Bioprocess systems analysis, modeling, estimation, and control. (September 2021) - Luo, Yu
Abstract : The production of monoclonal antibody (mAb) therapeutics, a rapidly growing multi-billion-dollar enterprise in the biopharmaceutical industry, faces major challenges in achieving desired productivity and product quality consistently. These challenges, traditionally addressed by genetic engineering and media recipe development, are now being addressed with process systems engineering (PSE) techniques. In this perspective paper, we discuss how this alternative approach, comprising three components — process modeling, estimation, and control — is being used to address biomanufacturing challenges. We survey the state of current practice for each component, identify existing gaps, and highlight some advances needed to achieve routine implementation of fully automated systems for optimal bioprocess operations.