Ardena Highlights the Biopharma Industry’s Shift Toward Integrated Support

Ardena is a Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) that supports biopharma companies with complex molecule development. They provide integrated services ranging from solid-state chemistry and analytical development to clinical and preclinical logistics and regulatory support.

In April, the company opened a new GLP bioanalytical laboratory in Somerset, New Jersey. The 2,500+ sqft laboratory expands Ardena’s scientific capabilities in North America and provides biotech and pharma companies with close access to a bioanalytical facility and the option for in-country sample analysis for studies with U.S. sites. 

The lab includes controlled sample storage, LC-MS/MS systems, and immunochemistry platforms supporting quantitative analysis for preclinical and clinical studies. These capabilities enable Ardena to analyze small and large molecules across a wide range of therapeutic modalities and support global clinical trials. Combined with Ardena’s bioanalytical operations in Europe, the new U.S. capability enables coordinated support for precision medicine development in North America and Europe.

Contract Pharma recently met with Henny Zijlstra, Chief Commercial Officer of Ardena, at BIO 2026 in San Diego, where we discussed the integrated CDMO model, Ardena’s new laboratory in New Jersey, and where the industry is headed. See the full interview below.

Interview with Ardena’s Henny Zijlstra

Contract Pharma: Sponsors are increasingly looking for streamlined development models. What are the biggest pressures driving this demand right now?

Henny Zijlstra: The pressure driving this is the widening gap between scientific ambition and development reality.

Biotechs are advancing more targeted, more complex molecules than ever, with many targeting small rare-disease and oncology populations, built on modalities like ADCs, oligonucleotides, RNA and nanomedicines. They rarely behave straightforwardly. At the same time, funding is selective and timelines are tight, and most of our clients run lean teams that cannot absorb the cost of coordinating five vendors and managing the gaps between them.

So, the pressure is not simply to move faster. It is to avoid weak decisions made early, when a misjudged formulation or an incomplete analytical package quietly becomes a clinical-supply problem later.

A fragmented model creates exactly those gaps. Every handoff is a point where knowledge is lost and risks are hidden. Streamlined development is the way sponsors close those gaps, and, increasingly, they want regional options too, so supply-chain and geopolitical uncertainty does not put a single program at risk.

CP: When sponsors talk about wanting “integrated” support, what does that actually mean in practice?

Zijlstra: Integrated does not mean a longer service list. It means continuity of scientific thinking across the whole program.

In practice, it means one partner is accountable across drug substance, drug product, bioanalysis and CMC regulatory, working under shared quality and data systems, not as separate businesses passing files between them. The differentiator is offering integrated solutions from drug substance through drug product and all the accompanying bioanalysis during the preclinical and clinical phases.

The outcomes sponsors value most are reduced handoff risk, timeline compression, and data continuity. When formulation, manufacturing and bioanalytical data live in one connected system, assumptions get challenged early and decisions get made with confidence rather than reconstructed from someone else’s report. Vendor consolidation is the enabler of that — not the goal in itself.

CP: How does an integrated CDMO model practically reduce handoff risk across preclinical, clinical, analytical, and manufacturing stages?

Zijlstra: Every transfer between separate providers is a risk point. Methods are re-qualified. Data is reformatted. Knowledge walks out of the door with the people who held it. The timeline slips while everyone needs to re-align. None of this helps advance the program, it simply recovers ground.

An integrated model removes those seams. A single program-management layer applies the right standards at the right development phase, so work is sequenced rather than reset each time. Shared eQMS and LIMS infrastructure means data integrity and traceability are maintained as a program moves from preclinical into the clinic. And because bioanalysis sits alongside manufacturing, what the molecule is actually doing in vivo can feed back into formulation and process decisions while there is still time to act on it.

Somerset shows the principle physically: integrating advanced drug product manufacturing and bioanalytical services on a single campus shortens the distance between the people generating the data and the people who must act on it.

