(426a) Rethinking Convective Chromatographic Separations

The use of membrane supports with immobilized protein A has not lead to a technological breakthrough as it was expected when the first protein A affinity membranes appeared on the market in the late 80’s/early 90’s. Their excellent flow properties were not sufficient to compensate the low binding capacity with respect to chromatographic beads for protein capture applications. Nevertheless, the development and booming of single use technology explains the success of membrane adsorbers for impurity removal in biopharmaceutical manufacturing.

Besides the widespread application of membrane chromatography in polishing steps, there is still a large and growing research interest in its implementation for capture and purification of high added value products such as antibodies and other therapeutic molecules. This research effort led to a remarkable progress in developing highly selective and efficient stationary phases. Indeed, the binding capacity of protein A immobilized on an optimized membrane base material, with respect to commercially available protein A membranes, could be increased about seven-fold that demonstrates the tremendous effect that the membrane support has on binding capacity. However, these values are still too low with respect of the capacity of chromatography beads, even if competitive binding capacities have been obtained with nonwoven ion-exchange membrane adsorbers.

Moreover, continuous biomanufacturing will underline the limits of the conventional chromatographic process based on packed bed columns and highlight the need of a novel chromatographic process. In this work, innovative supports for convective chromatography produced with 3D printing will be presented. These new stationary phases, inspired by nature, have the potential to dramatically change chromatographic separations.