Simulated Control Strategy For Product Diversion Management During Continuous Processing

By Rui Wheaton, Ahsan Munir, Thomas Erdenberger, Huanchun Cui, and Thomas Ransohoff

This poster introduces the details of an advanced continuous drug substance manufacturing platform for monoclonal antibodies and other biological molecules, including the digital strategy. The end-to-end platform integrates perfusion bioreactor technology, continuous product capture, continuous low pH viral inactivation, continuous polishing steps, viral filtration, and formulation steps.

This poster is focused on the use of process simulation models to support material diversion strategies that allow product impacted by disturbance to be diverted without impacting product quality recovered in the batch. This diversion strategy requires real-time detection of critical process parameter deviations outside of acceptable ranges, supported by residence time distribution models to inform the duration of product diversion in response to the deviation. Simulation of a few common deviation scenarios are provided as examples, including simulation methodologies.

By implementing this control strategy, we expect to enable a resilient continuous manufacturing, resulting in an ability to accommodate process disturbance/disruptions while still producing consistent product quality.