Fujifilm Holly Springs Pharma Factory is preparing for J & J, Regeneron

Holly Springs, NC – A corridor as long as three football fields connects four buildings to the new biological manufacturing plant in Fujifilm Biotechnologies in Holly Springs, in North Carolina.

The first two buildings are preparing to open this fall to produce a drug substance, essentially the basis of organic drugs, for the initial customers of Fujifilm Regeneron And Johnson & Johnson. The two seconds of installations are still under construction, with plans to open in 2028.

Fujifilm’s timing could not be better because President Donald Trump threatens to impose prices on pharmaceutical products to encourage companies to do more medicines in the United States, but this complex plans were underway before Trump offers higher functions.

It took five years and more than $ 3 billion to transform the idea into reality. And that shows how difficult it would be for drug manufacturers to quickly increase production in the United States, even with a possible period of grace that Trump has floated.

“This is a pharmaceutical manufacturing center, so everything must be sure to put to patients,” said Lars Petersen, CEO of Fujifilm Biotechnologies. “Everything requires an extreme level of high technology, very high cleanability. Everything must be documented, everything must be approved later by the authorities. So this process is simply tedious.”

While companies move to set up more American manufacturing, prices may not end up being as important for them as it thought before. On Thursday, the Trump administration said that in its commercial framework with the European Union, pharmaceutical products from the block would only be subject to a rate of 15%, and not to higher administration that the administration could implement drugs more generally.

The Fujifilm calendar for the opening of the Holly Springs site complies with the average of industry between three and five years to start a new factory, according to complexity, according to Gabriela de Almeida, managing director and partner at Boston Consulting Group. It is useful that the new installation is identical to that which Fujifilm operates in Denmark.

The company has decided to start reproducing its factories to speed up the process of designing and building them. The more Fujifilm is, the more it can open new sites and customers can start production there, said Petersen. Even once the first tenants are moving this fall, they will need the United States Food and Drug Administration before they can use the products manufactured here.

Biologicals are particularly complex drugs to manufacture because they count on living cells to produce exactly the same thing, each time, said the CEO of Regeneron, Len Schleifer.

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

When the four buildings are opened in 2028, the factory should have the capacity to produce 50 million doses of medicine per year with 16 bioreactors which can each contain 20,000 liters. Companies will not say exactly which drugs will be manufactured in the establishment, but it is designed to produce monoclonal antibodies.

It takes almost two months to produce a batch of drug drugs in bulk. The process involves growing cells that make a desired protein, purifying the resulting material and then preparing it to take the next step in the complex pharmaceutical supply chain. The opening of a valve at the wrong time and leaving a single bad molecule inside could mean that a whole lot is lost, said Petersen from Fujifilm.

Regeneron, one of the largest producers of organic drugs in the world, has signed a $ 3 billion contract over 10 years with Fujifilm for the space on the New Holly Springs site, doubling its American manufacturing capacity. At a time when Regeneron sought to increase production, Fujifilm was one step ahead of several years in the construction of the installation, it was therefore logical for the biotechnology company to ensure a space instead of building from zero, said Schleifer.

Regeneron refused to specify which drugs he will produce in Holly Springs. The company manufactures its drugs in a mixture of locations, including its own factories in the United States and Ireland, according to regulatory documents. Regeneron is also opening a new factory in New York, and he has acquired another property in this state that it could use for manufacturing.

It is one of the many biopharmaceutical companies that have recently announced plans to increase the American production of pharmaceutical products while Trump puts them pressure to do more of their drugs at the national level.

Medication manufacturers have already accelerated their American manufacturing capacities before Trump begins to threaten prices specifically on pharmaceutical products, that he exempt from sweeping samples from dozens of countries this spring. The number of American biopharmaceutical manufacturing facilities in the country has increased by more than 50% since 2018, according to pharmaceutical research and America manufacturers, the main lobbying group in the industry.

Johnson & Johnson’s financial director Joe Wolk said that changes in the US tax policy has made the United States a more attractive place to produce drugs. The company has signed an agreement of $ 2 billion over 10 years to secure space on the Holly Springs of Fujifilm website as part of its $ 55 billion commitment to invest in the United States in the coming years. These movements will allow J & J to provide all its advanced drugs from the United States, said Wolk, while refusing to name the drugs made in the installation of Fujifilm.

“It really comes back to a good tax policy,” said Wolk. “If you are thinking of the tax policy which is now in place in the United States at 21% [corporate] The tax rate, this places us in the middle of the pack, “allowing J & J to draw on the infrastructure that has emerged in the United States since the tax on tax reductions and 2017 jobs, he said.

North Carolina benefited from the boom. Life Sciences companies have announced about $ 28 billion in state investments since 2016, with a record of $ 10.8 billion promised last year, according to North Carolina Biotechnology Center.

At the bottom of the rue de la Nouvelle installation de Fujifilm in Holly Springs, Amgen built a factory for manufacturing substances of $ 1 billion, after another, she opened there in January. Genentech will later inaugurate this month on a filling finish installation of $ 700 million, where injectable drugs are packed in containers like bottles.

“This is talent,” said Laura Rowley, vice-president of economic development of life sciences in North Carolina Biotechnology Center, of what motivates companies in the state. “It is here among their peers, where there is still an opportunity for companies to shine, because we have this spirit of work together.”

Biopharmatic companies move to the United States to make innovative products with high margins that can resist the higher cost, said Almeida de BCG. But the catch -up will take time.

Only 18% of credits and finished brand Medicines come from the United States, excluding Puerto Rico, according to an analysis of 2024 data on the pharmaceutical import of Food and Drug Administration by American Pharmacopoeia, an organization which aims to improve the supply chain of medicines. The country of origin refers to the country where the last stage of major manufacture occurred, generally where the active pharmaceutical ingredient was produced.

For brand injectable drugs – like those that will be made in the installation of Holly Springs in Fujifilm – Europe is the dominant source, with almost half there.

Securing manufacturing capacity in the United States with an entrepreneur like Fujifilm is a change that companies can make to reduce their exposure to short-term potential prices, said Greg Graves, a main partner in McKinsey’s life science practice. The signature with an external site could be faster and cheaper than the construction of a new factory.

The simple fact of moving manufacturing to an existing space can take two to three years, said Almeida de BCG. Called a technological transfer, the drug production process in a new location Requires planning, tests to prove that the new process works in the same way, and then looking for regulator approval.

Anyway, each company tries to understand how to prepare for prices, said Almeida. Parag Patel, McKinsey’s main partner, Parag Patel, among their customers. However, they said, no one is preparing for a rate of up to 250%, a possibility that Trump raised earlier this month.

“I have not met any organization that goes so great in their planning because I think they all understand that if it happens, it would fundamentally change the way we are organized and run, and therefore we must have a different conversation,” said Patel.

On the Fujifilm Holly Springs site, the goal is to give customers flexibility, Petersen said. There is room to double the entire site, a decision that the company will take if the request justifies it. If Fujifilm decides to move forward, Petersen thinks he can build it in just three years this time, because the company accelerates more quickly with each installation clone it creates.

“There is no doubt that when you have these discussions as prices or as simultaneous or like any other disturbance of the supply chain, this creates a need for flexibility,” said Petersen. “This installation was built before some of these discussions, but it is definitively built to manage the capacity of the supply chain should require an increase or a decrease.”