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Advanced Characterization and Manufacturing Methods for mRNA Vaccine Development

The goal of this project is to accelerate and support mRNA vaccine production using advanced analytical and manufacturing methods.
Categories
Vaccines
Drug product

Industry Need

Cold-storage requirements for some vaccine formulations can impact the volume and speed of vaccine distribution, which directly affects the nation’s pandemic preparedness and ability to respond.  

Solution

Purdue University will construct/develop mRNA LNP formulations through available historical available scientific literature, which will be used to produce frozen, lyophilized, and spray dried formulations. These formulations will be further characterized for drug product stability.  

Characterizing the frozen, lyophilized and spray dried mRNA vaccine formulations will require: 

  • New analytical approaches (solid-state nuclear magnetic resonance (SSNMR spectroscopy) 
  • Solid-state hydrogen-deuterium exchange mass spectrometry (ssHDX-MS) 
  • Fourier transform infrared spectroscopy (FTIR-ATR) 



Analytical data related to mRNA degradation on storage in the solid state (~3-6 months) will be evaluated.  

Outcomes and Impacts

The knowledge gained from characterizing different formulations as part of this project will help prepare and respond to the future coronavirus waves by enabling rapid development and manufacture of mRNA vaccines that do not require ultracold shipping and storage.

In addition, by identifying stability-indicating methods this project can help to accelerate formulation and process development since the emergence of new variants of SARS-COV-2 may require new mRNA vaccines.

Updates, Related Publications, and Deliverables

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Project Lead

Purdue University

Purdue University

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