The broader impact/commercial potential of this Small Business Innovation Research Phase I project is the development of a polymeric material that dramatically improves protein purification. This project will focus on creating a material based on block-copolymers that specifically addresses the high purity needs of therapeutic proteins manufactured by the biopharmaceutical industry. Therapeutic proteins are utilized in the treatment of an array of diseases and the market for such products continues to grow. Proteins currently represent the majority of top revenue generating therapeutic pharmaceuticals, and their dominance in the industry is expected to increase as new therapeutic applications are discovered. While the need for therapeutic proteins is evident, materials and methods for their manufacture and processing have not kept up with demand. The structures generated through this project have unique physical and chemical properties that enable the rapid and selective purification of therapeutic proteins, resulting in lower production costs and higher production capacities for end-users. This novel and highly selective purification material has the potential to address pressing commercial needs in the biopharmaceutical industry, increase the availability of therapeutic proteins to individuals, and further our scientific understanding of block copolymer structures and their applicability to bioseparations.
The objectives of this Phase I research project are the development of a hierarchically porous membrane chromatography material and its application to the purification of therapeutic proteins. The use of affinity-based chromatographic resins for the purification of proteins is widespread but suffers from low throughput, which leads to high costs. An alternative to affinity resins are membrane chromatography units that utilize both diffusive and convective flow to increase throughput, however, typical media for membrane chromatography has limited functionality and capacity. For this project, a block copolymer that can be functionalized with highly selective ligands will be synthesized and processed into a membrane structure containing porosity on multiple length-scales. Using a facile and scalable process that leads to the spinodal decomposition of the block copolymer and a sacrificial polymer, this membrane chromatography material is expected to have macro-scale pores offering convective flow for separation applications as well as high surface areas offering high capacity for target proteins. After functionalizing with the appropriate chemical moiety, this new material will be investigated as a separation media using feed streams containing the target protein. Static and dynamic binding capacities of the block-copolymer membrane chromatography material will be investigated and benchmarked against competitive performance metrics.
