Introduction

The present invention belongs to the pharmaceutical/biomedical field, mainly to the area of ​​development of lipid formulations for DNA vaccination. The invention consists in the production of multicomponent lipid nanoparticles (LNPs) with high fusogenicity, obtained by combining cationic lipids and ionizable lipids at specific ratios. The present lipid nanoparticles are pre-arrayed using an automated microfluidic platform ensuring their reproducibility for large-scale production.

Technical features

The lipid nanoparticles (LNPs) of the invention are prepared by combining cationic lipids and ionizable lipids at a specific ratio to be administered subcutaneously (intradermally) or intramuscularly or systemically, with fewer side effects than the already known lipid nanoparticles. These LNPs are assembled using an automated microfluidic platform which guarantees the reproducibility of the preparation technique and the standardization of the chemical-physical characteristics, essential for large-scale production. The nanoparticles of the invention have in fact been obtained by suitably modifying the fluid dynamic parameters of microfluidic mixing, in order to optimize the efficiency of conveyance of their nucleotide load.

Possible Applications

• Vaccination through lipid nanoparticles encapsulating nucleic acids;
• Vaccination against infectious agents;
• Tumor vaccination;
• Delivery of non-coding RNA (ncRNA) for therapeutic purpose.

Advantages

• Simple and fast manufacturing processes;
• Easy manipulation, through DNA engineering;
• High thermo-stability that solves the complications related to maintaining the cold chain, essential to avoid the inactivation of less stable vaccines (e.g., mRNA vaccines).