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If it weren’t for the occasional “BIOHAZARD” sticker, you might mistake some of the lab equipment for office printers in Tonix Pharmaceuticals’ new facility. Boxes with white and gray plastic exteriors, some of them sporting touch screens, line the lab benches.
One device is not so unassuming. A clear plastic container roughly the shape and size of a pie is full of red, translucent fluid. Tubes of different colors poke in and out of it, including one that connects to what looks like an IV bag full of the same red fluid.
It’s a small bioreactor.
“It’s basically like the pot on the stove when you want to cook something,” Director of Facilities and Engineering Bill Riordan said. “We’re growing cells, and the cells are doing the work for us, generating the products we want to generate.”
This bioreactor fosters a carefully controlled, nutrient-rich environment for the specialized cells, which are selected by scientists to be the most efficient for the product they are making. It’s also where the cells are intentionally infected with viruses, allowing the pathogens to replicate.
Tonix is developing live virus vaccines for COVID-19 and monkeypox. No human has tried them yet — this new facility in Dartmouth is part of the company’s plan to change that. Here, scientists will refine the recipes needed to make the vaccines and produce some of the first doses for clinical trials.
The company’s work challenges the current scientific consensus on COVID-19. Many public health experts have abandoned the idea of reaching herd immunity with vaccines, and Dr. Anthony Fauci has said it probably won’t happen.
“He’s a great scientist,” Tonix CEO Dr. Seth Lederman said. “But I think that, from our point of view, he should have qualified that statement by saying: ‘… with the current vaccine technology.’”
Lederman said he thinks his company’s live virus platform could offer the long-lasting, transmission-blocking protection that the mRNA vaccines so far haven’t been able to. It was live virus vaccines that helped eradicate smallpox and make other diseases like measles rare in the U.S., thanks to the strong protection they offer.
“We don’t really know all of the things that a live virus vaccine does relative to an mRNA vaccine, but it certainly wakes up the body’s immune system in a fundamentally different way,” Lederman said.
Tonix’s COVID-19 vaccine uses a live horsepox virus modified to express a coronavirus protein, unlike Pfizer and Moderna’s mRNA vaccines, which only expose the immune system to a similar coronavirus protein on the virus.
It isn’t clear when the Dartmouth facility will start cranking out vials of COVID-19 vaccines — just like the other vaccine developers, Tonix is racing to keep up with emerging variants.
In the meantime, the company is responding to the monkeypox outbreak by “re-accelerating” work on a smallpox vaccine it had been developing for the last decade.
“We feel that we are at an important point for us, where we need to step on the gas and make sure that we can catch up to it,” Lederman said. “It’s also a real warning shot that we have to be very careful and prepared for the emergence of the Central African strain.”
The West African strain of monkeypox that is currently spreading across the world rarely kills, Lederman said, but another strain in Central Africa has a 10% mortality rate.
Early evidence suggests Tonix’s smallpox vaccine could protect against monkeypox, and the human trial is slated for 2023. Those trial doses will be produced in the Dartmouth facility.
Tonix, a company with headquarters in New Jersey, develops treatments for a range of diseases and conditions. It is traded publicly and listed as TNXP on the NASDAQ — the closing price on Tuesday was $1.40.
The company has hired about half of the 60 or so employees that will eventually work in the recently opened facility. When Tonix was choosing a location, they wanted to take advantage of the biotechnology expertise in Massachusetts, but they picked the New Bedford Business Park to avoid the congestion of the Boston area.
Editor’s note: This story was modified on July 13, 2022, to correct information on Tonix’s COVID-19 vaccine.
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The 45,000-square-foot building is tucked in the tree-lined business park on the far-north fringes of Dartmouth, but access to the facility is in New Bedford, which maintains the roads and utilities.
Three layers of security stand between the general public and the labs inside. Scientists must swipe through practically every door after they get past a security guard in the lobby. Water coming into the building is sterilized, and air going out of the building is filtered.
Some areas are still under construction. But even after the paint dries, the labs will undergo a monthslong qualification process of calibration and testing before they can facilitate the work the company has planned for them.
The first labs Tonix set up were the process development labs, where scientists work out the most reliable and efficient ways to manufacture vaccines. It usually takes two or three months and multiple inspections for labs to get a biosafety certification from the CDC, but Tonix “checked every single box” and had its permit in four days, according to Riordan.
“We’ve built everything here beyond spec,” Lederman said.
The labs are pressurized in such a way that air always flows in, preventing pathogens from escaping. Extensive air circulation systems take up what could be an entire second floor to the building.
“Per square foot, there’s ten times more utility requirements for a building like this than an office building,” Riordan said.
Even though production hasn’t begun yet, Lederman and his team still followed all the safety protocols as they took a reporter and photographer on a tour through the facility. As they stepped into the bright white corridors of the lab area, they donned safety goggles, white lab coats, and gloves — and media were required to do the same.
Computer systems constantly monitor conditions in the lab, from the air flow to the temperatures in the freezers, some of which are as cold as -200 degrees Celsius. Alarms can notify scientists as soon as anything goes “out of spec.”
Tonix’s 500-liter bioreactor, about double the size of a kitchen refrigerator, can produce enough doses to vaccinate a small country. But the raw product from the bioreactor isn’t what goes into patients’ arms.
“The next stage is the purification, or downstream,” Riordan said. “Now you’ve got the soup, you’ve got to extract what you want out of it.”
The scientists want to isolate the virus. The solution from the bioreactor is sent through progressively smaller filters, the smallest using “nanopores” tinier than even the virus itself.
Batches of vaccines for clinical trials will be manufactured in the Dartmouth facility’s 9,000 square feet of “clean rooms.” Reporters normally wouldn’t be allowed into the clean areas because of all the safety precautions, but the rooms are still under construction and Tonix was willing to offer a peek before they “go clean.”
In the first room, white lockers line the wall across from three small changing rooms. Workers will don scrubs, then move into the next room where they put on the first stage of protective gowns, plus booties, hairnets, and gloves. The room after that is for a second complete layer of gowning.
Next, workers walk into an airlock room and put on even more protective gear. The next door leads them into the manufacturing area, but it will only open if the other airlock door is closed.
“You exit on the other side and nobody ever goes backwards, because that’s a potential source of cross-contamination,” Riordan said. Materials have strictly enforced entrances and exits too, so that hazardous waste never goes where it shouldn’t.
The 500-liter bioreactor for manufacturing is the newest kind of reactor, designed for single-use cell bags that are blasted with gamma radiation for maximum sterilization.
The unit that fills the vaccine vials will take up an entire room when it arrives in the coming months. As soon as the tiny, Tonix-labeled vials are full of vaccine, a truck will take them to a warehouse.
Tonix used to contract all of this work out, but in the age of pandemics and disrupted supply chains, Lederman sees it as more important than ever to bring the work home.
“Something this new, this modern, from scratch — in 2019, you would probably only see this in China,” Lederman said. “We see ourselves as meeting a requirement to re-domesticate some of this capability.”
While the facility is now open, its labs will gradually ramp up work in the coming months.
Email Grace Ferguson at email@example.com.
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