Vogg Sebastian, Wolf Moritz Kai Florian, Morbidelli Massimo
ETH Zurich, Institute for Chemical and Bioengineering, Zurich, Switzerland.
Methods Mol Biol. 2018;1850:147-178. doi: 10.1007/978-1-4939-8730-6_11.
This chapter introduces the necessary concepts to design continuous expression and purification processes for monoclonal antibodies. The operation of a perfusion bioreactor is discussed containing the preparation procedures, the seeding train and the preparation and control of a long-term production run. The downstream processes exploit the benefits of countercurrent chromatography. Their design from batch experiments is presented. The CaptureSMB process is introduced for continuous capturing while for polishing applications the design of the two-column MCSGP process is described. The chapter also puts these processes together in the context of their integration to an end-to-end production process.
本章介绍了设计单克隆抗体连续表达和纯化工艺所需的概念。讨论了灌注生物反应器的操作,包括制备程序、接种流程以及长期生产运行的准备和控制。下游工艺利用了逆流色谱的优势。介绍了基于批次实验的下游工艺设计。引入了CaptureSMB工艺用于连续捕获,同时针对精制应用描述了双柱MCSGP工艺的设计。本章还将这些工艺放在它们集成到端到端生产工艺的背景下进行了整合。