Advances in Novel Pharmaceutical Process Design, Development, and Control using Data-Rich Experiments and/or Models

This session seeks submissions on the design, development, and control of processes for pharmaceutical applications. Submissions may be related to drug substance or drug product processes for small molecules, biologics, or other modalities. Examples of process development to optimize, drive understanding, or establish control strategies are welcomed. Integration of various experimental, modeling, and in-silico techniques to deliver processes are of relevance for this session. The successes and challenges associated with advanced control strategies, such as model predictive control and multivariate control, are included in this session. Academic and industrial research involving the novel use of Process Analytical Tools for on-line monitoring of quality are of interest. 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.