A Robust and Disposable Flow Through Purification Train For Post-ProteinA Mab Processing

In this work, we propose a novel mAb purification process replacing typical post-proteinA steps of bind/elute CEX chromatography, flow-through AEX chromatography and virus filtration with a fully-connected flow-through purification (FTP) train. The FTP train — comprising of 3 different single-use adsorbers, in-line pH adjustment, and virus filtration — was specifically designed to remove process- and product-related impurities like host-cell proteins, DNA, leached-PrA, virus, and aggregates in flow-through mode thereby eliminating the need for hold tanks and bind/elute CEX step. Experimental data highlighting robust performance (yield and impurity removal) of the fully-connected FTP train with multiple mAbs will be presented and discussed in detail. This novel purification process has the potential to not only improve manufacturing flexibility, productivity and economics but also enable fast and simple process development without compromising process robustness.