Subvisible aggregates are a critical quality attribute (CQA) and a key measure of physical stability for all biologics. Aggregates are comprised of proteins that have coalesced into larger particles that can only be detected by specialized analytical techniques. They can arise at various development stages and compromise the safety, efficacy, and stability of therapeutic biologics. To ensure the development of effective therapies with long shelf lives, these aggregates need to be accurately characterized and measured. However, traditional subvisible analysis methods require large sample volumes, are not sufficiently sensitive at low aggregate concentrations, and can be time-consuming to use.

In this GEN webinar, Dr. Karessa White presents a high throughput automated membrane microscopy system that is uniquely designed to rapidly and accurately size, count, and identify subvisible aggregates and extrinsic materials using low sample volumes. During the webinar, you’ll see examples of how the system is used to improve subvisible aggregate identification and characterization in viral vector and lipid nanoparticle therapeutic samples.

About the speaker

Dr. Karessa White is a Field Application Scientist at Halo Labs. She obtained her PhD from the University of Florida in Communication Sciences and Disorders emphasizing auditory neuroscience. After spending time serving her country as a United States Army Medical Service Officer, Karessa now leverages her expertise and training in molecular biology and analytical science to help biotherapeutic developers create safe and stable drugs with Aura®.