Developing Diverse Biopharmaceuticals with Light Scattering
From developability assessment to commercial manufacturing, the development of biopharmaceutical drug products entails multiple characterization challenges, made all the more complex when considering the range of diverse molecular formats from proteins to advanced therapy medicinal products (ATMPs).
Light scattering technologies provide key characterization tools that are key to addressing many of these challenges. Chief among these are multi-angle light scattering coupled to size-exclusion chromatography (SEC-MALS) and dynamic light scattering (DLS) performed without separation. Both techniques determine essential biophysical attributes in an absolute manner, rapidly and with no need for calibration against reference material or laborious sample preparation.
Following an introduction to light scattering technology and applications, this webinar will cover three case studies in the uses of SEC-MALS and DLS to characterize different types of biopharmaceuticals: antibodies, pegylated enzyme therapeutics and polyA-LNP. Attributes measured range from size and polydispersity, molar mass distribution and PEG-protein ratio to solution viscosity. These studies showcase the effectiveness of light scattering in supporting biopharmaceutical development towards successful commercialization.
Key Learning Objectives:
Strategies for assessing developability and optimizing drug formulations.
Technology and applications of light scattering for biopharmaceutical characterization.
Application of advanced analytical techniques (DLS, SEC-MALS) for biopharmaceutical characterization.
Addressing challenges specific to different biopharmaceutical molecule formats.
Presenter: Andrei Hutanu, Ph.D. (ten23 health)
Andrei Hutanu attended the Technical University of Munich from 2012-2018 where he got his degree in Biochemistry. He then started his Ph.D. at F. Hoffmann - La Roche Ltd with research focus on enhancing capillary electrophoresis (CE) methods for biopharmaceuticals. During his Ph.D., Andrei has established analytical methods for new modalities like mAb co-formulations and bispecific mAbs. In 2019, he switched his focus to method development for cell and gene therapy products with a special focus on recombinant adeno associated viruses. Since 2023, he is part of the analytical development team of ten23, a CDMO that aims to develop, manufacture, and test tomorrow’s medicines.
Presenter: Michal M. Raczy, Ph.D. (ten23 health)
Dr. Michal M. Raczy is a Senior Scientist for Drug Product Design at ten23 health. Since joining the company in January 2022, he has led formulation and process development projects, while also driving innovation within biologics and surfactants analytics. With a strong background in chemistry and nanotechnology, Dr. Raczy obtained his PhD in molecular engineering from the University of Chicago (USA). During his doctoral studies, he conducted research on novel drug delivery systems and immunomodulatory biomaterials, leading to several published papers in prestigious peer-reviewed journals.
Presenter: Daniel Some, Ph.D. (Waters | Wyatt Technology)
Dan Some leads product marketing for Wyatt’s process analytical and macromolecular interaction instrumentation. Prior to joining Wyatt he was involved in semiconductor and military electro-optics industries. Dan obtained his Ph.D in Physics from Brown University and carried out postdoctoral research at Los Alamos National Lab and Weizmann Institute of Science.
