Stability Assessment of mRNA Formulations – Toward the Development of Degradation Assays for mRNA-based Vaccines

This webcast features: Caio Henrique Barros, PhD, Research Scientist, National Institute for Bioprocessing Research and Training & James Geiger, PhD, Field Application Scientist, PerkinElmer.

The COVID-19 pandemic has demonstrated the potential of mRNA vaccines to protect against infectious diseases. These unprecedented circumstances have also highlighted the instability of the mRNA molecule, which required the first COVID vaccines to be distributed at ultracold temperatures. This limitation has intensified efforts to develop mRNA formulations that are sufficiently stable at room temperature. Dried forms of the vaccines show promise for improved stability; lyophilization (freeze-drying) is among the methods being considered to produce these materials.

Here, we show the potential of the PerkinElmer LabChip® GX II Touch™ HT microfluidics technology for assessing the rate and extent of degradation of mRNA in solution and lyophilized formulations. The high sensitivity that can be achieved with this instrument allows the analysis of formulations with mRNA concentrations as low as 15 ng/µl. Since the first mRNA vaccines for COVID contained mRNA doses of 0.3 mL at concentrations of the order of 100 ng/µl, these low limits of detection are needed to accurately monitor degradation kinetics to 50-90% loss.Key Takeaways:

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