Development of Pharmaceutical Process Control Strategies for Drug Substance Manufacture

This session encourages oral submission relevant to the methodologies and examples of selection and monitoring of critical quality attributes (CQA) to ensure desired performance in drug substance. Examples of the challenges and successes associated with the development and implementation of advanced control strategies, such as model predictive control and multiple input multiple output control, are discussed in these sessions. Examples of academic and industrial research involving the novel use of Process Analytical Tools for on-line monitoring of CQAs, applications of lab-based PAT to identify scalable process fingerprints, and advancements in technologies and methods toward real-time monitoring and release are also of interest in this session.