As demand for Exatecan-based antibody-drug conjugates (ADCs) grows, securing reliable manufacturing capacity and diversified supply chains has become a priority for drug developers. Axplora is addressing these challenges through Axotecan, its initiative to establish an independent European source of Exatecan. Biopharma Boardroom speaks with Arul Ramadurai, Chief Commercial Officer at Axplora, about the company's manufacturing strategy, growing customer requirements, integrated capabilities in Italy and France, and its plans to advance Axotecan towards commercial supply, with key regulatory milestones targeted for 2027.

Q. Axplora has completed its first R&D batches of Axotecan. What prompted you to invest in developing an independent European source of Exatecan, and what demand are you seeing from ADC developers?

Our investments are driven by what we learn from listening to our customers. Conversations with ADC developers highlighted a clear need for an additional European source of exatecan, offering greater choice and confidence in quality and reliability. Axotecan is our response.

Customers considering another source need the technical expertise and manufacturing capabilities to support their programs as they advance. Our aim is to expand their options within a global supply network.

The success of Enhertu has encouraged further development using exatecan-derived payloads. Our enquiries already extend beyond small research quantities, reinforcing the importance of considering future manufacturing requirements early enough to inform development decisions.

Axplora can respond by connecting Farmabios’ high-potency chemistry expertise with Novasep CDMO’s payload-linker and bioconjugation capabilities. We have completed the first R&D batches and produced gram quantities of exatecan.

For me, this is investing with intent: understanding what could constrain a customer’s progress, then applying our expertise and resources to address it. Axotecan turns that understanding into a manufacturing initiative.

Q. Supply chain reliability has become a major concern for ADC developers. What are the biggest sourcing challenges companies face with Exatecan today, and how could Axotecan help address them?

Customers seeking greater geographic diversity in their exatecan supply chains face a limited choice of Western suppliers. Some want an additional source as part of a dual-sourcing strategy, giving them more flexibility as their programs and the wider operating environment evolve.

Resilience requires a global view of the supply chain. An additional European source expands customers’ options, supported by the technical capability and dependable execution needed to make that choice useful.

Qualifying another source takes time. Developers must evaluate the material, review supporting information and establish its suitability for their process. Early engagement helps them plan those activities before an alternative becomes urgent.

Axotecan connects exatecan manufacture at our Gropello Cairoli site in Italy with downstream payload-linker and bioconjugation capabilities at our Le Mans site in France. Direct dialogue between our specialists can help align requirements, reduce unnecessary handoffs and resolve technical questions earlier.

By sharing progress openly and involving the right teams early, we aim to build partnerships that help customers plan ahead with greater confidence.

Q. Axotecan brings together Farmabios' expertise in highly potent APIs and Novasep CDMO's ADC manufacturing capabilities. What practical advantages does this integrated approach offer customers as their programmes move from development to commercial production?

The benefit comes from connecting the people and expertise responsible for successive manufacturing stages. Gropello Cairoli brings extensive experience in handling highly potent products, while Le Mans draws on more than 20 years of cGMP ADC development and manufacturing experience.

Decisions about synthesis, purification and material specifications can affect downstream processing. Bringing the relevant specialists together early helps align requirements and preserve knowledge as a program advances. Teams can consider how an upstream decision will affect payload-linker manufacture and subsequent bioconjugation.

Our commercial manufacturing experience also shapes those discussions. As programs progress, customers need processes that deliver consistently, batch after batch. Connecting development and manufacturing expertise early helps prepare for that transition.

For customers, this can mean fewer technical interfaces, clearer accountability and stronger continuity during transfer. We shape the support around their needs and existing arrangements, whether they require exatecan alone or a broader combination of services. Integration creates value when it makes their manufacturing pathway easier to manage.

Q. Exatecan-based ADCs are attracting growing interest across oncology. How do you see demand for these payloads evolving, and what opportunities could this create for Axplora over the next few years?

Clinical progress with exatecan-derived ADCs has encouraged developers to explore this payload family in further programs. That creates a corresponding need to prepare the manufacturing capabilities and supply arrangements supporting their development.

Requirements change as programs advance. Early work may depend on rapid access to small quantities. Later stages bring greater emphasis on reproducibility, manufacturing scale and continuity of supply. The opportunity for Axplora is to support those transitions with the appropriate expertise.

We also need to recognize uncertainty. Clinical outcomes, development priorities and the wider business environment will influence demand. Investment needs to reflect what customers require today while retaining flexibility as those requirements change.

That flexibility supports efficiency. Capabilities that accommodate different processes and scales give us more options as pipelines evolve, helping us use assets effectively and manage the cost implications of change.

Our focus is on matching our capabilities to customers’ needs and executing reliably. The commercial opportunity follows from providing a service they value and trust, helping promising medicines progress toward patients.

Q. You have been working closely with ADC developers to understand their requirements. What are customers telling you about their priorities around quality, manufacturing scale and lead times, and how is that feedback shaping the Axotecan programme?

Customers want to understand the supply pathway beyond their next purchase. They need confidence in quality and a realistic view of how manufacturing could develop with their program.

Their enquiries have reinforced the importance of considering scale early. Requirements beyond research quantities help us understand the potential manufacturing needs ahead, while recognizing that forecasts can change.

Quality discussions must address the material’s intended use. We need to understand which characteristics matter for the customer’s process and what information they require to evaluate a source. Involving downstream specialists helps connect those requirements across manufacturing stages.

Customers also need delivery commitments they can plan around. Speed matters, but an uncertain delivery date can disrupt every activity that depends on material availability. Clear communication about schedules and dependencies is essential.

These conversations help refine specifications, anticipated volumes and integration options. This is Partnership in Motion: understanding what matters to each customer, bringing the right expertise into the discussion and following through with dependable execution.

Q. With validation batches targeted for 2026 and GMP supply planned for late 2027, what are the main technical and regulatory milestones ahead, and how are you preparing to support customers as demand grows?

Our updated plan targets process development and an engineering batch in Q4 2026, followed by process validation and qualification in Q1 2027. Drug Master File filings for the EU and US are targeted for Q2–Q3 2027, subject to successful completion of the preceding work.

The focus is on establishing a process that consistently delivers material meeting defined quality requirements. The engineering batch will inform manufacturing readiness, while the qualification campaign will provide documented evidence of consistent process performance.

Alongside this work, we are preparing the supporting technical and quality documentation and engaging with customers on their evaluation and qualification requirements. That gives both sides greater visibility of the steps needed to establish another supply option.

Our responsibility is to communicate progress clearly and make commitments customers can plan around. Working through these milestones together—and remaining close as requirements change—is how we build dependable, long-term partnerships that support the delivery of important medicines to patients.