ANTI-IL-7R ANTIBODY COMPOSITION

PROBLEM TO BE SOLVED: To provide an antibody formulation with high concentration comprising a stable anti-IL-7R antibody, therefore, the problem over the delivery to patients from the manufacture of the formulation caused by the level of the viscosity of the antibody formulation is solved.SOLUTION: The invention provides a composition comprising an arginine HCl or NaCl, sucrose, a buffer, a chelating agent, and a polysorbate, wherein the concentration of an anti-IL-7R antibody is about 100 to about 300 mg/ml, and the pH is about 6.5 to about 7.5; and preferably, the concentration of a sucrose is about 1 to about 100 mg/ml, the polysorbate is polysorbate 80 with a concentration of about 0.01 to about 0.3 mg/ml, the buffer is histidine buffer with a concentration of about 1.0 to about 30 mM, and a chelating agent is EDTANawith concentration of about 0.01 to about 0.3 mg/ml.SELECTED DRAWING: Figure 1 【課題】抗体製剤の粘度の高さに起因する、製剤の製造から患者への送達にわたる問題点を解決した、抗ＩＬ−７Ｒ抗体の安定な、高い濃度の抗体製剤の提供。【解決手段】抗ＩＬ−７Ｒ抗体の濃度が約１００〜約３００ｍｇ／ｍｌであり、さらにアルギニンＨＣｌ又はＮａＣｌ、スクロース、緩衝液、キレート化剤、及びポリソルベートを含む組成物であって、ｐＨが、約６．５〜約７．５である組成物。好ましくは、スクロースの濃度が約１〜約１００ｍｇ／ｍｌであり、ポリソルベートがポリソルベート８０で、濃度が約０．０１〜約０．３ｍｇ／ｍｌであり、緩衝液がヒスチジン緩衝液で、濃度が約１．０〜約３０ｍＭであり、キレート化剤がＥＤＴＡＮａ２で約０．０１〜約０．３ｍｇ／ｍｌである、組成物。【選択図】図１