Advanced control strategies for bioprocess chromatography: Challenges and opportunities for intensified processes and next generation products

• Chromatography is an essential purification technology for therapeutic proteins. Advances in PAT and process modelling provide opportunities to enhance control. The current shortfalls chromatography control systems are outlined. Novel strategies development discussed compared. A future vision of presented. Recent advances analytical technologies techniques present improve industrial robustness, increase productivity move towards real-time release testing. This paper provides a critical overview batch continuous protein purification. Firstly, the limitations conventional fractionation using in-line UV spectroscopy on-line HPLC Following this, evaluation monitoring showing promise within research, manufacturing provided. These novel combine rapid data capture (e.g. NIR, MALS variable pathlength UV) with enhanced understanding obtained from mechanistic empirical techniques. Finally, summary states proposed, including buffer formulation, product fractionation, column switching fouling. implementation these improves capabilities fulfil quality criteria as processes scaled, transferred operated, thus fast tracking delivery new medicines market.