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