State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

Dr. John E. Schiel received his B.S. (2004) and Ph.D.(2009) in Chemistry from the University of Nebraska-Lincoln, and is currently a research chemist in the NIST Biomolecular Measurement Division. Dr. Darryl L. Davis holds a doctorate in Medicinal Chemistry from the Philadelphia College of Pharmacy and Science. Currently he leads an analytical group within the discovery organization at Janssen R&D. Dr. Oleg V. Borisov earned a B.S. degree (with honors) in Chemistry at Moscow State University (1992), and received his Ph.D. in Chemistry from Wayne State University (1997), after which he completed his post-doctoral studies at Lawrence Berkeley National Laboratories (2000) and Pacific Northwest National Laboratories (2001). He is currently a Director at Novavax, Inc., developing methods and strategies for analysis and characterization of recombinant vaccines, based on nano- and virus-like particle technologies.

1. Determination of the NISTmAb Primary Structure
2. Sequence Variants and Sequence Variant Analysis in Biotherapeutic Proteins
3. Structural Elucidation of Post-Translational Modifications in Monoclonal Antibodies
4. Orthogonal Technologies for NISTmAb N-Glycan Structure Elucidation and Quantitation
5. Separation Methods and Orthogonal Techniques
6. Biophysical Techniques for Characterizing the Higher Order Structure and Interactions of Monoclonal Antibodies
7. Developability Assessment of a Proposed NIST Monoclonal Antibody
8. Protein Particles (0.1 ?m to 100 ?m)
9. Analytical Methods for the Measurement of Host Cell Proteins and Other Process-Related Impurities