Claims for Patent: 9,018,361

Summary for Patent: 9,018,361

Title:	Isolation and purification of antibodies using protein a affinity chromatography
Abstract:	Disclosed herein are methods for the isolation and purification of antibodies wherein the use of an affinity chromatographic step results in an antibody composition sufficiently pure for pharmaceutical uses. The methods described herein comprise pH viral reduction/inactivation, ultrafiltration/diafiltration, affinity chromatography, preferably Protein A affinity, ion exchange chromatography, and hydrophobic chromatography. Further, the present invention is directed toward pharmaceutical compositions comprising one or more antibodies of the present invention.
Inventor(s):	Hickman; Robert K. (Worcester, MA), Huang; Qing (Singapore, SG), Weed; Cheryl L. (Scituate, RI), Ennis; Scott T. (South Grafton, MA), Perilli-Palmer; Barbara (Bolton, MA), Wan; Min (Frederick, MD)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	14/226,636
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,018,361
Patent Claims:	1. A process for purifying adalimumab from a fermentation harvest of a Chinese Hamster Ovary (CHO) cell culture expressing said adalimumab, said process comprising: a) binding adalimumab from said fermentation harvest to a Protein A resin, b) eluting the bound adalimumab at an elution pH of 3.6-4, and c) incubating the eluted adalimumab for 1 to 3 hours. 2. The process of claim 1, wherein said eluting is at an elution pH is 3.6. 3. The process of claim 1, wherein said eluting is at an elution pH of 3.7. 4. The process of claim 1, wherein said eluting is at an elution pH of 3.8. 5. The process of claim 1, wherein said eluting is at an elution pH of 4. 6. The process of claim 1, further comprising after said incubating, subjecting adalimumab to one or more further chromatographic separations, wherein said one or more further chromatographic separations comprise an ion exchange chromatography, a hydrophobic interactive chromatography or a combination thereof. 7. The process of claim 1, further comprising subjecting adalimumab to an ion exchange chromatography after said incubating. 8. The process of claim 7, wherein said ion exchange chromatography is cation exchange chromatography. 9. The process of claim 7, wherein said ion exchange chromatography is anion exchange chromatography. 10. The process of claim 1, further comprising subjecting adalimumab to a hydrophobic interaction chromatography after said incubating. 11. The process of claim 1, further comprising determining the monomer level of adalimumab purified according to said process. 12. The process of claim 1, wherein the adalimumab monomer level after said incubating is greater than 97%. 13. The process of claim 1, wherein the purified adalimumab is pharmaceutical grade.

Details for Patent 9,018,361

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2028-10-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2028-10-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2028-10-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2028-10-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2028-10-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016		2028-10-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10/17/2016		2028-10-20