Lipid nanoparticles (LNP) are the leading delivery systems for enabling the therapeutic potential of small interfering RNA (siRNA), mRNA for systemic applications or CRISPR. Lipid nanoparticles (LNPs), currently represent the most advanced platform for RNA delivery. The rapid development and approval of mRNA-based vaccines during the COVID-19 pandemic paved the way towards increased interest in mRNA LNP technologies. Besides IM administered vaccines, challenges like targeted delivery of LNPs to reach extrahepatic targets need to be solved. Efficient delivery of mRNA-lipid nanoparticles (LNPs) to specific cell types remains a major challenge for mRNA therapeutics. Conventional targeting approaches involve modifying the lipid composition or functionalizing the surface of LNPs, which complicates manufacturing.

Optimized LNP processes as well as a sound analytical method panel will be presented to show the feasibility of producing conventional as well as next generation LNPs, used in gene delivery or for extrahepatic therapeutic approaches.