Claims for Patent: 9,913,902

Summary for Patent: 9,913,902

Title:	Purified antibody composition
Abstract:	The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.
Inventor(s):	Wan; Min M. (Worcester, MA), Avgerinos; George (Sudbury, MA), Zarbis-Papastoitsis; Gregory (Watertown, MA)
Assignee:	ABBVIE BIOTECHNOLOGY LTD. (Hamilton, BM)
Application Number:	15/718,621
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,913,902
Patent Claims:	1. A liquid pharmaceutical composition comprising 50 mg/ml of adalimumab and a pharmaceutically acceptable carrier, wherein the adalimumab is expressed in a Chinese hamster ovary (CHO) cell expression system; and the composition is characterized in that when the composition is assayed in a cathepsin L kinetic assay, a level of cathepsin L activity less than 1.3 RFU/s/mg of adalimumab is observed, wherein the cathepsin L kinetic assay comprises: i. diluting the composition 600-fold in a polystyrene container in a solution containing 25 mM NaOAc, 5 mM DTT and 1 mM EDTA at pH 5.5, ii. adding dextran sulfate to a concentration of 0.035 .mu.g/mL and incubating at 37.degree. C. for six hours, iii. adding Z-leucine-arginine covalently bound at its C-terminus to a fluorescent 7-amino-4-methyl coumarin (Z-leucine-arginine-AMC), wherein the diluting, adding, and incubating steps are sufficient to permit the measurement of cathepsin L hydrolysis of the Z-leucine-arginine-AMC within a linear range, and iv. measuring Z-leucine-arginine-AMC hydrolysis in the linear range in RFU/s/mg of adalimumab. 2. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 1.0 RFU/s/mg of adalimumab. 3. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 0.6 RFU/s/mg of adalimumab. 4. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 0.85 RFU/s/mg of adalimumab. 5. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 0.9 RFU/s/mg of adalimumab. 6. The liquid composition of claim 1, wherein the composition is packaged in a pre-filled syringe. 7. The liquid pharmaceutical composition of claim 1, wherein the composition is suitable for subcutaneous injection. 8. The liquid pharmaceutical composition of claim 2, wherein the composition is packaged in a pre-filled syringe. 9. The liquid pharmaceutical composition of claim 2, wherein the composition is suitable for subcutaneous injection. 10. The liquid pharmaceutical composition of claim 3, wherein the composition is packaged in a pre-filled syringe. 11. The liquid pharmaceutical composition of claim 3, wherein the composition is suitable for subcutaneous injection. 12. The liquid pharmaceutical composition of claim 4, wherein the composition is packaged in a pre-filled syringe. 13. The liquid pharmaceutical composition of claim 4, wherein the composition is suitable for subcutaneous injection. 14. The liquid pharmaceutical composition of claim 5, wherein the composition is packaged in a pre-filled syringe. 15. The liquid pharmaceutical composition of claim 5, wherein the composition is suitable for subcutaneous injection. 16. A liquid pharmaceutical composition comprising 50 mg/ml of adalimumab and a pharmaceutically acceptable carrier, wherein the adalimumab is expressed in a Chinese hamster ovary (CHO) cell expression system; and the composition is characterized in that when the composition is assayed in a cathepsin L kinetic assay, a level of fluorescent activity no greater than 0.0144 RFU/sec is observed, wherein the cathepsin L kinetic assay comprises: i. diluting the composition 600-fold in a polystyrene container in a solution containing 25 mM NaOAc, 5 mM DTT and 1 mM EDTA at pH 5.5, ii. adding dextran sulfate to a concentration of 0.035 .mu.g/mL and incubating at 37.degree. C. for six hours, iii. adding Z-leucine-arginine covalently bound at its C-terminus to a fluorescent 7-amino-4-methyl coumarin (Z-leucine-arginine-AMC), wherein the diluting, adding, and incubating steps are sufficient to permit the measurement of cathepsin L hydrolysis of the Z-leucine-arginine-AMC within a linear range, and iv. measuring the fluorescent activity generated by the Z-leucine-arginine-AMC hydrolysis. 17. The liquid pharmaceutical composition of claim 16, wherein no detectable level of fluorescent activity is observed. 18. The liquid pharmaceutical composition of claim 16, wherein the composition is packaged in a pre-filled syringe. 19. The liquid pharmaceutical composition of claim 16, wherein the composition is suitable for subcutaneous injection.

Details for Patent 9,913,902

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002	9,913,902	2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008	9,913,902	2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013	9,913,902	2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014	9,913,902	2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015	9,913,902	2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016	9,913,902	2026-04-05