Hollly springs, NC – a hallway until Holi springs in three football grounds, Fujifilm in North Carolina, adds four buildings to the new biological manufacturing plant of biotechnology.
The first two buildings are preparing to open this decline, which is basically the basis of biological drugs, for early customers of Fujifilm. Regionon And Johnson & JohnsonThe second two facilities are still under construction, with a plan to open in 2028.
Fujifilm’s time as president may not be better Donald Trump Threatens to impose tariffs on pharmaceuticals to encourage companies to make more medicines in the US but Trump was running well for the campus before offering high duties.
It has taken more than five years and more than $ 3 billion to convert the idea into reality. And it shows how difficult it would be for drug manufacturers to increase the rapid production in production in the US, even with a possible grace period that Trump has swam.
“This is a drug manufacturing facility, so everything needs to be safe to put in patients,” said Larson, CEO of Fujifilm Biotechnology. “Everything requires an extreme high technology level, very high hygiene. Everything needs to be documented, everything needs to be approved by the authorities later. So this process is just very tedious.”
As companies move forward to establish more American manufacturing, tariffs already thought for them could not be a major problem for them. Trump administration on Thursday Clarified Under its trade structure with the European Union, the pharmaceuticals coming from the block will be subject to only 15% tariffs, not a administration may generally apply to drugs.
The timeline of the Fujifilm to open the Holi springs site is in line with the average of the industry between three and five years, depending on the complexity to start a new plant, according to the managing director and partner of Boston Consulting Group Gabriella de Almeeda. It helps that the new feature is similar to a fujifilm operated in Denmark.
The company decided to start copying its plants, so that the process of designing and creating them could be accelerated. Peterson said that the more Fujifilm is done, the faster the new sites can open and customers can start production there, the said Peterson said. Even once first tenants go into this decline, they will need American food and drug administration, before they can use the products made here.
Biologics are particularly to make complex drugs because they rely on living cells, which to produce the same thing, said, every time, Rejoron’s CEO Lane Schlefer said.
“It is very expensive, very complex and takes a long time,” said Shleeper.
When all four buildings are open in 2028, the plant should have a capacity to produce a 50 million dose drug a year with 16 bioriars that can keep 20,000 liters each. Companies will not say which medicines will be made in the convenience, but it is designed to produce monoclonal antibodies.
It takes about two months to produce a batch of bulk drug substance. This process includes growing cells that are creating a desired protein, resulting in purifying the material, then preparing it to go to the next stage in the complex drug supply chain. Opening a valve at the wrong time and just going into a wrong molecule inside can mean that a whole batch is lost, Pieterson of Fujifilms said.
Why drug manufacturers increase American manufacturing
Holi Springs, Fujifilm Diootechnology at Northern Carolina.
Courtesy: Fujifilm diosynth biotechnology
One of the largest producers of biologic drugs in the world, Regenronon signed a $ 3 billion, 10 -year contract with a fuzifilm for space on the New Holi springs site, doubled his American manufacturing capacity. By the time Regenron wanted to increase production, Fujifilm started many years in the construction of the facility, so it was understood to secure the place there instead of building a scratch for the biotech company, Schlefer said.
Rejoronon refused to specify which drugs it would produce in Holi springs. According to the company regulator Burada, the US and Ireland make their medicines on a mixture of places including their own factories. Regeneron is also in the process of opening a new plant in New York, and it has acquired another property in the state that it can use for manufacturing.
It is one of the many bioframacutical companies that have recently announced a plan to increase American production of pharmaceuticals as Trump has pressurized them to make their drugs domestically.
Trump, especially before threatening tariffs on pharmaceuticals, was already increasing his US manufacturing capabilities, which he had widely exempted levy in dozens of countries in this spring. According to data from pharmaceutical research and US manufacturers of the industry’s main lobbying group, the number of American bioframasutical manufacturing facilities in the country has increased by more than 50% since 2018.
Johnson & Johnson’s Chief Financial Officer Joe Walk said the change in US tax policy made the United States a more attractive place to produce drugs. The company signed a $ 2 billion, a 10 -year deal to secure the location on the Holi Spring site of the Phujifilm as part of a $ 55 billion commitment to invest in the US in the coming years. Those tricks will allow J&J to supply all their advanced drugs from the US, while Vok said, while dropping the name which drugs will be made in the facility of fujifilm.
“This really comes down to a good tax policy,” said Volk. “If you think about the tax policy that is now at 21% in the United States [corporate] The tax rate, which puts us correctly in the middle of the pack, allows J&J to tap into the infrastructure emerging in the US since the 2017 tax deduction and jobs Act.
Northern Carolina has benefited from bounce. According to the Northern Carolina Biotechnology Center, Life Sciences Companies have announced an investment of about $ 28 billion in the state since 2016, a record of $ 10.8 billion last year.
Under the road with the new facility of the Fujifilm in Holi Springs, Magen is constructing a $ 1 billion drug substance manufacturing plant after another opened in January. Genentech will break the ground at the end of this month at a phil-finish feature of $ 700 million, where the injectable drugs are packed in containers such as vials.
“This is talent,” Laura Rowle, Vice President of Life Sciences Economic Development at the Northern Carolina Biotechnology Center, said what companies are running for the state. “This is happening here among their colleagues, where the companies still have the opportunity to shine, because we have a feeling of working together.”
playing catch up
File photo: A visual stockton-on-tes, reflects the features of Fujifilm Diootechnology on January 29, 2021 in Britain.
Lee Smith | Roots
BCG’s Almeda said that bioforma companies are going to America to create innovative products with high margins, which can withstand high costs. But it will take time to catch.
Only 18% finished generic and branded According to the analysis of 2024 Food and Drug Administration Pharmaceutical Import data by US Pharmacopia, according to an organization that is to improve the supply chain of the drug, according to, the origin of drugs in the US, except Pureto Rico in the US, is the origin of drugs. The native country refers to the country where the final major manufacturing steps occurred, usually where the active drug component was produced.
For branded injectable drugs – such as Holi springs of Fujifilm will be made in the feature – Europe is a major source, which has about half.
Greg Graves, a senior partner of McKinse’s Life Sciences Practice, said that with a contractor like Fujifilm, manufacturing capacity in the US is a ticketed companies with a contractor that can do to reduce their potential tariff exposure in a short -term. Signing with an external site can be faster and less expensive than the construction of a new plant.
It may take two to three years to transfer manufacturing to an existing location, BCG’s Almeda said. A technical transfer is called the process of production of a drug in a new place The plan is required to prove the new process, the test is the same, then demanding approval from the regulators.
Regardless, every company is trying to find out how to prepare for the tariff, Almeda said. Parag Patel, senior partner of Graves and fellow McKinse, is looking at the same among his customers. However, he said, no one is preparing a high rate as 250%, earlier this month, Trump raised a possibility.
Patel said, “I have not come to any organization that is growing up in his plan because I all understand that if this happens, it will originally change the way we organized and run, and therefore we have to have a separate conversation,” said Patel.
On the Holi Springs site of the Fujifilm, the entire point is to give the customers flexibility, Peterson said. There is space to double the entire site, a decision that will warrant the company’s demand. Should Fujifilm decide to move forward, Peterson feels that it can build this time in only three years, as the company is growing rapidly with each feature, which makes it.
“There is no question that when you have this discussion such as tariff or covid or any other disruption in the supply chain, it makes the need for flexibility,” Peterson said. “This feature was created before some of these discussions, but it is certainly designed to handle the capacity of the supply chain, which should demand to go up or down.”
