The impact of cell retention devices in the industrialisation of perfusion processes for recombinant protein manufacture

点击翻译按钮获取中文摘要

With their increasing interest, it is important to understand the process development and industrialisation requirements of perfusion processes. Most studies in literature have so far focused on optimisation to reduce media consumption and increase productivity. Few studies have looked at the impact of cell retention devices and the action of pumps for fluid transfer between bioreactor and the cell retention devices. This project aims to establish the impact of cell retention devices in the industrialisation of perfusion processes. In particular, the project aims to determine the characteristics of perfusion culture when using different strategies (e.g. using pluronic F68 as shear-protectant for cells) or different cell retention device operation or when running at different scales. The product quality and impurity profile of the resulting perfusate will be investigated and their impact on downstream process steps will be assessed, e.g., their impact on resin properties during the lifetime of the affinity chromatography operation.The project will address the following bioprocess challenges:- the optimised operation of cell retention devices under different perfusion strategies or targets- the method of obtaining a consistent product profile and quality of perfusates for robust downstream processing.- the operation of perfusion processes at different development scale (e.g., 250 mL and 1L) to produce the same quality of bioprocess material for downstream processing.