Protein Characterization of Biopharmaceuticals

• Dr. Joseph Nawrocki, Catalent Pharmaceuticals, Morrisville, NC

Characterization of biological products is a necessary element for the introduction of new entities into the expanding biological drug market. Comprehensive analysis of these products, including bio-similars can only be accomplished using a variety of instrumental analytical techniques.  These techniques provide a variety of information but often require complementary methods to solve the questions at hand. This talk will provide several case studies in which a variety of biophysical approaches were used to help elucidate the structure or provide answers to the question at hand.

Self-Assembling Peptides: Analysis and Use

• Dr. Steve Kates, Ischemix Inc., Sudbury, MA

Certain self-assembling peptides (SAPs) form a β-sheet structure and self-assemble into nanofibers and scaffolds in favor of cell growth, hemostasis and tissue-injury repair.  These short peptides, which typically comprise 8, 16, 24, or 32 amino acid residues with internally repeating sequences, self-assemble in aqueous salt solution into three-dimensional matrices that interact with cells and tissues, thereby offering promise in bioengineering based on rational changes in peptide design.  The biophysical and morphological properties of SAPs still remain largely unclear in the public domain.  The synthetic preparation, characterization (using rheometry, atomic force microscopy (AFM), circular dichroism (CD), scanning electron microscopy (SEM), and other methods), utilization (hemostasis model) of SAPs will be discussed.

BIOS

Dr. Nawrocki is a Director of the Biophysical Characterization Department at Catalent Pharma Solutions, RTP Facility.  He holds a B.S. degree in chemistry from the University of Florida and his Ph.D. in Analytical Chemistry from the same institution. His dissertation focused on the use of Fourier transform ion cyclotron mass spectrometry for the characterization of peptides in combinatorial libraries. Dr. Nawrocki was a postdoctoral fellow at the NIH where his work centered on the characterization of protein by mass spectrometry including glycosylation, disulfide analysis, peptide mapping and other post-translational modifications.  In 2001 he accepted a position at Charles River Laboratories in Worcester where he led the mass spectrometry group with a main emphasis on protein characterization and then managed similar activities for the Cardinal Health in San Diego. In 2010 he relocated to the Biophysical Characterization Department at the RTP facility in Morrisville, NC.

Dr. Kates joined Ischemix  as a Vice President, Research in October 2003 bringing more than fifteen years experience in the biotechnology and pharmaceutical industries. He served as Senior Scientist at Surface Logix, a drug development company specializing in the repositioning of the already-approved drugs and late-stage compounds. His previous positions included tenures as a Director of Chemistry at Consensus Pharmaceuticals and Director of Peptide Research at Millipore. Dr. Kates is a renowned expert in peptide design and manufacture. He has written or co-authored more than 100 articles, reviews, and patents. Dr. Kates has served as editor of Solid-Phase Synthesis: A Practical Guide, guest editor of Biopolymers, and as a member of the Editorial Board of International Journal of Peptide Research and Therapeutics. He was also a Visiting Professor of Chemistry at Brandeis University. Dr. Kates earned his B.S. in chemistry from Bates College and his Ph.D. in Synthetic Organic Chemistry from Brandeis University.