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.
Claims15
A formulation comprising a lyophilized mixture of a non-reducing sugar, a humanized antibody, and histidine, wherein the molar ratio of non-reducing sugar to humanized antibody is within the range from 100 to 600 mole non-reducing sugar:1 mole humanized antibody.
A sterile formulation comprising a lyophilized mixture of a non-reducing sugar and a humanized antibody, wherein the molar ratio of non-reducing sugar to humanized antibody is within the range from 200 to 600 mole non-reducing sugar:1 mole humanized antibody.
Dependencies are inferred from the claim text.