FARGO — A Fargo biotechnology company will manufacture genetic material for an experimental vaccine to protect against infection from the coronavirus in a partnership with researchers at Massachusetts General Hospital.
The manufacturing partnership, which involves Aldevron and two other biotechnology firms, was announced Thursday, May 28, and involves first-phase clinical studies that will begin later this year.
The experimental COVID-19 vaccine uses a harmless, adeno-associated virus to create a vehicle to insert genetic material into the body, serving as a vaccine.
Aldevron’s role in the project will be to manufacture what’s called plasmid DNA. The tiny, circular snippets of genetic material are combined with bacteria, grown in controlled conditions to massively replicate the DNA, which then is removed from the bacteria and purified in a series of steps.
“We’re producing the DNA that will carry the sequence into the viral vector,” said Michelle Berg, president of Aldevron’s unit for making nucleic acids. “The material is produced right here in Fargo.”
So far, the vaccine candidate has been used only in mice. The next step will be to test whether it’s safe for people in clinical trials and to see if it shows signs of working as a vaccine.
The AAVCOVID vaccine program, as the initiative is called, is one of about 90 experimental vaccines being developed around the world as researchers race for a solution to the pandemic.
Use of the altered virus has already been approved in three other forms of gene therapy, which the vaccine’s researchers believe offers an advantage. The virus has proven to be an effective way of getting the DNA into cells in a person’s body, where it can be mass produced to alert the immune system against the coronavirus.
Aldevron produces plasmid DNA, custom proteins, antibodies and messenger RNA for research laboratories, biotechnology and pharmaceutical firms around the world and has been involved in helping develop many therapies and vaccines.
Still, Berg said, being involved in developing an experimental vaccine against COVID-19 makes Aldevron employees “excessively proud.”
Aldevron is involved in providing materials for other experimental COVID-19 vaccines and therapies but can’t discuss those projects without permission from the clients, she said.
“Company-wide, we are involved,” she said, including the company's locations in Fargo, Germany and Madison, Wis.
The experimental vaccine being developed at Massachusetts General Hospital, a Harvard teaching hospital in Boston, is led by Luk Vandenberghe, director of the Grousbeck Gene Therapy Center.
“One important aspect of our vaccine is that it can leverage the extensive and established AAV industry that currently supports dozens of gene therapy products and programs,” Vandenberghe said in a statement. “The expertise, capacity and capabilities in terms of manufacturing that these companies offer will help us reach our goal of a widely distributed vaccine.”
Viralgen, a Spanish company that specializes in developing and manufacturing AAV gene therapies, and Catalent, a New Jersey company that provides “advanced delivery technologies” as well as development and manufacturing for gene therapies, also are partners in the experimental vaccine project.
Aldevron, founded 22 years ago by Michael Chambers and John Ballantyne, is expanding its manufacturing capacity with a 189,000-square-foot addition to its Fargo campus.
“We are investing and building capacity,” Berg said. If any of the experimental COVID-19 therapies or vaccines win approval, Aldevron would like to have a role in manufacturing the medicine.
“We would aim to continue our support for that program,” Berg said. “It’s been exciting.”
Given the massive research effort going into cures and vaccines involving the coronavirus, Berg predicts that there will be spin-off benefits for other potential medicines.
“I see many good things coming out of this,” she said.