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Abstract
A next-generation potency assay named pSIM provides effective concentration-based readouts for mRNA-lipid nanoparticle vaccines.
- The pSIM assay utilizes mass spectrometry to co-process test and reference lipid nanoparticles.
- It demonstrates applicability for both monocistronic and multivalent self-amplifying mRNA constructs targeting influenza and SARS-CoV-2.
- An exploratory correlation exists between in vitro potency and in vivo neutralization in mice.
- The assay shows stability performance under conditions such as heat stress, real-time storage, and freeze-thaw cycles.
- It is co-qualified for early phase quality control to support phase-appropriate release and stability testing.
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