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Manufacturing and Process Scale-Up

A 2D Chromatographic Tool for the Comprehensive Characterisation of Complex Novel RNA-LNP Drug Products

Mojca Bavčar – Scientist, Sartorius BIA Separations; Tristan Kovačič – Project Manager, Sartorius BIA Separations; Andreja Gramc Livk – Head of Process Analytics Development, Sartorius BIA Separations; Aleš Štrancar – Managing Director, Sartorius BIA Separations
Introduction:

Lipid nanoparticles (LNPs) have emerged as the most advanced drug delivery system for gene therapies and vaccines, due to their ability to encapsulate a diverse range of payloads, including nucleic acids and proteins. They provide protection from enzymatic degradation, enhanced cellular uptake, and controlled release. The complex composition and inherent instability of LNPs pose significant challenges for their characterization, particularly in assessing encapsulation efficiency, mRNA payload integrity, and LNP size distribution.

Learning Objectives:

  • understand operation of the two-dimensional chromatography (2D) system for direct LNP analysis.
  • interpret key LNP quality attributes—encapsulation efficiency, payload integrity, and particle size.