An automated, high throughput, resin-free device for large scale protein purification

Protein manufacturing is of paramount importance to chemical and biological defense applications. Existing protein purification methods primarily rely on synthetic-resin based chromatography, which is time-consuming, labor-intensive, expensive, and consequently, ill-suited for developing rapid countermeasures to chemical and biological threats. To overcome these limitations, the overall goal of this effort is to develop a novel high-throughput, resin-free technology for automated protein recovery and purification. Our technology is based on multi-scale electrokinetics and enables order-of-magnitude improvement in investment and operating cost. In Phase I, we designed, fabricated, characterized, and demonstrated a pilot-scale prototype to establish proof-of-principle of the proposed technology. The designs of the purification device were first evaluated using high-fidelity, multi-physics simulations, followed by prototype fabrication and engineering. The assembled prototypes were extensively tested and salient protein purification performance similar to the traditional resin based methods was demonstrated, but with the benefits of resin-free operation, reduced analysis time, ease of operation, and significantly lower cost. In Phase II, design optimization and protocol refinement will be carried out for enhanced performance, manufacturability, and cost effectiveness. The most promising purification mechanisms will be selected for device scale up and integration with COTS technologies. The integrated prototype will be demonstrated for purification of DoD-relevant proteins in composite samples from various expression systems. The Phase II end-product will be a fully automated, high throughput and low cost system for rapid protein purification, which will be commercialized to meet the needs in both military and civilian markets.