Claims for Patent: 10,010,611

Summary for Patent: 10,010,611

Title:	Antibody formulations
Abstract:	The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.
Inventor(s):	Gokarn; Yatin (South San Francisco, CA), Zarraga; Isidro E. (South San Francisco, CA), Zarzar; Jonathan (South San Francisco, CA), Patapoff; Thomas (South San Francisco, CA)
Assignee:	GENENTECH, INC. (South San Francisco, CA)
Application Number:	14/207,885
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,010,611
Patent Claims:	1. A stable aqueous pharmaceutical formulation, the formulation comprising (a) a monoclonal antibody in an amount of about 45 mg/mL to about 55 mg/mL; (b) trehalose in an amount of about 50 mM to about 70 mM; and (c) sodium phosphate in an amount of about 22 mM to about 28 mM, wherein said formulation has a pH of about 5.9 to about 6.5; wherein said antibody is bevacizumab. 2. The formulation of claim 1, further comprising a surfactant. 3. The formulation of claim 2, wherein said surfactant is polysorbate or poloxamer. 4. The formulation of claim 3, wherein said polysorbate is polysorbate 20. 5. The formulation of claim 3, wherein said poloxamer is poloxamer 188. 6. The formulation of claim 2, wherein said surfactant concentration is about 0.01% to about 0.1%. 7. The formulation of claim 2, wherein said surfactant concentration is about 0.01% to about 0.05%. 8. The formulation of claim 2, wherein said surfactant concentration is about 0.04%. 9. The formulation of claim 4, wherein said polysorbate 20 concentration is about 0.02%. 10. The formulation of claim 1, wherein formation of trailing edge dimer after storage is reduced relative to formation of trailing edge dimer in a formulation comprising 50 mg/mL bevacizumab, 25 mM sodium phosphate, 60 mM trehalose, 0.04% PS20, pH 6.2, wherein the formulation shows reduced trailing edge dimer after storage for at least 12 months at -20.degree. C. 11. The formulation of claim 1, wherein formation of trailing edge dimer after storage is reduced relative to formation of trailing edge dimer in a formulation comprising 50 mg/mL bevacizumab, 25 mM sodium phosphate, 60 mM trehalose, 0.04% PS20, pH 6.2, wherein the formulation shows reduced trailing edge dimer after storage for at least 24 months at -20.degree. C. 12. The formulation of claim 1, wherein formation of trailing edge dimer after storage is reduced relative to formation of trailing edge dimer in a formulation comprising 50 mg/mL bevacizumab, 25 mM sodium phosphate, 60 mM trehalose, 0.04% PS20, pH 6.2, wherein the formulation shows reduced trailing edge dimer after storage for at least 12 months at -40.degree. C. 13. The formulation of claim 1, wherein formation of trailing edge dimer after storage is reduced relative to formation of trailing edge dimer in a formulation comprising 50 mg/mL bevacizumab, 25 mM sodium phosphate, 60 mM trehalose, 0.04% PS20, pH 6.2, wherein the formulation shows reduced trailing edge dimer after storage for at least 24 months at -40.degree. C. 14. The formulation of claim 1, wherein formation of trailing edge dimer after storage is reduced relative to formation of trailing edge dimer in a formulation comprising 50 mg/mL bevacizumab, 25 mM sodium phosphate, 60 mM trehalose, 0.04% PS20, pH 6.2, wherein trailing edge dimer is determined by size exclusion chromatography. 15. The formulation of claim 14, wherein the size exclusion chromatography is dilute size exclusion chromatography.

Details for Patent 10,010,611

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2033-03-13