Claims for Patent: 7,682,609

Summary for Patent: 7,682,609

Title:	Protein formulation
Abstract:	A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.
Inventor(s):	Andya; James (Milbrae, CA), Cleland; Jeffrey L. (San Carlos, CA), Hsu; Chung C. (Los Altos Hills, CA), Lam; Xanthe M. (South San Francisco, CA), Overcashier; David E. (Montara, CA), Shire; Steven J. (Emerald Hills, CA), Yang; Janet Yu-Feng (San Mateo, CA), Wu; Sylvia Sau-Yan (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Franisco, CA)
Application Number:	11/441,994
Patent Claims:	1. A formulation comprising a lyophilized mixture of a recombinant humanized HER2 monoclonal antibody, a lyoprotectant, and a buffer. 2. The formulation of claim 1 wherein the pH of the formulation is from 5-7. 3. The formulation of claim 2 wherein the pH of the formulation is 6.0. 4. The formulation of claim 1 wherein the buffer is histidine, phosphate, Tris, citrate, succinate, or other organic acid. 5. The formulation of claim 4 wherein the buffer is histidine. 6. The formulation of claim 1 wherein the antibody is huMAb4D5-8. 7. The formulation of claim 1 further comprising a surfactant. 8. The formulation of claim 7 wherein the surfactant is a nonionic surfactant. 9. The formulation of claim 7 wherein the surfactant is a polysorbate. 10. The formulation of claim 1 wherein the lyoprotectant is a sugar. 11. The formulation of claim 1 which is stable at 30.degree. C. for at least 6 months. 12. The formulation of claim 1 wherein the concentration of the humanized HER2 antibody is from about 5-40 mg/mL. 13. The formulation of claim 12 wherein the concentration of the humanized HER2 antibody is from about 20-30 mg/mL. 14. A vial containing a formulation comprising a lyophilized mixture of a recombinant humanized HER2 monoclonal antibody, a lyoprotectant, and a buffer. 15. The vial of claim 14 which is a 3, 5, 10, 20, 50, or 100 cc vial. 16. The vial of claim 14 wherein the antibody is huMAb4D5-8. 17. The vial of claim 14 wherein the pH of the formulation is from 5-7. 18. The vial of claim 17 wherein the pH of the formulation is 6.0. 19. The vial of claim 14 wherein the buffer is histidine, phosphate, Tris, citrate, succinate, or other organic acid. 20. A formulation comprising a lyophilized mixture of huMAb4D5-8 in an amount from 5-40 mg/mL, a sugar in an amount from 10-400 mM, a surfactant in an amount from 0.001-0.5%, and histidine buffer, wherein the pH of the formulation is 6.0. 21. A method of treating HER2 overexpressing breast cancer comprising administering to a patient with the breast cancer a reconstituted formulation comprising recombinant humanized HER2 antibody, wherein the reconstituted formulation has been prepared by reconstituting of claim 1 with a diluent to generate the reconstituted formulation. 22. The method as in claim 21 wherein the pH of the formulation is from 5-7. 23. The method as in claim 22 wherein the pH of the formulation is 6.0. 24. The method as in claim 21 wherein the buffer is histidine, phosphate, Tris, citrate, succinate, or other organic acid. 25. The method as in claim 21 wherein the concentration of the humanized HER2 antibody in the reconstituted formulation is from about 5-50 mg/mL. 26. The method as in claim 25 wherein the concentration of the humanized HER2 antibody in the reconstituted formulation is from about 10-40 mg/mL. 27. The method as in claim 21 wherein the antibody is huMAb4D5-8. 28. The method as in claim 21 wherein the pH of the reconstituted formulation 6.0. 29. The method as in claim 21 wherein the diluent is sterile water. 30. The method as in claim 21 wherein the diluent is bacteriostatic water for injection (BWFI).

Details for Patent 7,682,609

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2015-07-27