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Rapid mRNA LNP Potency Testing for Thermostable Process Development and Point-of-Use Quality Assurance

The project aims to correlate the results of the rapid LNP assay with changes in manufacturing conditions and storage insults such as heating or freeze/thaw cycling to determine which are detectable by the method and with what sensitivity.
Categories
Vaccines
Assays
Process control
Project status
66% Completed

Industry Need

  • The industry would benefit from more rapid potency testing methods of mRNA LNPs for use in mRNA vaccines, which could be used for point-of-use quality assurance and for testing formulated LNPs at various stages of manufacture and/or storage. 

Solution

This project aims to implement a rapid, reliable electrophoretic assay of critical quality attributes (CQA) of mRNA lipid nanoparticles (LNPs) to be used in mRNA vaccines.  

  • The assay has a less than 10 min readout time and can assay mRNA from LNPs without a separate mRNA release step.  
  • It has the ability to quantitate multiple mRNAs in a single run and can also indicate problems with lipid chemistry.  
  • It can distinguish between folded and unfolded versions of mRNA, as improper mRNA folding may serve as a sentinel of minor mRNA damage.  
  • The assay is compatible with commercial capillary electrophoresis (CE) instrumentation and requires only small volumes to be sampled.  

The team will also subject LNPs to various manufacturing and storage insults and compare CE assay readout with that from state-of-the-art bioassays of mRNA quantity, delivery efficacy, and immunogenicity. 

Impacts

Optimize the assay so it can be used to rapidly quantitate mRNA from LNPs

Distinguish between folded and unfolded versions of mRNA to help detect damage

Method could be used to routinely test formulated LNPs at various stages of their manufacture and/or storage

Updates, Related Publications, and Deliverables

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Participating Organizations

Carnegie Mellon University

Carnegie Mellon University

Eli Lilly and Company

Eli Lilly and Company