Streamlining analytical validation for fast-tracking mRNA therapeutic development
mRNA vaccines are heralded as a part of the future of biotherapeutics. With advancements in lipid nanoparticle (LNP) delivery technology, mRNA can now be packaged and protected within LNPs, with less concern for stability and ensuring efficient delivery of therapeutics. However, achieving optimal encapsulation of mRNA within these LNPs is still challenging. Improper encapsulation of mRNA within LNPs fails to provide therapeutic benefits and can also trigger harmful immune reactions¹. It is for this reason that this part of development of mRNA therapeutics and their analytical testing is subject to rigorous regulatory scrutiny.
Currently, procedures for analytical validation of mRNA packaging into LNPs involve two complementary methods—capillary electrophoresis for assessing encapsulation efficiency, and mass spectrometry for identifying impurities in the drug product. Both these methods can be quite complex and time-consuming, lengthening the development of mRNA therapeutics. Removing existing roadblocks in the execution of routine analytical validations and expediting the development of mRNA-LNPs to enable faster rollout of therapeutics is needed.
Understanding encapsulation efficiency remains challenging. The SCIEX BioPhase 8800 Capillary Electrophoresis system allows for optimization of sample preparation conditions and rapid generation of calibration curves, with the capability for up to eight capillary electrophoresis runs in parallel. SCIEX’s ZenoTOF 7600 Mass Spectrometer with integrated data analysis software can also help labs understand LNP packaging in mRNA drug products. Past studies have shown that the oxidation of lipid species adversely impacts the therapeutic activity of mRNA-LNPs. With a comprehensive mass spectrometry and integrated software solution, labs can now perform complete lipid characterization in mRNA vaccine samples in one LC–MS run and detect lipid impurities at 0.01% relative abundance using a streamlined method. SCIEX OS software can ensure precise structural identification of the lipid impurities.
Streamlining the analytical validation of mRNA-LNPs can fast-track mRNA vaccine development and help to get key medicines to market faster. Explore more about our robust analytical solutions for your process development lab. Contact an expert at the Life Sciences companies of Danaher today.
References
- Packer, M. et al. A novel mechanism for the loss of mRNA activity in lipid nanoparticle delivery systems. Nat Commun. 2021. 10.1038/s41467-021-26926-0.