Highly potent drugs now account for over 30% of the global pipeline, with more than 1,000 molecules in development, Axplora’s investments in HPAPI capacity help customers bring these complex therapies to market faster

• $60 million investment to expand highly potent API (HPAPI) development and manufacturing at Axplora’s Farmabios site in Gropello Cairoli, Italy
• New 4,500 m² R&D and laboratory hub to accelerate development and scale-up, building on one of Europe’s largest HPAPI manufacturing workshops, with OEB 5 containment and 105m³ of installed capacity
• Expansion supplements Axplora’s recent investment in its Le Mans, France site, one of the world’s leading facilities for ADC and cytotoxic drug manufacturing.

Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme in highly potent API (HPAPI) manufacturing at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale.

The investment builds on recent expansions across the Axplora network, including the multi-million-euro lyophilization expansion in Le Mans, France, one of the world’s leading sites for ADC and cytotoxic drug production. Once operational, the new facility will increase development and analytical throughput, reduce technology transfer complexity and compress timelines from early development to commercial production.

HPAPI molecules now make up over 30 % of the global drug development pipeline, with over 1,000 highly potent small molecules in development. The new facility will house state-of-the-art R&D laboratories, Quality Control laboratories, Microbiology laboratories, and integrated support areas, directly connected to existing manufacturing operations. Co-locating development, analytics and large-scale HPAPI production within a single specialised site eliminates multi-site delays, improves scale-up efficiency and enhances overall programme economics.

Farmabios already operates one of Europe’s largest HPAPI manufacturing workshops, built to an OEB 5 containment strategy. The site has five independent manufacturing lines and 105 m³ of installed capacity, supporting batch sizes from 0.5 to 300 kilograms. This platform is fully operational today, enabling immediate execution of high-volume, high-potency programmes.

Martin Meeson, Chief Executive Officer of Axplora, said: “This investment is about enabling our customers to move more quickly at scale to and through the clinic, helping them bring their products to patients sooner. As pharma pipelines consist of molecules of higher potency and additional complexity, customers are looking to avoid delays through fragmented supply chains. By expanding R&D, analytical and quality capabilities alongside large-scale HPAPI production, we are shortening development cycles and helping them control cost while accelerating time to market.”

He added: “Axplora already manufactures 6 of the 14 FDA-approved commercial ADCs, and we continue to see strong momentum across ADC and other high-potency programmes. This additional expansion of our HPAPI capabilities in Gropello ensures we remain ahead of demand and fully aligned with the needs of innovators bringing next-generation therapies to patients.”

Mario Di Giacomo, Managing Director of Farmabios, commented: “Our HPAPI customers are increasingly looking to move quickly without compromising quality. This new R&D hub strengthens our ability to deliver integrated, end-to-end programmes within a single site. By reducing complexity and avoiding unnecessary transfers, we improve both timeline predictability and overall programme costs.”

Construction is underway, with completion targeted for February 2027. The underlying HPAPI manufacturing capacity supporting this growth is qualified and operational, with first projects under way.

Through this continued investment, Axplora is reinforcing its industrial platform for complex, high-potency modalities, combining containment expertise, development speed and commercial-scale capacity to meet accelerating market demand