Advanced FISH Assay and Mechanism Hybrid Surrogate to Improve mRNA Vaccine Potency Assessment and Prediction

The objective of this project is to develop and validate single-molecule RNA-fluorescence in situ hybridization (smFISH), mechanistic & hybrid surrogate model, and PATs for mRNA delivery and translation processes to ensure vaccine efficacy.

Project status

97% Completed

Industry Need

The COVID-19 pandemic promoted the rapid development of mRNA-based vaccines targeting a wide range of infectious diseases.
The ongoing emergence of various virus variants creates the critical need for quality control and assurance (QC/QA) to ensure mRNA vaccines have high potency (i.e., a quantifiable biological response elicited by the antigen or vaccine product).

Solution

Northeastern University aims to provide a multiplexed potency assay and a delivery process mechanism surrogate that can be useful for commercially QC/QA screening multivalent mRNA vaccines encoding multiple proteins of variant strains.

Impacts

Develop and validate an efficient single-molecule RNA-fluorescence in situ hybridization (smFISH) technique-based potency assay that can track mRNA structural-functional integrity, detect RNA degradation, and monitor mRNA delivery process

Apply molecular dynamics simulations for mRNA structure-function analysis to improve the efficiency and understanding of mRNA translation

Develop a hybrid model and risk/sensitivity/predictive analysis of integrated RNA delivery and translation processes that can integrate heterogeneous measurements, identify critical root causes of the loss of potency, evaluate the value of smFISH measures, and improve the prediction accuracy of mRNA potency

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Project Lead

Northeastern University