International Biopharmaceutical Industry journal speaks with Ardena’s CEO Jeremie Trochu on the company’s U.S. expansion, capabilities in late-stage development and nanomedicine, and its role in supporting next-generation therapies across global markets.
Ardena is a fully integrated Contract Development and Manufacturing Organisation (CDMO) that provides end-to-end solutions to biotech innovators, supporting the development of complex and precision-medicine therapies from early stages through to small-scale commercial manufacturing. The company’s unique strength lies in its ability to integrate comprehensive development expertise across drug substance, drug product, and bioanalytical capabilities, coupled with strong CMC and regulatory services.
This integrated approach ensures that molecules are developed with a full understanding of their chemistry and manufacturing requirements, enabling faster and more reliable progression from preclinical stages into the clinic and ultimately to commercial launch. Over recent years, Ardena has expanded both organically and through strategic acquisitions to build a global network that supports clients in moving new therapies forward with greater precision and coordination, supporting more efficient development pathways that bring innovation to patients sooner.
What motivated Ardena to expand into the United States through the acquisition of a drug product manufacturing facility in Somerset, New Jersey?
Expanding into the United States was a very deliberate and strategic move for Ardena. It is essential to be able to support U.S. clients with a local presence and capacity, just as it is important to support European clients that want to launch in the U.S. market. That dual-region approach has always been part of the company’s long-term roadmap.
The opportunity to acquire the Somerset facility came at the right time. Ardena had been planning to strengthen its U.S. base, and when this asset became available last year, the timing proved ideal, particularly in light of the broader macro environment. The acquisition was transformational for the organisation, adding more than 200 new talented colleagues and extending both its development and commercial manufacturing capabilities.
The site already held approvals from the FDA and multiple other regulators, including the MHRA, EMA, and agencies in Japan, China, Australia and Brazil. That strong regulatory history gives clients significant flexibility to launch products from the U.S. while also serving global markets from the same site.
Another important aspect of the acquisition is its large footprint, which provides scope for future expansion. Ardena has invested in new bioanalytical GLP capabilities in the U.S., complementing its two existing European GLP laboratories in the Netherlands. This allows the company to support global clinical trials on both sides of the Atlantic, with European patient samples handled in Europe, U.S. samples processed at the Somerset facility, and ultimately parallel capacity being developed in Asia.
Finally, as Ardena recently opened its state-of-the-art, dedicated nanomedicine GMP facility in the Netherlands, Somerset also offers the GMP footprint to build redundant nanomedicine capacity in the U.S. The site is therefore not only strategic for oral solid dose manufacturing but also key to strengthening two of the company’s other core capabilities currently based in Europe.
How does this acquisition enhance Ardena’s capabilities in late-stage development and small-scale commercial manufacturing of oral drug products?
A key focus for Ardena has been supporting biotech companies that are developing therapies for unmet patient needs, particularly for orphan, rare or ultra-rare diseases. Many oncology programmes, for example, target very small patient populations, and often only a subset of those patients respond to existing treatments. This creates a need for more precise, tailored formulations and drug delivery solutions.
Having a facility like Somerset, capable of taking products from early clinical phases through to commercial launch, is therefore highly valuable. For these small patient populations, the batch sizes used in clinical trials often mirror those required for commercial production. This means clients can progress through trials and into the market without additional technology transfers, avoiding delays and reducing risk.
The site also provides fully integrated capabilities across formulation development, process development, and CMC analytical testing. Combined with Somerset’s extensive regulatory track record and experience launching products in multiple global markets, this makes it an attractive option for biotech companies seeking a reliable CDMO partner.
Ardena also operates facilities in the Netherlands, Sweden, Spain and Belgium. Could you outline the capacities and areas of expertise across these European sites?
Ardena’s European network provides an integrated and flexible framework to support clients from early development through to commercial production.
Belgium – Early-Stage Drug Product Development and CMC Regulatory Support
The operations in Ghent include formulation development teams working from pre-clinical through to Phase II, providing fit-for-purpose dosage forms and process development, including non-sterile as well as aseptic fill & finish capabilities. In addition, a dedicated team of 30+ professionals provides CMC regulatory support, including IME and MLA filing strategies and preparation of Module 3 documentation throughout the development cycle.
Spain – Late-Stage and Commercial Drug Product Manufacturing
The Pamplona site focuses on oral solid dosage forms and bioavailability enhancement technologies such as spray drying. It supports late-phase and commercial programmes, including high-potency formulations up to OEB5, which are increasingly important for oncology products.
Netherlands –Drug Substance Development, Nanomedicines and Bioanalysis
The operations in Oss focus on complex drug substance development, including advanced chemistry and linker technology for antibody drug conjugates. The site also hosts a solid state chemistry lab for crystallisation, polymorph screening and salt selection. The recently opened GMP nanomedicine facility, also in Oss, fully dedicated and purpose-built, already supports more than 30 clinical programmes, several of which are now in Phase III. The site in Assen serves as Ardena’s bioanalytical centre of excellence, offering immunoassay, LC-MS/MS, flow cytometry and qPCR, with a strong focus on biomarker analysis.
