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Use and Optimization of a Dual‐Flowrate Loading Strategy To Maximize Throughput in Protein‐A Affinity Chromatography

The effect of an alternate strategy employing two different flowrates during loading was explored as a means of increasing system productivity in Protein‐A chromatography. The effect of such a loading strategy was evaluated using a chromatographic model that was able to accurately predict experimental breakthrough curves for this Protein‐A system. A gradient‐based optimization routine is carried out to establish the optimal loading conditions (initial and final flowrates and switching time). The two‐step loading strategy (using a higher flowrate during the initial stages followed by a lower flowrate) was evaluated for an Fc‐fusion protein and was found to result in significant improvements in process throughput. In an extension of this optimization routine, dynamic loading capacity and productivity were simultaneously optimized using a weighted objective function, and this result was compared to that obtained with the single flowrate. Again, the dual‐flowrate strategy was found to be superior.