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Last Updated: March 29, 2024

Claims for Patent: 9,283,273


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Summary for Patent: 9,283,273
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 (Millbrae, 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 Francisco, CA)
Application Number:13/619,576
Patent Claims:1. A stable lyophilized pharmaceutical formulation comprising a lyophilized mixture of a lyoprotectant and a monoclonal anti-HER2 antibody, wherein the lyoprotectant is trehalose or sucrose and the molar ratio of lyoprotectant: antibody is 200-600 mole lyoprotectant: 1 mole antibody.

2. The formulation of claim 1, wherein the monoclonal anti-HER2 antibody is huMab4D5-8.

3. The formulation of claim 1 or 2 comprising the anti-HER2 antibody in a pre-lyophilized amount of 20-30 mg/mL, sucrose or trehalose in a pre-lyophilized amount of 40-80 mM, a buffer and a surfactant, wherein the buffer is histidine or succinate buffer.

4. The formulation of claim 1 or 2, wherein the lyoprotectant is trehalose.

5. The formulation of claim 3, wherein the lyoprotectant is trehalose.

6. The formulation of claim 4, wherein the molar ratio of trehalose:antibody is 360:1.

7. The formulation of claim 5, wherein the molar ratio of trehalose:antibody is 360:1.

8. The formulation of claim 5, wherein the surfactant is polysorbate 20.

9. The formulation of claim 7, wherein the surfactant is polysorbate 20.

10. The formulation of claim 8, which is lyophilized and stable at 40.degree. C. for at least 1 month.

11. The formulation of claim 9, which is lyophilized and stable at 40.degree. C. for at least 1 month.

12. The formulation of claim 3, which is reconstituted with a diluent such that the anti-HER2 antibody concentration in the reconstituted formulation is 10-30mg/mL, wherein the reconstituted formulation is stable at 2-8.degree. C. for at least 30 days.

13. The formulation of claim 5, which is reconstituted with a diluent such that the anti-HER2 antibody concentration in the reconstituted formulation is 10-30 mg/mL, wherein the reconstituted formulation is stable at 2-8.degree. C. for at least 30days.

14. The formulation of claim 9, which is reconstituted with a diluent such that the anti-HER2 antibody concentration in the reconstituted formulation is 10-30 mg/mL, wherein the reconstituted formulation is stable at 2-8.degree. C. for at least 30days.

15. The formulation of claim 13, wherein the diluent is sterile water or bacteriostatic water for injection (BWFI).

16. The formulation of claim 14, wherein the diluent is sterile water or bacteriostatic water for injection (BWFI).

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