Backed by years of biologics formulation development for mRNA vaccines, monoclonal antibodies and peptide drugs, Ying Wang, associate professor of chemistry, started The Wang Lab at the University of North Carolina Wilmington in July 2015. 

Since then, The Wang Lab has developed new formulation technologies in collaboration with four large pharmaceutical firms and one biotech startup. 

An offshoot of the lab, Wang and his colleagues, chemistry major Carson Jackson and graduate student Harrison Wooten, launched DuraVax Inc. to develop formulation technologies that solve the cold-storage requirement challenge for mRNA vaccines like the COVID vaccine.

“We were studying a cool natural phenomenon of mRNA in cells during COVID lockdown,” Wang said. “And we realized that our scientific understanding may help solve the cold chain challenges of mRNA vaccines.”

mRNA vaccines introduce a small piece of a protein found on the virus’s outer membrane. When it’s not inside a cell, mRNA needs protection to keep it from disintegrating. A cold chain for transporting and storing the vaccines is required. 

The cold chain begins when the vaccine is manufactured and continues through transportation to the distribution center, ending with the local immunization provider at the time of administration. Throughout the entire supply chain, the vaccines are maintained within a range from -112 degrees Fahrenheit to -4 degrees Fahrenheit. Once the vaccines are unboxed and thawed, they can be kept in a refrigerator for approximately two weeks. 

“At ambient temperatures in southern America or in tropical countries that reach as high as 100 degrees Fahrenheit, mRNA degrades in a couple of hours without cold storage,” Wang said. 

The knowledge underlying the technology that eliminates the need for the cold chain was accumulated over the years during formulation development research at The Wang Lab. 

“We have been working on the specific mRNA formulation technology for two years,” Wang said. “Because we don’t need to change the chemical composition of mRNA and lipid nanoparticles in the existing vaccine, pharmaceutical companies can easily adopt our secret ingredients and process to convert their own vaccines into a thermostable formulation.” 

Vaccine development is a 10-plus-year process consisting of basic research and preclinical studies, including tests in animals, followed by clinical studies on humans. Formulation development is an integrated part of vaccine development from a very early stage. The development plan for DuraVax was made after talking with literally hundreds of drug and vaccine developers. 

“When DuraVax developed our formulation technology, we kept the entire vaccine development process in mind. Using only FDA-approved ingredients, our formulation process can be seamlessly incorporated into vaccine developers’ existing pipelines,” he said. “While we didn’t make new vaccines directly, our novel formulation technologies allow room temperature storage and transportation of the Pfizer/BioNTech and Moderna COVID mRNA as well as any other emerging mRNA vaccines and therapeutics for treating various infectious diseases, cancers and other diseases.” 

This development distributes vaccines to areas without adequate cold-storage facilities or trained personnel. This, in turn, reduces vaccine waste due to improper storage, freezer malfunction and open vial wastage.

Wang recently received nearly $275,000 in funding from the National Science Foundation Small Business Technology Transfer to test DuraVax’s technology on additional mRNA-based vaccines and therapeutics.

He intends to push the limit of room-temperature shelf life with the expectation of launching the formulation technology globally to large pharmaceutical companies in two years.

The Wang Lab collaborates with large pharmaceutical companies, including Merck and Eli Lilly.

“Wilmington is one of the most vibrant communities of entrepreneurship in the country,” he said. “UNCW has provided support to incubate advances in sciences and innovations. And state funding agencies such as NC Biotech Center and NCInnovation have provided essential funding and business training to help scientists move their innovation outside the lab.

“Like all scientists,” he added, “we feel content and excited to see our research get out of the lab door and help people in real life.”