(277c) The Center for Pharmaceutical Development (CPD) – an I/U CRC for Late-Stage Pharmaceutical Development

The pharmaceutical industry currently faces simultaneous challenges in form of both increased cost of drug development and increased price pressure in most markets. The Center for Pharmaceutical Development (CPD), established in February 2010, provides a forum for academic and industrial scientists to develop novel approaches for the improvement of pharmaceutical API manufacturing, drug product formulation, and analytical methods.  The CPD seeks to address the needs of our industrial partners through the development of selective and robust manufacturing processes, formulations with enhanced performance and stability, and better analytical methods for characterizing products.  The Center’s mission is to create more selective and robust biological and chemical catalysts, to develop methods for stabilizing drugs and vaccines, to design of new techniques for nondestructive evaluation of pharmaceutical products.

            The presentation will discuss how university-industry collaboration within the CPD fits into the framework of options generated by a recent Council for Chemical Research (CCR) workshop.[1]  As the CPD is a representative of the Industry/University Cooperative Research Center program by the National Science Foundation (NSF), the NSF established most rules under which the CPD operates.  The presentation will conclude with some of the success stories of the CPD over the last few years; selected publications are listed here.[2-8]      

References

[1]           Precompetitive Collaboration on Enabling Technologies for the Pharmaceutical Industry, C.J. Welch, J.M. Hawkins, and J. Tom, Org. Process Res. Dev. 2014, 18, 481-487

[2]           “Development of a Novel Amine Dehydrogenase for Synthesis of Chiral Amines“, M.J. Abrahamson, E. Vazquez-Figueroa, N.B. Woodall, J.C. Moore, A.S. Bommarius,  Angew. Chem. Intl. Ed. 2012, 51, 3969-3972

[3]           “The Evolution of an Amine Dehydrogenase Biocatalyst for the Asymmetric Production of Chiral Amines“, M.J. Abrahamson, J.W. Wong, A.S. Bommarius, Advanced Synthesis & Catalysis 2013, 102, 377-386

[4]           “Molecular Dynamics Simulation of Amorphous Indomethacin–Poly(Vinylpyrrolidone) Glasses: Solubility and Hydrogen Bonding Interactions”, Tian-Xiang Xiang and Bradley Anderson, J. Pharm. Sci. 2013, 102, 876–891

[5]           "Water Uptake, Distribution, and Mobility in Amorphous Poly(D,L-Lactide) by Molecular Dynamics Simulation", T.-X. Xiang, and B.D. Anderson, J. Pharm. Sci.,  DOI 10.1002/jps.23855.

[6]           "Investigating miscibility and molecular mobility of nifedipine-PVP amorphous solid dispersions using solid-state NMR spectroscopy", X. Yuan, D. Sperger, and E. J. Munson, Molecular Pharmaceutics, 2014, 11, 329-337

[7]           “Salt-Induced Aggregation of a Monoclonal Human Immunoglobulin G1”, J. Rubin, L. Linden, W.M. Coco, A.S. Bommarius, S .Behrens, Journal of Pharmaceutical Sciences, 2013, 102, 377-386

[8]           “Gauging Colloidal and Thermal Stability in human IgG1 – Sugar Solutions through Diffusivity Measurements”, J. Rubin, A. Sharma, L. Linden, A.S. Bommarius, S.H. Behrens, J. Phys. Chem. B 2014, 118, 2803-2809