Thermo Fisher’s Greenville, North Carolina site takes on flagship status in North America
Thermo Fisher Scientific’s pharma services business is strategically expanding in 2025 to support growth in its capacity and capabilities to better serve its customers. The company is investing in locations across its network, including a sprawling 1.7-million-square-foot campus on 142 acres in Greenville, North Carolina.
Currently, Thermo Fisher has more than 8,000 employees across the state of North Carolina, with the Greenville site employing a staff of roughly 2,000 people. The company took over the site in 2017 when it purchased contract development and manufacturing organization Patheon for $7.2 billion.
Michelle Logan, vice president and general manager of the Drug Product Division North America at Thermo Fisher, describes Greenville today as a large multipurpose pharmaceutical manufacturing campus and the company’s “flagship site” for sterile fill-finish, driven in part by growing demand for biologics. The company is making investments in high-speed prefilled syringe lines and sterile fill-finish lines at the location.
“We do not have another pharmaceutical sterile fill-finish facility within North America,” Logan said. “Because of sister sites in Europe, one of the things we’re focused on is leveraging the same technology and platform across our broader pharma services business. What that means is our customers might start in Greenville and need something in the European market, or they might start in Europe and need presence in the U.S.”
While Greenville is Thermo Fisher’s only site focused on steriles, the company has also opened up sterile fill-finish capacity at its Plainville, Massachusetts site. Plainville is solely dedicated to viral vector manufacturing and recently added sterile lines at the site in response to customer demand.
At the Greenville site, the 160,000-square-foot Building 52 is the newest facility with the first sterile fill-finish line there going through its final qualifications, according to Logan. From a prefilled syringe and vial filling perspective, she noted that the company has been investing in new combination lines — Combi 1&2 in Building 52 — with not only high-speed commercial capabilities but also with more flexibility, such as providing both vial and prefilled syringe filling as well as smaller batch sizing.
In April, Thermo Fisher announced it is making a $2 billion commitment to U.S. manufacturing and R&D over the next four years. Of that amount, $1.5 billion is earmarked for capital expenditures to enhance and expand manufacturing.
“Part of the announcement for investment was around sterile fill-finish, and we have procured four additional lines which will be coming into the network,” Logan said. “It’s definitely a part of the most recent announcement.”
Rise of continuous manufacturing
Greenville is Thermo Fisher’s first site to feature a fully functional continuous manufacturing line. Continuous manufacturing relies on a fully integrated process that runs uninterrupted from beginning to end, providing an alternative to traditional batch manufacturing in which drug production is segmented into a series of slow-moving steps.
“We did announce the sunset of our [traditional batch] oral solid dose business,” said Logan, who is also Greenville’s interim general manager. “We will keep continuous manufacturing, which is a new technology, for oral solid dose here. As that continues to grow, we will expand in that space.”
Despite the potential efficiencies and the FDA encouraging manufacturers to make the switch from batch processing, the pharmaceutical industry has been slow to adopt continuous manufacturing. However, Logan contends that continuous manufacturing is gaining momentum. The Greenville site is taking the plunge when it comes to oral solid dose (OSD), given that Thermo Fisher is seeing “a lot of interest” in continuous manufacturing from customers, she said.
“With continuous manufacturing, we actually load the raw materials on to the start of the line and it’s real-time feeding, granulating in a vacuum system to the line — straight into either capsules or tableting,” Logan said. “We’re in the process of adding coating as an option with real-time [process analytical technology]. So, we’re doing all our measurements in-line instead of having to send them to the lab for testing.”
Continuous manufacturing involves material constantly being loaded, processed and unloaded without interruption through the various phases of the process. Logan called out the “robustness” of this manufacturing process, with increased efficiency when it comes to use of space, time, labor, and raw materials as well as improved product yield and quality.
“You have the real-time quality indicators, you’re not relying on a batch review 30 days afterward,” Logan said. “You have all the data there in real time that you can assess quality. The equipment actually makes adjustments for you in real time so if you start to trend out on a critical process parameter, it adjusts and fixes it.”
While Thermo Fisher has been using continuous manufacturing at Greenville on the clinical side, the first commercial product is slated for this year, according to Logan. Although the site is sunsetting its oral solid dose business, the company is serving OSD customers at additional sites throughout its global network.
