Improving the Safety of LNP-mRNA Therapeutics and Vaccines by Utilizing Monolithic Chromatography

Lipid nanoparticle (LNP) based therapeutics and vaccines have been at the forefront of the non-viral delivery since SARS-CoV-2 vaccines rolled out and proved their worth. LNP’s safety profile is a critical attribute that must be considered during its formulation and manufacturing. Major safety issues can stem from the heterogeneity of LNPs, including the presence of impurities such as empty particles, and fused or aggregated particles. These issues can be addressed by utilizing monolithic chromatography at both, analytical and preparative level.

Lipid nanoparticles enable a high degree of modularity depending on the desired outcomes. Manufacturing of LNPs provides a major advantage over established viral vector therapies due to its easy to formulate and scale characteristics. All that modularity enables large diversity of LNP properties and heterogeneity within the samples. However, LNP formulation typically requires a considerable effort to achieve an optimal outcome.

Commonly, it is very difficult to accurately predict in-vivo LNP activity and immunogenicity. Better, faster and more insightful analytical methods are needed to better predict LNP effectiveness, safety and stability, so that the development of therapeutics can be accelerated at a lower cost.

In this webinar, a novel chromatographic approach utilizing monolithic columns is presented for determination of crucial LNP parameters such as encapsulation efficiency, particle size, nucleic acid quantity and integrity, all measured without any sample pretreatment. In addition, the webinar demonstrates the use of monolithic chromatographic analytical methods with applications to monitoring critical quality attributes in mRNA LNP production.

The webinar covers the unique suitability of monolithic columns for LNPs as they are made from one piece with large pores that exhibit minimal shear stress to the nanoparticles and can thus keep particles intact. Various diverse surface modifications of the monoliths can be made to achieve the desired LNP binding selectivity. LNP particles can thus be separated based on their size, charge, hydrophobicity, hydrophilicity, hydrogen bonding or a combination of those. This unique selectivity of monolithic columns offers a powerful insight into the LNP composition and structure.


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