在双特异性抗体净化过程中去除聚合物,使用疏水性相互作用染色学
1Shanghai AsymChem Biotechnology Co., Ltd., Building 8, No.12, Lane 855, Jinzheng Road, Jinshan Industrial Park, Shanghai 201507, China.
Membranes
|October 28, 2025
概括
疏水性相互作用膜色谱 (HIMC) 在双特异抗体净化中有效减少蛋白质聚合物. 这种方法为传统染色学提供了一种高效且具有成本效益的替代方案,提高了生物产品的安全性.
科学领域:
- 生物技术是生物技术.
- 蛋白质化学 蛋白质化学
- 生物加工是一种生物加工.
背景情况:
- 哺乳动物细胞培养经常产生蛋白质聚合物,特别是在双特异性抗体中.
- 生物制品中的高聚合物含量构成安全风险,需要严格控制.
- 传统的净化涉及蛋白质A的捕获,其次是阴离子交换染色谱 (AEX) 和阴离子交换染色谱 (CEX).
研究的目的:
- 为了评估在双特异性抗体净化过程中通过流动模式去除聚合物的疏水性相互作用膜色谱 (HIMC).
- 评估运行缓冲器和加载条件对HIMC总体移除效率的影响.
- 调查HIMC期间聚合物结合的机制.
主要方法:
- 利用水相互作用膜染色学 (HIMC) 在流通模式下进行聚合物去除.
- 测试了各种操作缓冲系统和负载样本的pH/导电性.
- 在不同的负载条件下分析了聚合物结合机制.
主要成果:
- 希姆克公司实现了20%的总体水平降低.
- 运行缓冲器的组成显著影响了聚合物去除.
- 装载条件对聚合物结合的影响最小.
- 在总量减少方面,HIMC表现出了稳健性和效率.
结论:
- 通过流动模式的疏水相互作用膜色谱 (HIMC) 是减少双特异抗体净化中的聚合物的有效策略.
- 与传统方法相比,HIMC在生产效率,成本降低和风险降低方面具有优势.
- 这种方法有助于提高生物产品的安全性和纯度.
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