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
Emergence of new variants of SARS-COV-2 may require new mRNA vaccines.
The knowledge gained from characterizing different formulations as part of this project will help prepare & respond to the future coronavirus waves by enabling rapid development & manufacture of mRNA vaccines that do not require ultracold shipping&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.
Arte, Kinnari, Poster Presenter, Formulation and Lyophilization of mRNA Lipid Nanoparticles, ISLFD Midwest Chapter Conference, Chicago, IL, 2024.
Arte, Kinnari, Poster Presenter, Investigating the Impact of Drying Processes on RNA Lipid Nanoparticles, AAPS Conference, Salt Lake City, UT, 2024
Munson, E., Presenter, ARP-11 Applying Advanced Characterization and Manufacturing Methods for New, Stable Formulations for mRNA-LNP Complexes, NIIMBL National Meeting, Washington, D.C., July 28, 2022.
Munson, E., Presenter, Enabling Solid-State Biological Products Through Advanced Engineering and Characterization: Solution and Solid-State NMR, AAPS 360, Boston, MA, October 2022
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, Alexion, New Haven, CT, December 2024
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, AstraZeneca, Gaithersburg, MD, December 2024
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, AstraZeneca, Gaithersburg, MD, May 2024
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, Eli Lilly, Indianapolis, IN, June 2024
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, Medicines and Healthcare products Regulatory Agency (MHRA), London, England, July 2024
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, Purdue University, West Lafayette, IN, November 2023
Munson, Eric, Presenter, Correlating Structure and Mobility Information to Functional Properties of Pharmaceutical Formulations, University of Iowa, Iowa City, IA, February 2024
Munson, Eric, Presenter, Predicting Properties of Amorphous Solid Dispersions and Biological Formulations Using Advanced Characterization, Abbvie, Abbot Park, IL, October 2024
Munson, Eric, Presenter, Structure-Function Relationships in Lyophilized Biologics for Stability Prediction, National Biotechnology Conference, San Francisco, CA, May 2024
Munson, Eric, Virtual presenter, Characterization of Protein Stability in Formulations Using Solid-State NMR Spectroscopy, Merck, June 2023
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