ChromaCon AG, Zurich, Switzerland.
Methods Mol Biol. 2023;2699:31-50. doi: 10.1007/978-1-0716-3362-5_3.
Continuous countercurrent chromatography can be applied for both capture and polishing steps in the downstream processing of biopharmaceuticals. This chapter explains the concept of countercurrent operation, focusing on twin-column processes and how it can be used to alleviate the trade-offs of traditional batch chromatography with respect to resin utilization/productivity and yield/purity. CaptureSMB and MCSGP, the main twin-column continuous countercurrent chromatography processes, are explained, and the metrics by which they are compared to single-column chromatography are identified. Practical hints for process design and application examples are provided. Finally, regulatory aspects, scale-up, and UV-based process control are covered.
连续逆流色谱可应用于生物制药下游处理的捕获和抛光步骤。本章介绍逆流操作的概念，重点介绍双柱工艺以及如何利用其缓解传统批处理色谱在树脂利用率/生产力、产率/纯度方面的权衡问题。解释了主要的双柱连续逆流色谱工艺CaptureSMB 和 MCSGP，并确定了将它们与单柱色谱进行比较的指标。提供了工艺设计的实用提示和应用实例。最后，还介绍了监管方面、放大和基于 UV 的过程控制。