CP: Ardena recently opened a GLP bioanalytical laboratory in Somerset, New Jersey. What specific sponsor needs was this investment designed to address, and why was North America — particularly Somerset — a strategic priority?

Zijlstra: This investment was about closing distance — putting high-quality bioanalytical science physically closer to our North American clients’ programs.

The lab is operational and supporting studies today, with controlled sample storage, LC-MS/MS systems and immunochemistry platforms for quantitative analysis across both small and large molecules, preclinical through clinical.

North America was a priority for a straightforward reason: around a quarter of our clients are based in the U.S., and it remains the number-one market for innovation and new launches.

Somerset specifically, because we already operate an FDA-approved facility there for advanced drug product manufacturing, supporting clinical development and commercial supply. Adding bioanalysis to that campus means a client can be supported through the critical stages of development in one place — and as programs move toward registration and launch, the ability to offer U.S. local manufacturing is genuinely de-risking.

Proximity is not a convenience here. It is part of the development strategy.

CP: How does the Somerset site connect with Ardena’s European bioanalytical operations, and what does that mean for sponsors running global or multi-regional studies?

Zijlstra: Somerset complements our European teams; it does not duplicate them. It strengthens our capacity for complex modalities — antibody-drug conjugates and other conjugates, plus biomarker analysis — across both regions, alongside our Bioanalytical Center of Excellence in Assen and our laboratory in Oss.

The connective tissue is a fully integrated eQMS and LIMS infrastructure, so methods, standards, instruments and data are harmonized across sites, streamlining the set-up process for our sponsors. 

For a sponsor running a global or multi-regional study, that has practical consequences. Samples can be handled in-region, which reduces shipping, customs and stability risk. The data packages stay consistent and comparable wherever the work is done. And the network builds the redundancy clients increasingly ask for, so a single program is not exposed to disruption in one location.

The point is continuity: the same scientific judgement and the same data discipline, whether the work happens in Somerset, Assen or Oss.

CP: Ardena has discussed further expansion at Somerset, including additional platforms such as qPCR and flow cytometry. How do those investments reflect where sponsor demand is heading?

Zijlstra: These investments follow the science. We plan to expand Somerset with a larger bioanalytical laboratory to have more space, additional platforms including qPCR and flow cytometry, and additional scientific teams to meet growing demand for bioanalysis and biomarker services.

LC-MS/MS and immunochemistry cover a great deal, but not everything the current pipeline demands. For a science-driven biomarker and bioanalytical approach, we must cover the biological continuum, from DNA to protein, to cell and tissue. Expanding our platforms allows us to analyze a greater variety of compounds and the key pharmacodynamic biomarkers.

So the platforms are not an arbitrary shopping list. They are a direct response to what clients need. Bioanalysis is a fast-growing field precisely because it needs to keep pace with innovation, covering traditional  small molecules, large molecules and advanced therapy products alike.

Building this capability in North America signals where we see demand heading: toward biomarker-driven, modality-agnostic bioanalysis as a central part of how complex therapies are developed — not a downstream measurement at the end.

CP: Looking ahead, how do you expect demand for integrated bioanalytical and development services to evolve over the next few years?

Zijlstra: Integration will shift from a differentiator to an expectation. As therapies grow more targeted and more complex, sponsors — biotech especially — will want a partner who can carry a molecule from substance through product with the bioanalytical data woven in, rather than assembling and coordinating that themselves. Demand for genuinely integrated development and bioanalytical services will keep rising for that reason.

Geographic optionality will matter more, not less. Clients want a global supply chain with the right local and regional redundancy, so there is no single point of disruption.

The data layer will keep maturing too. Global LIMS, automation in bioanalysis to lift throughput and shorten turnaround, and AI applied to areas like regulatory documentation and analytical testing as the technology matures, not before.

But the real differentiator will not be the claim. Many will say they are integrated. Fewer will prove it through execution — consistent quality, connected data, and faster decisions because the science sits under one roof. That is the part we know.