Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01)

The goal of this project is to develop a process simulation and modeling platform for integrated pharmaceutical manufacturing processes. Specifically, the project will focus on manufacturing processes for solid based drug products which comprise the majority of pharmaceutical products. The tools developed during this project will be used to facilitate the risk assessment of manufacturing processes and control strategies and to identify critical material and process attributes through sensitivity analysis. The project will advance the understanding of how raw material attributes and process parameters affect quality of the final drug product.