Structural Characterization Of The Cationic Lipid Nanoparticle Component, ALC-0315, And Its Impurities

By Zhichang Yang, Paul Baker, Sahana Mollah, Robert Proos, and Jonathan Le Huray

This content is brought to you by SCIEX, a Danaher Operating Company.

Lipid nanoparticles (LNP) are increasingly used as drug delivery devices, especially for COVID-19 vaccines and recently emerging gene therapeutics. Key features of the comprehensive LNP characterization study performed by SCIEX include:

• EAD fragmentation using the ZenoTOF 7600 system provided informative fragment ions to structurally characterize ALC-0315 with minimal tuning
• Information-rich MS/MS spectra were used for definitive and distinct structural elucidation of low-abundant impurities, including oxidation and hydroxyl-to-carboxyl transformation
• Detection and identification of lipid impurities at levels<0.2% abundance relative to the main peak were achieved using the Zeno trap

This study will help you to gather a deeper understanding of EAD use when characterizing ALC-0315 and its impurities, as well as identify the nature and site of chemical alterations in ALC-0315 resulting from forced degradation.