As the biopharma industry advances toward more targeted and complex therapies, the need for specialized CDMO partners has never been greater. Ardena is answering this demand with a precision-medicine-driven approach, supporting the development of innovative molecules through its fully integrated drug substance, drug product, nanomedicine, and bioanalytical services. With a strong foothold in oncology, rare diseases, and other high-value therapeutic areas, the company is expanding its global presence—including a recent U.S. site acquisition—to accelerate the path from discovery to clinic.

At the helm of Ardena is Jeremie Trochu, a seasoned life sciences executive with a track record of leading global CDMO growth and transformation. Since joining as CEO in June 2024, Jeremie has been steering Ardena through a period of strategic expansion, investment in cutting-edge technologies, and deeper integration of bioanalytical and manufacturing capabilities. With 20 years of experience in scaling life sciences businesses, he previously played a key role in transforming Catalent into a publicly traded global CDMO, driving multiple acquisitions and integrations.

In this exclusive Q&A, Jeremie shares his insights on the evolving CDMO landscape, Ardena’s role in advancing precision medicine, and how the company is investing in next-generation bioanalytical, nanoparticle drug delivery, and high-potency API capabilities to meet the needs of biopharma innovators.

Contract Pharma: Can you provide an overview of Ardena’s capabilities and how the company differentiates itself in the competitive CDMO landscape?

Jeremie Trochu: Ardena is a specialist CDMO focused on precision medicine and the development of innovative, complex molecules. We provide fully integrated drug substance, drug product, nanomedicine, and bioanalytical services, enabling biotech and pharma innovators to accelerate their path from discovery to clinic. With over 500 scientists, 30+ years of experience, and more than 600 active programs, we specialize in guiding companies through the challenges of drug development with a phase-appropriate, science-driven approach.

A key differentiator for Ardena is our CRO bioanalytical expertise, which supports every stage of drug development, from preclinical and early-phase analysis to late-stage clinical trials. Our team ensures comprehensive, high-quality bioanalytical data that enables confident clinical decision-making and accelerates development timelines.

In addition, our bioavailability enhancement platforms, including spray drying, hot melt extrusion (HME), and nanosuspensions, are designed to overcome the challenges of poorly water-soluble drugs. These technologies are essential for optimizing drug performance and ensuring successful formulation development. Coupled with our expertise in complex chemistry development, we can tackle even the most challenging API synthesis processes, providing tailored solutions for high-potency and controlled substances.

Finally, we are leaders in nanoparticle drug delivery systems, advancing next-generation precision therapies such as RNA-based treatments and complex biologics. Our nanomedicine capabilities span lipid nanoparticles (LNP), liposomes, polymer-based systems, and iron oxide matrix formulations, enabling a broad range of payload encapsulation strategies for innovative drugs.

CP: What industry trends are currently shaping the CDMO sector, and how is Ardena positioning itself to address these evolving needs?

Jeremie: The industry is seeing a surge in precision medicine, targeted therapies, and advanced drug delivery systems, particularly in oncology and rare diseases. This is driving demand for high-potency API development, innovative nanoparticle drug delivery, complex formulation development, and advanced bioanalytical testing across a wide range of modalities.

In addition, regulatory expectations continue to increase, particularly around data integrity and ATMP analytical requirements, while at the same time, biotech funding dynamics continue to evolve, requiring more flexible outsourcing models. 

Ardena is responding to these shifts by expanding our high-potency capabilities, enhancing our bioanalytical services, and integrating digital solutions to optimize workflows. We are also strengthening our presence in North America, reinforcing our ability to support clients on a global scale.

CP: As regulatory expectations grow more stringent, how does Ardena ensure compliance while maintaining speed and efficiency in drug development?

Jeremie: Regulatory compliance is embedded in our approach to drug development. With a dossier-centric mindset, we ensure that CMC regulatory considerations are integrated from the earliest stages of development. Our team brings over 30 years of experience in CMC regulatory support, helping clients navigate the complexities of global requirements while maintaining efficiency. We have successfully supported hundreds of IND, CTA, and BLA/NDA submissions across a wide range of modalities over the years, ensuring that every program is aligned with evolving regulatory expectations.

We also leverage a global LIMS (Laboratory Information Management System) platform across our entire network to ensure data integrity, traceability, and real-time quality oversight, allowing us to maintain compliance without compromising speed. This, combined with our phase-appropriate development approach, ensures regulatory readiness at every milestone.

CP: What roles do digitalization, automation, and AI play in enhancing Ardena’s services, and how do you see these technologies transforming the CDMO industry?

Jeremie: Ardena is leveraging automation and digitalization to improve efficiency and data integrity. Our global LIMS platform streamlines sample management and ensures seamless data tracking across sites. In bioanalysis, we have implemented automation instruments to enhance throughput and accuracy in assays, reducing variability and turnaround times.

