Abstract:
The first initiative of the Systems Research Institute at Tufts University, an International Industrial Consortium on Batch Manufacturing of Pharmaceuticals and Chemicals (BMPC), is currently in development. The research mission of the BMPC consortium is to produce methodologies and tools that enable the rapid development and design, as well as the effective operation, of the next generation of batch pharmaceutical and specialty chemical processes. The Consortium’s goals are to reduce by half the time it takes to complete process development and design and to facilitate development of processes that are optimal from the beginning. The program also aims to develop novel model-based multivariable monitoring and feed-back control strategies that enable the effective implementation of the Process Analytical Technology (PAT) initiative of the Food and Drug Administration (FDA).

To significantly reduce process development time and improve design accuracy, considerably new software tools and methodologies need to be developed. Utilizing considerable industry feedback, the research program will initially focus on making significant progress in designing the reaction and crystallization sections of process. Additional critical unit operations will also be selected for study following a two-way dialog with and feedback from the industrial partners on their importance. We will also examine the presently available process simulation tools and suggest and possibly undertake their further advancement. An additional benefit lies in using the process models, simulations, and experimental verification data to identify and confirm "worst case" conditions with regards to product purity and yield, information that could be valuable for process validation studies required for regulatory filings.

Current Research Projects:

• Lin, Rongrong: Tendency Stoichiometric and Kinetic in Complex Reaction Systems
• Schupmann, Lisa: Development of an Experimental High Throughput Multi-Reactor System
• Wong, Sze Wing: On-line Estimation of PSD in Polymorphic Crystallization