Monolithic Columns Enable Streamlined Downstream Processing and Analytics of Lipid Nanoparticles

Lipid nanoparticles (are leading non viral carriers for therapeutics, offering versatility in encapsulating diverse payloads. Their manufacturing superiority over viral systems allows for modularity, speed, and scalability. However, this modularity poses challenges in purification and characterization due to sample uniqueness LNPs require downstream processing for in vivo application and adherence to critical quality attributes. Analytical methods for those currently predominantly require undesirable particle disassembly beforehand.

Monolithic columns offer ideal chromatography for LNPs due to laminar flow, minimizing shear forces, and surface modification enabling selective options. Here is presented the purification method for LNPs on monolithic columns utilizing the PATfix analytical chromatographic system, efficiently separating LNPs from free cargo.

An analytical scale two dimensional chromatographic tool was developed. It delivers comprehensive characterization of encapsulation efficiency, nucleic acid content, degradation, and separation of co encapsulated cargos, without any sample pre treatment. Highly tunable and automatable, this method maximizes efficiency and facilitates precise separation of LNP populations.

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