Axplora, a global manufacturer of small-molecule active pharmaceutical ingredients (APIs) and antibody-drug conjugates (ADCs), has completed its first R&D batches of Exatecan as part of a program to establish an independent European supply source for ADC developers.

The company has produced gram quantities of Exatecan and plans to complete validation batches by the end of 2026. Registration activities are targeted for 2027, with initial GMP supply planned for late 2027, subject to technical, quality, and regulatory milestones.

Exatecan is a highly potent topoisomerase I inhibitor used as a starting material for ADC payloads. Axplora said the new manufacturing route is intended to provide an additional European supply source and connect Exatecan production with its downstream payload-linker and ADC manufacturing capabilities.

The Exatecan program will be supported by Axplora’s Farmabios operations in Gropello Cairoli, Italy, which provide high-potency development, containment and manufacturing capabilities. The site operates five independent manufacturing lines under an OEB 5 containment strategy, with batch sizes ranging from 0.5 to 300 kilograms.

Axplora’s Novasep contract development and manufacturing organization (CDMO) operations in Le Mans, France, will provide payload-linker development and manufacturing, as well as bioconjugation capabilities. The company said connecting these operations with Exatecan production is intended to reduce technical handoffs and support technology transfer and scale-up from payload starting material through ADC drug substance manufacturing.

The program adds to recent changes in Axplora’s manufacturing network. In June, the company announced plans to consolidate ursodeoxycholic acid (UDCA) production at its Vizag, India facility, transferring manufacturing from Gropello Cairoli by the end of 2026. The move follows an investment to expand UDCA capacity and integrate bile sourcing with API production at the Vizag site.