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Article

mAb Production Modeling and Design Space Evaluation Including Glycosylation Process

1
Department of Chemical and Biochemical Engineering, Rutgers—The State University of New Jersey, Piscataway, NJ 08854-8058, USA
2
Department of Chemical and Biomolecular Engineering, University of Delaware, Newark, DE 19716-3196, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Abdollah Koolivand
Received: 3 January 2021 / Revised: 5 February 2021 / Accepted: 6 February 2021 / Published: 9 February 2021
(This article belongs to the Special Issue Advanced Chemical Reaction Kinetics of Pharmaceutical Processes)
Due to high demand, monoclonal antibodies (mAbs) production needs to be efficient, as well as maintaining a high product quality. Quality by design (QbD) via predictive process modeling greatly facilitates process understanding and can be used to adjust process parameters to further improve the unit operations. In this work, mechanistic and dynamic kriging models are developed to capture the protein productivity and glycan fractions under different temperatures and pH levels. The design of experiments is used to generate input and output data for model training. The dynamic kriging model shows good performance in capturing the dynamic profiles of cell cultures and glycosylation using only limited input data. The developed model is further used for feasibility analysis, and successfully identifies the operating design space, maintaining high productivity and guaranteed product quality. View Full-Text
Keywords: glycosylation; kinetic modeling; dynamic kriging; feasibility analysis glycosylation; kinetic modeling; dynamic kriging; feasibility analysis
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MDPI and ACS Style

Yang, O.; Ierapetritou, M. mAb Production Modeling and Design Space Evaluation Including Glycosylation Process. Processes 2021, 9, 324. https://0-doi-org.brum.beds.ac.uk/10.3390/pr9020324

AMA Style

Yang O, Ierapetritou M. mAb Production Modeling and Design Space Evaluation Including Glycosylation Process. Processes. 2021; 9(2):324. https://0-doi-org.brum.beds.ac.uk/10.3390/pr9020324

Chicago/Turabian Style

Yang, Ou, and Marianthi Ierapetritou. 2021. "mAb Production Modeling and Design Space Evaluation Including Glycosylation Process" Processes 9, no. 2: 324. https://0-doi-org.brum.beds.ac.uk/10.3390/pr9020324

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