Pure and simple: understanding LNP analytics for better mRNA-based drugs

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Pure and simple: understanding LNP analytics for better mRNA-based drugs

Ionizable lipids, the enabling technology of lipid nanoparticles (LNPs), are especially susceptible to N-oxidation affording impurities that cause loss of mRNA potency. Consequently, careful assessment of ionizable lipid purity throughout the LNP manufacturing process is of paramount importance.

In this webinar, we will explore how mRNA inactivation across 12 ionizable lipids was screened to elucidate a predictive model. Learn how lipid purity is carefully characterized using high resolution mass spectrometry coupled with a novel fragmentation technology to both detect harmful N-oxide impurities at very low abundance, and distinguish them from other oxidated impurities. We will also present key insights into ionizable lipid selection for LNP programs and demonstrate how combining LNP expertise with detailed lipid analysis streamlines process development and mitigates risk.

Join this webinar to:

Understand how two days of careful analytics can save weeks of development time
Discover why process-related lipid impurities are a concern in therapeutics and vaccines
See how different ionizable lipids impact the potency of LNP therapeutics via mRNA modification
Explore how to achieve detailed characterization of ionizable lipids through liquid chromatography mass spectrometry (LC-MS) leveraging more descriptive fragmentation
Learn how to elucidate structures of ionizable lipid impurities, allowing differentiation of oxidative species and positioning of double bonds and saturations thereof at low levels (< 1%)

Adam Crowe

Senior Manager, Analytical Development at Precision NanoSystems ULC (part of Cytiva)

Adam Crowe manages a multi-discipline team at Precision NanoSystems ULC (part of Cytiva) tasked with developing novel analytical assays related to lipid nanoparticles (LNP) and nanomaterials for drug delivery. Notably, Adam and his team have increasingly leveraged cutting-edge technologies, such as LC-MS approaches, to tackle the complexities of LNP characterization. Latest studies were focused on the detailed characterization of impurities found in ionizable lipids.