(270) End-To-End Process for Improved Purity, Combined With Innovative Analytics of LNP-Based Therapeutics
Introduction: Lipid nanoparticles (LNPs) are at the forefront of nucleic acid delivery technologies, playing a crucial role in the advancement of these therapies. There are, however, several challenges that need to be addressed regarding their manufacturing and characterization: correct formation and integrity of the drug product, sufficient recovery during purification while maintaining functionality, and producing a well-purified and thoroughly characterized product.To introduce fine-tuned separation and obtain uniform and functional product, purification on CIM® monolithic columns was developed.
Learning Objectives:
Explaining CIM monolith chromatography and differences between standard purification methods.
Combining advanced analytics methods (PATfix) for end-to-end RNA-LNP process.
Using high-throughput techniques for RNA-LNP process development.
Tristan Kovačič – Project Manager, Sartorius BIA Separations; Ana Železnik – Scientist, Sartorius BIA Separations; Ana Ferjančič Budihna – Scientist, Sartorius BIA Separations; Matija Povh – Scientist, Sartorius BIA Separations; Nejc Pavlin – Project Manager, Sartorius BIA Separations; Polona Megušar – Scientist, Sartorius BIA Separations; Rok Sekirnik – Head of Department, Sartorius BIA Separations; Andreja Gramc Livk – Head of Department, Sartorius BIA Separations; Maja Leskovec – Head of Department, Sartorius BIA Separations; Aleš Štrancar – Managing director, Sartorius BIA Separations
