Advancing Light Scattering Assays for AAV Products
AAV-based gene therapy products are heterogeneous, composed of empty, partial, and full monomer capsid species as well as capsid aggregates and fragments. Tracking the relative abundance of these populations allows for greater control in delivering a consistent product to patients.
This webinar describes a DLS method to monitor capsid aggregation, including generation of a capsid aggregation standard and bringing the method to a GMP setting. This webinar also describes an FFF-MALS method for quantifying the relative abundance of capsid aggregates. Finally, this webinar describes SEC-MALS as a platform method for quantifying the relative abundance of full capsids.
Key Learning Objectives:
- DLS applications to monitor capsid aggregation in a GMP setting
- FFF-MALS applications to quantify the relative abundance of capsid aggregates
- SEC-MALS applications to quantify the relative abundance of full capsids
Who Should Attend:
- CMC teams supporting AAV-based therapies
- Scientists involved in AAV characterization, analytical method development, process development, and quality control
- Lab managers that need to select and support an optimal set of AAV characterization methods
Presenter: Margaret Butko, Ph.D. (Adverum)
Margaret Butko is Director of CMC Assay Development at Adverum, leading protein analytical and biophysical characterization. Dr. Butko has 12 years of experience in analytical and biophysical characterization supporting small molecule discovery, therapeutic antibody development, and gene therapy development. She earned her B.A. in chemistry from the College of Wooster and her Ph.D. in biomedical sciences from the University of California, San Diego, then completed a postdoctoral fellowship at Genentech in the protein analytical chemistry department. She has ben at Adverum for 4.5 years.
