基于膜的下游净化工艺的评估,作为单克隆抗体净化传统树脂珠的替代品
Victor Pasquier1, Kevin Botelho Ferreira1, Morgane Lergenmuller1
1Biotech Development Center, Merck Serono SA (an affiliate of Merck KGaA, Darmstadt, Germany), Fenil-sur-Corsier, Switzerland.
Biotechnology progress
|September 16, 2024
概括
膜色谱为净化单克隆抗体和Fc融合蛋白提供了一个高效的替代方案. 这些膜在许多周期中表现出强大的性能,有可能取代传统的树脂染色学.
科学领域:
- 生物技术是生物技术.
- 化学工程是化学工程的重要组成部分.
- 生物工艺工程 生物工艺工程
背景情况:
- 包装床树脂是蛋白质净化的标准.
- 膜色谱为生物处理提供了一种新的方法.
- 单克隆抗体和Fc融合蛋白需要有效的净化方法.
研究的目的:
- 为了评估和比较离子交换和蛋白质A膜染色学与树脂基系统.
- 评估膜染色学装置的性能,容量,聚合清除和寿命.
- 确定在净化级联中用膜色谱代替树脂色谱的可行性.
主要方法:
- 对离子交换和蛋白质A膜染色学的性能评估.
- 与传统的包装床树脂色谱相比较.
- 进行了动态结合能力,总清除率和终身研究.
主要成果:
- 蛋白A膜在短停留时间 (0.2分钟) 中显示出高动态结合能力 (>50g/L).
- 与树脂相比,膜的聚合物清除率一般较低,但产量和生产率相似或更高.
- 膜在100个循环中保持了强大的性能,对产品质量没有影响.
结论:
- 膜色谱是单克隆抗体和Fc融合蛋白净化的一种可行和高效的替代方案.
- 使用膜的完整净化级流实现了对宿主细胞蛋白质和聚合物的优秀去除.
- 膜色谱有可能在生物制药制造中完全取代树脂色谱.
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