SBIR Phase II: High-capacity Multimodal Anion-exchange Membranes for Purification of Biologics

Project Summary This SBIR Phase II project will address the need for column chromatography products that can simplify the purification process for therapeutic biologics and increase purification speedThe rapid pace of biologics developmentdriven in part by growth of emerging markets such as personalized medicinehas increased the demand for affordable and fastsmall batch production runs in multi product biopharmaceutical facilitiesDisposable technologies like the one proposed that can rapidly and efficiently purify biologics will contribute to improving human health by enabling the small batch production of affordable medicationsThe products of this SBIR Phase II project will be single usemultimodal anion exchange membraneMMAEXchromatography columns that have a high capacity for removing impurities such as host cell proteinsDNA and aggregates from biologic products under conditions of high solution conductivityCurrent products have low capacitiesand the efficiency of impurity removal is heavily compromised at elevated solution conductivitiesBy overcoming these limitationsPurilogicsandaposproducts will enable rapid purification without buffer exchange or adding additional chromatography stepsthus saving time and simplifying the purification processIn Phase Iwe proved the feasibility of fabricating high capacity MMAEX membrane columnsProduct prototypes outperformed the best competing productsand performance metrics exceeded the defined acceptance criteria for moving to Phase IIA partner biopharmaceutical company used the prototypes to purify cancer antibodiestimes faster than their current practice and attained the same purity levelThe aims of the Phase II study areito develop MMAEX membranes with increased capacityreduced purification timeand enhanced impurity removal capabilityiito finalize a production process for sterile membrane columns with defined product shelf lifeandiiito delineate operating ranges and conduct field research on membrane column prototypesIn Specific Aimsystematic studies will be carried out to determine the roles played by synthesis conditions and membrane properties on performanceIn Specific Aima semi continuous process will be established to produce prototypes for determining sterilization protocols and product shelf lifeA scale down spiral wound membrane column will be designed and fabricated to collect data for predicting performance at large scaleIn Specific AimPurilogics will collaborate with researchers at Clemson University and University of Arkansas to identify the MMAEX column operating design space and to determine viral clearanceField research will be done at the facilities of three industry partners to develop novel purification schemes for different types of biologicsThe new column will be compared against commercial productsMarket entry will be through sales to scientists and engineers in biologics research and development laboratories through established channelsThe addressable market for single use polishing step purification columns andltL is expected to reach $million byPublic Health Relevance Statement In this Phase II SBIR projectPurilogicsLLC will develop single use membrane chromatography products that simplify the purification process for biologics and increase the purification speedBiologics are in high demand to treat chronic conditions including a number of cancersautoimmune disorderscardiovascular diseasesand many orphan diseasesPurilogicsandaposmembrane products will contribute to improving human health by enabling the rapid production of affordable medications