High-throughput LNP-mRNA integrity profiling

Lipid-based nanoparticles (LNPs) are effective non-viral vectors for delivering messenger RNA products (mRNA), most notably used for vaccine production against the recent SARS-CoV-2 pandemic. In this webinar, we will demonstrate a robust and high-throughput kit-based analysis of nucleic acids extracted from mRNA-LNP samples subjected to a series of stressing conditions. This method provides an amplification free workflow for characterization of the main mRNA product encapsulated by LNPs and RNA fragmentations present as impurities. The sample preparation steps for optimal RNA extraction, separation, detection and quantification by using capillary gel electrophoresis with laser-induced fluorescence detection (CGE-LIF) on the multi-capillary BioPhase 8800 system and using the RNA 9000 Purity & Integrity kit will be discussed. Additionally, software for automated and highly reproducible size determination of nucleic acid products released from the LNPs will be shown. Finally, the accuracy of this method, the limit of quantitation (LOQ) and the limit of detection (LOD) will be highlighted for these mRNA-LNPs samples. The results indicates that this robust method can be used to monitor the stability of the mRNA in these mRNA-LNP based drugs in different storage conditions during the manufacturing process.

 

Learning Objectives