With continued innovation in the areas of precision medicine, high-potency drugs, such as cytotoxic cancer therapies, and cell and gene therapy, comes the need for fit-for-purpose development and manufacturing services. For example, high-potency drugs require specialized handling capabilities, formulation development expertise is needed to address bioavailability challenges, and bioanalytical services are key to supporting the development of cell and gene therapies, to name a few. Sponsors are not just looking for capacity from CDMOs, they are also seeking regulatory expertise along with scientific and technical expertise to help advance today’s complex therapies.
Ardena, a specialist pharmaceutical CDMO and bioanalytical Contract Research Organization with facilities in Belgium, Spain, the Netherlands, and Sweden, recently completed the acquisition of Catalent’s drug product manufacturing facility in Somerset, NJ. This acquisition marks a milestone in Ardena’s strategic expansion into North America, strengthening its capabilities in late-stage and small-scale commercial manufacturing of oral drug products. The Somerset facility encompasses over 50,000 sq. ft. of cGMP manufacturing space for advanced oral dosage forms, specializing in modified-release formulations, Hot Melt Extrusion for enhanced bioavailability, and the handling of controlled substances.
Additionally, Ardena is expanding its Bioanalytical Services in North America with plans to open a new bioanalytical lab at the Somerset facility. The initial investment will include a new 2,500+ sq.-ft. lab, providing advanced analytical testing services for both small and large molecules, mirroring the company’s European capabilities in immunochemistry, LC-MS/MS, flow cytometry, and qPCR platforms.
Jeremie Trochu, Chief Executive Officer of Ardena discusses the facility acquisition, plans for the Somerset site, and the trends driving outsourcing in the CDMO space.
Contract Pharma: What is the strategic importance of the acquisition of Catalent’s manufacturing facility and what does it mean for the industry?
Jeremie Trochu: This acquisition marks a significant milestone in Ardena’s growth strategy, strengthening our capabilities in advanced drug product development and manufacturing while expanding our footprint in North America. The Somerset facility enhances our ability to support complex oral solid formulations, an area of increasing demand, particularly among small and mid-sized biotechs seeking agile, integrated CDMO and CRO solutions.
In parallel, we are expanding our bioanalytical capabilities in North America, with plans to establish a GLP bioanalytical lab at the Somerset site later this year. This will complement our existing services and enable us to provide our clients with additional integrated development solutions, from formulation through to bioanalytical testing.
For the industry, this move reflects a broader trend of specialist CDMOs scaling globally to meet evolving client needs—offering not just capacity but deep scientific and technical expertise, regulatory excellence, and end-to-end CMC support. As outsourcing continues to increase, companies are looking for agile partners who can provide fit-for-purpose solutions across the entire development lifecycle.
Contract Pharma: Where do you see the most growth in outsourcing?
Jeremie Trochu: Outsourcing is increasingly driven by the need for specialized expertise across a number of rapidly growing areas:
Nanomedicine and targeted delivery: The convergence of nanotechnology with novel drug delivery systems is unlocking new opportunities for precision medicine. As biologics and complex small molecules require more targeted delivery methods for targeted patient populations, CDMOs with advanced capabilities in nanomedicine will see heightened demand for their services.
Advanced formulation technologies: Drugs that face bioavailability challenges—particularly in complex small molecules—are pushing the demand for specialized formulation technologies. Techniques such as spray drying, hot melt extrusion, and lipid-based delivery systems are more crucial than ever in helping biopharma innovator overcome these barriers.
Bioanalytical support for novel modalities: With the rise of cell & gene therapies, nucleic acid-based drugs, bioconjugates and complex biologics, GLP bioanalytical services are in high demand. The need for advanced pharmacokinetics (PK), immunogenicity, and biomarker analysis is expanding rapidly, driving rapid growth in this segment.
