Optimizing LNP Formulations: Leveraging Monolithic Columns for Precise Insight and Improvement Strategies

Watch this webinar to learn about:

  • How to capitalize on the advantages of scalable methods for separation of different biomacromolecules
  • Understand the benefits of highly tunable chromatographic methods
  • Discover how to enable a high degree of automation in LNP downstream processing
  • Optimize LNP formulations and enable their comprehensive analysis

Nejc Pavlin, Project Manager, Sartorius BIA Separations
Tristan Kovacic, Scientist, Sartorius BIA Separations

Lipid nanoparticles (LNPs) have emerged as the foremost non-viral carriers for therapeutics and vaccines, capable of encapsulating various payloads. LNP carriers provide a significant advantage over traditional viral delivery systems, enabling modularity, speed, and better scalability. However, they pose significant challenges in terms of their purification and characterization.

Post-formulation, LNPs require downstream processing to make the formulation applicable for in vivo applications and monitoring of CQAs. Analytical methods for process monitoring and QC analytics of LNPs are mostly offline and require disassembling the particles into individual components beforehand. The process of formulation and purification can be monitored by chromatographic methods using monolithic columns. More specifically, two-dimensional chromatographic analytics enables direct analysis of LNP formulation, without any sample pre-treatment. Multiple detectors allow for the determination of encapsulation efficiency, nucleic acid content, nucleic acid integrity, and separation of co-encapsulated cargos in a single chromatographic run. Additional chromatographic methods that further address the heterogeneity of LNPs by utilizing different monolithic column chemistries and buffer effects are presented.

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