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Understanding and Controlling Stress in Biomanufacturing

September 27, 2018
12:00 pm - 1:00 pm

Understanding and Controlling Stress in Biomanufacturing

Sarah W. Harcum Professor
Department of Bioengineering
Clemson University
Thursday September 27, 2018
Noon in 1003 Kemper Hall


Biopharmaceuticals had over a $170 billion global market in 2017 with an annual growth rate of 11%. One of the greatest challenges confronting biomanufacturing is the separation of the biopharmaceuticals (also known as therapeutic proteins) from its isoforms. These isoforms are the result of degradation, incomplete reactions inside the cell, or alternative reactions occurring inside the cell. Higher levels of isoforms negatively impact product quality and process economics. About half the biopharmaceuticals entities on the market are produced Chinese hamster ovary (CHO) cell lines, where protein glycosylation is the key protein quality attribute. Another major host organism for biopharmaceuticals is Escherichia coli, where protease degradation and protein solubility are key drivers of product quality. In order to improve overall process economics, my research group has focused on gaining a better understanding of the relationship between bioreactor stresses and product quality. We have used protease characterization, metabolic analysis, as well as transcriptome tools, to characterize the effects of known bioreactor stresses on the cells. Major bioreactor stress examined have included serum, acetate, ammonia, temperature, and substrate levels. These studies have resulted in closed process protocols for feeding that sense the metabolic state of the cells. On-going work is investigating means to control genome instability in CHO cells to improve product quality. This seminar will also highlight the integration of process understanding from these transcriptome tools to improve the product quality in both E. coli and CHO cells.

Bio: Dr. Harcum is a Professor in Bioengineering at Clemson University (CU). Dr. Harcum has a BSE in Engineering Science – Bioengineering from the University of Michigan, a MS in Chemical Engineering from Colorado State University, and a PhD in Chemical Engineering from the University of Maryland, College Park. Dr. Harcum has extensive experience in the scale-up of biopharmaceuticals from bacterial and mammalian cell systems. Dr. Harcum was a Staff Fellow and Certified Product Reviewer in the Division of Monoclonal Antibodies within the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA). She was a faculty member at New Mexico State University in Chemical Engineering and the Molecular Biology Program prior to moving to the Department of Chemical Engineering at CU in 2002. Due the growing Bioengineering program, Dr. Harcum transferred to Bioengineering in 2004.


1003 Kemper Hall

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