Commercialization of Integrated Continuous and Single-use Bio-production Capture Platform (ICS)

DESCRIPTION provided by applicant 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 reduction in production costs for life saving therapies that treat conditions such as cancer Crohnandapos s disease and Rheumatoid Arthritis Continuous and flexible single use processing for monoclonal antibodies and other bio therapeutics has been established as a significant unmet need Dr Janet Woodcock Director of the FDA Center for Drug Evaluation and Research stated in a AAPS meeting andquot It is predicted that manufacturing will change in the next years as current manufacturing practices are abandoned in favor of cleaner flexible more efficient continuous manufacturing andquot 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 $ M in funding Phase I grant R RR A Phase II grant R GM CCTC has shown over X 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 Continuous operation will lead to lower capital cost and lower equipment footprint Single use and closed system features will reduce capital cost enable flexible manufacturing and eliminate cleaning and cleaning validation requirements True steady state operation will enable in line process monitoring of bioreactor and purification performance leading to better robustness and product quality ICS flexibility will enable manufacturers to launch processes faster and at a lower cost resulting in better availability of life saving therapis to patients around the world PUBLIC HEALTH RELEVANCE 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 reduction in production costs for life saving therapies that treat conditions such as cancer Crohnandapos s disease and Rheumatoid Arthritis