making adalimumab, said method comprising culturing mammalian cells comprising a nucleic acid encoding said adalimumab in a cell culture production medium in large scale, wherein the pH of the cell culture production medium is adjusted according to a pH linear ramp comprising beginning at a starting pH and ending at a final pH that is less than the starting pH, such that said adalimumab is produced, and wherein said produced anti-TNF.alpha. antibody is further affinity purified using a Protein A resin. 16. The fed batch method according to claim 15, wherein the starting pH is 8 or less. 17. The fed batch method according to claim 15, wherein the final pH is 6.5 to 7.0. 18. The fed batch method according to claim 17, wherein the starting pH is 8 or less. 19. The fed batch method according to claim 15, wherein the starting pH is 7.1 to 7.2. 20. The fed batch method according to claim 15, wherein the starting pH is 6.5 to 8 and the final pH is 6.5 to 7. 21. The fed batch method according to claim 15, wherein the starting pH is 7.1 and the final pH is 6.9. 22. The fed batch method according to claim 15, wherein the pH is adjusted over a period of at least 24 hours. 23. The fed batch method according to claim 15, wherein the pH is adjusted within the first 72 hours of the culturing. 24. The fed batch method according to claim 15, further comprising supplementing the cell culture production medium, wherein the pH is adjusted prior to the supplementing. 25. The fed batch method according to claim 15, wherein the mammalian cells are Chinese Hamster Ovary (CHO) cells. 26. The fed batch method according to claim 15, wherein the pH is adjusted over a period of at least 48 hours. 27. The fed batch method according to claim 15, wherein the pH is adjusted over a period of at least 72 hours.

Details for Patent 9,073,988

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2026-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2026-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2026-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2026-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2026-09-13