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Center for Pharmaceutical Development (CPD)

Georgia Institute of Technology

University of Delaware

University of Kentucky

Last Reviewed: 10/04/2017

The Center for Pharmaceutical Development (CPD), 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.

Center Mission and Rationale

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 distinctive strengths of each of the University partners will provide industrial participants with unique opportunities to advance topics pertaining to these three key areas. The CPD facilitates technologies including but not limited to the following: the creation of robust biological and chemical catalysts with better selectivity that will allow for more streamlined processes, the development of improved methods for stabilizing pharmaceuticals to protect the nation’s drug supply, and the design of new analytical techniques for the nondestructive, accurate, and rapid evaluation of pharmaceutical products.

Our mission is to create more selective and robust biological and chemical catalysts, to develop methods for stabilizing drugs and vaccines, and to design new techniques for nondestructive evaluations of pharmaceutical products.

Research program

Develop a better understanding of raw materials quality and its effect on product performance

  • Development of raw materials critical quality attribute variability database to improve manufacturability and enhance the prediction of dosage from performance and non-destructive prediction of the physical and chemical stability of dosage forms

 

Develop methods to ensure long-term stability of tablets, proteins and vaccines

  • Development of raw materials critical quality attribute variability database to improve manufacturability and enhance the prediction of dosage from performance
  •  Non-destructive prediction of the physical and chemical stability of dosage forms

 

Develop more selective and robust processes with less environmental footprint

We seek to enable novel routes to small-molecule targets through the finding of new and improving of existing biocatalysts and chemical catalysts.  In addition, we seek to conceive new ways for the achievement of condensations in aqueous solutions and for the formation of the integration of reaction and product/(bio) catalyst separation, all with the goal of rapidly scaleable, robust, and thus economical processes.

  • Novel and improved redox biocatalysts
  • C=C bond reduction
  • Nitro group reduction
  • Reductive amination of ketones.
  • Novel and improved hydrolases
  • Lipases and proteases for group transfer reactions and kinetic resolutions
  • Glycosidases for group transfer reactions
  • Beta-lactam hydrolases
  • Selective C-C coupling reactins with a focus on Heck & Suzuki couplings
  • Moving-bed chromatography separation schemes

 

Develop novel analytical approaches and testing protocols for the prediction of drug stability

New methods for accelerated and non-accelerated  stability testing of pharmaceutical products will reduce the time required for stability testing, simplify the experimental designs of stability studies and enhance the shelf-life of pharmaceutical products through better understanding of chemical and physical degradation mechanisms and improved time resolution.

  • Development of methods to improve drug stability and solubility
  • Novel analytical approaches and testing protocols for stability assessment of pharmaceutical products
  • Characterization of dry powder aerosols
  • Solid-state characterization of small-molecule API and drug formulations,  including excipients
  • Molecular dynamics simulations of amorphous drug-excipient mixtures
  • Spray-dried dispersions and aerosol performance modeling

Special Activities

Technology Transfer

Amine dehydrogenase.

Patents & Publications

  • Amine Dehydrogenase: Sequences and Process
    Highlights: Technology Transfer:
    Amine dehydrogenase gene and/or protein sent to three companies

    Publications 2012-2013:

    • “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

    • “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

    • “Novel Protease Inhibitors via Computational Redesign of Subtilisin BPN′ Propeptide”, A.B. Daugherty, P. Muthu, S. Lutz, Biochemistry, 2012, 51 (41),8247-8255

    • “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

    • “Molecular Dynamics Simulation of Amorphous Indomethacin–Poly(Vinylpyrrolidone) Glasses: Solubility and Hydrogen Bonding Interactions”, Tian-Xiang Xiang and Bradley Anderson, Journal of Pharmaceutical Sciences 2013, 102,876–891

Facilities and Laboratory

  • Georgia Institute of Technology 
  • University of Kentucky
  • Emory University
  • Armstrong State University

Locations

Georgia Institute of Technology

Administrator: Denice Shorter denice.shorter@chbe.gatech.edu
Engineered Biosystems Building 950 Atlantic Dr.

Atlanta, Georgia, 30332

United States

University of Kentucky

CPD Admin Operations Facilitator: Tonya Vance tonya.vance@uky.edu
789 South Limestone Street

Lexington, Kentucky, 40536

United States

(859) 257-5891

(859) 257-7564

http://pharmacy.mc.uky

University of Delaware

Admin Assist: Kristi Halberg khalberg@udel.edu
Department of Chemical & Biomolecular Engineering, 223 Colburn Lab

Newark, Delaware, 19716

United States

(302) 831-4500

302-831-1048