Research Project
9452077
The overall goal of the proposed SBIR project is to commercialize an Integrated Continuous and Single-use bio-production platform (ICS) for flexible and robust manufacturing of therapeutic proteins. This novel platform will enable continuous, single-use, and low cost purification of therapeutic proteins. Successful commercialization of the ICS system will lead to at least a 50% reduction in production costs for life saving therapies that treat conditions such as cancer, Crohn?s disease, and Rheumatoid Arthritis. Continuous and flexible single-use processing for monoclonal antibodies and other biotherapeutics has been established as a significant unmet need. Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, stated in a 2011 AAPS meeting: ?It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing.? Significant bottlenecks in downstream processing as well as the explosive growth in the number of therapeutics in development are the primary drivers of this unmet need. The purpose of the ICS system will be to integrate two of the most promising flexible and continuous technologies in the market ? single-use perfusion and the novel single-use purification system called Continuous Countercurrent Tangential Chromatography (CCTC). The CCTC technology was developed by the Chromatan Corporation and supported by NIH with over $1.3M in funding (Phase I grant # 1R43RR031935-01A1, Phase II grant # 9R44GM108259). CCTC has shown over 5X improvement in productivity vs. conventional columns with equivalent product quality in multiple pilot studies. CCTC is being commercialized by Chromatan in partnership with Thermo Fisher Scientific. Overall, commercialization of the ICS system will have the following impacts on bio-production: 1. Continuous operation will lead to lower capital cost and lower equipment footprint. 2. Single-use and closed system features will reduce capital cost, enable flexible manufacturing, and eliminate cleaning and cleaning validation requirements. 3. True steady state operation will enable in-line process monitoring of bioreactor and purification performance, leading to better robustness and product quality. 4. ICS flexibility will enable manufacturers to launch processes faster and at a lower cost resulting in better availability of life saving therapies to patients around the world.
