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Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP)

Center Overview

For the U.S. pharmaceutical sector, there is an acute need for innovative research and technical advances to reduce product development time, achieve cost-efficient manufacturing of quality products, and develop effective regulatory science. To address these issues, the Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP) will advance and promote the fundamental understanding of material properties, drug-additive interactions at molecular and particulate levels, and manufacturing processes to increase product quality and performance and reduce costs.

Universities

New Jersey Institute of Technology
University of Minnesota

View Center Website

Center Personnel

Rajesh N Dave
Center Director
+1 973 596 5860
dave@njit.edu

Changquan Calvin Sun
Site Director
+1 612 624 5599
sunx0053@umn.edu

Research Focus

The CIMSEPP team will develop fundamental understanding of structure-function-performance of drug products and process engineering through its expertise in four areas:

Predictive understanding of particulate behavior.
Processes, such as feeding, mixing, coating, and compaction.
Multiscale modeling, materials characterization and particle engineering.
Quality by design (QbD) to attain desired drug product performance.

Awards

2137209

IUCRC Phase I NJIT: 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 NJIT as a Lead Site and Minnesota 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, which 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 combined with particle and crystal engineering, will enable development of mechanistic models and predictive tools required for enabling manufacturing decisions and better products. NJIT’s expertise in particle engineering and contact-physics will enable development of predictive models for particle agglomeration, drug content uniformity, and tablet weight variation using dimensionless parameter(s) based on material sparing measurements of particle properties such as size, shape, and roughness. Compared to the data-driven approaches, such models and computer simulations for process modeling, will enable better understanding of traditional and emerging technologies, promoting efficient design of high-quality products and manufacturing processes, while reducing time and cost for product and scalable process development.

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. Read More >

2137264

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. Read More >

Member Organizations

IUCRC affiliated member organizations are displayed as submitted by the Center. Non-federal organizations are not selected, approved, or otherwise endorsed by the U.S. National Science Foundation.

The opinions, findings, and conclusions or recommendations expressed are those of the Center author(s) and do not necessarily reflect the views of the U.S. National Science Foundation.