Bothell, Washington / Boulder & Longmont, Colorado

The company’s vision to be the go-to contract manufacturer for biopharmaceutical companies worldwide runs right through Colorado.

Japan-based AGC Inc. launched AGC Biologics in 2018 after acquiring a pair of therapeutics manufacturers to align with AGC’s existing contract development and manufacturing organization (CDMO). With facilities in the U.S., Europe, and Asia, AGC Biologics now has about 1,800 employees globally, about a third of them based in the U.S.

A growing number of those employees are based in Colorado: In 2020, AGC Biologics acquired the 180,000-square-foot former AstraZeneca plant in Boulder for about $70 million. The company has hired 150 employees to staff it, with a planned commencement of contract manufacturing in early 2022.

Mark Womack

Then, on July 1, 2021, AGC Biologics announced its pending acquisition of Novartis Gene Therapies’ commercial manufacturing facility in Longmont, Colorado. Located on a 229-acre campus 40 miles north of Denver, the 622,000-square-foot facility will specialize in gene therapy and have an initial staff of about 250 employees.

Chief Business Officer Mark Womack says both acquisitions are part of a broader strategy. “We’re looking to be one of the few CDMOs in our industry that is truly end-to-end,” he says. “We want to be end-to-end in terms of all the modalities customers might want — whether microbial, mammalian, plasmid, cell and gene therapy — the scales customers might want — from small production scale to the largest production scales — capacities — whether they need one batch or a few batches or need a tremendous amount of volume.”

In May 2021, AGC Biologics began the first test runs to get the Boulder facility ready for cGMP production. The facility’s two 20,000-liter bioreactors in Boulder “are among the largest mammalian scale in the world,” says Womack. “There’s just no scale or volume that our customers might need or evolve to that we can’t serve on the mammalian side, now that we have Boulder.”

Womack says AGC could invest in as many as four additional 20,000-liter bioreactors at the Boulder facility over two phases if the demand is there. Early signs indicate it will be, as AGC has already closed major deals with its first two customers as of early summer 2021. “Both of those are very high-volume programs,” says Womack.

Directly overseeing the Boulder facility, EVP of U.S. Operations J.D. Mowery says the plant’s infrastructure was upgraded for nine months before it resumed production with live cells for testing and qualifying in early May 2021.

J.D. Mowery

The head count will rise with future expansions. “As we get ready to bring bioreactors three and four online, we will have to increase the staff,” says Mowery. “It will happen again when we bring bioreactors five and six online. It’s not linear: You have to hire some additional support staff, some of the manufacturing teams will have to grow, some QA staff as well.”

Raw materials have been hard to come by with the needs of COVID-19 vaccine production worldwide. “From a raw-materials, supply-chain perspective, there were certain high-risk items we had to manage,” says Mowery. “We had to look for alternative supplies.”

That said, the pandemic has also generated contract manufacturing opportunities around the world. Notes Womack: “We have seven COVID programs globally.”

Look for AGC Biologics’ upward trajectory to continue. “It’s been tremendous growth over the last few years,” says Womack. “We’re going to grow even more in the next few years — we have a clear line of sight to that.”

Challenges: Getting the Boulder plant up and running. “Bringing a facility of that size online and making sure we appropriately train our staff,” says Mowery. “You’re operating at a scale where you have an opportunity to produce amounts of drug substance that treat thousands and thousands of patients. With that comes some additional risks to operating at that scale. We have to make sure we have the best of the best talent, best of the best infrastructure, best of the best systems, and we leverage all of those things for delivery at a very high success rate so we make sure our customers have the drug substance they need to treat the patients they serve around the world.”

“The battle for top talent, globally, is intense,” adds Womack. “Our industry is flourishing so much and it’s growing at such an amazing rate that the competition for top talent is amazing.”

Opportunities: Sustained growth in a dynamic market. “The opportunity is to be that CDMO that brings it all together,” says Womack.

Needs: Mowery identifies a need to partner with local universities to build a talent pipeline. “We’re also in close dialogue with the local government authorities about the additional capacity we want to bring online and the continued growth of the Boulder facility,” he says. “Partnership with the local governments, that’s a big need for that facility.”

Photos courtesy AGC Biologics