The therapeutic potential of lipid nanoparticles (LNPs) as delivery vehicles has been demonstrated in recent years, with mRNA-based COVID-19 vaccines an outstanding example of global benefit. In order to ensure the safety and efficacy of an LNP-RNA vaccine or therapeutic, multiple quality attributes of LNP-RNA products need to be measured throughout the product development cycle. This webinar will review the use of two essential technologies for biophysical characterization and screening of LNP-RNA products.
Dynamic light scattering (DLS) in an automated plate reader effectively performs fast screening and quality control of LNP preparations. Multi-angle light scattering combined with ultraviolet (UV) and refractive index (dRI) detectors, following separation by either size-exclusion chromatography (SEC-MALS) or field-flow fractionation (FFF-MALS), provides in-depth characterization. Case studies cover the quantitation of particle size distribution, particle concentration, the molecular weight of RNA and LNP in each eluting fraction, and sized-based RNA payload distribution of the LNP formulation.
Key Learning Objectives:
- How DLS screens LNP-RNA samples for size distribution, aggregation, particle concentration and stability.
- How SEC-MALS and FFF-MALS quantify multiple LNP-RNA quality attributes (QAs) in a single run: particle size, polydispersity, particle concentration, and sized-based distributions of RNA payload along with RNA and LNP molecular weights of each size fraction.
Who Should Attend:
- Scientists and managers working in the gene and cell therapy field, seeking a robust, reliable, simple, and fast method to characterize and quantify LNP-RNA/DNA samples.
- CMC regulatory specialists in need of an analytical tool for determining quality attributes of LNP-RNA/DNA that is validatable and 21CFR Part 11 compliant, as well as orthogonal and complementary to legacy methods.
- Academic core labs that need an automated, rapid biophysical characterization method for gene vectors as well as drug-delivery nanoparticles.