Lipid nanoparticle and liposome certified reference materials: ALIPO-1, ALNP-1, and LNP-2

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Abstract Following the rapid and successful deployment of the mRNA-based, lipid nanoparticle-delivered COVID-19 vaccines, lipid-based drug delivery systems became integral to mainstream medicine. To support continued advancement of such systems, we developed three relevant anionic nanoparticle reference materials, which were thoroughly characterized and certified for mean particle hydrodynamic diameter with additional reference and informational values provided. The certified reference materials comprise one liposome formulation (ALIPO-1) and two distinct siRNA-loaded lipid nanoparticle formulations (ALNP-1 and LNP-2), each exhibiting a monodisperse particle population. The certified mean hydrodynamic diameter (Z-average) and the associated expanded uncertainty are, respectively, equal to (90.8 ± 1.2) nm, (123.2 ± 1.5) nm, and (68.8 ± 1.6) nm; the corresponding polydispersity index (PdI) and expanded uncertainty values are 0.054 ± 0.017, 0.041 ± 0.008, and 0.083 ± 0.020. The formulations are stored long-term at −70 °C and are projected to maintain size stability for several years. When dispersed, they also demonstrate sufficient short- to medium-term stability to support a range of biological and biomedical applications.

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