CBE Seminar (Zoom): A Host Cell Protein Contaminant That May Impact Antibody Drug Product Stability

Abstract: Chinese hamster ovary (CHO) cells are the preferred platform for biotherapeutic protein production. Monoclonal antibodies (mAbs) alone reached global sales of 125 billion USD in 2020 and are used to treat many oncological, immunological and cardiovascular diseases. During the production of therapeutic proteins by CHO cells, host cell proteins (HCPs) are also secreted by the cells. Certain HCPs, if not removed during subsequent purification processes, have been shown to cause immunogenic responses in patients. In this presentation, we will discuss the role of having an accurate, high quality genome in the identification and characterization of HCPs as well as in the identification and characterization of particularly problematic HCPs that are difficult to remove and can impact product stability. We will also discuss how a large-scale public-private partnership, the National Institute for Innovation in Manufacturing Biopharmaceuticals, brings together academic scientists to work with colleagues from government and industry to tackle biopharmaceutical manufacturing technology innovation.

Bio: Kelvin H. Lee is the Gore Professor of Chemical and Biomolecular Engineering at University of Delaware and is director of the National Institute for Innovation in Manufacturing Biopharmaceuticals, one of 16 Manufacturing USA Institutes. He received a bachelor's degree in chemical engineering from Princeton and a doctorate in chemical engineering from Caltech. He spent several years in the Biotechnology Institute at the ETH in Zurich, Switzerland and also completed a postdoc in Caltech's Biology Division. Prior to his current appointment, he was on the faculty at Cornell University where he held the titles of Samuel C. and Nancy M. Fleming Chair Professor, professor in the School of Chemical and Biomolecular Engineering, director of the Cornell Institute for Biotechnology and director of the New York State Center for Life Science Enterprise.

Host: Professor Szu-Wen Wang