LNP Characterisation: From LNP Formulation to Protein Corona in Human Serum

Speaker:

Aleš Štrancar, BIA Separations, Inc.

Abstract:

Lipid nanoparticles (LNPs) are becoming essential delivery systems for mRNA therapeutics, gene editing, and advanced cell therapies, yet their increasing complexity creates major challenges in safety, reproducibility, manufacturing, and analytical characterization. Recent advances in ionizable lipid design enable the development of next-generation LNP systems with improved stability, tunable immunogenicity, and reduced side effects compared with first-generation formulations.

Advanced analytical approaches based on two-dimensional liquid chromatography (2D-LC) provide comprehensive characterization of LNP formulations through simultaneous assessment of nucleic acid purity, encapsulation efficiency, particle heterogeneity, lipid oxidation, and surface conjugation processes within a single workflow.

The integration of novel lipid chemistries with robust orthogonal analytical methodologies represents an important step toward improved development, manufacturing, and quality control of LNP-based therapeutics for gene therapy, gene editing, and RNA delivery applications.