Integrated development services: Biotechs, particularly those in early development stages, are looking for partners that can seamlessly integrate services, from early-phase formulation to clinical GMP manufacturing, through to bioanalytical testing. The demand for integrated service offerings, which reduce complexity and accelerate timelines, is a key growth driver.
Geographic expansion and regulatory expertise: With an increasingly complex global regulatory environment, biopharma companies are seeking CDMOs with strong local CMC expertise in both North America and Europe. The ability to navigate regional regulatory landscapes and ensure compliance is crucial for small and mid-sized biotechs.
Contract Pharma: What are the pharma/biopharma R&D trends impacting CDMOs and services?
Jeremie Trochu: A few key trends are driving change in the biopharma sectors, placing increasing demand on CDMOs to provide specialized, high-value, fit-for-purpose services:
Precision medicine: The push toward personalized therapies is expanding the demand for flexible manufacturing solutions. CDMOs must be able to produce small, bespoke batches efficiently, often requiring advanced, adaptable systems that can cater to niche and individualized treatments.
Evolving drug delivery technologies: The field of drug delivery is rapidly shifting toward more sophisticated systems, including nanoparticle-based formulations and lipid-based carriers. This shift is especially important for improving the solubility, stability, and delivery precision of complex molecules, requiring CDMOs to develop or refine expertise in these emerging technologies.
Regulatory complexity: As drug development becomes more complex, regulatory requirements are growing more stringent. CDMOs that can offer both technical expertise and deep knowledge of regulatory pathways will be critical in helping clients navigate the challenges of market approval.
Digitalization and process controls: The adoption of digital technologies, including automation, predictive modeling, and advanced analytics, is helping improve manufacturing processes. These tools are being deployed with a clear focus on improving quality, ensuring compliance, and enhancing operational efficiency.
As the landscape continues to evolve, CDMOs with expertise in complex formulations, precision delivery, and regulatory compliance, will play an essential role in helping the industry meet the demands of new drug modalities and new regulatory requirements.
Contract Pharma: What factors do you anticipate will drive growth in the CDMO sector?
Jeremie Trochu: Several driving forces will influence the future of the CDMO sector:
Continued innovation: With increasing investments and scientific progress in the life sciences sector, across both existing and new modalities, the demand for flexible, fit-for-purpose, cost-efficient manufacturing solutions is expected to grow exponentially. As biopharma innovators face new challenges of translating promising molecules into viable therapies, the demand for specialized CDMOs will rise.
Regulatory complexity and expertise: As the regulatory landscape becomes more intricate, biopharma companies will rely more heavily on CDMOs that possess not only technical and scientific expertise but also deep regulatory and CMC knowledge to ensure compliance and successful approval pathways.
Focus on high-potency drugs: The growing focus on high-potency molecules requires CDMOs with specialized capabilities in handling potent compounds, as well as expertise in bioavailability enhancement and tailored manufacturing processes. This will also accelerate the adoption of new, targeted drug delivery platforms such as nanomedicine.
Need for integrated solutions: Companies are increasingly looking for partners who can offer integrated, fit-for-purpose services, from formulation development to GMP manufacturing and bioanalytical testing. CDMOs that can provide such solutions will benefit from further outsourcing growth.
By offering more than just manufacturing capacity, CDMOs that combine expertise in specialized drug formulations, regulatory affairs, and seamless service integration will see the greatest growth opportunities.
Jeremie Trochu is the Chief Executive Officer of Ardena, with over 20 years of experience in the life sciences and CDMO sectors. He has a proven track record of growing businesses globally, expanding into new markets, and managing large-scale transformations in both publicly traded and privately held companies. Jeremie’s expertise spans the global biopharma landscape, where he has successfully built and scaled operations across North America, Europe and Asia. Before joining Ardena, Jeremie was part of the leadership team at Catalent, where he played a key role in transforming the company from a private equity spinoff into a publicly traded global CDMO, and led the successful acquisition and integration of several businesses over his tenure there.