Process intensification continues to be an important trend in the biopharmaceutical industry. The need to respond rapidly to global health emergencies, together with diversification of pipelines mean that the drive for more flexible intensified processes is likely to increase. Development in upstream processes have lead to higher cell densities and impurity levels as process developers strive for higher titers in the bioreactor to increase productivity. This is putting increasing pressure on the downstream process and harvest clarification step to clear these soluble and insoluble impurities.<br/><br/>In this talk we will explore the impact of a novel, single stage, chromatographic clarification solution, which has been designed for high cell density cell cultures, on process economics. The process modelling, conducted using Biosolve, investigates the impact of replacing existing clarification technologies such as depth filtration and centrifugation with this novel technology. Specifically, the impact on overall cost of goods, sustainability and process productivity will be explored.

Investigating the impact of a novel single stage chromatographic clarification solution on process economics

ACS Fall 2021

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