LOW PH PHARMACEUTICAL ANTIBODY FORMULATION

To provide low pH formulations comprising, e.g., an antigen-binding protein that binds to CD3, at least one buffer agent, at least one saccharide and at least one surfactant.SOLUTION: In one aspect, described herein is a pharmaceutical composition comprising an antigen binding protein described here...

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Bibliographische Detailangaben
Hauptverfasser: SHAN DAXIAN, TWINKLE R CHRISTIAN
Format: Patent
Sprache:eng ; jpn
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Zusammenfassung:To provide low pH formulations comprising, e.g., an antigen-binding protein that binds to CD3, at least one buffer agent, at least one saccharide and at least one surfactant.SOLUTION: In one aspect, described herein is a pharmaceutical composition comprising an antigen binding protein described herein, at least one buffer, at least one surfactant and at least one saccharide, the pH of the pharmaceutical composition ranging from 3.5 to 5. In some embodiments, the antigen-binding protein is an antibody. In some embodiments, the antibody is a bispecific antibody, such as a bispecific antibody that binds to CD3.SELECTED DRAWING: None 【課題】例えば、CD3に結合する抗原結合タンパク質、少なくとも1種の緩衝剤、少なくとも1種の糖類及び少なくとも1種の界面活性剤を含む低pH製剤を提供すること。【解決手段】一態様では、本明細書では、本明細書に記載される抗原結合タンパク質、少なくとも1種の緩衝剤、少なくとも1種の界面活性剤及び少なくとも1種の糖類を含む医薬組成物が記載され、その医薬組成物のpHは、3.5~5の範囲である。いくつかの実施形態では、抗原結合タンパク質は、抗体である。いくつかの実施形態では、抗体は、CD3に結合する二重特異性抗体などの二重特異性抗体である。【選択図】なし