This SBIR Phase I project is significant because it addresses a critical need for products that increase research productivity during drug discovery and development. Improving research productivity plays a key role in translating biologics from research labs to approved medications efficiently and economically. Product purification often limits the productivity, and time delays in bringing an approved medication from discovery to market can incur million dollar-per-day losses in revenue. Thus, our innovation will have a major impact on the industry since it will reduce the research and development purification cycle times from hours to minutes. Numerous campaigns are underway to develop biologics such as monoclonal antibodies (mAbs) for many chronic conditions, but the process from biologics discovery to a commercial medicine is long and expensive. Customer discovery interviews with over 130 experts in the biopharmaceutical industry suggest that new research-scale products that can isolate and purify mAbs faster and with higher capacity than the current low productivity Protein A resin chromatography products would be highly significant and impactful, as speed of the Protein A capture step purification currently is a bottle neck for biologics discovery and development. The goal of the proposed SBIR project is to prove the feasibility of developing highly productive Protein A membranes for the rapid capture step purification of mAb drugs. Products derived from this innovation will be prepacked, disposable Protein A membrane chromatography columns enabling 100 times faster capture step purification of mAbs and higher binding capacity than the current best Protein A products. To achieve this outcome, the Purilogics team will adapt a unique, proprietary membrane fabrication method pioneered by Purilogics' founder to prepare membranes with a high density of Protein A ligands. Our hypothesis is that this method will enable us to control the density of Protein A ligands, yielding high binding capacity while reducing steric hindrance to enable fast antibody binding.
Key aims of the project are to synthesize and characterize Protein A membranes and to evaluate membranes for capture step purification of antibodies produced by commercial cell lines.
In Specific Aim 1, systematic membrane development, characterization and screening studies will be done at Purilogics.
In Specific Aim 2, comprehensive membrane performance testing using antibody cell culture supernatant will be done at three collaborator facilities: one university laboratory and two globally recognized biopharmaceutical companies. In Phase II, Purilogics will conduct membrane scale up and optimization, and work with partners to complete validation work and to develop a continuous manufacturing method for the products. Market entry will result from direct sales of these column products to purification scientists and engineers in discovery and development laboratories. The addressable market for our products is expected to reach $330 million by 2020.
Numerous campaigns are under way to develop new biologics for treating chronic conditions including many cancers, cardiovascular diseases, and autoimmune disorders. However, the pace of biologics development often is constrained by the slow processes used for product isolation purification. Therefore, there is a vital need to develop new technologies, such as the one studied in this project, to increase isolation and purification speeds in research and development laboratories and move biologics to market faster, where they are needed to treat the large and growing patient populations.
