(335s) Performance Comparison Between Anion Exchange Membrane Adsorbers and Anion Exchange Chromatography Resins for Removing Select Impurities From Monoclonal Antibody Solutions

Anion exchange (AEX) membrane adsorbers are gaining popularity in industry as an alternative to packed bed chromatography for the removal of DNA, leached protein A, endotoxin, and viruses during a polishing purification step for therapeutic protein products produced from mammalian cell lines. This study compares the performance of a traditional AEX resin with that of an AEX perfusive resin and two AEX membranes to determine the productivity of each technology. Binding capacities of BSA and DNA were determined for each technology at the 1 mL scale using pure solutions of each molecule. Process representative feed streams containing monoclonal antibodies were also evaluated by spiking in DNA and determining removal of DNA, protein A, and host cell proteins from the feed streams across both AEX membranes and resins at two different loadings. Analysis of the data revealed the AEX membranes were able to provide higher impurity clearance at higher loadings and higher flowrates than the traditional AEX resin. The membranes were shown to be over 300 times more efficient than the resin in terms of product processed per column or membrane volume per time. Cost analysis also revealed the membranes would be more cost efficient for pilot scale batches where a limited number of injections are done on the resin, provided the scale-up path for the membranes is straightforward.