Control Strategies in Pharmaceutical Drug Substance and Biologics Development and Manufacturing

This session highlights the selection and monitoring of critical quality attributes (CQA) to ensure desired performance in drug substance and biologics during pharmaceutical development and/or manufacturing. The integration of empirical and theoretical process models with a control strategy is a focus of this sessions. The successes and challenges associated with advanced control strategies, such as model predictive control and multivariate control, are presented. The scope of this session includes batch, semi-continuous, and continuous processes. Academic and industrial research involving the novel use of Process Analytical Tools for on-line monitoring of CQAs are explored. Applications of lab-based PAT to identify scalable process fingerprint and establish control strategy, as well as advancements in technologies and methods toward real-time monitoring and release are included.