通过阳离子交换色谱的弱分区模式有效地去除双特异抗体中的同分体
Xiaoying Liang1, Qingquan He1, Guohong Qin1
1Nanjing Chia-Tai Tianqing Pharmaceutical Co.Ltd, Fanghua Pharmaceutical Research Institute, Department of Biology, Nanjing 210046, China.
概括
再组合抗体的产生会产生难以去除的同分体副产品. 一种新的单步离子交换色谱法有效地去除同位素,提高抗体纯度和工艺效率.
科学领域:
- 生物技术是生物技术.
- 蛋白质化学 蛋白质化学
- 生物制药制造业 生物制药制造业
背景情况:
- 类似IgG的双特异抗体的重组生成可以产生同分体的副产品.
- 同型分子与目标抗体具有相似的特性,使净化复杂化.
- 现有的同位素净化方法具有诸如长时间的过程时间和低容量的局限性.
研究的目的:
- 开发一种强大的,高效的净化工艺,以去除同聚体副产品.
- 为了提高双特异抗体的纯度.
- 为了优化离子交换染色学对同位体清除.
主要方法:
- 研究的单步离子交换染色学 (AEX) 用于同位体去除.
- 在AEX中采用弱分区策略.
- 利用实验设计 (DoE) 来建立一个强大的操作范围.
主要成果:
- 通过使用单步AEX实现了同时高容量和有效的同分体清除.
- 证明弱分区是提高异构聚合物纯度的有效策略.
- 开发了一个强大的操作范围,用于AEX步骤在同质体去除.
结论:
- 单相离子交换色谱为同极体去除提供了高容量和有效的解决方案.
- 在AEX中弱分区是双特异抗体净化的一种优质抛光策略.
- 开发的AEX工艺提供了一种可靠的方法来实现高异构聚物纯度.
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