In this guest editorial, Axplora’s Chief Commercial Officer, Arul Ramadurai, explains how its Axotecan project aims to create an independent European source of exatecan for ADC developers, and what it reveals about CDMO partnerships.
The value a CDMO brings to its customers is determined not by the capacity it has available, but by how effectively it applies its capabilities to their needs. Every molecule follows a different path, shaped by its own scientific challenges, development milestones, commercial pressures and supply risks. Progress depends on understanding that context and bringing together the right expertise, technology and investment at the right time.
At Axplora, our ambition is to be āthe CDMO that knows its customer the best.ā Speed matters in every program, but never in isolation. It must be balanced with reliability, efficiency, and the programās specific technical and commercial requirements. That balance changes according to development stage, scale, cost, supply security and evolving demand. Understanding where it lies allows us to align our expertise, investment and manufacturing decisions with what each customer needs to progress.
Axotecanāour project to establish an independent European source of exatecan for antibody-drug conjugate (ADC) developersāshows how this works in practice. Customer conversations revealed a consistent set of needs: earlier visibility of material availability, confidence that quality would remain consistent as volumes increased, greater sourcing diversity, shorter and more predictable lead times, and a clearer route into downstream payload-linker and bioconjugation activities. Axotecan turns that understanding into a defined development and manufacturing pathway.
Anticipating Ever-Increasing Exatecan Demand
Exatecan is a highly potent topoisomerase I inhibitor and an important starting point for a growing class of ADC payloads. As more exatecan-based candidates progress, access to material at the right quality, scale, and time is unlikely to remain a niche sourcing question. Customers will need suppliers capable of moving from early quantities to validated and ultimately commercial supply without repeatedly rebuilding the technical and quality package.
Limited sourcing options, lengthy qualification, and multiple handoffs can introduce risk just as a promising program needs to accelerate. Axotecan is our response. We have completed the first R&D batches and produced gram quantities of exatecan. Validation batches are targeted before the end of 2026, followed by registration activities during 2027 and initial GMP supply targeted for late 2027, subject to successful completion of the required technical, quality, and regulatory milestones.
Starting now gives us time to build that evidence, so customers have another credible option when they need it. As Axotecan progresses, discussions with ADC developers will continue to inform specifications, volumes and integration options. Customer insight is not simply the origin of the project; it remains part of how the proposition is being shaped.
Connecting Chemistry, Purification, and Conjugation
Highly potent APIs (HPAPIs) and ADCs are an important part of Axplora, but they are one application of a much broader platform. Small molecules are our foundation. Across PharmaZell, Farmabios and Novasep CDMO, Axplora combines complex and regulated small-molecule development, steroid and high-potency chemistry, advanced purification and industrial manufacturing. The common thread is the ability to take challenging chemistry from process development into reliable production at the scale the customer requires.
Industrial chemistry is central to that proposition. Our teams combine route and process development with engineering, hazardous and low-temperature chemistry, scale-up and large-workshop execution. This allows manufacturing considerations to shape development decisions early, reducing the risk that an elegant laboratory route proves impractical, unsafe or uneconomic at industrial scale.
Purification and chromatography provide another point of specialist depth. Axplora draws on more than 75 years of purification experience, more than 30 cGMP chromatography systems and over 20 validated chromatography processes for APIs. These capabilities span techniques including preparative and continuous chromatography and support quantities ranging from grams to multi-hundred-ton scale. The value is not the equipment count alone, but the process knowledge required to select, design, and industrialize the right purification strategy.
The limiting factor is therefore not always physical capacity. Increasingly, it is access to the expertise needed to develop, contain, purify, analyze, and scale complex molecules successfully. Equipment can be installed relatively quickly; the scientific and operational judgment built through years of working with difficult chemistry cannot.
Axotecan applies that wider foundation to a specific ADC supply challenge. At Gropello Cairoli in Italy, Farmabios brings more than 35 years of experience in high-potency synthesis and purification, supported by OEB5 containment and manufacturing capabilities spanning development quantities to commercial scale. At Le Mans in France, Novasep CDMO locates payload-linker development and manufacturing alongside bioconjugation, drawing on more than 20 years of cGMP ADC experience.
Together, these capabilities create a potential pathway from exatecan manufacture through payload-linker production and into ADC drug substance. Decisions made during synthesis and purification can be considered alongside conjugation, analytical control and scale-up. For customers, this can mean fewer supplier relationships to coordinate, less repetition during technology transfer, earlier identification of scale-up risks, better visibility and clearer accountability.
Where monoclonal-antibody or drug-product capabilities sit with specialist partners, the priority is to create effective interfaces and preserve knowledge across the program. Integration creates value when it removes complexity for the customer, not when it simply makes a network look larger.
Partnership Must Be Supported by Evidence
Axplora has contributed to the supply chains of six of the 15 FDA-approved ADCs as of September 2026, helping serve more than 600,000 patients globally. Our teams have completed more than 320 cGMP ADC batches, while Le Mans has maintained a 100 percent success rate through customer and regulatory inspections. These figures matter because claims about partnership and expertise ultimately have to be demonstrated through repeatable execution.
This is the operating approach we describe as Partnership in Motion. The name is new, but the way of working is not. Partnership has long meant listening closely, involving the right experts early, being transparent about risk and taking shared responsibility for progress. A good partner does not simply say yes to a scope of work. It helps the customer identify the right problem and makes the trade-offs between speed, quality, cost, scalability and resilience visible.
Customer Knowledge Is an Investment Discipline
Axotecan also demonstrates what we mean by investing with intent. Investment should begin with an outside-in question: what technical barrier, scale gap, or supply risk are customers looking to overcome? Only then should a CDMO decide which combination of assets, people, and expertise can make a meaningful difference.
This discipline matters because pharmaceutical demand rarely develops exactly as predicted. An internal Axplora study found that only around 20 percent of plants built over the past decade are still manufacturing what they were originally designed to produce. The lesson is not to avoid long-term investment, but to understand where pipelines and supply strategies are moving and build enough flexibility to remain useful as molecules, volumes and priorities change.
The same logic applies across the portfolio. At our Mourenx site, investment in industrial-scale chemistry and purification supports next-generation therapies including GLP-1 drug substances. At Le Mans, multi-kilogram payload-linker manufacturing, preparative HPLC and high-containment freeze-drying strengthen the route to commercial ADC supply. At Gropello Cairoli, five high-potency manufacturing lines and a new 4,500-square-meter R&D, quality control and microbiology hub connect scientific work more closely with commercial operations.
The headline investment figure is not the point. Axotecan connects those capabilities with an identified market requirement. Customer knowledge therefore becomes both a relationship discipline and a capital-allocation discipline: the better we understand what could constrain a program, the more precisely we can invest to remove that constraint.
Turning Understanding into Progress
The future CDMO market will not be decided by who builds the most capacity or claims the broadest network. It will favor organizations that understand why they are investing, apply specialist depth where complexity demands it, and remain agile as customer needs change.
Axotecan illustrates that model: recognize an emerging constraint, connect complementary expertise, invest with a defined purpose, and continue shaping the solution with customers. That is how we intend to become the CDMO that knows its customer the bestānot through the claim itself, but through repeated evidence that we understand what could hold a program back and are prepared to act.
Partnership in Motion is the discipline of converting that understanding into progress: helping complex science move toward reliable manufacturing and ultimately helping important medicines reach patients with greater confidence.
