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Creating the Next Generation of Stable mRNA Vaccines: From -80 oC Freezers to Room Temperature Storage

Purdue research hub to transform freeze-drying process used to make lifesaving drugs, preserve food

Funded by: NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals) as part of the American Rescue Plan Completed in 2023

Investigators: Eric Munson (PI, Purdue IMPH), Alina Alexeenko (Co-PI, Purdue ChemE/AAE), Elizabeth Topp (Co-PI, Purdue IMPH), Tony Zhou (Co-PI, Purdue IMPH)

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Current mRNA/LNP vaccines are solutions which must be stored at -80 °C to remain stable. Refrigeration accounts for a large portion of the costs associated with vaccine shipment and storage. In this project, formulation and manufacturing methods for solid roomtemperature stable vaccines were explored.

This project explored advanced analytical and manufacturing methods which can be implemented rapidly and used to quickly develop next-generation vaccines with improved manufacturing and stability performance. Various formulation excipients were explored to understand their impact on stability. New analytical approaches, such as solid-state nuclear magnetic resonance (SSNMR) spectroscopy were used to understand the structural and molecular nature of mRNA LNP complexes. Lyophilization, spray drying and spray freeze drying were evaluated as manufacturing methods for mRNA vaccines. This was significant as neither lyophilization nor spray drying have been thoroughly developed and characterized for manufacturing mRNA formulations.

It was shown that freeze dried formulations using 5% (w/v) or 10% (w/v) sucrose stored at room temperature maintained better integrity when compared to solution formulations stored at the same temperature. Spray drying and spray-freeze drying techniques were evaluated but did not produce viable mRNA/ LNP vaccines. Advanced characterization methods provided insightful information about the structure of mRNA LNP vaccines in the solid state.

Purdue research hub to transform freeze-drying process used to make lifesaving drugs, preserve food

Purdue University researchers and industry leaders are teaming up to transform the freeze-drying process, formerly known as lyophilization, used to make everything from lifesaving drugs and biotech products to food.