Host-cell proteins (HCPs) are one of the main classes of impurities that must be cleared in producing a pure biopharmaceutical. Although HCP levels are usually assayed collectively using ELISA, there have been numerous and ongoing cases of product or formulation degradation or immune responses in patients attributable to individual HCPs. This presentation will summarize the origins and implications of such events and fundamental investigations that have shed light on the mechanisms and root causes involved. Although HCP removal is clearly associated with purification, additional factors include the impact of cell culture on various HCP issues and issues arising from the formulation environment, especially for monoclonal antibodies. The result is an end-to-end, multiscale industry challenge that can benefit from direct problem solving but also from improved fundamental insights.
More about Professor Lenhoff:
Dr. Abraham “Bramie” M. Lenhoff is the Allan P. Colburn Professor in the Department of Chemical & Biomolecular Engineering at the University of Delaware, where he joined the faculty in 1984. He holds a B.Sc. in Chemical Engineering from the University of Cape Town and an M.S. and Ph.D. in Chemical Engineering from the University of Wisconsin–Madison. His research focuses on the application of thermodynamics, transport phenomena, biophysics and colloid science to the behavior of proteins and colloidal particles—especially in the context of protein phase behavior, separations and crystallization. Dr. Lenhoff is a Fellow of both the American Institute for Medical and Biological Engineering and the American Association for the Advancement of Science, and he has earned major recognitions including the ACS Award in Separations Science & Technology.