Axplora Has Produced First Exatecan Batches
The company launched the Axotecan project to establish a European source for the critical topoisomerase I inhibitor.
Updated on Sept. 30, 2026 in Biotech
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Axplora has successfully produced the first R&D batches of Exatecan, a topoisomerase I inhibitor used in drug development. This milestone marks the start of the Axotecan project, which aims to create a reliable European supply chain for the compound.
Why it matters
Biotech developers increasingly require consistent quality and predictable lead times to maintain the production of antibody-drug conjugates (ADCs). By domesticating this source in Europe, Axplora aims to diversify supply chains for firms that depend on high-potency ingredients.
The Gropello Cairoli facility utilizes an OEB 5 containment strategy to support production batch sizes ranging from 0.5 to 300 kilograms. Axplora currently provides manufacturing services for six commercial FDA-approved ADCs.
The players
Axplora
This organization specializes in high-potency synthesis and cGMP ADC development for the global pharmaceutical and biotech industries.
FDA
The Food and Drug Administration is the U.S. federal agency responsible for regulating food, drugs, and medical devices to protect public health.
The details
The production process integrates Farmabios manufacturing expertise in Italy with Novasep CDMO capabilities in France. This infrastructure links the synthesis of Exatecan with downstream payload-linker and ADC manufacturing workflows.
Timeline
Validation batches are targeted for completion before the end of 2026.
Registration activities are scheduled to take place throughout 2027.
Initial GMP supply is targeted for availability in late 2027.
The Tech Race
This project reflects a broader trend of reshoring high-potency API manufacturing to ensure the stability of the antibody-drug conjugates (ADCs) market. It positions the company to compete more effectively against legacy suppliers by offering a vertically integrated European alternative.
This development may stabilize the future availability and production timelines of next-generation cancer therapies for developers. By diversifying the source of critical ingredients, it helps mitigate potential shortages that could delay clinical trials or drug rollouts.
The takeaway
Securing local production of high-potency ingredients is a vital step for companies aiming to gain independence from global supply fluctuations. Developers should watch these milestones as they signal a shift toward more reliable, localized biotech manufacturing.
Further reading
For more information on innovations in the drug supply chain, visit the Biotech section.
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