Dynamic design, optimization and simulation of a control strategy for a pharmaceutical bioprocess

In recent years, pharmaceutical companies have grown interest in developing new technologies for the continuous manufacturing of drug products. The continuous manufacturing of pharmaceuticals is critical in order to increase productivity and to reduce the amount of overall waste in a time-efficient manner. To strive towards this goal, in this work, the realistic case study of the continuous production of lovastatin is investigated and modeled. Therefore, based on the steady-state model proposed by Colombo et al. (2018) [1], a control plant-wide control strategy is developed and simulated for a semi-continuous benchmark simulation model for the production of lovastatin. Hence, the upstream and downstream processes have been integrated with feedback control systems using rigorous non-linear dynamic process models, in order to reach an accurate control of the process variables, and thus consistently maintain the predefined product quality. The proposed strategy ultimately leads to the identification and the development of a comprehensive benchmark model of an end-to-end plant-wide controlled system that, as it captures the generic dynamics of a bio-pharmaceutical process, can be deemed as a starting point for further simulations and implementations of other chemical process units. The results showed that under considerable and durable disturbances, the designed control strategy is capable to take action and adjust the process variables to their set points values, thus attesting for the effectiveness of the proposed model.