Autonomous Liquid–Liquid Extraction Operation in Biologics Manufacturing with Aid of a Digital Twin including Process Analytical Technology

Liquid–liquid extraction has proven to be an aid in biologics manufacturing for cell and component separation. Because distribution coefficients separation factors can appropriately adjusted via phase screening, especially aqueous two-phase systems, one stage is frequently feasible. For separation, systems have feasible efficient. The simple mixer–settler equipment type still not standard operations. Therefore, a scalable digital twin would of operator training, process design under the regulatory demanded quality by approach risk analysis, control space definition, predictive maintenance. Autonomous operation achieved with analytical technology update real time events allow near any optimal point. first demonstrated experimental feasibility study based on industrial example pDNA lysis from E. coli without performance.