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

细胞保留装置对重组蛋白生产灌注工艺工业化的影响

基本信息

批准号：
2585666
负责人：
金额：
--
依托单位：
University College London
依托单位国家：
英国
项目类别：
Studentship
财政年份：
2021
资助国家：
英国
起止时间：
2021 至无数据
项目状态：
未结题

来源：
https://gtr.ukri.org/projects?ref=studentship-2585666
关键词：
impact cell retention devices industrialisation

项目摘要

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.

随着人们对灌注过程的兴趣越来越大，了解灌注过程的工艺开发和工业化要求非常重要。到目前为止，文献中的大多数研究都集中在优化以减少介质消耗和提高生产力。很少有研究关注细胞保留装置的影响以及用于生物反应器和细胞保留装置之间的流体转移的泵的作用。该项目旨在确定细胞保留装置在灌注过程工业化中的影响。特别是，该项目旨在确定使用不同策略（例如使用pluronic F68作为细胞的剪切保护剂）或不同细胞保留装置操作或以不同规模运行时灌注培养的特征。将研究所得灌注液的产品质量和杂质谱，并评估其对下游工艺步骤的影响，例如，该项目将解决以下生物工艺挑战：-在不同灌注策略或目标下细胞保留装置的优化操作-获得稳定的产品特征和灌注液质量的方法，以实现稳健的下游处理。-灌注过程在不同开发规模下的操作（例如，250 mL和1 L），以生产相同质量的生物工艺材料用于下游加工。