Liquid formulations comprising anti-CD38 antibodies

The present invention provides a pharmaceutical composition comprising an anti-CD38 antibody at a concentration of about 15 to 40 mg/mL, sorbitol or mannitol at a concentration of about 20 to 30 mg/mL, a histidine-histidine salt buffer at a concentration of about 5 to about 28 mM, sodium chloride at...

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Bibliographische Detailangaben
Hauptverfasser: XING RONGKANG, BAO ZHIHAO, WANG HUI, CHEN JING
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The present invention provides a pharmaceutical composition comprising an anti-CD38 antibody at a concentration of about 15 to 40 mg/mL, sorbitol or mannitol at a concentration of about 20 to 30 mg/mL, a histidine-histidine salt buffer at a concentration of about 5 to about 28 mM, sodium chloride at a concentration of about 2 to 5 mg/mL, and Tween 20 or Tween 80 at a concentration of about 0.1 to 1 mg/L; wherein the anti-CD38 antibody is a Darumumab (Darumumab), and the anti-CD38 antibody is a Darumumab. 本发明提供了一种药物组合物,其包含浓度为约15~40mg/mL的抗CD38抗体,浓度为约20~30mg/mL的山梨醇或甘露醇,浓度为约5~约28mM的组氨酸-组氨酸盐缓冲液,浓度为约2~5mg/mL的氯化钠,浓度为约0.1~1mg/L的吐温20或吐温80;其中所述抗CD38抗体为达雷木单抗(Daratumumab)。