The lyophilized mRNA lipid nanoparticles post-treatment regulation methods data

A significant particle size variation exists between freshly prepared and freeze-dried mRNA-Lipid nanoparticles (mRNA-LNPs). This characteristic may potentially impact the subsequent in vivo attributes of the product. Three post-treatment methods for mRNA-LNPs, including the combination the mRNA-LNP solution with NaCl, or subjecting the mRNA-LNP solution to dialysis using a pH 8 buffer, or allowing the mRNA-LNP solution to age for 10 days prior to the Tangential Flow Filtration (TFF), were employed to reduce this particle size variation without altering the formulation or processing parameters for the propose of regulating the particle size of freshly prepared LNPs. The particle size, size variation, entrapment efficiency, and integrity of these methods were accumulated and analyzed for both freshly prepared and freeze-dried mRNA-LNPs. These post-treatment methods were successfully applied to regulate the particle size variation of mRNA-LNPs without altering the formulation and preparation processing parameters.