Biologics manufacturing still remains dominated by batch operations. As upstream titers continue to increase due to developments in higher producing cell lines, the downstream purification process must adapt to meet the demands of productivity and processing cadence as to avoid becoming the bottleneck in manufacturing operations. In this work, we propose a methodology for developing a new process utilizing multi-column capture (MCC) operation using model assisted design practices. Through in-depth knowledge of column breakthrough behavior gained though simulation and column modeling, an optimal loading strategy for 2-column MCC can be derived based on product titer and column parameters (i.e. flowrate, dimensions, etc.). The outputs of this approach may be seamlessly integrated into GMP distributed control systems in order to alleviate operator intervention and decrease the barrier for entry for implementing continuous operations in the manufacturing environment.

Methodology for optimized development and implementation of multi-column capture chromatography

ACS Fall 2021

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