IUCRC Phase I UMN: Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP)

The pharmaceutical sector in America is a major, trillion-dollar industry, having broad impacts on the US population through benefits to their health and well-being. Despite US leadership, the industry is facing major problems, including, difficulties in developing newer molecules, high cost and lengthy time of bringing a new drug to market, lack of adequate and efficient regulatory science, consumer drug affordability, quality issues, and drug shortages. The COVID-19 pandemic has further exacerbated many of these challenges. These issues point to an acute need for innovative research and technical advances to develop high-quality drug products, achieve manufacturing efficiency, and support US-based pharmaceutical manufacturing. This IUCRC phase I project addresses such issues through establishing a joint two-university Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP), with New Jersey Institute of Technology (NJIT) as the Lead Site and University of Minnesota (UMN) as a Partner Site. Its mission is to advance and promote fundamental understanding of the material properties, drug-additive interactions at molecular and particulate level, as well as manufacturing processes, on product quality and performance, at lower cost.

The CIMSEPP team will develop fundamental understanding of structure-function-performance of drug products and process engineering under three industry vetted Research Thrusts: A) Particle and Crystal Engineering, B) Model Predictive Understanding of Materials and Product Performance, and C) Bioavailability Enhancement and Stability. Research at CIMSEPP will 1) promote predictive enhancement of key properties of drugs, their engineered counterparts, and their blends for improving product quality, and 2) significantly reduce time and cost of drug product development. Key advances include, 1) identification of critical particle properties that impact fine particle behavior, 2) better understanding of their impact on cohesion and behaviors of powders, and 3) enabling accurate prediction of properties of blends as well as compacted tablets. That understanding will enable the development of mechanistic models and predictive tools required for efficient manufacturing of better products. The UMN team's expertise in powder characterization and property enhancement through integrated crystal engineering and particle design will 1) enable the development of both highly effective and easy-to-adopt strategies to solve manufacturing problems and 2) contribute to the fundamental understanding of structure - property relationship through systematic research at length scales, ranging from molecular dimension to single crystal/particles, to powders, and to finished products.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.