Sweden – Drug Substance Scale-Up and Commercial Manufacturing
The Södertälje site specialises in scaling up API synthesis from early phase development to late-stage and commercial manufacturing. It supports several marketed products and provides a strong platform for complex chemistry and commercial production, with world-class expertise in chromatographic purification and falling film distillation.
Together, these European sites form an integrated network that enables clients to progress smoothly from early development to clinic, and ultimately to market, with scientific, technical and regulatory continuity.
How are Ardena’s bioanalytical investments, particularly in qPCR, flow cytometry, biomarker analysis and automation, supporting global clinical trials?
The regulatory landscape for drug development is increasingly demanding, with a growing requirement for comprehensive testing data. To meet these expectations, clients need access to a broad panel of assays and a wide range of analytical techniques. Ardena’s bioanalytical capabilities ensure that biotech companies do not have to rely on multiple service providers, as our integrated platform provides the full suite of techniques and instruments required to support complex analyses.
Global capacity is equally important. While clinical trials often start locally, whether in Europe, the U.S. or Asia, they quickly expand to global studies to support future regulatory filings. Ardena offers harmonised capabilities across multiple regions, with consistent techniques, instruments and workflows. Integrated systems such as LIMS and eQMS ensure that samples analysed in different locations are reported and packaged consistently, giving clients confidence in the integrity and comparability of their data.
Investments in automation and AI further enhance our offering. Instrument automation and the digitisation of laboratory systems increase throughput, reduce variability and allow our teams to manage high volumes of samples efficiently. Combined with our global footprint, this ensures that clients can conduct multi-regional clinical trials smoothly while maintaining high-quality, reproducible results.
With continued growth in ADCs and nanomedicines, how can CDMOs like Ardena help advance next-generation therapies?
The field of antibody-drug conjugates and nanomedicines is one of the most exciting areas in drug development, and it generates a great deal of energy and purpose at Ardena. Working on these innovative therapies allows us to collaborate with passionate clients and purpose-driven individuals who are driving the next generation of precision medicines.
The core of the innovation lies in conjugation. ADCs and nanomedicines aim to deliver a therapeutic payload precisely to the target area within the patient, achieving accurate dosing and controlled release. In ADCs, the monoclonal antibody serves as a carrier while the linker attaches the payload to deliver it directly to the tumour or target site. In nanomedicines, the carrier can be lipid-based, polymer-based or metallic-based. The therapeutic payload may be embedded within the matrix and/or conjugated to the surface, depending on the intended mechanism of action.
Clients seek partners with deep nanomedicine expertise and a proven track-record across the full breadth of payload-carrier combinations. Ardena has more than twelve years of experience in this space, successfully supporting molecules from initial discovery through clinical development. Our track record spans lipid, polymer, and metallic-based matrices, allowing us to guide clients through complex formulations and delivery strategies while maintaining regulatory and clinical confidence.
What is your focus for the next year?
Over the past year, a significant amount of energy has been dedicated to integrating our Somerset operation. The team has delivered well on time and budget, particularly around the IT integration. With the heavy lifting largely complete, we are now progressing new investments in new capabilities and additional capacity.
Many of our clinical programmes are advancing to Phase III, and some are about to launch. Our priority remains on strong operational execution. As I often say, good execution is a good strategy. Our clients rely on us to be a dependable partner throughout development and commercialisation.
Looking ahead, we are doubling down on areas of growth where we have already invested. Nanomedicine remains a key focus, as does bioanalysis. Another strategic area is sterile fill & finish. There has been an underserved market for small-volume aseptic fill & finish, and our Ghent facility is well positioned to address this demand. We can support fast formulation and small batch production with agility, both for our nanomedicine downstream needs and for standalone clients seeking reliable manufacturing to move products into clinical trials.
Overall, there is a lot to be excited about. We remain very confident in the space and energised by the unprecedented amount of scientific and technology innovation across the industry, and are grateful to have such a dedicated and passionate team driving Ardena’s growth across our global network.
Chief Executive Officer (CEO) Jeremie Trochu
Jeremie joined Ardena as Chief Executive Officer in June 2024. He brings an extensive knowledge of the life sciences and CDMO industry, and a proven track record of success in the biopharma sector, with 20 years of experience building and growing businesses globally, expanding into new markets, and leading large-scale transformations in both publicly traded and privately held companies. Jeremie was previously part of the team that helped transform Catalent from a private equity spinoff into a publicly traded global CDMO, and during his tenure there, led the successful acquisition and integration of multiple companies.
For more information – https://ardena.com