We see numerous opportunities for AI to support areas like regulatory documentation, quality management, formulation optimization, and analytical testing, but its true impact will be realized over time as the technology matures. Our immediate focus is on leveraging proven automation and digital solutions that directly enhance quality and productivity today.

CP: Ardena has built a reputation for its integrated drug development services. How does this approach benefit clients compared to a more fragmented outsourcing strategy?

Jeremie: Drug development is an inherently complex and multidisciplinary process. When companies rely on multiple service providers, they often face challenges in communication, data transfer, and project continuity. Ardena’s integrated approach eliminates these inefficiencies by offering end-to-end expertise under one roof. This seamless coordination minimizes risks, accelerates timelines, and ensures that scientific, regulatory, manufacturing and clinical considerations are aligned throughout the development journey. 

This approach is particularly valuable for emerging biotechs developing precision medicine therapies, such as targeted oncology treatments or rare disease indications, where bioavailability, efficacy, stability, and regulatory considerations must be closely aligned across multiple disciplines. By integrating CMC development, regulatory support, and bioanalysis, we help clients move faster and with greater confidence.

CP: What are some of the biggest challenges biotech and pharma companies face when outsourcing drug development, and how does Ardena help them navigate these complexities?

Jeremie: One of the biggest challenges in outsourcing is maintaining control over a project while ensuring technical excellence and regulatory compliance. Many companies struggle with fragmented workflows, unexpected delays, or gaps in expertise. At Ardena, we address these challenges by acting as an extension of our clients’ teams, providing deep scientific and regulatory expertise while maintaining open and transparent communication. Our phase-appropriate development strategy ensures that clients get the right level of quality and oversight at every stage, preventing overengineering in early phases while ensuring regulatory readiness as they move toward commercialization.

CP: With increasing demand for specialized capabilities in areas such as complex formulations, biologics, and high-potency APIs, how is Ardena evolving its service offerings?

Jeremie: Ardena is continuously investing in specialized capabilities to meet the evolving needs of the industry. A key differentiator is our 12+ years of GMP manufacturing experience in nanoparticles, an area where few CDMOs can match our depth and breadth of expertise. We’ve supported the successful development and production of dozens of lipid-based formulations, polymeric nanoparticles, and other advanced nanomedicine drug delivery systems over the years.  And we now have a brand new, state-of-the-art, fully qualified and operational cGMP facility in the Netherlands, solely dedicated to support new nanomedicine development programs from pre-clinical all the way through to commercial supply.

Additionally, by integrating our nanomedicine expertise with in-house aseptic fill & finish capabilities, we deliver enhanced value and minimize risks for our customers’ advanced programs. Our fill & finish capabilities extend to biologics and complex formulations, addressing growing industry demand for high-quality sterile manufacturing solutions. Our bioanalytical division is also expanding, with new GLP laboratories in Europe and the US including enhanced capabilities for large molecules, biomarkers, and cell-based assays. These strategic expansions ensure that we remain at the forefront of drug development innovation.

CP: Ardena recently acquired Catalent’s Somerset, NJ facility. What strategic advantages does this acquisition bring, and how does it enhance Ardena’s service offerings?

Jeremie: The acquisition of the Somerset facility is a key step in Ardena’s global expansion, significantly enhancing our drug product manufacturing capabilities, particularly for oral solid dose formulations. The site is a center of excellence for hot melt extrusion (HME), a critical technology for improving the bioavailability of poorly soluble drugs. It is also highly specialized in modified-release formulations and controlled substances, making it an important asset for clients developing complex oral drug products. The facility holds a clean record of approvals from the FDA, PMDA, MHRA, EMA, ANVISA and other global regulatory bodies, providing reliable manufacturing support for clients targeting multiple markets.

The Somerset site brings a very experienced and highly qualified team of 200+ professionals in science and operations, ensuring deep expertise and operational excellence from day one. This acquisition also strengthens Ardena’s presence in North America, enabling us to provide local support to U.S. clients while maintaining the same high-quality standards that define our services globally.

Additionally, our bioanalytical expansion in Somerset is well underway and will be operational this summer. This will allow us to provide local bioanalytical support for both small and large molecules, complementing our European capabilities and further solidifying Ardena’s position as a global partner in drug development.

CP: Looking ahead, what are Ardena’s key strategic priorities for growth and innovation in the coming years?

Jeremie: Our focus remains on expanding our capabilities, strengthening our global reach, and driving innovation in precision medicine drug development. We will continue investing in specialized services, particularly in complex formulations, high-potency API handling, and bioanalysis for emerging modalities. Strengthening our presence in North America through our Somerset site and future bioanalytical expansions is also a key priority. 

Ultimately, our goal remains to accelerate the development of groundbreaking treatments, helping our clients bring next-generation therapies to patients faster.