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Last Updated: October 17, 2019

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Claims for Patent: 8,883,156

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Summary for Patent: 8,883,156
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:13/927,576
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,883,156
Patent Claims:1. A method of treating a disorder in which TNF.alpha. activity is detrimental in a subject, the method comprising administering a composition comprising a therapeutically effective amount of adalimumab to the subject such that the disorder is treated, wherein the adalimumab is produced in a Chinese Hamster Ovary (CHO) cell expression system; wherein the disorder is selected from the group consisting of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis, and juvenile rheumatoid arthritis; 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 method of claim 1, wherein the cathepsin L activity is from 0.4 to 1.3 RFU/s/mg of adalimumab.

3. The method of claim 1, wherein the cathepsin L activity is from 0.5 to 1.5 RFU/s/mg of adalimumab.

4. A method of treating a disorder in which TNF.alpha. activity is detrimental in a subject, the method comprising subcutaneously administering a composition comprising a therapeutically effective amount of adalimumab to the subject such that the disorder is treated, wherein the adalimumab is produced in a Chinese Hamster Ovary (CHO) cell expression system; wherein the disorder is selected from the group consisting of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis, and juvenile rheumatoid arthritis; 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.

5. The method of claim 4, wherein the cathepsin L activity is from 0.4 to 1.3 RFU/s/mg of adalimumab.

6. The method of claim 4, wherein the cathepsin L activity is from 0.5 to 1.5 RFU/s/mg of adalimumab.

7. The method of any one of claims 1-6, wherein the composition is packaged in a pre-filled syringe.

8. The method of any one of claims 1-6, wherein the composition comprises 50 mg/ml of adalimumab.

9. The method of any one of claims 1-6, wherein the composition further comprises mannitol.

10. The method of any one of claims 1-6, wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold.

11. The method of any one of claims 1-6, wherein the diluted composition has an adalimumab concentration of 50 .mu.g/ml.

12. The method of any one of claims 1-6, wherein the diluted composition has an adalimumab concentration of 20 .mu.g/ml.

13. The method of claim 4, wherein the disorder is rheumatoid arthritis.

14. The method of claim 4, wherein the disorder is Crohn's disease.

15. The method of claim 4, wherein the disorder is ulcerative colitis.

16. The method of claim 4, wherein the disorder is ankylosing spondylitis.

17. The method of claim 4, wherein the disorder is psoriatic arthritis.

18. The method of claim 4, wherein the disorder is psoriasis.

19. The method of claim 4, wherein the disorder is juvenile rheumatoid arthritis.

Details for Patent 8,883,156

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial AbbVie Biotechnology Ltd. (Hamilton, BM) 2026-04-05 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial AbbVie Biotechnology Ltd. (Hamilton, BM) 2026-04-05 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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