Claims for Patent: 7,060,268

Summary for Patent: 7,060,268

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. (San Francisco, CA), Overcashier; David E. (El Granada, CA), Shire; Steven J. (Belmont, CA), Yang; Janet Yu-Feng (San Mateo, CA), Wu; Sylvia Sau-Yan (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	10/428,728
Patent Claims:	1. A stable isotonic reconstituted formulation comprising an anti-IgE antibody in an amount in the range from about 80 mg/mL to about 400 mg/mL and a diluent, which reconstituted formulation has been prepared from a lyophilized mixture of the anti-IgE antibody, sucrose, histidine buffer and a surfactant, wherein the anti-IgE antibody concentration in the reconstituted formulation is about 2-40 times greater than the anti-IgE antibody concentration in the mixture before lyophilization. 2. A sterile reconstituted formulation comprising a full length humanized anti-IgE antibody in an amount in the range from about 80 mg/mL to about 400 mg/mL and a diluent, which reconstituted formulation has been prepared from a lyophilized mixture of the anti-IgE antibody, sucrose, histidine buffer and a surfactant, wherein the anti-IgE antibody concentration in the reconstituted formulation is about 2-40 times greater than the anti-IgE antibody concentration in the mixture before lyophilization. 3. The formulation of claim 2 wherein the diluent is selected from the group consisting of sterile water, bacteriostatic water for injection (BWFI), a pH buffered solution, sterile saline solution, Ringer's solution and dextrose solution.

Details for Patent 7,060,268

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