Bioprocessing Summit

Join us at the Bioprocessing Summit!
Listen to a lecture and visit our booth to explore the first-hand experience of using our PATfix analytical system.

Title: Monolithic Columns for mRNA-LNP Therapeutics and Vaccines

Abstract: 
Lipid nanoparticles (LNPs) have emerged as the foremost non-viral carriers for therapeutics and vaccines due to their ability of encapsulating various payloads. They show limited adverse effects, are straightforward to formulate and are easier scaled than other viral delivery systems.

Post formulation, LNPs require downstream processing to ensure the formulation is applicable for in vivo applications and adherent to the desired specifications. Therefore, comprehensive, high resolution analytical tools for process monitoring and quality control (QC) of LNPs are critical for ensuring the patients’ safety and product efficacy.

The presentation will outline diverse applications of monolithic column chromatographic analytics for monitoring critical quality attributes (CQAs) during mRNA LNP production, purification, and release. The monolithic column applications will include:

• Two-dimensional chromatography tool for the analysis of LNPs with no sample pre-treatment. This approach enables determination of critical quality attributes, such as encapsulation efficiency, nucleic acid quantification and size distribution.
• mRNA integrity analysis using ion pair-reverse phase approach.
• Lipid composition analysis.
• Using those, you can streamline your mRNA-LNP optimization and manufacturing, setting optimal critical process parameters.

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