Laterally-fed membrane chromatography (LFMC) device

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The biopharmaceutical industry has experienced remarkable progress in the upstream production capacity of life-saving recombinant protein drugs, both in terms of reactor volumes and product titers. However, downstream processing, which refers to the purification and formulation of these products have failed to keep up. Resin-based column chromatography is considered the main bottleneck in downstream processing. Membrane chromatography which uses a stack of adsorptive membranes as the separation media is one of the promising alternatives. It is significantly faster, more scalable, and cost-effective. However, currently available commercial membrane chromatography devices offer limited product resolution (i.e. purity) and therefore their application is largely limited to the late-stage polishing steps where impurities such as host cell proteins (HCPs), DNA, and viruses are purified in a flow-through mode. A careful evaluation of these devices clearly shows that they have serious design deficiencies. The laterally-fed membrane chromatography (LFMC) device proposed in this project was designed and developed to address this challenge. Our recently published studies have shown that not only are LFMC devices significantly better than other type of membrane chromatography devices, the separation obtained with these is comparable or even better than that obtained with resin-based columns. These devices therefore represent a win-win situation, i.e. high-productivity with high-resolution. We feel that the LFMC devices will revolutionize separation and purification in the biopharmaceutical industry. Overall, the exploitation of this technology would make the life-saving therapeutic proteins more affordable and will speed up their development timelines.