B.A. St. John’s University, Minnesota, Chemistry Ph.D. Iowa State University, Physical Chemistry

Lyophilization of proteins and other pharmaceuticals – process, formulation and stability Solid state chemistry of proteins Dynamics in the glassy state and pharmaceutical stability

Luthra, S.A., Shalaev, E.Y., Medec, A., Hong, J., Pikal, M.J. (2012) Chemical stability of amorphous materials: Specific and general media effects in the role of water in the degradation of freeze-dried zoniporide, J. Pharm. Sci. 101(9), 3110-3123. Padilla, A.M., Pikal, M.J. (2011) The study of phase separation in amorphous freeze-dried systems, part 2: Investigation of Raman mapping as a tool for studying amorphous phase separation in freeze dried protein formulations, J. Pharm. Sci.100(4), 1467-1474. Patel, S.M., Pikal, M.J. (2011) Emerging Freeze-Drying Process Development and Scale-up Issues, AAPS PharmSciTech 12(1), 372-378. Murdande, S.B., Pikal, M.J., Shanker, R.M., Bogner, R.H. (2010) Solubility advantage of amorphous pharmaceuticals: I. A thermodynamic analysis, J. Pharm. Sci. 99(3), 1254-1264. Wang, B., Cicerone, M.T., Pikal, M.J. (2010) The impact of thermal treatment on the stability of freeze dried amorphous pharmaceuticals: II. Aggregation in an IgG1 Fusion Protein, J. Pharm. Sci. 99, 683-700. Abdul-Fattah, A.M., Kalonia, D.S., Pikal, M.J. (2007) The challenge of drying method selection for protein pharmaceuticals: product quality implications, J. Pharm. Sci. 96(8), 1886-1916.