High concentration antibody-containing liquid formulation
AssigneeChugai Seiyaku Kabushiki Kaisha
InventorsToshiyuki MORICHIKA, Daisuke Kameoka, Yoshimi Imaeda, Terutoshi Maeda, Oliver Boris Stauch
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Abstract
The problem to be solved is to provide an antibody-containing formulation which is stable and suited for subcutaneous administration, wherein dimerization and deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and methionine.
Claims19
A method for inhibiting dimerization of antibody molecules in a liquid formulation comprising the antibody, comprising adding arginine and methionine to the liquid formulation.
A method for inhibiting dimerization of humanized anti-IL-6 receptor IgG1 antibody in a liquid formulation comprising 100 to 300 mg/mL of the antibody, comprising adding 50 to 300 mM arginine and 10 to 50 mM methionine to the formulation.
A method for preparing a stable liquid formulation suitable for subcutaneous administration comprising a humanized anti-IL-6 receptor IgG1 antibody, wherein the method comprises combining 150 to 200 mg/mL of the antibody with 50 to 300 mM arginine and 10 to 50 mM methionine.
A stable liquid formulation comprising 150 to 200 mg/mL humanized anti-IL-6 receptor IgG1 antibody, 50 to 100 mM arginine, 10 to 50 mM methionine, 0.005 to 3% surfactant, and histidine buffer, pH 5.5 to 6.5.
Dependencies are inferred from the claim text.