(354a) Approaches to Knowledge Management and Data Transformations in Pharmaceutical Process Invention

Over the past decade, the increased molecular complexity of small molecule drugs has resulted in synthetic complexity. However, traditional unit operations (reactions, separations, crystallization, filtration, etc.) continue to be the basis for the manufacture of small molecule drug substances even as innovations in organic synthetic techniques such as new catalysts and coupling reagents are implemented to improve sustainability and efficiency. Chemical engineers are well-poised to support chemical route invention, process invention and process characterization activities to develop robust commercial manufacturing processes through utilization of limited data to quantify and metricize competing attributes of proposed synthesis approaches and process designs. Specifically, methods to understand and quantify process risks, process capabilities, and expected failure rates have the potential to speed development activities. Addressing these challenges requires innovations in tools supporting data generation and curation, and new approaches to metrics and modeling. This talk will cover some current work in this knowledge space and its potential to drive innovation in pharmaceutical development in the future.