Integrated continuous manufacturing is of growing interest in the biopharmaceutical industry due to process intensification and operational flexibility that can be achieved within a reduced manufacturing footprint. An effective control strategy for a fully-automated continuous process must ensure adequate control of critical quality attributes (CQA) while maintaining synchronous operation with other process stages. Process Analytical Technologies (PAT) facilitate product monitoring in real time and can enable implementing intuitive divert-to-waste strategies over long run times. Adopting feedback control in continuous processes can be challenging due to limited availability of PAT tools that can monitor a breadth of CQAs.<br/> <br/>This work describes PAT development for inline protein concentration monitoring and its utilization for implementing Model Predictive Control (MPC) in a continuously operating Single-Pass Tangential Flow Filtration (SPTFF) system. Linking multiple inputs to multiple outputs proves beneficial in continuous operation by enabling control over product quality as well as process parameters. Maintaining target output concentration in SPTFF is a complex function of incoming feed concentration, flowrate, and membrane area. While PID loops can effectively control each input to its respective output, the complexity of SPTFF with multiple interrelated variables drives the need to introduce strategies that account for parameter interactions. The controller is hence trained to account for system dynamics and is utilized to control CQAs across disturbances.

Advancement of process control using process analytical technology (PAT) in continuous biomanufacturing: Case study

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.