Presented by: Michelle Chen, Ph.D., Wyatt Technology
Presented Live: January 18, 2023
For emerging gene-based medicines, light scattering techniques provide multi-attribute quantification (MAQ) and hence play a critical role in product and process development as well as quality control. Dynamic light scattering (DLS), performed in microcuvettes or microwell plate, rapidly estimates size, polydispersity, and particle concentration. Size-exclusion chromatography with multi-angle light scattering (SEC-MALS) offers a platform method for quantifying multiple quality attributes of AAV-delivered or LNP-formulated gene therapy products including titer, payload and aggregate content as well as extended biophysical characterization. For AAV aggregates and large LNP samples, field-flow fractionation (FFF) is an essential alternative separation method placed upstream of MALS and DLS (FFF-MALS-DLS). In the webinar, we share some case studies using light scattering for these different pharmaceutical analytes.