Navigating Regulatory Guidance for LNP and Liposomal Drug Characterization Using FFF-MALS
Lipid nanoparticles (LNPs) and liposomal drug products present unique analytical challenges due to their structural complexity and sensitivity to formulation and processing conditions.
Regulatory guidance from the FDA, EMA, and USP highlights critical quality attributes (CQAs) such as particle size, surface charge, morphology, and encapsulation efficiency as essential for ensuring product quality, consistency, and performance.
This webinar introduces field-flow fractionation coupled with multi-angle light scattering (FFF-MALS) as a powerful platform for comprehensive LNP and liposome characterization. We will review the fundamental principles of FFF-MALS and demonstrate how the technique enables size-resolved measurement of key CQAs while preserving native particle structure. Practical guidance on method development, implementation, and best practices will be shared to help achieve robust, reproducible, and regulatory-relevant results.
Top 3 Key Takeaways:
Review recent and upcoming regulatory changes affecting LNP and liposomal drug CQAs
Learn how FFF‑MALS can address critical quality attributes
Discover resources and practical tips for implementation
Who should attend?
This webinar is designed for you if you are a scientist, analyst, or lab manager working on vaccine, LNP, or liposome characterization, or if you are part of a CDMO, CRO, or testing organization looking to expand analytical capabilities.
Speaker
Nemal Gobalasingham is a Product Manager for the Eclipse FFF system and DAWN MALS instrument line. He joined Wyatt Technology in 2018 as an Application Scientist and works closely with customers across a broad range of fields to provide application support and training. Nemal also serves as the Global Training Manager, overseeing and developing Wyatt’s field staff training programs. He earned a B.S. in Chemistry from Syracuse University and a Ph.D. in Chemistry from the University of Southern California, where his research focused on semiconducting polymers and materials science.
Bud Halimis a senior marketing analyst at Waters | Wyatt Technology with a PhD in physical chemistry from UCLA. He began his career teaching biochemistry and chemistry and contributing to laboratory manuals before transitioning into the scientific instrumentation industry as an applications scientist. At Waters, he supports researchers in the characterization of peptides, biologics, lipid nanoparticles (LNPs), and viral vectors.
