- Axplora has completed its first R&D batches of Axotecan, a project aimed at establishing an independent European source of Exatecan for antibody-drug conjugate (ADC) developers.
- The company has produced gram quantities of Exatecan and is targeting validation batches by the end of 2026, with initial GMP supply planned for late 2027, subject to technical, quality, and regulatory milestones.
Axplora, a manufacturing partner for small-molecule active pharmaceutical ingredients (APIs) and ADCs, has completed the first R&D batches of Axotecan, its project to establish an independent European supply route for Exatecan. The project is intended to provide ADC developers with an additional European sourcing option connected to downstream payload-linker and ADC manufacturing capabilities.
The company said ADC developers are seeking greater confidence in consistent quality, sourcing diversity, and shorter and more predictable lead times for critical supply chains. Axotecan is being developed in response to these requirements, with Axplora applying expertise across its businesses to develop the supply route.
Axplora has now produced gram quantities of Exatecan through the first R&D batches. The company is targeting completion of validation batches before the end of 2026, followed by registration activities planned for 2027.
Initial GMP supply is targeted for late 2027, subject to successful completion of the required technical, quality, and regulatory milestones. The Axotecan project forms part of Axplora’s “Partnership in Motion” approach, which the company says focuses on working with customers to anticipate supply-chain constraints and develop solutions.
