Monolith-Based Solutions for Fast and Efficient LNP Purification at High-Throughput and Lab Scales

Ana Železnik – Associate Scientist, Sartorius BIA Separations d.o.o.; Maja Štokelj – Project Manager, Sartorius BIA Separations d.o.o.; Nika Samsa – Technician/Lab Assistant, Sartorius BIA Separations d.o.o.; Sergeja Lebar – Associate Scientist, Sartorius BIA Separations d.o.o.; Tristan Kovačič – Scientist, Sartorius BIA Separations d.o.o.; Petra Dekleva – Scientist, Sartorius BIA Separations d.o.o.; Andreja Gramc Livk – Head of Analytics Department, Sartorius BIA Separations d.o.o.; Maja Leskovec – Head of Virus Purification Departiment, Sartorius BIA Separations d.o.o.; Aleš Štrancar – Executive Director, BIA Separations, Inc; Mojca Tajnik Sbaizero – Head of Virus and Nanoparticle Innovation Group, Sartorius BIA Separations d.o.o.

Introduction: Lipid nanoparticle (LNP)-based biopharmaceuticals enable nucleic acid delivery but present manufacturing challenges due to structural sensitivity and limited purification options. Hydrophobic interaction monolithic chromatography was identified as an effective strategy for producing highly active LNPs. CIM (convective interaction media) high-throughput screening and lab-scale chromatography products were evaluated. Recovery, encapsulation efficiency, particle size, and activity were maintained upon scale-up to large-scale monolith chromatography, demonstrating consistency across scales.