FARGO — Aldevron has placed Fargo on the map as the location of a vital link in the supply chain for coronavirus vaccines by quietly making record amounts of DNA that provide a critical starter ingredient.
The Fargo-based company has worked overtime to produce DNA — enough for pharmaceutical companies to produce hundreds of millions of doses — for vaccines that have helped to subdue the COVID-19 outbreak in the United States.
Aldevron, a leader in producing custom DNA genetic material and other products for development and production of genetic medicines, makes DNA and other materials for Moderna, a major producer of a COVID-19 vaccine that uses messenger RNA, also known as mRNA.
The two companies announced that they are expanding their collaboration involving materials for vaccines and other drugs that are in Moderna’s product development pipeline.
“Aldevron has been a longstanding partner of Moderna,” Juan Andres, Moderna’s chief technical operations and quality officer, said in a statement. “We look forward to our ongoing work with this expanded partnership.”
Kevin Ballinger, Aldevron’s CEO, said his company is well-positioned to support Moderna’s efforts. “Aldevron’s support of the Moderna pipeline spans nearly a decade, and we’re incredibly proud of the trust they’ve placed in us,” he said.
Throughout the development and production of COVID-19 vaccines, Aldevron has been working behind the scenes and at times around the clock to produce the large volumes of messenger RNA required for the massive vaccination effort.
“We are producing record amounts of DNA,” said Michael Chambers, Aldevron’s executive chairman and co-founder.
Employees at Aldevron’s Fargo campus have worked extra shifts to produce the DNA that the pharmaceutical companies use to make the vaccines. “Lots of overtime,” Chambers said.
Moderna is one of three companies authorized to make vaccines for emergency use in the United States. Pfizer/BioNTech also makes an approved messenger RNA vaccine and Johnson & Johnson makes a vaccine as well.
Aldevron’s expanded collaboration with Moderna goes well beyond vaccines, said Michelle Berg, a business unit president at Aldevron.
“It’s exciting because it’s much bigger than the COVID-related efforts,” she said. “It’s a pretty exciting and compelling pipeline” of products. “There’s just great opportunities that we see to serve patients globally.”
A team from Moderna recently toured Aldevron’s campus, which Chambers said has unique capabilities for custom manufacturing to serve the biopharmaceutical industry. “There’s nothing else like it in the biotechnology world,” he said.
Aldevron is supplying materials for at least 43 COVID-19 projects that include vaccines, diagnostics and therapeutics. The company started mass producing DNA for vaccines last summer.
Pharmaceutical companies and their suppliers worked at unprecedented speed to develop and manufacture vaccines, Chambers said.
“The industry has never moved this fast before,” he said. “It’s really remarkable. We’re moving at warp speed,” a reference to the Trump administration’s Operation Warp Speed initiative, when development of the vaccines began.
“You can’t speed biology up, but you can work around the clock,” said John Ballantyne, Aldevron’s chief scientific officer. “We’re prepared to do whatever we have to do to meet whatever need is put on us.”
Chambers and Ballantyne founded Aldevron in 1998 on the campus of North Dakota State University. The company’s growth has paralleled growth in the biotechnology industry and has coincided with the era of mRNA research and development.
“We’re going to probably make more DNA this year than we have made in all of our existence, and it’s not just RNA,” Ballantyne said. “It could be for DNA vaccine as well.”
Aldevron has hired about 100 new employees over the past year and now has about 600 employees. The company recently began operations in the second of four planned buildings on its campus at 4055 41st Ave. S.
The second building, occupying 190,000 square feet, increased Aldevron’s production capacity tenfold, giving a significant boost to the drive to provide key ingredients for COVID-19 vaccines. It is located beside the campus’s first building, with 70,000 square feet housing office and production space.
“We’re still hiring people,” Chambers said. Aldevron also is expanding its research laboratory space at a new location on South University Drive.
Aldevron’s success in supplying biotechnology and biopharmacy is due to the area’s skilled workforce, he said.
“What we do at Aldevron isn’t easy,” he said. “It’s a real testament to the high-tech, biotech workforce here in the Fargo-Moorhead area.”
Messenger RNA vaccines send signals to cells enabling them to detect and defend against the coronavirus' spike proteins, which allow them to attach to human cells — a technology that enables more rapid development and tweaking of vaccine formulas.
Moderna has announced that it is formulating a booster dose that should offer better protection against variants of the virus, some of which pose greater challenges for the immune system to combat.
“I think in the future most vaccines for infectious diseases will use mRNA,” Chambers said.
The tremendous scientific and industrial push for vaccines to protect against the coronavirus has given biotechnology a boost of creative efforts that will pay dividends in developing other vaccines and therapies for a wide range of diseases, Chambers said.
“We’re really showing what’s possible,” he said. “It’s analogous to the space program. One year from now we’ll look back and realize we’re in a new biotechnology age. It all comes from this effort.”
The DNA Aldevron produces in Fargo is one of the primary building blocks for the mRNA vaccines. “We make a blueprint, essentially,” said Angelica Meyer, Aldevron’s manager of plasmid DNA. A plasmid is a DNA molecule found in bacteria and other cells.
Aldevron produces a DNA “template” of material that is multiplied with bacteria in a fermenter, then purified and delivered to vaccine manufacturers, who add proteins and chemicals to turn it into a vaccine.
“This is something that is affecting literally everyone on the planet, and we are helping to deliver treatments and a safer environment for everyone on the planet,” she said. “It’s definitely very, very motivating to be part of that.”
Companies including Aldevron have raced to develop new processes and make their processes more efficient in order to ramp up vaccine production — achievements that “blaze the trail” for combating other infectious diseases, Ballantyne said.
“We’ve always prided ourselves on our ability to innovate on the fly,” he said. “People know what’s at stake. The immediacy of the need is not lost on anybody.”
Aldevron is not only the world’s largest plasmid DNA manufacturer, but one of the world’s few biotechnology suppliers that also provides essential enzymes and proteins, said Ballinger, the CEO.
“We have the ability to really be a one-stop shop,” he said. The pandemic and the innovation it is spurring will fuel more growth in the industry, and Aldevron. “It opens many new avenues for us for growth potential,” Ballinger said.
For example, he said, Aldevron is well positioned to supply the needs of other vaccines and therapies that use mRNA.
“This is just the beginning for mRNA-based technologies,” Ballinger said. “That’s what’s so exciting.” Future therapies and vaccines could treat or prevent diseases, including seasonal flu and cancers, and usher in a new era of personalized medicine. “Really this last year, it’s been accelerated by 10 years, we think.”