SV-AUC as a stability-indicating method for the characterization of mRNA-LNPs

Anian Thaller, Lukas Schmauder, Wolfgang Frieß, Gerhard Winter, Tim Menzen, Andrea Hawe, Klaus Richter

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

During the SARS-CoV2 pandemic mRNA vaccines in the form of lipid nanoparticles (LNPs) containing the mRNA, have set the stage for a new area of vaccines. Analytical methods to quantify changes in size and structure of LNPs are crucial, as changes in these parameters could have implications for potency. We investigated the application of sedimentation velocity analytical ultracentrifugation (SV-AUC) as quantitative stability-indicating method to detect structural changes of mRNA-LNP vaccines upon relevant stress factors (freeze/thaw, heat and mechanical stress), in comparison to qualitative dynamic light scattering (DLS) analysis. DLS was capable to qualitatively determine size and homogeneity of mRNA-LNPs with sufficient precision. Stress factors, in particular freeze/thaw and mechanical stress, led to increased particle size and content of larger species in DLS and SV-AUC. Changes upon heat stress at 50 °C were only detected as increased flotation rates by SV-AUC. In addition, SV-AUC was able to observe changes in particle density, which cannot be detected by DLS. In conclusion, SV-AUC can be used as a highly valuable quantitative stability-indicating method for characterization of LNPs.

Original languageEnglish
Pages (from-to)152-156
Number of pages5
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume182
DOIs
StatePublished - Jan 2023
Externally publishedYes

Keywords

  • Analytical ultracentrifugation
  • Dynamic light scattering
  • Flotation
  • Lipid nanoparticle
  • Nanoparticle density
  • Particle size distribution
  • Vaccines

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