CN115666613A - 一种稳定的高浓度抗人il-5单克隆抗体液体制剂 - Google Patents

一种稳定的高浓度抗人il-5单克隆抗体液体制剂 Download PDF

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CN115666613A
CN115666613A CN202180040146.7A CN202180040146A CN115666613A CN 115666613 A CN115666613 A CN 115666613A CN 202180040146 A CN202180040146 A CN 202180040146A CN 115666613 A CN115666613 A CN 115666613A
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human
monoclonal antibody
liquid formulation
polysorbate
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杨泗兴
杨芳
黄浩旻
朱祯平
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Sunshine Guojian Pharmaceutical Shanghai Co Ltd
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Sunshine Guojian Pharmaceutical Shanghai Co Ltd
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Abstract

一种稳定的高浓度抗人IL‑5单克隆抗体液体制剂，包括抗人IL‑5单克隆抗体、缓冲液、蛋白保护剂及表面活性剂。通过优化配方极大的改进了现有抗IL‑5单克隆抗体不能制备成高浓度液体制剂的缺陷。液体制剂药品成品在2‑8℃至少可保存36个月，25℃至少可保存6个月。因此，液体制剂能够提供抗人IL‑5单克隆抗体高浓度的制剂稳定性，具有广泛的工业应用前景。

Description

PCT国内申请，说明书已公开。

Claims (12)

  1. PCT国内申请，权利要求书已公开。
CN202180040146.7A 2020-06-10 2021-06-08 一种稳定的高浓度抗人il-5单克隆抗体液体制剂 Pending CN115666613A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202010521390.2A CN113769081A (zh) 2020-06-10 2020-06-10 一种稳定的高浓度抗人il-5单克隆抗体液体制剂
CN2020105213902 2020-06-10
PCT/CN2021/098803 WO2021249373A1 (zh) 2020-06-10 2021-06-08 一种稳定的高浓度抗人il-5单克隆抗体液体制剂

Publications (1)

Publication Number Publication Date
CN115666613A true CN115666613A (zh) 2023-01-31

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CN202010521390.2A Pending CN113769081A (zh) 2020-06-10 2020-06-10 一种稳定的高浓度抗人il-5单克隆抗体液体制剂
CN202180040146.7A Pending CN115666613A (zh) 2020-06-10 2021-06-08 一种稳定的高浓度抗人il-5单克隆抗体液体制剂

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WO (1) WO2021249373A1 (zh)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114306576A (zh) * 2022-01-11 2022-04-12 北京志道生物科技有限公司 一种防止il-2衍生物蛋白复合体聚集及非共价连接蛋白亚基脱落的制剂
CN114137202B (zh) * 2022-01-12 2023-12-01 杭州隆基生物技术有限公司 单克隆抗体保存液

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5693323A (en) * 1994-12-23 1997-12-02 Smithkline Beecham Corporation Recombinant IL-5 antagonists useful in treatment of IL-5 mediated disorders
BRPI0811526A2 (pt) * 2007-05-14 2017-05-16 Biowa Inc uso de um anticorpo monoclonal, quimérico, humanizado ou humano que liga o il-5r, anticorpo anti-il-5r isolado, e, epítopo isolado de il-5r alfa
JP5490714B2 (ja) * 2007-11-28 2014-05-14 メディミューン，エルエルシー タンパク質製剤
CN113350278B (zh) * 2013-10-24 2023-03-24 阿斯利康(瑞典)有限公司 稳定的水性抗体配制品
CN109942706A (zh) * 2017-12-21 2019-06-28 三生国健药业（上海）股份有限公司 结合人il-5的单克隆抗体、其制备方法和用途
CN109966487B (zh) * 2017-12-28 2023-08-25 上海复宏汉霖生物制药有限公司 一种包含抗pd-l1单克隆抗体的药物配制剂

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CN113769081A (zh) 2021-12-10

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