McGee Lecture Series
The Henry A. McGee Lectures in Chemical and Life Science Engineering honors the founding dean of VCU’s School of Engineering, Dr. Henry McGee, who is also a distinguished Emeritus professor in the Chemical and Life Science Engineering department. The lecture series is made possible by the Betty Rose and Henry McGee Endowment for Chemical Engineering. Details about Dr. Henry McGee can be found here.
The 2018 Henry A. McGee lecture takes place April 4, 2018. The Speaker for this year's Henry A. McGee Lecture series is Babatunde A. Ogunnaike, Ph.D., professor of Chemical & Biomolecular Engineering and dean of the College of Engineering at the University of Delaware.
Toward Achieving Online Quality Control During Biopharmaceutical Manufacturing of Monoclonal Antibodies (MAbs)
Monoclonal antibodies (MAbs), proteins that exhibit high specificity for a target antigen, are used therapeutically in oncology, organ transplantation, inflammatory disease, etc. With more than 200 in development pipelines, MAbs have become the fastest growing therapeutic class of the biopharmaceutical industry. As with other manufactured products, MAbs are effective only when their product quality attributes (bioactivity, potency, purity, etc.) lie within a specific range of values. Of the many factors that affect the quality and bioactivity of MAbs, arguably the most important is glycosylation, a post-translational modification in which a carbohydrate chain (a glycan), is added to a protein. MAbs validated for use as human therapeutics have precise glycosylation patterns that must be accurately replicated for the MAb to function as intended in vivo. However, unlike other cellular processes such as DNA replication and protein production, glycosylation has no master template. As a result, glycan formation and attachment are subject to variability and are often non-uniform. Furthermore, with current technology, glycosylation patterns can only be determined post-production, and if a batch fails to meet the quality benchmarks for glycosylation patterns, the entire lot must be discarded due to potential problems with end-use performance (potency, immunogenicity, etc.) and associated regulatory concerns. The major challenges that manufacturers face in meeting the stringent quality criteria requirements, and the necessity to guarantee the safety and effectiveness of all pharmaceutical products, has prompted the U.S. Food and Drug Administration (FDA) to recommend strongly that manufacturers demonstrate the ability to ensure product quality on-line during production. To date, no such techniques exist for real-time, on-line quality control in MAb manufacturing.
In this presentation we will discuss our efforts to date toward developing—and validating experimentally—a comprehensive strategy for effective real-time, on-line control of glycosylation patterns, using a combination of multi-scale modeling, hierarchical control, and state estimation.
About the speaker
Babatunde A. Ogunnaike is the William L. Friend Chaired Professor of chemical engineering and dean of the College of Engineering at the University of Delaware. He received a B.Sc. in Chemical Engineering from the University of Lagos, Nigeria; M.S. in statistics and a Ph.D. in chemical engineering, both from the University of Wisconsin–Madison. He is the author or co-author of four books including a widely used textbook, "Process Dynamics, Modeling and Control, and Random Phenomena: Fundamentals of Probability and Statistics for Engineers." His awards include the American Institute of Chemical Engineers 1998 CAST Computing Practice Award, the 2007 ISA Eckman Award, and the 2008 AACC Control Engineering Practice award. He was named a fellow of the American Institute of Chemical Engineers in 2009, a fellow of the American Association for the Advancement of Science in 2015; he was also elected to fellowship of the Nigerian Academy of Engineering and elected to the US National Academy of Engineering, both in 2012.
2017 Robert K. Prud'homme, Ph.D.
2016 Gregory Stephanopoulos, Ph.D.
2015 Vicki L. Colvin, Ph.D.
2014 Benny D. Freeman, Ph.D.
2013 Mark E. Davis, Ph.D.
2012 Jay Keasling, Ph.D.
2011 Joseph M. DeSimone, Ph.D.
2010 Charles Liotta, Ph.D.