Claims for Patent: 8,916,153

Summary for Patent: 8,916,153

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:	13/927,236
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,916,153
Patent Claims:	1. A pharmaceutical composition comprising adalimumab and a pharmaceutically acceptable carrier, wherein the adalimumab is produced in a Chinese Hamster Ovary (CHO) cell expression system; and wherein the composition is characterized in that when the composition is assayed in a cathepsin L kinetic assay, a level of cathepsin L activity from 0.4 to less than 1.84 RFU/s/mg of adalimumab is observed, wherein the cathepsin L kinetic assay comprises: i) diluting the composition 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 pharmaceutical composition of claim 1, wherein the cathepsin L activity is from 0.4 to 1.3 RFU/s/mg of adalimumab. 3. The pharmaceutical composition of claim 1, wherein the cathepsin L activity is from 0.5 to 1.5 RFU/s/mg of adalimumab. 4. The pharmaceutical composition of claim 1, wherein the cathepsin L activity is from 0.4 to 1.0 RFU/s/mg of adalimumab. 5. The pharmaceutical composition of claim 1, wherein the cathepsin L activity is from 0.4 to 0.6 RFU/s/mg of adalimumab. 6. The pharmaceutical composition of claim 1, wherein the cathepsin L activity is from 0.4 to 0.85 RFU/s/mg of adalimumab. 7. The pharmaceutical composition of claim 1, wherein the cathepsin L activity is from 0.4 to 0.9 RFU/s/mg of adalimumab. 8. The pharmaceutical composition of any one of claims 1-3 and 4-7, wherein the composition is packaged in a pre-filled syringe. 9. The pharmaceutical composition of any one of claims 1-3 and 4-7, wherein the composition comprises 50 mg/ml of adalimumab. 10. The pharmaceutical composition of any one of claims 1-3 and 4-7, wherein the composition further comprises mannitol. 11. The pharmaceutical composition of any one of claims 1-3 and 4-7, wherein the composition is suitable for subcutaneous injection. 12. The pharmaceutical composition of any one of 1-3 and 4-7, wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold. 13. The pharmaceutical composition of any one of claims 1-3 and 4-7, wherein the diluted composition has an adalimumab concentration of 50 .mu.g/ml. 14. The pharmaceutical composition of any one of claims 1-3 and 4-7, wherein the diluted composition has an adalimumab concentration of 20 .mu.g/ml.

Details for Patent 8,916,153

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2026-04-05
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2026-04-05