Webinar Description:

For biopharmaceutical development, the number of sub-visible protein particles in solution is an indicator of stability and is important for regulatory compliance. Measuring and visualizing these particles is also of great value in guiding a formulation development study or assessing the impact of various stress conditions on a sample. Sub-visible particle analysis has become a fundamental part of our protein formulation process. In multiple instances, this technique has provided information that would not otherwise be accessible, and the data have aligned with other stability indicating methods. In this webinar, we will present comparative analytical data spanning across several different research programs then present a more detailed story about a particular monoclonal antibody for which we have recently completed accelerated and real-time stability studies.

Learning Objectives:

• Learn how sub-visible particle analysis can support biopharmaceutical development.
• Learn the importance of sub-visible particle analysis for stability assessment in biologic formulations.
• Learn how sub-visible particle analysis can be deployed in high throughput.

Speakers:

Katherine Bowers, PhD
Principal Scientist and Group Leader
Analytical Development
Fujifilm Diosynth Biotechnologies, U.S.A.

Katherine Bowers received her B.S. in Chemistry from Shepherd University in Shepherdstown WV, followed by her PhD in Chemistry at the Pennsylvania State University. Her graduate research, under the direction of Dr. Robert Matthews, focused on studying the protein folding mechanisms of E. coli DHFR and the a-subunit of tryptophan synthase, using a protein fragmentation approach coupled to biophysical techniques to search for independent folding domains. Katherine Bowers then conducted Postdoctoral training in mechanistic enzymology at the University of Michigan, Department of Chemistry, under the direction of Dr. Carol Fierke. This research involved probing the chemical mechanism of mammalian farnesyltranferase, an enzyme involved in the post-translation lipidation of key signaling proteins, using site-directed mutagenesis, transient kinetics and kinetic isotope effects. After Postdoctoral training, Katherine Bowers worked as a Formulation Development Scientist at Regeneron Pharmaceuticals in Tarrytown NY. Katherine Bowers is currently employed at Fujifilm Diosynth Biotechnologies as a Formulation and Analytical Development Scientist for this contract manufacturer of protein-based therapeutics. In this role, Dr. Bowers works with a wide variety of protein molecules, using biophysical techniques to support manufacturing process development and the development of stable parenteral formulations.

Mark Spears Jr., PhD
Senior Scientist
Analytical Development
Fujifilm Diosynth Biotechnologies, U.S.A.

Mark Spears is a Senior Scientist at Fujifilm Diosynth Biotechnologies in Research Triangle Park, NC. He earned a PhD from Georgia Tech in 2014 where his work focused on biocompatible polymer microstructures and their surface coating applications. Mark joined Wyatt Technology in 2015 as an Applications Scientist where he developed expertise in light scattering techniques and biophysical characterization of polymers and proteins; he also supported business development and sales activity in the southeastern United States. In 2018, Mark joined the Formulation Development group at Fujifilm where he works primarily on protein formulations including analytical characterization and innovation. When not working, Mark loves spending time with his wife and son.

Cost: No Cost!