(263d) Framework to Asses Optimum Operating Strategies On Capture Chromatography

The removal of host cell protein (HCP) contaminants is a significant concern during downstream process development for biopharmaceuticals. Initial capture chromatography can clear a large proportion of these impurities from cell culture harvest. Conventionally, a wash is employed between column loading and elution to minimise HCP levels after this step. However, selection of wash conditions to optimise product purity may also cause concomitant reductions in the overall yield of the capture step. Such product loss can have a significant effect on the economics of biopharmaceutical production.

This paper presents a framework for determining the operating parameters for initial capture chromatography. The framework is based on the use of a verified mathematical model which describes the dynamic relationships acting within the chromatographic system. The effects of loading and post-load washing on cost of goods and productivity are investigated so as to identify the most favorable operating strategy.