拟议的Omalizumab生物类似剂的充电变体:通过HPLC方法进行隔离,净化和分析
Tarun Gupta1, Sriram Seshadri2
1Institute of Science, Nirma University, 382481 Ahmedabad, Gujarat, India; Downstream Process Development, Kashiv BioSciences Pvt Ltd., 382210 Ahmedabad, Gujarat, India.
Annales pharmaceutiques francaises
|September 14, 2023
概括
研究人员成功地隔离和净化了生物类似Omalizumab (Xolair) 的酸性,主要峰值和基本电荷变体. 这种净化对于评估生物相似性和进一步表征研究至关重要.
科学领域:
- 生物制药的发展.
- 蛋白质化学 蛋白质化学
- 分析化学是一种分析化学.
背景情况:
- 奥马利祖马布 (Xolair) 是一种单克隆抗体,向免疫球蛋白E (IgE),在过敏反应中至关重要.
- 电荷变量是生物制品中的关键质量属性 (CQA),影响异质性和生物相似性评估.
研究的目的:
- 隔离和净化生物类似物Omalizumab的酸性,主要峰值和基本电荷变体.
- 为了进一步研究,描述这些孤立的电荷变体的纯度.
主要方法:
- 哺乳动物细胞培养生物类似的Omalizumab表达.
- 准备性离子交换染色学用于变种隔离.
- 尺寸排除色谱 (SEC-HPLC) 和阳离子交换色谱 (CEX-HPLC) 用于表征.
主要成果:
- 孤立的电荷变体 (酸性,主要峰值,基本) 被净化到高水平.
- 在SEC-HPLC中,纯度分别为99.58%,99.98%和98.64%.
- 在CEX-HPLC中,各个变体的纯度水平为94.25%,95.58%和91.33%.
结论:
- 孤立的电荷变体具有后续分析所需的纯度.
- 这些纯化的变种适用于工艺表征,体外功效和体内动力学研究.
关键词:
染色图学 (chromatographie) 是一种关于色谱的方法.染色体学 染色体学 是一种染色学.这是一种单克隆抗体.免疫球蛋白E 免疫球蛋白E免疫球蛋白E 免疫球蛋白E单克隆抗体是一种单克隆抗体.强度 强度 强度 强度强大的力量 强大的力量一个Xolair的Xolair.更多相关视频
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