NucleoDry: Development of a platform for dry mRNA vaccines and lipid nanoformulations

Purpose and goal:

NucleoDry aims at developing a platform for production of lipid nanoparticle (LNP)-based mRNA drug formulations with long shelf life at 4°C or higher temperatures to improve stability and ease transport, storage and use of these products. In addition, the project aims at building a national infrastructure around the development of nucleotide-based formulations.

Expected results and effects:

The project aims at developing a platform for LNP manufacturing that will be assessed from a GMP-perspective. The project will study LNP-mRNA formulations before and after drying and study important factors upon re-dispersion. Promising formulations with mRNA will be tested for in vivo efficacy. Approach and implementation:

The project will start with mRNA manufacturing in parallel with LNP formulation development and development of drying processes. The formulation work later in the project is an iterative process with feedback from analyses and in vivo efficacy tests. The most promising formulations will be the basis for a GMP-adaption plan for early clinical phases and a plan for upscaled GMP-manufacturing for later clinical phases.