Claims for Patent: 9,067,990

Summary for Patent: 9,067,990

Title:	Protein purification using displacement chromatography
Abstract:	Disclosed herein are compositions and methods for the isolation and purification of proteins from a sample. In particular, the present invention relates to compositions and methods for isolating and purifying proteins incorporating a displacement chromatographic step. The present invention is also directed toward pharmaceutical compositions comprising one or more antibodies purified by a method described herein.
Inventor(s):	Wang; Chen (Shrewsbury, MA), Coppola; Germano (Shrewsbury, MA), Chumsae; Chris (North Andover, MA)
Assignee:	AbbVie, Inc. (North Chicago, IL)
Application Number:	13/803,808
Patent Claims:	1. A method for producing an antibody composition comprising a reduced amount of acidic species of the antibody, wherein the antibody comprises the heavy and light chains of adalimumab, the method comprising: (a) contacting a first composition comprising the antibody with a chromatography media, wherein the first composition comprises more than 10% total acidic species of adalimumab, wherein the acidic species of the antibody comprise species selected from the group consisting of charge variants, size variants, fragmentation variants, and any combinations thereof, wherein the acidic species of the antibody do not include process-related impurities selected from the group consisting of host cell proteins, host cell DNA, and media components, wherein the antibody binds to the chromatography media; (b) displacing the antibody bound to the chromatography media with a displacing buffer; and (c) collecting a second composition comprising the displaced antibody, wherein the second composition comprises less than 10% total acidic species of the antibody, thereby producing an antibody composition comprising a reduced amount of acidic species of the antibody. 2. The method of claim 1, wherein the chromatography media is an ion exchange adsorbent material. 3. The method of claim 2, wherein the ion exchange adsorbent material is an anion exchange adsorbent material. 4. The method of claim 2, wherein the ion exchange adsorbent material is a cation exchange adsorbent material. 5. The method of claim 4, wherein the cation exchange adsorbent material is a CEX membrane adsorber. 6. The method of claim 4, wherein the cation exchange adsorbent material is a CEX resin. 7. The method of claim 1, wherein the chromatography media is a multimodal adsorbent material comprising cation exchange and hydrophobic interaction functional groups. 8. The method of claim 1, wherein the pH of the displacing buffer is lower than the isoelectric point of the antibody. 9. The method of claim 8, wherein the pH of the displacing buffer is 6.0 to 8.0. 10. The method of claim 1, wherein the displacing buffer carries a positive charge. 11. The method of claim 1, wherein the conductivity of the displacing buffer is 2 to 20 mS/cm. 12. The method of claim 1, wherein the chromatography media is present in a column having a length of 10 cm to 30 cm, and wherein flow residence time is 5 min to 25 min. 13. The method of claim 1, wherein displacing the antibody bound to the chromatography media comprises using a first displacing buffer followed by using a second displacing buffer. 14. The method of claim 1, wherein one displacing buffer is used. 15. The method of claim 1, wherein displacing is achieved using a multiple-step displacement, a two-step displacement, or a linear displacement. 16. The method of claim 1, wherein the displacing buffer comprises protamine sulfate. 17. The method of claim 1, wherein the displacing buffer comprises a quaternary ammonium salt. 18. The method of claim 16, wherein the displacing buffer comprises 0.25 mM protamine sulfate. 19. The method of claim 17, wherein the displacing buffer comprises 0.1 to 10 mM quaternary ammonium salt. 20. The method of claim 16, wherein the displacing buffer comprises 0.1 to 5 mM protamine sulfate. 21. The method of claim 1, wherein the chromatography media is a mixed mode media. 22. The method of claim 1, wherein the second composition comprises less than 9% acidic species of the antibody. 23. The method of claim 1, wherein the second composition comprises less than 8% acidic species of the antibody. 24. The method of claim 1, wherein the second composition comprises less than 7% acidic species of the antibody. 25. The method of claim 1, wherein the second composition comprises less than 6% acidic species of the antibody. 26. The method of claim 1, wherein the second composition comprises less than 5% acidic species of the antibody. 27. The method of claim 1, wherein the second composition comprises less than 4.5% acidic species of the antibody. 28. The method of claim 1, wherein the second composition comprises less than 4% acidic species of the antibody. 29. The method of claim 1, wherein the second composition comprises less than 3% acidic species of the antibody. 30. The method of claim 1, wherein the second composition comprises less than 1.4% acidic species of the antibody.

Details for Patent 9,067,990

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2039-02-26