R44GM117682

PROJECT SUMMARYABSTRACT The overall goal of the proposed SBIR project is to commercialize an Integrated Continuous and Single use bio production platformICSfor flexible and robust manufacturing of therapeutic proteinsThis novel platform will enable continuoussingle useand low cost purification of therapeutic proteinsSuccessful commercialization of the ICS system will lead to at least areduction in production costs for life saving therapies that treat conditions such as cancerCrohn s diseaseand Rheumatoid ArthritisContinuous and flexible single use processing for monoclonal antibodies and other biotherapeutics has been established as a significant unmet needDrJanet WoodcockDirector of the FDA Center for Drug Evaluation and Researchstated in aAAPS meetingIt is predicted that manufacturing will change in the nextyears as current manufacturing practices are abandoned in favor of cleanerflexiblemore efficient continuous manufacturingSignificant bottlenecks in downstream processing as well as the explosive growth in the number of therapeutics in development are the primary drivers of this unmet needThe purpose of the ICS system will be to integrate two of the most promising flexible and continuous technologies in the marketsingle use perfusion and the novel single use purification system called Continuous Countercurrent Tangential ChromatographyCCTCThe CCTC technology was developed by the Chromatan Corporation and supported by NIH with over $M in fundingPhase I grantRRRAPhase II grantRGMCCTC has shown overX improvement in productivity vsconventional columns with equivalent product quality in multiple pilot studiesCCTC is being commercialized by Chromatan in partnership with Thermo Fisher ScientificOverallcommercialization of the ICS system will have the following impacts on bio productionContinuous operation will lead to lower capital cost and lower equipment footprintSingle use and closed system features will reduce capital costenable flexiblemanufacturingand eliminate cleaning and cleaning validation requirementsTrue steady state operation will enable in line process monitoring of bioreactor andpurification performanceleading to better robustness and product qualityICS flexibility will enable manufacturers to launch processes faster and at a lower costresulting in better availability of life saving therapies to patients around the world PROJECT NARRATIVE The overall goal of the proposed SBIR project is to commercialize an Integrated Continuous and Single use bio production platformICSfor flexible and robust manufacturing of therapeutic proteinsThis novel platform will enable continuoussingle useand low cost purification of therapeutic proteinsSuccessful commercialization of the ICS system will lead to at least areduction in production costs for life saving therapies that treat conditions such as cancerCrohn s diseaseand Rheumatoid Arthritis