NISKAYUNA — Scientists at GE Research are working to develop a small-scale portable vaccine factory under a Department of Defense contract worth up to $41 million.
The five-year time window on the project means it will be far too late for use in the COVID pandemic, even if it works exactly as envisioned. But future diseases will be prime candidates for the technology, which is planned to be transportable in a container via a large truck and make DNA-based vaccines in just three days, a thousand or more doses at a time.
“We’re taking an entire pharmaceutical production facility and putting it into that box and completely automating it,” said John Nelson, who is leading the General Electric team in Niskayuna
The project is a joint effort with the Broad Institute, DNA Script, MEDInstill, Molecular Assemblies, and the University of Washington, each of which brings a separate piece of expertise to the table.
The Defense Advanced Research Project Agency is leading the effort. Its interest is in having a portable vaccine factory that can be moved to a forward position to keep military personnel safe.
Synthesizing DNA for vaccine isn’t challenging — the base ingredients are widely available and cheap. But automating the process by which they are combined, multiplied and placed in vials is a much bigger hurdle.
The idea has been in the talking stages for years, well before COVID-19 was recognized as a massive threat to public health, Nelson said.
“Nothing in particular prompted it other than general readiness,” he said, and the need extends beyond COVID to the next pandemic. “Everyone has already said it’s not a question of if, it’s only a question of when.”
DARPA put out the call for proposals two years ago; GE and its partners submitted their proposal Jan. 9, 2020. It still wasn’t a COVID-specific project at that late date, even as the virus had begun to spread in China.
“I knew that things were going on in Wuhan, and we were lamenting the fact that we hadn’t started the process 10 years ago,” Nelson recalled.
The Moderna and Pfizer/BioNTech vaccines authorized in late 2020 are both messenger RNA vaccines that trigger the body to create a protein that the human immune system can attack, while the Johnson & Johnson vaccine authorized this past weekend is a modified vector virus is harmless but is attacked by the human immune system.
The RNA-based vaccines weren’t hard to create, Nelson said. Within 24 hours of the COVID-19 virus genome being published in January 2020, he said, pharmaceutical companies knew how to make a vaccine for it, and within two months had batches ready for testing. Safety trials took longer because the technique hadn’t gained widespread use — the two-dose protocol was considered too cumbersome, so other approaches were preferred, he said.
“DNA and RNA vaccines have been around for years and no one had really made the jump,” Nelson said.
That long test period would obviously be a deal breaker for any rapid manufacturing process in a portable box that GE and its partners could create.
“What we’re hoping is that by the time our box is ready to use, that the technology is already considered safe,” he said. “I can only hope that in five years the nucleic acid [model] has ridden the coattails of two different nucleic acid therapies.”
The partners will have two years to work on their project before a major test that will determine whether DARPA awards further funding: Every component must work individually at that point.
“We have to demonstrate every step, some of which mankind has never seen before,” Nelson said.
If the team passes that hurdle it must meet other benchmarks in years three, four and five.
Nelson described the design as a large box containing three smaller boxes. The ingredients are placed in the first box and a master copy is made of the nucleic acid chain needed for the vaccine. The second box creates billions of copies of that chain. The third box prepares and packages it into individual dose units.
The second box is what GE will focus on.
A key advantage of this concept is that synthesizing the nucleic acid production is a much faster and more streamlined process than culturing it from living cells and then purifying it.
Nelson said components and processes developed during the project may have commercial and scientific applications of their own, above and beyond the project dubbed NOW (Nucleic Acids On-Demand Worldwide).
Also working on the project for GE are Weston Griffin, Erik Kvam and Brian Davis. Together with Nelson the team has expertise in chemistry, molecular biology, cell biology, fluidic handling, engineering, automation, and quality control.
Nelson, a Clifton Park resident, is a molecular biologist who has been awarded 64 patents either alone or with fellow researchers.
He tried to handicap the process and timed two patent submissions in an attempt to win the 10 millionth patent issued in the United States. He guessed the date correctly — June 19, 2018 — but they wound up being Nos. 9,999,856 and 10,000,742.