Fujifilm Holly Springs pharma factory readies open with J&J, Regeneron

HOLLY SPRINGS, N.C. — A hallway as long as three football fields connects four buildings at Fujifilm Biotechnologies’ new biologics manufacturing plant in Holly Springs, North Carolina.

The first two buildings are preparing to open this fall to produce drug substance, essentially the base of biologic drugs, for Fujifilm’s initial customers Regeneron and Johnson & Johnson. The second two facilities are still under construction, with plans to open in 2028.

Fujifilm’s timing couldn’t be better, as President Donald Trump threatens to impose tariffs on pharmaceuticals to encourage companies to make more medicines in the U.S. But the plans for this complex were underway well before Trump proposed higher duties.

It’s taken five years and more than $3 billion to turn the idea into reality. And it shows how difficult it would be for drugmakers to quickly increase production in the U.S., even with a possible grace period that Trump has floated. 

“This is a pharmaceutical manufacturing facility, so everything needs to be safe to put into patients,” said Fujifilm Biotechnologies CEO Lars Petersen. “Everything requires an extreme high technology level, very high cleanability. Everything needs to be documented, everything needs to be approved later on by the authorities. So that process is just extremely tedious.”

As companies move to set up more U.S. manufacturing, tariffs may not end up being as big a problem for them as previously thought. The Trump administration on Thursday clarified that under its trade framework with the European Union, pharmaceuticals coming from the bloc would be subject to only a 15% tariff, not a higher one the administration may implement on medicines more generally.

Fujifilm’s timeline for opening the Holly Springs site is in line with the industry average of between three and five years to start up a new plant, depending on the complexity, according to Gabriela de Almeida, managing director and partner at Boston Consulting Group. It helps that the new facility is identical to the one Fujifilm operates in Denmark.

The company decided to start replicating its plants to speed up the process of designing and building them. The more Fujifilm does that, the faster it can open new sites and customers can start production there, Petersen said. Even once the first tenants move in this fall, they’ll need the U.S. Food and Drug Administration to sign off before they can use the products that are made here.

Biologics are particularly complex drugs to make because they rely on living cells to produce the exact same thing, every single time, said Regeneron CEO Len Schleifer.

“It’s very expensive, very complicated and takes a very long time,” Schleifer said. 

When all four buildings are open in 2028, the plant should have the capacity to produce 50 million doses of medicine a year with 16 bioreactors that can each hold 20,000 liters. The companies won’t say exactly which drugs will be made at the facility, but it is designed to produce monoclonal antibodies.

It takes almost two months to produce one batch of bulk drug substance. The process involves growing cells that are making a desired protein, purifying the resulting material then preparing it to go to the next step in the complex pharmaceutical supply chain. Opening a valve at the wrong time and letting just one wrong molecule inside could mean an entire batch is lost, Fujifilm’s Petersen said.