Comparison of ionizable lipids for lipid nanoparticle mediated DNA delivery

Eur J Pharm Sci. 2024 Dec 1:203:106898. doi: 10.1016/j.ejps.2024.106898. Epub 2024 Sep 10.

Abstract

Lipid nanoparticles (LNPs) are successfully used for RNA-based gene delivery. In the context of gene replacement therapies, however, delivery of DNA expression plasmids using LNPs as a non-viral vector could be a promising strategy for the induction of longer-lasting effects. Therefore, DNA expression plasmids (3 to 4 kbp) coding for fluorescent markers or luciferase were combined with LNPs. Different clinically used ionizable lipids (DLin-MC3-DMA, SM-102, and ALC-0315) were tested to compare their influence on DNA plasmid delivery. DNA-LNPs were characterized with respect to their colloidal properties (size, polydispersity, ζ-potential, morphology), in vitro performance (cellular uptake, DNA delivery, and gene expression), and in vivo characteristics (biodistribution and luciferase gene expression). At an optimized N/P ratio of 6, spherical, small and monodisperse particles with anionic ζ-potential were obtained. Efficient transgene expression was achieved with a minimum amount of 1 pg DNA per initially plated cells. Zebrafish studies allowed selection of DNA-LNPs, which demonstrated prolonged blood circulation, avoidance of macrophage clearance, and vascular extravasation. Our comparative study demonstrates a high impact of the ionizable lipid type on DNA-LNP performance. Superior transfection efficiency of DNA-LNPs containing the ionizable lipid ALC-0315 was confirmed in wildtype mice.

Keywords: DNA gene delivery; Gene therapy; Ionizable lipids; Lipid nanoparticles.

Publication types

  • Comparative Study

MeSH terms

  • Animals
  • DNA* / administration & dosage
  • Gene Transfer Techniques*
  • Humans
  • Lipids* / chemistry
  • Liposomes
  • Luciferases / genetics
  • Mice
  • Nanoparticles* / administration & dosage
  • Nanoparticles* / chemistry
  • Plasmids* / administration & dosage
  • Tissue Distribution
  • Transfection / methods
  • Zebrafish*

Substances

  • Lipids
  • DNA
  • Luciferases
  • Lipid Nanoparticles
  • Liposomes