Advanced Purification Strategies for LNP Therapeutics: Enhanced Purity, Uniformity, and Performance

Ana Železnik – Scientist, Sartorius BIA Separations; Tjaša Leban – Scientist, Sartorius BIA Separations; Tristan Kovacic – Project Manager, Sartorius BIA Separations; Maja Štokelj – Project Manager, Sartorius BIA Separations; Jasmina Puc – Product manager, Sartorius BIA Separations; Nina Mencin – Project Manager, Sartorius BIA Separations; Sergeja Lebar – Scientist, Sartorius BIA Separations; Rok Sekirnik – Head of Department, Sartorius BIA Separations; Andreja Gramc Livk – Head of Department, Sartorius BIA Separations; Ales Strancar – Managing director, Sartorius BIA Separations; Maja Leskovec – Head of Department, Sartorius BIA Separations

Poster Presenter(s)

Mojca Tajnik Sbaizero, n/a

Head of product-application area
Sartorius BIA Separations
Ajdovscina, Slovenia

Introduction: As key players in nucleic acid delivery technologies, lipid nanoparticles (LNPs) are driving forward the evolution of therapeutic applications. Despite their promise, several hurdles remain in their production and characterization: ensuring proper formation and integrity of the drug product, achieving sufficient recovery during purification while preserving functionality, and delivering a well-purified and comprehensively characterized end product (1). To address these challenges, purification using CIM® monolithic columns has been developed to facilitate precise separation and yield a consistent and functional product.

Learning Objectives:

1) Explaining CIM monolith chromatography and differences between standard purification methods
2) Combining advanced analytics methods (PATfix) for end-to-end RNA-LNP process
3) Using high-throughput techniques for RNA-LNP process development