Session: Developing Process Control Strategies for Drug Substance Manufacture

These sessions highlight the methodologies and examples of selection and monitoring of critical quality attributes (CQA) to ensure robust manufacturing process and desired performance in drug substance or drug product processes. Examples of the challenges and successes associated with the development and implementation of advanced control strategies, such as model predictive control and multivariate control, are discussed in these sessions. Examples of academic and industrial research involving the novel use of Process Analytical Technology (PAT) Tools for on-line monitoring of CQAs, applications of lab-based PAT to either identify scalable process fingerprints or determine clinically relevant process endpoints, and advancements in technologies and methods toward real-time monitoring and release are also of interest in these sessions. Submissions to sessions I-III of this topic are considered for oral presentations.