Adducts and N-oxides: Understanding Lipid Nanoparticles (LNPs) for Better mRNA-Based

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The development of genetic medications using lipid nanoparticles (LNPs) requires rethinking analytical technology. Learn how to gain valuable insights into your LNP quality in a new and streamlined manner.

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Event Overview:

Lipid nanoparticles (LNPs)—composed of helper lipids, PEGylated lipids and ionizable lipids—are widely used vehicles for oligonucleotide-based therapeutics and vaccines. However, mRNA LNPs are susceptible to inactivation of their payload by N-oxide-based impurities. Distinguishing harmful N-oxides from other oxidation products can be an analytical challenge for most existing technology, especially for ionizable lipids, as they come with various structures consisting of several potential oxidation sites. To complicate matters, harmful impurities can be present at very low abundance. This webinar explains how to address challenges related to N-oxide-based impurities during LNP-based development.

Key Learning Objectives:

  • Discover why process-related lipid impurities are a concern in LNP therapeutics and vaccines
  • Explore how to achieve detailed characterization of ionizable lipids by using liquid chromatography with mass spectrometry (LC-MS) and 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 at low levels
  • Hear about streamlining complex data interpretation of ionizable lipid fragmentation with dedicated novel software for MS/MS interpretation

Featured Speaker:

Dr. Adam Crowe
Manager Analytical Development
Precision NanoSystems ULC

Adam Crowe manages a multi-discipline team at Precision NanoSystems ULC, tasked with developing novel analytical assays related to lipid nanoparticles (LNPs) and nanomaterials for drug delivery. During his tenure, Adam has garnered broad expertise over the 50+ unique LNP compositions manufactured at PNI in analyzing particle payloads, excipients (such as lipids), physiochemical characteristics, and in vitro potency. Notably, Adam and his team have increasingly leveraged cutting-edge technologies, such as LC-MS approaches, to tackle the complexities of LNP characterization. Additionally, Adam is the technical lead for ASTM’s guide document on analytical methodologies for RNA LNPs, a comprehensive document drafted by leaders in industry, academia, and regulatory bodies outlining best analytical practices for the LNP field.

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