Malvern MicroCal PEAQ-DSC for monitoring thermal stability of mRNA-lipid based vaccines

Click2Contact

The success of the SARS-CoV-2 mRNA vaccine has propelled this modality from a niche industry into a runaway success. Built from decades of research, mRNA lipid nanoparticle vaccines are an exciting development that highlights the potential for vaccines against other infectious diseases and immunotherapies for multiple diseases.

Whilst mRNA-based vaccines have great potential, they can be highly temperature-sensitive. The requirement for cold storage not only adds high costs to vaccine transport and storage, it severely limits the reach and distribution of vaccines in areas that lack adequate transport and electrical infrastructure. As well as measuring the stability of the vaccine under different conditions, thermal stability data is also essential in monitoring key manufacturing steps like formulation and buffer exchange (helping to ensure consistency) and in comparing the quality of different production lots. A better understanding of their complex structure and behaviour in solution enables control of production and secures designed function and stability on storage.

Differential scanning calorimetry (DSC) is a well-established technique that is helping vaccine developers and manufacturers to create more stable vaccines. DSC provides direct measure of thermal transition points (Tm) as well as the enthalpy (ΔH) and heat capacity of denaturation processes. It provides direct and label-free measurement of biomolecular native-state stability in solution, and is non-spectroscopic, meaning it is not affected by optical artefacts like solution turbidity and background fluorescence. This adds to the reliability of DSC as a method to test the thermal stability of vaccines.

The MicroCal PEAQ-DSC system has been described as the gold standard stability-indicating technique requiring minimal assay development. Able to measure tight binding constants, up to 10²⁰M^-1, MicroCal PEAQ-DSC can be used to explore thermally induced structural transitions of the free mRNA and the mRNA-lipid complexes. Automated data analysis supports the generation of high-integrity thermal stability data and delivers compliance with regulatory requirements, whilst allowing easy integration into existing data handling and transfer systems. Unattended operation of the instrument after sample loading frees operator time. This complete system requires no additional accessories, reagents or consumables.

For more information: https://www.atascientific.com.au/products/malvern-microcal-peaq-dsc/.