The Bioprocessing Summit

SC8: Biophysical Characterization in Developing Biopharmaceuticals: The Path to Developability, Stability and Comparability

Thursday, August 21, 2014 | 6:30 - 9:00pm

In this short course, we will focus our attention on discussions concerning the integral role that biophysical characterization plays in developing biopharmaceuticals. Much of the biophysical characterization activities that are carried out in the biopharmaceutical industry are dependent on the building and utilizing a biopharmaceutical’s biophysical fingerprint. This fingerprint is a key element in assessing information on the higher-order structure (HOS) of a biopharmaceutical, which is then employed as the master comparator for determining the developability properties of the molecules (in drug candidate selection studies), in assessing stability (in formulation selection), and comparability studies (that includes drug variant analysis, consistency and compatibility assessments) where we are concerned with detecting differences in test samples. Although no one biophysical tool can adequately provide this complete fingerprint, its development over time is achieved via a composite of three general approaches: low-resolution biophysical tools, assessing biophysical properties, and advanced high-resolution biophysical tools. A large part of this course will explore the development of this fingerprint via the use of a number of specific biophysical tools. In so doing we will look at their capabilities and limitations.

6:30pm: Dinner- Meet & Greet

(Speaker and attendee introduction - what are your expectations for this course and what are the challenges/problems that you are hoping this course might help you overcome or solve)

 6:50 pm

  • 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

8:00 pm: Short Break 

8:10 pm

  • Part III: The challenges of high-resolution biophysical characterization tools
  • NMR
  • The H/DX-MS story
  • Discussing the unique problems, challenges and approaches in biophysically characterizing biopharmaceuticals at high concentration

9:00 pm: End of course

Instructor:

Steven Berkowitz, Ph.D., Consultant; formerly Senior Principal Scientist, Analytical Development, Biogen Idec

Speaker Bios

StevenBerkowitzSteven Berkowitz, Ph.D., Consultant; formerly Senior Principal Scientist, Analytical Development, Biogen Idec

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.