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Last Updated: April 24, 2024

Claims for Patent: 9,365,645

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Summary for Patent: 9,365,645

Title:	Methods for controlling the galactosylation profile of recombinantly-expressed proteins
Abstract:	The present invention relates to methods for modulating the glycosylation profile of recombinantly-expressed proteins. In particular, the present invention relates to methods of controlling the galactosylation profile of recombinantly-expressed proteins by supplementing production medium, e.g., a hydrolysate-based or a chemically defined medium, with manganese and/or D-galactose.
Inventor(s):	Bengea; Cornelia (Auburn, MA), Rives; Lisa M. (Natick, MA), Hossler; Patrick (Westborough, MA)
Assignee:	AbbVie, Inc. (North Chicago, IL)
Application Number:	15/014,694
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,365,645
Patent Claims:	1. A composition comprising an antibody comprising the heavy and light chain variable domains of adalimumab, wherein less than 70% of the total N-linked oligosaccharides present on said antibody are of an agalactosyl fucosylated biantennary oligosaccharide form (sum NGA2F+NGA2F-GlcNAc). 2. The composition of claim 1, wherein the antibody is adalimumab. 3. The composition of claim 1, wherein 49-69% of the total N-linked oligosaccharides present on said antibody are of an agalactosyl fucosylated biantennary oligosaccharide form (sum NGA2F+NGA2F-GlcNAc). 4. The composition of claim 1, wherein 55-65% of the total N-linked oligosaccharides present on said antibody are of an agalactosyl fucosylated biantennary oligosaccharide form (sum NGA2F+NGA2F-GlcNAc). 5. The composition of claim 1, wherein 26-40% of the total N-linked oligosaccharides present on said antibody are of a galactose-containing fucosylated biantennary oligosaccharide form (sum of NA1F+NA2F). 6. The composition of claim 1, wherein 35-44% of the total N-linked oligosaccharides present on said antibody are of a galactose-containing fucosylated biantennary oligosaccharide form (sum of NA1F+NA2F). 7. The composition of claim 1, wherein 30-40% of the total N-linked oligosaccharides present on said antibody are of a galactose-containing fucosylated biantennary oligosaccharide form (sum of NA1F+NA2F). 8. The composition of claim 1, wherein said antibody has been produced by culturing a mammalian cell in a cell culture media which has been supplemented with a manganese supplement and a galactose supplement. 9. The composition of claim 8, wherein the cell culture media has been supplemented with 0.2-100 .mu.M of a manganese supplement and 1-100 mM of a galactose supplement. 10. The composition of claim 8, wherein the cell culture media comprises a hydrolysate based media or a chemically defined media. 11. The composition of claim 8, wherein the mammalian cell is a CHO cell or an NSO cell. 12. A pharmaceutical composition comprising the composition of claim 1 and a pharmaceutically acceptable carrier. 13. The pharmaceutical composition of claim 12, wherein the pharmaceutically acceptable carrier comprises a polyalcohol. 14. The pharmaceutical composition of claim 12, wherein the pharmaceutically acceptable carrier comprises mannitol, sodium chloride, sodium phosphate or polysorbate 80. 15. The pharmaceutical composition of claim 12, wherein the pharmaceutical composition is suitable for parenteral administration. 16. A composition comprising adalimumab, wherein less than 70% of the total N-linked oligosaccharides present on said adalimumab are of an agalactosyl fucosylated biantennary oligosaccharide form (sum NGA2F+NGA2F-GlcNAc). 17. The composition of claim 16, wherein 49-69% of the total N-linked oligosaccharides present on said adalimumab are of an agalactosyl fucosylated biantennary oligosaccharide form (sum NGA2F+NGA2F-GlcNAc). 18. The composition of claim 16, wherein 55-65% of the total N-linked oligosaccharides present on said adalimumab are of an agalactosyl fucosylated biantennary oligosaccharide form (sum NGA2F+NGA2F-GlcNAc). 19. The composition of claim 16, wherein 26-40% of the total N-linked oligosaccharides present on said adalimumab are of a galactose-containing fucosylated biantennary oligosaccharide form (sum of NA1F+NA2F). 20. The composition of claim 16, wherein 35-44% of the total N-linked oligosaccharides present on said adalimumab are of a galactose-containing fucosylated biantennary oligosaccharide form (sum of NA1F+NA2F). 21. The composition of claim 16, wherein 30-40% of the total N-linked oligosaccharides present on said adalimumab are of a galactose-containing fucosylated biantennary oligosaccharide form (sum of NA1F+NA2F). 22. The composition of claim 16, wherein said adalimumab has been produced by culturing a mammalian cell in a cell culture media which has been supplemented with a manganese supplement and a galactose supplement. 23. The composition of claim 22, wherein the cell culture media has been supplemented with 0.2-100 .mu.M of a manganese supplement and 1-100 mM of a galactose supplement. 24. The composition of claim 22, wherein the cell culture media comprises a hydrolysate based media or a chemically defined media. 25. The composition of claim 22, wherein the mammalian cell is a CHO cell or an NSO cell. 26. A pharmaceutical composition comprising the composition of claim 16 and a pharmaceutically acceptable carrier. 27. The pharmaceutical composition of claim 26, wherein the pharmaceutically acceptable carrier comprises a polyalcohol. 28. The pharmaceutical composition of claim 26, wherein the pharmaceutically acceptable carrier comprises mannitol, sodium chloride, sodium phosphate or polysorbate 80. 29. The pharmaceutical composition of claim 26, wherein the pharmaceutical composition further comprises polysorbate 80. 30. The pharmaceutical composition of claim 26, wherein the pharmaceutical composition is suitable for parenteral administration.

Details for Patent 9,365,645

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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	2031-04-27
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2031-04-27
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2031-04-27
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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