I/UCRC Phase II: Collaborative Research: Center for Pharmaceutical Development (CPD)

Intellectual merit of the proposal: The proposed Center for Pharmaceutical Development addresses current challenges in the pharmaceutical industry with the aim of developing solutions towards more selective and robust manufacturing processes, more stable formulations, and better characterized and consistent products. Research at the Georgia Institute of Technology focuses on the development of efficient, environmentally benign routes to small-molecule pharmaceuticals or their intermediates and on the prediction of the propensity of proteins to aggregate, unfold, or dissociate. Research at the University of Kentucky is focused on developing new techniques and methods for improving the formulation, characterization, and stabilization of small and large molecule pharmaceutical dosage forms. The Center will provide a mechanism for collaborative projects between scientists from government, academia, and industry to develop innovative methods to more selective and robust processes with less environmental footprint and to improve the safety of the nationfs drug supply. The Center will encourage active participation of federal agencies such as the NSF, NIH, CDC, and FDA. The Centerfs research goals are: . Manufacturing To enable novel and improved routes to small-molecule targets via new and improved biocatalysts and integration of reaction and product/(bio)catalyst separation. . Formulation To predict the long-term stability of the active ingredient in vials, tablets and vaccines to extend the safety of drugs and vaccines being stored for extended periods with the aim of new approaches to formulating vaccines. . Analytical To establish accelerated and non-accelerated stability testing of pharmaceutical products to enhance the shelf-life of pharmaceutical products and to explore rapid identification of drug product to detect counterfeit, degraded and adulterated drugs. The Center will be located at two sites, the Georgia Institute of Technology and the University of Kentucky. Georgia Institute of Technology is the lead institution, with Professor Andreas Bommarius, School of Chemical and Biomolecular Engineering, as the Center director and Site director; Eric Munson is the Site director at Kentucky. The broader impact of our research: . Collaborations with the pharmaceutical industry will add value by promoting the rapid dissemination and application of technologies and information. . It will promote the rapid development of safe and efficacious drugs and drug formulations by increasing the number of drugs which can be analyzed, and identifying potential problems with proposed drug formulations, with the potential of improving or even saving human lives. . It will promote graduate education and the dissemination of information by training graduate students and postdoctoral associates in performing and presenting their research. . Extensive emphasis is placed on recruiting underrepresented groups in the graduate education, including presentations and visits to colleges and universities that serve underrepresented groups, especially where the faculty are alumni.