High concentration antibody-containing liquid formulation
AssigneesChugai Seiyaku Kabushiki Kaisha, Hoffmann-La Roche Inc.
InventorsToshiyuki MORICHIKA, Daisuke KAMEOKA, Yoshimi IMAEDA, Terutoshi MAEDA, Oliver Boris STAUCH
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Abstract
The problem to be solved is to provide a humanized anti-IL-6 receptor antibody MRA-containing formulation which is suitable for subcutaneous administration, wherein dimerization or deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and histidine buffer. A method of inhibiting deamidation or dimerization of such an antibody in a concentrated liquid formulation includes histidine buffer in the liquid formulation.
Claims4
A stable liquid formulation comprising 50 to 300 mg/ml of a monoclonal IgG antibody, 50 to 300 mM arginine, 5 to 100 mM histidine, and 0.005 to 3% polysorbate 80 or polysorbate 20, pH 5.5 to 7.2.
A method for formulating a monoclonal IgG antibody for use for subcutaneous administration, comprising combining 50 to 300 mg/ml of the antibody with 50 to 300 mM arginine, 5 to 100 mM histidine, and 0.005 to 3% polysorbate 80 or polysorbate 20, pH of 5.5 to 7.2, to prepare a liquid formulation, wherein the arginine inhibits dimerization or deamidation of the antibody in the formulation.
Dependencies are inferred from the claim text.