New production method developed to freeze-dry COVID-19 vaccines

UMass Lowell scientists are developing a production method to freeze-dry COVID-19 vaccines activated by messenger-RNA so they can be transported and stored at room temperature.

If successful, the innovation could eliminate the need for mRNA vaccines manufactured by Moderna and Pfizer-BioNTech to be refrigerated in very cold temperatures to maintain their effectiveness against the coronavirus. The development would ease supply chain issues and deliver the lifesaving immunizations to countless more people around the world.

"Our goal is to develop a freeze-drying process that can be used for mRNA-based COVID-19 vaccines to make them more stable and extend their shelf life, as well as make them easier to transport, store and use," said UMass Lowell Chemical Engineering Prof. Seongkyu Yoon, who is leading the project with Emily Gong of Physical Sciences, Inc., in Andover, Massachusetts, along with researchers from Merck and the University of Connecticut.

Scientists call the freeze-drying process lyophilization. The work is being conducted in UMass Lowell's Lyophilization Research Bay (LyoBay), a state-of-the-art facility and the first of its kind on the East Coast, which opened in 2019 inside the university's Mark and Elisia Saab Emerging Technologies and Innovation Center.

The aim of the research is to freeze-dry COVID mRNA vaccines to demonstrate the new production method is sound, according to Yoon. The study is funded through a one-year, $930,223 grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA network institute that works to advance U.S. leadership in biopharmaceutical manufacturing and accelerate innovation.

Currently, the Centers for Disease Control recommends storing Pfizer-BioNTech vaccines in an ultralow-temperature freezer between minus 112 degrees and minus 76 degrees Fahrenheit (minus 80 degrees and minus 60 degrees Celsius) to keep their ingredients stable and ensure the vaccines' viability. The CDC suggests storing Moderna's COVID vaccines between minus 58 and 5 degrees F (minus 50 and minus 15 degrees C). The Johnson & Johnson/Janssen vaccine requires conventional refrigeration, between 36 and 46 degrees F (2 and 8 degrees C), for transportation and storage.

Freeze-drying enables a product to be stored as a powder at room temperature and then reconstituted when it's ready to be used. The process removes water from sensitive, perishable materials. It works by freezing the substance, then reducing the air pressure and adding low heat to allow the frozen water in the material to change directly from ice to vapor without melting. In contrast, conventional dehydration uses high heat to evaporate the water.

So far, none of the COVID-19 vaccines has been able to be stored at room temperature, which makes our approach unique and very attractive."

Seongkyu Yoon, Professor, Chemical Engineering, University of Massachusetts Lowell

The team hopes the project will enable a more rapid response to the coronavirus by creating a stockpile of thermally stable, freeze-dried vaccines that is ready to be shipped and distributed even to remote, rural areas without the need for ultracold freezers.

"We will use the LyoBay to demonstrate the ability to scale up the freeze-drying process, similar to what large companies do to mass-produce vaccines," Yoon said. The researchers hope to one day apply the technique to vaccines that fight other diseases as well.

UMass Lowell chemical engineering Ph.D. students Caitlin Morris of Tewksbury and Richard Marx of Cambridge are assisting Yoon in the research, which is being performed under a Project Award Agreement from NIIMBL and financial assistance award 70NANB21H085 from the U.S. Department of Commerce, National Institute of Standards and Technology.

"Our research is based on three years of study at the LyoBay, with support from NIIMBL. As far as I know, this is the first project of its kind funded by a public-private manufacturing institute," Yoon said.

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