Claims for Patent: 9,550,826

Summary for Patent: 9,550,826

Title:	Glycoengineered binding protein compositions
Abstract:	Provided are glycoengineered populations of Fc domain-containing binding proteins with a reduced anti-drug immune response (ADA). Also provided are methods of treating disease using such compositions, and methods and host for making such compositions.
Inventor(s):	Labkovsky; Boris (Marlborough, MA), Ghayur; Tariq (Holliston, MA), Gaza-Bulseco; Georgeen (Princeton, MA), Mishra; Pratibha (Shrewsbury, MA), Hegde; Subramanya (Shrewsbury, MA), Krishnan; Sudha (Acton, MA)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	15/198,696
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,550,826
Patent Claims:	1. A composition comprising a population of Fc domain-containing binding proteins wherein 0.1 to 3% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms and wherein the Fc domain-containing binding proteins comprise the polypeptide sequence of adalimumab. 2. The composition of claim 1, wherein 0.1-2% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms. 3. The composition of claim 1, wherein 0.1-3% of the Fc domain-containing binding proteins in the population comprise M5-M7 glycoforms. 4. The composition of claim 1, wherein the level of M3-M9 glycoforms is determined using a 2-AB labeling method. 5. The composition of claim 4, wherein the 2-AB labeling method employs a fluorophore selected from the group consisting of a 2-AB (2-aminobenzamide) and a 2-AA (anthranilic acid or 2-aminobenzoic acid). 6. The composition of claim 1, wherein the composition is produced in a cultured mammalian host cell line. 7. The composition of claim 6, wherein the cultured mammalian host cell line is selected from the group consisting of a CHO cell line, a HEK 293 cell line, a NS0 myeloma cell line, a COS cell line and a SP2 cell line. 8. The composition of claim 6, wherein the cultured mammalian host cell line is a CHO cell line. 9. A pharmaceutical composition comprising the population of Fc domain-containing binding proteins of claim 1, and a pharmaceutically acceptable carrier. 10. The pharmaceutical composition of claim 9, wherein the population of Fc domain-containing binding proteins is formulated for administration at a dosage of about 0.1-20 mg/kg. 11. The pharmaceutical composition of claim 9, wherein the pharmaceutically acceptable carrier comprises one or more excipient selected from the group consisting of a buffering agent, a surfactant and a polyol, or a combination thereof. 12. The pharmaceutical composition of claim 11, wherein the buffering agent is an amino acid. 13. The pharmaceutical composition of claim 12, wherein the amino acid is histidine. 14. The pharmaceutical composition of claim 11, wherein the surfactant is polysorbate 80. 15. The pharmaceutical composition of claim 11, wherein the polyol is mannitol. 16. The pharmaceutical composition of claim 9, wherein the pharmaceutical composition is in a syringe. 17. A composition comprising a population of Fc domain-containing binding proteins wherein 0.1 to 3% of the Fc domain-containing binding proteins in the population comprise M5-M9 glycoforms and wherein the Fc domain-containing binding proteins comprise the polypeptide sequence of adalimumab. 18. The composition of claim 17, wherein 0.1-2% of the Fc domain-containing binding proteins in the population comprise M5-M9 glycoforms. 19. A pharmaceutical composition comprising the population of Fc domain-containing binding proteins of claim 17, and a pharmaceutically acceptable carrier. 20. The pharmaceutical composition of claim 19, wherein the population of Fc domain-containing binding proteins is formulated for administration at a dosage of about 0.1-20 mg/kg. 21. The pharmaceutical composition of claim 19, wherein the pharmaceutically acceptable carrier comprises one or more excipient selected from the group consisting of a buffering agent, a surfactant and a polyol, or a combination thereof. 22. The pharmaceutical composition of claim 21, wherein the buffering agent is an amino acid. 23. The pharmaceutical composition of claim 22, wherein the amino acid is histidine. 24. The pharmaceutical composition of claim 21, wherein the surfactant is polysorbate 80. 25. The pharmaceutical composition of claim 21, wherein the polyol is mannitol. 26. The composition of claim 8, wherein the CHO cell line is a glycoengineered CHO cell line. 27. The composition of claim 17, wherein the composition is produced in a cultured mammalian host cell line. 28. The composition of claim 27, wherein the cultured mammalian host cell line is selected from the group consisting of a CHO cell line, a HEK 293 cell line, a NS0 myeloma cell line, a COS cell line and a SP2 cell line. 29. The composition of claim 27, wherein the cultured mammalian host cell line is a CHO cell line. 30. The composition of claim 29, wherein the CHO cell line is a glycoengineered CHO cell line.

Details for Patent 9,550,826

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2033-11-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2033-11-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2033-11-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2033-11-15