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:

Speakers

Michelle Chen
Vice President of Analytical Sciences,
Wyatt Technology Corporation

Jeff Huber
Contributing Editor,
C&EN Media Group

Registration

Forwarded this event? Clear the form

Email Address*

Salutation

First Name*

Last Name*

Company*

Job Role*

Address 1*

City*

State

Zip / Post Code*

Country*

Business Phone*

What are your primary analytical challenges for nanoparticle-based therapeutics?*

Which technologies are you using or considering for nanoparticle and payload characterization?*

What is your timeframe for purchasing instrumentation for characterizing gene therapeutics?*

I would like to receive more information on products and services from the American Chemical Society

*By submitting this form, you agree to receive more information on related products and services from the American Chemical Society (ACS Publications) and its sponsor via email. ACS takes your privacy seriously. For more information, please see the ACS Privacy Policy.

View On Demand Webinars