LNP composition & impurities analysis with compliance-ready LC & LC-MS workflows

Lipid nanoparticles (LNPs) have been proven to be highly effective delivery vehicles for nucleic acid-based therapeutics. As multi-component delivery vehicles, LNPs are comprised of four lipid components, each with a specific function and requiring a specific ratio to effectively and safely deliver the nucleic acid payload (mRNA, siRNA guide RNA, etc.). Recent studies have shown that some lipid impurities associated with ionic lipids in particular can result in lipid adduct formation on mRNA that negatively impacts the safety and efficacy of the final drug product, highlighting the need for robust LNP composition and impurities analysis.

LC-based methods are frequently used as the principal platform in the analysis of LNPs. MS-based methods tend to be deployed in upstream activity for characterization and identification purposes, whereas optical-based methods using detectors such as ELSD are deployed in late-stage development or manufacturing environments as part of monitoring or screening assays.

In this webinar, LC-ELSD and LC-ELSD-MS workflows that can be run under Empower CDS for easy deployment in regulated and non-regulated labs will be reviewed along with LNP composition and impurities analysis data. Guidance will be provided as well on ELSD parameters that can be adjusted for optimum results.

Key Learning Objectives

• How LC and LC-MS workflows can be readily deployed for LNP composition and impurities analysis in regulated and non-regulated labs
• How integrated MS detection improves limit of detection and diagnostic power for impurity screening workflows
• Guidance on achieving optimum ELSD performance for LNP composition analysis

Who should attend

• Lab Directors and Managers engaged in the development of LNPs for in-vivo delivery of nucleic-acid therapeutics and vaccines.
• Analytical Development and Quality Control Scientists focused on ensuring the safety and efficacy of LNP formulations
• Incoming QC managers who perform raw materials analysis on lipid components used in LNP formulations.

Presenter: Kellen DeLaney, PhD (Senior Scientist, Waters Corporation)

Kellen received her PhD from the University of Wisconsin-Madison, where she developed mass spectrometry methods for identifying and quantifying neuropeptides. She joined Waters in 2021 and currently works on developing applications for peptide mapping and lipid nanoparticle composition analysis.

Presenter: Duanduan Han, PhD (Senior Scientist, Waters Corporation)

Duanduan received her PhD of chemical engineering from the Texas A&M University. She joined Waters in 2021 and currently works on lipid nanoparticle composition analysis and surfactant quantification.