Protein formulation
AssigneeGenentech, Inc.
InventorsJames Andya, Jeffrey L. Cleland, Chung C. Hsu, Xanthe M. Lam, David E. Overcashier, Steven J. Shire, Janet Yu-Feng Yang, Sylvia Sau-Yan Wu
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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.
Claims16
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.
Dependencies are inferred from the claim text.