Claims for Patent: 9,334,319

Summary for Patent: 9,334,319

Title:	Low acidic species compositions
Abstract:	The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the amount of charge variants, aggregates, and fragments of a protein of interest, as well as host cell proteins, present in purified preparations by applying particular chromatography conditions during such protein purification.
Inventor(s):	Ramasubramanyan; Natarajan (Westborough, MA), Yang; Lihua (Westborough, MA), Herigstad; Matthew Omon (Charlestown, MA), Yang; Hong (Worcester, MA), Chumsae; Christopher (North Andover, MA)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	13/829,989
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,334,319
Patent Claims:	1. A composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab correspond to the peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab, wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5), and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm. 2. The composition of claim 1, wherein the acidic species of adalimumab comprise a first acidic region (AR1) and a second acidic region (AR2). 3. The composition of claim 1, wherein the composition comprises less than 3.8% total acidic species of adalimumab. 4. The composition of claim 2, wherein the composition comprises 0.8% AR1 and 3.0% AR2. 5. The composition of claim 1, wherein the composition comprises less than 2.4% total acidic species of adalimumab. 6. The composition of claim 2, wherein the composition comprises 0.2% AR1 and 2.2% AR2. 7. The composition of claim 1, wherein the composition comprises 4.7%-8.3% total acidic species of adalimumab. 8. The composition of claim 7, wherein the composition comprises 4.7% total acidic species of adalimumab. 9. The composition of claim 7, wherein the composition comprises 5.0% total acidic species of adalimumab. 10. The composition of claim 7, wherein the composition comprises 5.8% total acidic species of adalimumab. 11. The composition of claim 7, wherein the composition comprises 6.1% total acidic species of adalimumab. 12. The composition of claim 7, wherein the composition comprises 6.4% total acidic species of adalimumab. 13. The composition of claim 7, wherein the composition comprises 8.1% total acidic species of adalimumab. 14. The composition of claim 7, wherein the composition comprises 8.3% total acidic species of adalimumab. 15. The composition of claim 2, wherein the composition comprises 0.8%-1.4% AR1. 16. The composition of claim 2, wherein the composition comprises 3%-9% AR2. 17. The composition of claim 2, wherein the composition comprises 0.8% AR1 and 6.4% AR2. 18. The composition of claim 2, wherein the composition comprises 0.9% AR1 and 9% AR2. 19. The composition of claim 2, wherein the composition comprises 1.2% AR1 and 7.7% AR2. 20. The composition of claim 2, wherein the composition comprises 1.2% AR1 and 8.2% AR2. 21. The composition of claim 2, wherein the composition comprises 1.4% AR1 and 8.4% AR2. 22. The composition of claim 2, wherein the composition comprises 1.4% AR1 and 8.6% AR2. 23. The composition of claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier. 24. A pharmaceutical composition suitable for administration to a human subject, comprising a composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab correspond to the peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab, wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5), and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm; and a pharmaceutically acceptable carrier. 25. The pharmaceutical composition of claim 24, wherein the acidic species of adalimumab comprise a first acidic region (AR1) and a second acidic region (AR2). 26. The pharmaceutical composition of claim 24, wherein the composition comprises less than 3.8% total acidic species of adalimumab. 27. The pharmaceutical composition of claim 25, wherein the composition comprises 0.8% AR1 and 3.0% AR2. 28. The pharmaceutical composition of claim 24, wherein the composition comprises less than 2.4% total acidic species of adalimumab. 29. The pharmaceutical composition of claim 25, wherein the composition comprises 0.2% AR1 and 2.2% AR2. 30. The pharmaceutical composition of claim 24, wherein the composition comprises 4.7%-8.3% total acidic species of adalimumab. 31. The pharmaceutical composition of claim 30, wherein the composition comprises 4.7% total acidic species of adalimumab. 32. The pharmaceutical composition of claim 30, wherein the composition comprises 5.0% total acidic species of adalimumab. 33. The pharmaceutical composition of claim 30, wherein the composition comprises 5.8% total acidic species of adalimumab. 34. The pharmaceutical composition of claim 30, wherein the composition comprises 6.1% total acidic species of adalimumab. 35. The pharmaceutical composition of claim 30, wherein the composition comprises 6.4% total acidic species of adalimumab. 36. The pharmaceutical composition of claim 30, wherein the composition comprises 8.1% total acidic species of adalimumab. 37. The pharmaceutical composition of claim 30, wherein the composition comprises 8.3% total acidic species of adalimumab. 38. The pharmaceutical composition of claim 25, wherein the composition comprises 0.8%-1.4% AR1. 39. The pharmaceutical composition of claim 25, wherein the composition comprises 3%-9% AR2. 40. The pharmaceutical composition of claim 25, wherein the composition comprises 0.8% AR1 and 6.4% AR2. 41. The pharmaceutical composition of claim 25, wherein the composition comprises 0.9% AR1 and 9% AR2. 42. The pharmaceutical composition of claim 25, wherein the composition comprises 1.2% AR1 and 7.7% AR2. 43. The pharmaceutical composition of claim 25, wherein the composition comprises 1.2% AR1 and 8.2% AR2. 44. The pharmaceutical composition of claim 25, wherein the composition comprises 1.4% AR1 and 8.4% AR2. 45. The pharmaceutical composition of claim 25, wherein the composition comprises 1.4% AR1 and 8.6% AR2. 46. The composition of any one of claims 1-23, wherein the composition is a lyophilized composition. 47. The pharmaceutical composition of any one of claims 24-45, wherein the composition is a lyophilized composition. 48. The composition of any one of claims 1-23, wherein the adalimumab is produced in a mammalian host cell grown in cell culture. 49. The composition of claim 48, wherein the mammalian host cell is selected from the group consisting of a CHO cell, an NSO cell, a COS cell, and an SP2 cell. 50. The composition of claim 49, wherein the mammalian host cell is a CHO cell. 51. The pharmaceutical composition of any one of claims 24-45, wherein the adalimumab is produced in a mammalian host cell grown in cell culture. 52. The pharmaceutical composition of claim 51, wherein the mammalian host cell is selected from the group consisting of a CHO cell, an NSO cell, a COS cell, and an SP2 cell. 53. The pharmaceutical composition of claim 52, wherein the mammalian host cell is a CHO cell. 54. The pharmaceutical composition of any one of claims 24-45, wherein adalimumab is present in the pharmaceutical composition at a concentration of 0.1-250 mg/mL. 55. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises mannitol. 56. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises sodium chloride. 57. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises polysorbate 80. 58. The pharmaceutical composition of any one of claims 24-45, wherein the pharmaceutically acceptable carrier comprises a buffer. 59. The pharmaceutical composition of claim 58, wherein the buffer is sodium citrate. 60. The pharmaceutical composition of claim 58, wherein the buffer is histidine. 61. A pre-filled syringe which contains the pharmaceutical composition of any one of claims 24-45.

Details for Patent 9,334,319

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2032-04-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2032-04-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2032-04-20
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2032-04-20