Planning IUCRC at University of Minnesota-Twin Cities: Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP)

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This IUCRC planning project focuses on establishing a collaborative three-university center to advance fundamental materials science and engineering research for facilitating high quality drug product development. The pharmaceutical sector in the USA is a major, trillion-dollar industry, having broad impacts on the health and well-being of the US population. Yet, there are major problems, e.g., slowing market growth, long time and high costs of bringing a new drug to market, product quality, and drug shortages. These arise largely due to highly complex nature of pharmaceutical products that contain many different components, the inadequate understanding of the manufacturing processes, and lack of predictive tools to assess product performance from material properties. This Center aims to address these problems and the needs of industry through paradigm shifting mechanistic approach for developing predictive understanding of the impact of processes and material properties on product performance. Proposed material science based translational research is expected to have significant economic impact, due to improved product quality, reduced product failures, simplified manufacturing operations, and significantly reducing product development times and manufacturing costs. The Center will also positively impact students from under-represented minority groups, through training in cutting edge research methodologies, tech-transfer, innovation and entrepreneurship. The proposed research aims at developing a fundamental understanding of structure-function-performance of particulate-based drug products and their process engineering, paving the way for applying crystal and particle engineering towards enhancing drug bioavailability, manufacturability, product stability, and product quality. Center research thrusts, designed for transformative impact, are: A) Particle and Crystal Engineering, B) Model Predictive Understanding of Materials and Product Performance, and C) Bioavailability Enhancement and Stability. The CIMSEPP team will advance and promote fundamental understanding of the material properties and interactions among drug(s) and additives at the molecular and particulate level as affected by manufacturing processes. The UMN team's expertise in powder characterization and property enhancement through integrated crystal engineering and particle design will enable the development of both highly effective and easy-to-adopt strategies to solve manufacturing problems. Fundamental understanding in structure - property relationship will be gained through systematically characterizing materials at length scales, ranging from molecular dimension to single crystal/particles, to powders, and to finished products. The highly collaborative efforts within the CIMSEPP are expected to benefit the health and well-being of the U.S. population through enabling high quality pharmaceutical products using more efficient design and development process, robust scale-up, and continuous manufacturing.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.