Model‐based control of titer and glycosylation in fed‐batch mAb production: Modeling and control system development

Abstract Therapeutic monoclonal antibodies (mAbs) are typically manufactured using mammalian cell cultures in fed‐batch bioreactors, with increasing emphasis on meeting productivity and product quality attribute targets that depend strongly such process variables as nutrient feed rates bioreactor operating conditions. In this article, we identify, categorize, address the challenges of achieving both goals simultaneously, by developing a multivariable, model‐based control system can satisfy multiple production objectives culture process. Here, discuss model development present theoretical concepts observability controllability essential to understanding handling effectively these intrinsic challenges. Subsequently, evaluate via simulation performance outer‐loop predictive demonstrate overall capability complex laboratory scale bioreactor, first step toward ultimate goal creating an advanced for mAb manufacturing processes.