This SBIR Phase II project will address the need for capture-step chromatography products that dramatically increase the isolation and purification speed for therapeutic biologics, particularly monoclonal antibody drugs. Numerous campaigns are under way to develop new biologics for treating chronic conditions, and there is increasing demand for affordable and fast, small-batch production runs. Technologies like the one proposed will contribute to improving human health by enabling the rapid production of affordable medications. The products of this SBIR Phase II project will be prepacked, disposable Protein A membrane chromatography columns that rapidly isolate and purify monoclonal antibody drugs from cell culture supernatant. Available products have low productivity because of the long column residence times needed for purification. Based on customer discovery interviews with over 180 biopharmaceutical experts, Purilogics expects that the products of this Phase II project will have a major impact on the industry by reducing the purification cycle from hours to minutes. In Phase I, we proved the feasibility of fabricating high productivity Protein A membrane columns. Product prototypes significantly outperformed the best competing commercial products, and the productivity performance metric exceeded the defined acceptance criterion for moving to Phase II. University collaborators compared the prototypes to a commercial resin for purification of an anti-HIV human monoclonal antibody. The purification was faster and attained the same antibody recovery and purity.
The aims of the Phase II study are (i) to develop Protein A membranes with increased capacity and reduced purification time; (ii) to finalize a production process for Protein A membrane columns with defined product shelf life and reusability, and (iii) to determine Protein A membrane column operating ranges and conduct field research on prototypes through university and industry collaborations.
In Specific Aim 1, we will systematically evaluate the roles played by synthesis conditions and membrane pore size on performance.
In Specific Aim 2, we will establish a process to produce prototypes for determining sterilization protocols, product shelf life, and reusability over 100 cycles. We will fabricate a spiral-wound membrane column prototype to collect data for predicting performance at large scale.
In Specific Aim 3, Purilogics will collaborate with researchers at Clemson University to delineate the Protein A column operating conditions. Field research will be done at the facilities of three industry partners to study purification schemes for 8-10 different monoclonal antibodies and compare performance against commercial products. Initially, market entry for the new column products will be sales to purification scientists and engineers in biopharmaceutical companies. These individuals are end-users, influencers and decision makers. The addressable market for prepacked, disposable capture-step chromatography columns for research and development alone is expected to reach $324 million by 2021.
In this Phase II SBIR project, Purilogics, LLC will develop disposable membrane chromatography products that dramatically increase the isolation and purification speed for biologics. Numerous campaigns are under way to develop new biologics for treating chronic conditions including many cancers, autoimmune disorders, cardiovascular diseases, and many orphan diseases. Purilogics' membrane products will contribute to improving human health by enabling the rapid production of affordable medications.
