Size, concentration, payload and quality: Comprehensive characterization of LNP-RNA therapeutics by light scattering

DATE
September 21, 2021
TIME
8:00 a.m. PDT, 11:00 a.m. EDT, 16:00 BST, 17:00 CEST - Duration: 60 Minutes

Overview

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.

Brought to you by:
Wyatt Technology

Speakers

Michelle Chen
Vice President of Analytical Sciences,
Wyatt Technology Corporation
Jeff Huber
Contributing Editor,
C&EN Media Group

Registration

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