Led by the University of Delaware, the team will develop new and complementary technologies for achieving and monitoring the removal of host-cell proteins (HCPs) in purification of monoclonal antibodies (mAbs) made by Chinese hamster ovary (CHO) cells.
This project will address the need to remove HCPs and to measure the amounts of individual HCPs in process streams. Once completed, the project will enable more robust processes in which HCP removal is achieved and monitored efficiently and in versatile process configurations.
This will be accomplished by improving HCP removal in multiple applications by employing novel LigaGuardTM materials that specifically capture CHO HCPs while allowing the mAb product to flow through unbound, characterizing HCP aggregates that contribute to HCP persistence in process streams and develop new methods to improve their removal, and benchmarking and standardizing liquid chromatography-mass spectrometry (LC-MS) technology to monitor HCP levels in biomanufacturing.
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University of Delaware