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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.
Process control
Project status
54% 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). 


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.  

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Project Lead

Northeastern University

Northeastern University