Journal
INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH
Volume 61, Issue 40, Pages 14898-14909Publisher
AMER CHEMICAL SOC
DOI: 10.1021/acs.iecr.2c00736
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Funding
- Japan Agency for Medical Research and Development (AMED)
- [JP21ae0121015]
- [JP21ae0121016]
- [JP18ae0101064]
- [JP18ae0101058]
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This paper presents a three-module hybrid approach for studying monoclonal antibody production processes. The approach combines kinetic models, data-driven modules, and consideration of quality aspects, facilitating the design and control of cultivation processes.
Representative cultivation models are needed for designing efficient monoclonal antibody (mAb) production processes. Simple Monod-type kinetic models could fail to capture changes at different phases and conditions. Current models rarely account for process-related impurities, which hinders optimizing integrated processes. A three-module hybrid approach is thus introduced here. Module 1 is a kinetic metabolism model until cell death based on Monod-type equations. Module 2 is a data-driven module for updating parameters based on system dynamics and changes in cultivation conditions. Module 3 proposes a kinetic model for the generation of host cell proteins and DNA. The model is applied to newly established high-performance CHO cell lines and is validated with experiments at different operating conditions. The adopted modular approach helps identify weak model links, which can be corrected via the data-driven module. The proposed model combines accuracy and simplicity for design and control applications of cultivation processes considering quality aspects.
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