Evaluation of the critical quality attributes of lipid nanoparticles stored under different conditions

Lipid nanoparticles (LNPs) are emerging new modalities for mRNA therapeutics which have been in the spotlight for the past decade. Since these are relatively new drug delivery systems compared to conventional medicines, new analytical techniques for the robust characterization of their critical quality attributes (CQAs) are needed [1]. It has been reported that several stimuli can affect the stability of the LNPs such as leakage of the nucleic acid cargo from the nanoparticle and LNP aggregation, resulting in low translation efficiency. Hence, understanding the duration of stability is key during formulation development. The aim of the present study is to evaluate the stability of PolyA-LNPs: 1) Stored at different temperatures (4oC and 25oC); 2) Dialysed in the absence and presence of cryoprotectant sucrose. We measured the impact of the above storage conditions on LNP physicochemical parameters.