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HIGH CONCENTRATION FORMULATION OF FACTOR XII ANTIGEN BINDING PROTEINS

机译:因子XII抗原结合蛋白的高浓度制剂

摘要

The present application is directed to a liquid formulation comprising at least 100mg/ml of a protein comprising an antigen binding domain that binds to FXII (and/or an activated form thereof), an organic buffer, a non-ionic surfactant and an amino acid stabilizer, wherein the pH of the formulation is 5.0-6.5 and the viscosity is less than 30 mPa*s at 20°C. Exemplary formulations comprise the specific Factor XII antibody 3F7, in formulation with a histidine buffer, a polysorbate 80 surfactant and the amino acid stabilizers arginine and proline.
机译:本申请涉及一种液体制剂,其包含至少100mg / ml的蛋白质,所述蛋白质包含抗原结合结构域,所述抗原结合结构域与FXII(和/或其活化形式),有机缓冲液,非离子表面活性剂和氨基酸结合 稳定剂,其中制剂的pH为5.0-6.5,粘度在20℃下小于30mPa * s。 示例性配方包含特定因子XII抗体3F7,其用组氨酸缓冲液,聚山梨醇酯80表面活性剂和氨基酸稳定剂精氨酸和脯氨酸。

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