Hidden Threats: High-Throughput Strategies to Detect Aggregates in Biotherapeutics
Presented by: Karessa White, Ph.D. and Udayabagya (Bud) Halim, Ph.D. (Waters Corporation)
Presented Live: November 4, 2025
Aggregation and the formation of oligomers and high molecular weight species (HMWS) remain critical challenges in biotherapeutic development. Left unchecked, they can impact product efficacy, safety, and regulatory approval. To that end, regulators suggest the use of orthogonal techniques that can detect and characterize particles of different sizes. In this GEN webinar, our expert speaker will present a systematic approach for identifying oligomers, HMWs, and aggregates in biotherapeutics manufacturing. You will learn about a high-throughput workflow integrating dynamic light scattering (DLS) and background membrane imaging (BMI) to characterize particles across size regimes, from nanometers to sub-visible and beyond.