Claims for Patent: 9,096,666

Summary for Patent: 9,096,666

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:	14/550,809
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,096,666
Patent Claims:	1. A liquid composition comprising adalimumab, 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 1.84 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 liquid composition of claim 1, wherein the cathepsin L activity is no greater than 1.3 RFU/s/mg of adalimumab. 3. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 1.0 RFU/s/mg of adalimumab. 4. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 0.6 RFU/s/mg of adalimumab. 5. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 0.85 RFU/s/mg of adalimumab. 6. The liquid composition of claim 1, wherein the cathepsin L activity is no greater than 0.9 RFU/s/mg of adalimumab. 7. The liquid composition of claim 1, wherein the composition is packaged in a pre-filled syringe. 8. The liquid composition of claim 1, wherein the composition comprises 50 mg/ml of adalimumab. 9. The liquid composition of claim 1, wherein the composition is suitable for subcutaneous injection. 10. The liquid composition of claim 1, wherein the diluted composition has an adalimumab concentration of 20 .mu.g/ml. 11. The liquid composition of claim 1, wherein the diluted composition has an adalimumab concentration of 50 .mu.g/ml. 12. The liquid composition of claim 1, wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold. 13. The liquid composition of claim 2, wherein the composition is packaged in a pre-filled syringe. 14. The liquid composition of claim 2, wherein the composition comprises 50 mg/ml of adalimumab. 15. The liquid composition of claim 2, wherein the composition is suitable for subcutaneous injection. 16. The liquid composition of claim 2, wherein the diluted composition has an adalimumab concentration of 20 .mu.g/ml. 17. The liquid composition of claim 2, wherein the diluted composition has an adalimumab concentration of 50 .mu.g/ml. 18. The liquid composition of claim 2, wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold. 19. The liquid composition of claim 3, wherein the composition is packaged in a pre-filled syringe. 20. The liquid composition of claim 3, wherein the composition comprises 50 mg/ml of adalimumab. 21. The liquid composition of claim 3, wherein the composition is suitable for subcutaneous injection. 22. The liquid composition of claim 3, wherein the diluted composition has an adalimumab concentration of 20 .mu.g/ml. 23. The liquid composition of claim 3, wherein the diluted composition has an adalimumab concentration of 50 .mu.g/ml. 24. The liquid composition of claim 3, wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold. 25. The liquid composition of claim 4, wherein the composition is packaged in a pre-filled syringe. 26. The liquid composition of claim 4, wherein the composition comprises 50 mg/ml of adalimumab. 27. The liquid composition of claim 4, wherein the composition is suitable for subcutaneous injection. 28. The liquid composition of claim 4, wherein the diluted composition has an adalimumab concentration of 20 .mu.g/ml. 29. The liquid composition of claim 4, wherein the diluted composition has an adalimumab concentration of 50 .mu.g/ml. 30. The liquid composition of claim 4, wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold.

Details for Patent 9,096,666

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2034-11-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2034-11-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2034-11-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2034-11-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015		2034-11-21

International Patent Family for US Patent 9,096,666

Country	Patent Number	Estimated Expiration
South Africa	201100565
South Africa	200808372
World Intellectual Property Organization (WIPO)	2007117490
United States of America	9913902
United States of America	9328165