Leveraging SEC-MALS for Regulatory-Aligned Biosimilarity Assessment
Unlock the Secrets of Biosimilarity: Master SEC-MALS for Confident Comparability
Assessing biosimilarity requires a robust suite of analytical tools that directly address the biophysical characterization parameters emphasized in the latest US FDA biosimilar guidance and ICH Q6B.
Size-exclusion chromatography coupled with multi-angle light scattering (SEC-MALS) has emerged as a critical technique for defining molecular weight, aggregation, impurity profiles, and related quality attributes that underpin regulatory decision-making.
In this webinar, we will discuss how SEC-MALS can be applied to key biosimilar comparability challenges, including quantifying molecular weight, aggregates and reversible aggregates, confirming identity, and measuring extinction coefficients.
Why should you attend?
Get clarity on key biophysical characterization parameters outlined in ICH Q6B.
Understand how SEC-MALS addresses critical quality attributes (CQAs) for biosimilars and other biologic modalities.
Build confidence in light scattering fundamentals and their role in macromolecule characterization.
Who should attend?
This webinar is designed for you if you work on antibody or protein therapeutic characterization in discovery, development, quality control, or analytical services.
Don’t miss this opportunity to strengthen your expertise and stay ahead in biosimilar development.
Speaker
Bretton Fletcher is an application scientist in the Analytical Sciences team at Waters | Wyatt Technology. He assists customers in identifying the best light scattering solutions for their analytical needs by leveraging her expertise in multi-angle light scattering. He performs feasibility studies to characterize customer samples and participates in Wyatt’s Light Scattering University. He completed his Ph.D. in Biomolecular Sciences and Engineering from the University of California, Santa Barbara.
