GRAND RAPIDS, MI — Amid soaring demand for the coronavirus vaccine, one Grand Rapids company is doing its part to put shots in arms.
On Friday morning, workers at Grand River Aseptic Manufacturing were suited up in personal protective gear, watching closely as thousands of vials swirled through a network of high-tech equipment on their way to be filled with Johnson and Johnson’s COVID-19 vaccine.
“It will save many lives, and that’s truly the mission,” said Tom Ross, president and CEO of Grand River Aseptic Manufacturing (GRAM).
His company was hired to help produce J&J’s COVID-19 vaccine, which was granted emergency use authorization by the U.S. Food and Drug Administration on Feb. 27. J&J says it will deliver 100 million doses of the vaccine by the end of June.
Ross says it’s an “honor and a privilege” to be part of the effort.
GRAM, founded in 2010, was born out of a partnership between The Van Andel Institute and Grand Valley State University.
It manufactures clinical and commercial pharmaceutical products for pharmaceutical and biotech companies. The company has about 350 employees, ranging from engineers to lab managers to quality control specialists, spread among five small- to mid-size buildings on Front Avenue SW near Grand Valley State University’s PEW campus.
GRAM has been working on the J&J vaccine since at least August.
The company announced on Aug. 7 that it had been awarded a $160 million federal contract to help manufacture the vaccine. It signed a contract in September with J&J to manufacture its vaccine, Ross said, and that over the coming month it’s aiming to increase the number of vaccine doses it’s producing.
Ross said he’s prohibited from disclosing the exact number of J&J vaccine doses GRAM has manufactured. But, to give an idea of the scale of his firm’s operations, he said production has stretched into the “millions” of doses.
“Our team has just done a remarkable job,” he said. “They’ve worked tirelessly.”
Related: 6 things you need to know about new Johnson & Johnson COVID-19 vaccine
J&J’s CVOID-19 vaccine is the third such drug developed in response to the coronavirus pandemic.
It differs from the Pfizer and Moderna vaccines because it requires one, not two, doses of the vaccine.
An FDA analysis found the vaccine is about 66% effective overall at preventing moderate to severe COVID-19, and has a 86% efficacy rate against severe forms of Covid-19 in the United States, and 82% in South Africa.
Clinical trials showed the Pfizer and Moderna vaccines were 95% effective once the vaccine fully kicked in. But experts note the Pfizer and Moderna clinical trials occurred over the summer and early fall, before the emergency of variants, while the J&J shot was tested later as those variants were emerging.
David Powell, vice president of business development at GRAM, said the pharmaceutical industry has never been known for “super speed.” But the sped-up fashion under which the COVID-19 vaccine was developed has represented a “new paradigm” for the industry.
“We’re accelerating everything,” he said. “That’s been the biggest change. You’re always thinking how can we make things quicker, but with the same quality standards and everything that we’re used to in the pharmaceutical world.”
To meet demand for the vaccine, GRAM has added more employees.
Ross said his company has hired 125 people over the past six months, and that it plans to bring on another 75 people this year. He said those additional 75 workers are needed to “continue to support our growth.” They include entry-level science-based roles up to experienced management positions.
“It’s been incredible growth,” Ross said. “These are fantastic jobs. They’re highly technical, high-paying jobs, which is great for our community.”
At GRAM, the process of manufacturing the vaccine can take a matter of days.
The drug arrives at the company in a bulk form, Powell said. GRAM’s job is to take the bulk vaccine and transform it into a “final dosage form.”
The final dosage form is then injected, using high-tech machinery, into glass vials under sterile conditions in a “clean room.” Any workers in the clean room must be outfitted with gloves, gowns, goggles, masks and other personal protective equipment.
“Our line is a very highly automated line,” Powell said, describing GRAM’s production of the vaccine. “The goal in sterile filling is the more you can remove the people from the process — that’s better.”
He added, “The glass vials get washed, sterilized, filled and then put a stopper and cap in all under conditions that are removed from people.”
Powell said he and his colleagues feel like they’re playing an important part in the fight against COVID-19.
“It’s a great feeling,” he said. “We have made a difference.”
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