A Review on Applications of Artificial Intelligence (AI) in Monoclonal Antibody (mAb) Manufacturing.

This review paper offers a comprehensive exploration of the many Artificial Intelligence (AI) applications in monoclonal antibody (mAb) manufacturing, covering a wide spectrum of topics, including upstream and downstream processes, process control, optimisation, product property monitoring and regulatory compliance. We present several case studies showcasing the predictive modelling capabilities of AI and ML algorithms for cell culture optimisation, media formulation, and bioreactor control, highlighting their potential to enhance cell growth, productivity, and product quality. Furthermore, we explore its potential in process monitoring, fault detection, and real-time decision-making, towards improved process robustness and reduced production costs.