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 AMA-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.
Claims6
A concentrated liquid formulation comprising 180 mg/mL of a humanized anti-IL-6 receptor antibody MRA, 0.005 to 3% surfactant, and histidine buffer, pH 6.0, wherein the formulation has no more than 2.70% dimers after storage at 40° C. for 3 months or no more than 1.88% dimers after storage at 25° C. for 6 months.
Dependencies are inferred from the claim text.