A framework for assessing the solutions in chromatographic process design and operation for large-scale manufacture

Abstract

Chromatographic separation of biopharmaceuticals is complex and tools for the prediction of performance and the trade-offs necessary for efficient operation are limited and time-consuming. This complexity is due to the large number of possible column aspect ratios that satisfy process and economic needs. This paper demonstrates a framework for the design and analysis of chromatographic steps. The functionalities are illustrated by application to a Protein A separation where the effects of column diameter, bed length and linear flow rate on cost of goods (COG/g) and productivity (gh-1) are investigated so as to identify the optimal operating strategy. Results are presented as a series of 'win..