Integrated Monoclonal Antibody (mAbs) Process

Kelvin Lee of the University of Delaware in the U.S. will develop components of a biomanufacturing platform for low-cost production of monoclonal antibodies. The project will be implemented through the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) headquartered at the University of Delaware, with John Erickson of NIIMBL. It will focus on economic modeling, development of a mammalian cell line for expressing the antimalarial monoclonal antibody MAM01, and a head-to-head comparison of two antibody purification approaches, including isoelectric point purification (IPP) and continuous precipitation operations that reduce the number of process steps. Based on these tests, the platform components could be integrated into an end-to-end continuous processing system and co-developed with a next-generation facility design and regulatory strategy.