26th Interphex Japan

Join us at the 26th Interphex Japan!
Listen to a lecture by Tristan Kovačič. 
Visit us at Biopharma Expo, booth nr. 45-10 (in the Research & Development Zone) to explore the first-hand experience of using our PATfix analytical system that will be presented by Blaž Goričar. 

Lecture Title: Monolithic Columns for Purification and Analytics of 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 viral delivery systems. LNPs are highly modular, which carries many advantages, but brings with it heterogeneity and non-generality of analytical and purification methods.

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 purification methods for LNPs on monolithic columns, that is fast, ensures minimal shear forces for maintaining particle integrity and is capable of adhering to process requirements, while also being capable of achieving separation of different biomacromolecules – separating LNPs from its free cargo.

Additionally, it will outline monolithic column chromatographic analytics for monitoring critical quality attributes (CQAs) during mRNA-LNP production, purification, and release. The analytical 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.

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