Dinner Short Courses – Detailed Agenda

Thursday March 12, 2015, 6:00-9:00pm

SC4: Assessing Biopharmaceutical Comparability via Biophysical Characterization

Instructor: Steven A. Berkowitz, Ph.D., Consultant

In this short course, we will focus our attention on discussions concerning the integral role that biophysical characterization plays in supporting comparability studies in developing biopharmaceuticals. Much of the activities centered in this area are concerned with the task of building and utilizing a biopharmaceutical’s biophysical fingerprint. This fingerprint is a key element in assessing the higher-order structure (HOS) information on a biopharmaceutical, which is then employed as the master comparator for detecting differences in the biopharmaceutical during its development. Since no one biophysical tool can adequately provide this complete fingerprint, a battery of biophysical tools will be required.

Agenda outline:

• Setting the stage as to what the needs and goals are in conducting biophysical characterization
• Building the biophysical fingerprint
• Part I: Low resolution biophysical characterization tools
• Part II: Assessing biophysical properties
• Part III: The challenges of high-resolution biophysical characterization tools
• The H/DX-MS & NMR story
• Discussing the unique problems and challenges in biophysically characterizing biopharmaceuticals at high concentration

Instructor Bio:

Dr. Berkowitz received his B.S. degree in Biology from Fairleigh Dickinson University and his Ph.D. degree in Biochemistry from New York University. He then spent several years as a post-doctoral fellow at Yale University and the NIH. After his post-doctoral work Dr. Berkowitz held various positions at Celanese Research Company, J.T. Baker, and Lederle Laboratories before taking a position at Biogen Idec where he has spent his last twenty year working in the areas of purification, analytical and formulation development before retiring at the end of 2013. Dr. Berkowitz’s technical areas of expertise are concentrated in the separation and physical sciences associated with the characterization of a wide range of biopolymers and synthetic polymers. Much of Dr. Berkowitz’s work has centered on assessing the physicochemical properties, micro-heterogeneity, aggregation properties and higher-order structure of biopharmaceuticals using a range of biochemical and biophysical techniques that has predominately involved the use of light scattering, analytical ultracentrifugation, chromatography, electrophoresis, and various forms of spectroscopy.