Hidden Threats: High-Throughput Strategies to Detect Aggregates in Biotherapeutics

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.

Key Learning Objectives:

• How oligomers and HMWs compromise stability, safety, and regulatory approval in today’s biologics
• How orthogonal detection methods deliver complementary quantitative and qualitative insights into stability
• Practical strategies for monitoring aggregation from early formulation through development and manufacturing

Presenter: Karessa White, Ph.D. (Waters Corporation)

Dr. Karessa White is a Sr. Market Application Scientist at Waters Corporation. She obtained her Ph.D. 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.

Presenter: Udayabagya (Bud) Halim (Waters | Wyatt Technology)

Bud Halim is a Senior Marketing Analyst at Wyatt Technology, bringing a wealth of scientific expertise to the analytical instrumentation field. He earned both his B.S. and Ph.D. in Physical Chemistry from UCLA, where he first developed his passion for science. Bud began his career in academia as an adjunct professor, teaching Biochemistry, Analytical Chemistry, and Physical Chemistry, while also contributing as an editor and author to several laboratory manuals. He later transitioned into the scientific instrumentation industry, serving in roles such as applications scientist, where he gained hands-on experience in the characterization of peptides, traditional biologics, lipid nanoparticles (LNPs), and viral vectors.