Abstract
Success of industrial science is measured by the speed of transforming innovation into tangible products that can be tested clinically and then scaled-up and launched to as many patients as possible. Protein higher order structure (HOS) is an important product quality attribute that governs the structure-function characteristics, safety, and efficacy of therapeutic proteins. Circular Dichroism (CD), Differential Scanning Calorimetry (DSC), Infrared (IR) spectroscopy, and Fluorescence spectroscopy have long been recognized as powerful biophysical tools in determining protein secondary and tertiary structure and monitoring dynamic structural changes. In this presentation, I am going to highlight contemporary biophysical methods for more efficient, higher resolution analysis of biopharmaceutical HOS and some success stories of the innovative analytical characterization to address an immediate and global unmet medical need.
BioSketch
Dr. Hai-Young (Anne) Kim, PhD, is a Director at Therapeutic Discovery, Johnson and Johnson. Prior to Johnson and Johnson, Dr. Kim was employed by Merck and Pfizer and held roles in leading the Structural Elucidation Group at the Boston site and Biophysical Characterization at the Andover site. She led the group to apply heightened characterization and develop innovative analytical methods for well-characterized biotherapeutics including early- and late-stage molecules ranging from various IgG based therapeutic antibodies, recombinant proteins, and conjugated vaccines to mRNA. Dr. Kim received her Ph.D. in Chemistry under the guidance of Christian Griesinger and Markus Zweckstetter at the Max Planck Institute for Biophysical Chemistry in 2009, followed by postdoctoral research in Steve Fesik’s group at Vanderbilt University’s Medical School until 2011. She is a member of the Scientific Organizing Committee for CASSS Higher Order Structure from 2021 and co-chair for the 2024 CASSS HOS committee.