Axplora, a manufacturing partner for small-molecule active pharmaceutical ingredients (APIs) and antibody-drug conjugates (ADCs), has completed the first R&D batches of Axotecan, its project to establish an independent European source of Exatecan for ADC developers.
Axplora
ADC developers have been clear about what they need from critical supply chains: confidence in consistent quality, greater sourcing diversity and shorter, more predictable lead times. Axotecan is Axplora's response - an additional European supply route connected directly to downstream payload-linker and ADC manufacturing capabilities.
Partnership has long been fundamental to how Axplora works: listening closely to customers, anticipating emerging constraints and bringing together expertise from across its businesses to develop practical solutions. Under the banner of ‘Partnership in Motion’ Axplora will bring greater visibility to this established approach, with Axotecan providing a clear example of the benefits it can deliver for customers.
Axplora has completed its first R&D batches and produced gram quantities of Exatecan. Validation batches are targeted before the end of 2026, with registration activities planned during 2027 and initial GMP supply targeted for late 2027, subject to successful completion of the required technical, quality and regulatory milestones.
Exatecan is a highly potent topoisomerase I inhibitor and an important starting point for a growing class of ADC payloads.
As more Exatecan-based programs progress through development, reliable access to material at the required quality, scale and time becomes increasingly important. Limited sourcing options, lengthy qualification processes and technical handoffs between multiple suppliers can create risk precisely when programs need to accelerate.
Axotecan is designed to open another route. It will offer customers an independent European source of Exatecan, greater visibility over future material availability and a more streamlined pathway into payload-linker and ADC manufacturing.
By linking Exatecan manufacture with downstream ADC capabilities, Axplora aims to provide technical continuity, reduce unnecessary handoffs and support earlier planning for scale-up and commercial supply.
Axplora brings together three complementary businesses: PharmaZell, with expertise in complex small- molecule APIs; Farmabios, a specialist in steroids and highly potent APIs; and Novasep CDMO, which provides development and manufacturing services for complex small molecules and ADCs.
Axotecan demonstrates the added value of combining these capabilities within one organisation. Farmabios provides highly potent development, containment and manufacturing expertise at Gropello Cairoli, Italy, while Novasep CDMO contributes integrated payload-linker and bioconjugation capabilities at Axplora’s ADC center of excellence in Le Mans, France.
Axplora has more than 35 years of experience in high-potency synthesis and purification. At Gropello Cairoli, one of Europe’s largest HPAPI manufacturing workshops operates five independent manufacturing lines under an OEB 5 containment strategy, supporting batch sizes from 0.5 to 300 kilograms. This provides a credible route from development quantities to commercial-scale supply as demand grows.
At Le Mans, payload-linker development and manufacturing are located alongside bioconjugation. Connecting these capabilities with Exatecan manufacture at Gropello Cairoli creates a streamlined pathway from payload starting material to ADC drug substance.
For customers, this means fewer technical handoffs, stronger continuity between development and scale-up, and clearer accountability. It is a practical example of Axplora’s businesses working together to create value beyond capacity alone.
This integrated model allows decisions made during synthesis and purification to be considered alongside their impact on conjugation and the final ADC drug substance. It supports faster technical transfer, earlier scale-up planning and stronger continuity from development toward commercial supply.
Axotecan also reflects Axplora’s strategy of investing with intent: directing expertise and development resources toward emerging customer needs rather than simply adding capacity. Customer conversations have highlighted the importance of consistent quality, greater supply-chain diversity and more predictable lead times for critical ADC materials.
“Partnership starts with listening carefully to customers and understanding not only what they need today, but what could constrain their progress tomorrow,” said Martin Meeson, CEO of Axplora. “With Axotecan, we are turning that insight into action. We are moving early to create an independent European supply option while continuing to work with ADC developers to ensure it meets their requirements. That is what Partnership in Motion means in practice: investing with purpose, shaping the solution with customers and helping important new medicines progress toward patients with greater confidence.”
In line with its ambition to be the CDMO that understands its customers’ needs the best, Axplora has been engaging closely with ADC developers as Axotecan advances. These discussions help define the required specifications, volumes and integration options ahead of GMP availability.
Axplora brings more than 20 years of cGMP ADC development and manufacturing experience. It has supported dozens of biotechnology and pharmaceutical companies across the US and Europe and is an integral part of the supply chain for six commercial FDA-approved ADCs.