Thermo Fisher Scientific Highlights Multiple Expansions: Sterile Drug-Product & Biologics Mfg
Thermo Fisher Scientific is advancing several expansions, including in biologic drug-substance and sterile drug-product manufacturing. Jennifer Cannon, President, Commercial Operations, Pharma Services, Thermo Fisher Scientific, provided an update at the DCAT Member Company Announcement Forum held on March 18th, 2024, at DCAT Week.
In 2024, Thermo Fisher is embarking on major expansions in steriles and biologics across multiple global sites. Its Ferentino, Italy, facility is undergoing an expansion of prefilled syringe capacity, including the addition of a new, high-speed filling line and doubling the current production area to 30,000 square feet. In Greenville, North Carolina, the company is adding three new prefilled syringe filling lines, including one small-volume line to support the development of new therapies and two large-volume commercial lines. Its Lengnau, Switzerland, site is also seeing growth with the addition of large-scale bioreactors and a 40,000-square-foot expansion to enhance capabilities to produce biologics at a larger scale.
Its Monza, Italy, site has received GMP approval for RNA-based products, which includes a 25,000-square-foot expansion dedicated to RNA-based therapy production. Its Cincinnati, Ohio, site is enhancing its oral solid dose (OSD) manufacturing capabilities with an addition of 30,000 square feet of production space and advanced OSD processing equipment. Finally, in Bend, Oregon, the company’s R&D lab is undergoing a major expansion by adding 15,000 square feet of laboratory space for drug development and testing.
As part of the company’s strategy to meet growing global demand, Thermo Fisher is launching and expanding facilities in the Netherlands, Argentina, and Switzerland. Its new site in the Netherlands is a facility spanning 50,000 square feet, dedicated to specialized temperature management, designed to support complex logistics of temperature-sensitive biologics and vaccines. In Argentina, Thermo Fisher is introducing a 20,000-square-foot clinical supply-chain management center to streamline and enhance clinical trial support in South America. And the company is adding a 15,000-square-foot facility to its Basel, Switzerland,site, focused on label-manufacturing capabilities. This new facility is equipped with advanced technologies for high-speed and high-precision label production tailored for pharmaceutical products.
In the second half of this year (2024), Thermo Fisher is expanding the efficiencies introduced by its 2021 acquisition of the contract research organization, PPD,by implementing integrated project planning connecting CRO and CDMO activities, centralized program management, a streamlined governance structure, alignment on key performance indicators, and proactive risk mitigation.
On the advanced technology front, the company is partnering with InspectifAI on a pilot of its artificial intelligence (AI)-driven automated visual inspection at the company’s Monza, Italy, sterile manufacturing site, and Thermo Fisher is planning to expand this offering to additional sites throughout its network in 2024.
Thermo FIsher also is opening a 4,000-square-foot Clinical Trials Innovation Lab its Center Valley, Pennsylvania, site. This facility is an innovation and co-creation/working lab space, showcasing the latest investments and capabilities. The lab will support the creation, testing, and validation of new services and products and will provide a location for internal teams to partner and innovate with customers.