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Developability assessments with four mRNA-LNP vaccine formulations comparing mouse immunogenicity, structural
Max Fairlamb1, Ozan S Kumru1, John M Hickey1
1Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
Journal of Pharmaceutical Sciences
|February 13, 2026
Summary
A new workflow standardizes mRNA-LNP vaccine stability testing. This platform ranks formulations by stability, identifying candidates with better pharmaceutical properties for improved vaccine development.
Area of Science:
- Biotechnology
- Vaccine Development
- Nanomedicine
Background:
- Lipid nanoparticle (LNP) delivery systems are crucial for mRNA vaccines.
- Assessing the stability of mRNA-LNP formulations is essential for vaccine efficacy and shelf-life.
Purpose of the Study:
- To establish a standardized workflow for ranking mRNA-LNP vaccine formulation stability.
- To correlate in vitro stability profiles with specific physicochemical mechanisms and structural attributes.
Main Methods:
- Benchmarking four mRNA-LNP formulations using immunogenicity and stability studies.
- Employing a routine analytical toolbox to assess chemical, structural, and functional integrity.
- Utilizing heat-map analysis, cryo-electron microscopy (cryo-EM), and proton nuclear magnetic resonance (¹H-NMR) for characterization.
Main Results:
- While in vivo immunogenicity was similar across formulations, in vitro stability varied significantly.
- Functionality loss correlated with mRNA degradation (heat) and LNP disruption (agitation, freeze-thaw).
- Initial structural attributes like bleb formation and lipid surface topology predicted stability.
Conclusions:
- A standardized developability platform aids in identifying mRNA-LNP vaccine candidates with superior pharmaceutical properties.
- Understanding stability mechanisms is key to optimizing mRNA-LNP vaccine design.
- Early structural characterization can predict formulation stability.
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