A PSE perspective for the efficient production of monoclonal antibodies: integration of process, cell, and product design aspects
Sara Badr, Hirokazu Sugiyama
Abstract
In a highly complex and interconnected system as that for monoclonal antibody production, integrated design approaches are necessary to avoid unforeseen consequences. This review presents developments in process modeling approaches: mechanistic, data-driven, and hybrid modeling. Challenges and requirements of process control in terms of the underlying models, data availability, and quality are presented. Impacts of system variations and their propagation across the production chain are discussed to encourage early development of integrated plant-wide process models. The balance between model robustness and resolution should be maintained for process design and control and can lead to faster commercialization, for example, for continuous production. Cell and product developments should also be considered and integrated in process design to avoid early registration of suboptimal alternatives.