Team cuts one to two-year vaccine production timeline to fewer than 100 days

The Frederick National Laboratory for Cancer Research has developed a new rapid-response workflow to produce ready-for-testing vaccines in 13 weeks rather than the conventional timeline of 12 to 24 months.  

"Going from a gene sequence to a vaccine to first in human testing in under 100 days is remarkable," said David Lindsay, director of the Frederick National Laboratory’s Vaccine Clinical Materials Program 

The Frederick National Laboratory’s production process has been beta tested and will be used this fall to manufacture a potentially more durable vaccine for mumps. The project is part of efforts on behalf of the National Institute of Allergy and Infectious Diseases to develop the ability to rapidly respond to emerging health threats. 

Although past vaccination programs drove down the incidence of mumps, the disease has resurged in recent years in the United States and other developed countries. There is also evidence that the current vaccine becomes less effective over time and new strains of mumps have caused additional concerns. 

The national laboratory's Vaccine Clinical Materials Program will manufacture two new mumps vaccines, one using the conventional approach involving protein purification and another using the new workflow to produce the nucleic acid vaccine. 

Image

The process 

Gene sequences from a virus are used in a bacterial cell bank to produce plasmid DNA containing the viral genes. These circular plasmids are processed into linear strips of mRNA, which are encapsulated in a lipid layer to make nanoparticles that can be injected as a vaccine. After administration the vaccine activates the immune system against the virus. 

"The secret sauce is in the lipids,” Lindsay said. “On the mumps vaccine we are working on this year, there are five lipids, three commercially available and two proprietary. We are looking at getting those sourced from specific companies. They are all part of the vaccine, mixed in a certain proportion." 

Manufacturing manager Doug Cooper said mRNA vaccines are an established technology. The commercial production of the first COVID vaccines was rapid and massive, curtailing the pandemic.

So far, the Frederick National Laboratory production facility has conducted two successful test runs to be sure the nucleic acid vaccine will hit its intended target. They used a firefly luciferase gene that illuminates in fluorescent light to visually confirm the test vaccine reached the target cells.