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.
Claims30
A formulation comprising a lyophilized mixture of a recombinant humanized HER2 monoclonal antibody, a lyoprotectant, and a buffer.
A vial containing a formulation comprising a lyophilized mixture of a recombinant humanized HER2 monoclonal antibody, a lyoprotectant, and a buffer.
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.
Dependencies are inferred from the claim text.