Development of Lipid NanoParticles (LNPs) for therapeutic purposes
Lipid nanoparticles (LNPs) are small, spherical structures composed of lipids (fatty components such as cholesterol and phospholipids) and other biocompatible components that are used as delivery vehicles for drugs and other therapeutic agents.
The Food and Drug Administration (FDA) requires that LNPs be manufactured under strict quality control conditions, using good manufacturing practices (GMPs), to ensure consistent quality and purity. The level of impurities in the LNP formulation must be carefully controlled and documented, and the LNP must be tested for its ability to maintain stability and efficacy over time. Since potency is largely controlled by the ionizable lipid and the manner in which the lipids and mRNA are assembled during manufacturing. it is essential to verify the level of purity of the lipids and identify all possible degradation products which could potentially be detrimental to the vaccine potency or trigger unwanted adverse reactions. Therefore, we need to perform comprehensive qualitative and quantitative analysis of impurities in every batch of manufactured lipids, before starting the formulation, and following LNPs to extraneous conditions to assess stability.
