Ardena’s US expansion positions the CDMO for growth amid geopolitical uncertainty

Timing is everything and for Ardena, a Belgium-headquartered contract development and manufacturing organization (CDMO), its acquisition in February 2025 of a Catalent drug product manufacturing facility in Somerset, New Jersey was part of a strategic expansion in the works before President Trump’s talk of pharmaceutical tariffs and push to onshore production to the U.S.

“About 25% of our clients were in the U.S. and it was clearly a strategic next step to add capacity and capabilities,” Ardena CEO Jeremie Trochu told Pharma Manufacturing. “That opportunity presented itself — and we’re talking months before the 2024 election. The U.S. market remains number one in terms of innovation and new launches.”

The purchase of Catalent’s 50,000-square-foot facility in Somerset — a Center of Excellence for advanced oral dosage forms — is aimed at better supporting biopharma innovators by boosting Ardena’s capabilities in late-stage and small-scale commercial manufacturing of oral drug products, while integrating its suite of drug development services.

More than 200 scientists and technicians at the site joined Ardena as part of the acquisition. The facility’s specialized capabilities include modified-release formulations and Hot Melt Extrusion for enhanced bioavailability, as well as the handling of controlled substances.

Trochu, who took the helm of Ardena in June 2024 and previously served as division head of bioanalytics for Catalent, said the acquisition of the Somerset oral solid manufacturing site was critical to “accompany” the CDMO’s clients all the way through to commercial launch.

“Most of the new therapies, the new indications are for smaller patient populations for rare, orphan diseases and in oncology for targeted and precise subsegments of the patient populations,” he said. “A lot of the batch size in the clinic remains the same all the way through to commercial, so you don’t need to have the very large-scale capacity to be able to support a lot of our clients — which are primarily biotech.”

When it comes to the potential threat of pharma-specific tariffs, Trochu said Ardena’s strategically located facilities across Europe and the U.S. give “optionality” to its clients.

“In some of the early-phase decisions, it’s less about tariffs but quickly as you get into registration and going for launch prep you want to know which market you’re going to be in,” he added. “Having the ability to offer U.S. local manufacturing is clearly de-risking for our clients.”

Drug manufacturing, bioanalytical services

The integration of advanced drug manufacturing and bioanalytical services in a single campus in North America is the main purpose of the Somerset site, according to Trochu.

“One of the differentiators we have as a company is to offer integrated solutions, from drug substance through drug product and all the accompanying bioanalysis during the clinical phases,” Trochu said.

Ardena has repurposed Catalent’s existing labs to create a bioanalytical lab at the Somerset facility, adding over 2,500 square feet of testing space. The new lab will offer immunochemistry, LC-MS/MS, flow cytometry, and qPCR services to support global clinical trials and complement the company’s bioanalytical capabilities in Europe.

In addition to its existing Bioanalytical Center of Excellence in Assen, The Netherlands, Ardena has invested in new bioanalytical laboratory in Oss, The Netherlands which initiated several client projects and completed its first sample testing earlier this year. The facility, which develops assays across various matrices, supports both small and large molecule programs and adds more than 3,000 square feet of lab space to Ardena’s European network — with the goal of seamless project execution across Europe and North America.

“This is a fast-growing market because bioanalysis supplies to small molecules, large molecules, and [Advanced Therapy Medicinal Products],” Trochu said, underscoring Ardena’s commitment to precision medicine development and the needs of its clients across molecules, modalities, and geographies.

Ardena has also invested in another fast-growing market — nanomedicine and the medical application of nanotechnology. The CDMO has expanded its advanced nanomedicines facility in Oss, which received Good Manufacturing Practice (GMP) approval from the Dutch Healthcare Authority last year, with labs for process development and analytical work as well as GMP-compliant cleanrooms.

“We owe it to our clients to have a long view and ensure we have a global supply chain with the right local and regional redundancies and specificity to make sure that there’s no disruption risk,” Trochu concluded. “Clearly, the last nine months have reinforced the rationale.”