Axplora has announced a major milestone in its $60 million investment program to expand highly potent API (HPAPI) development and manufacturing at its Farmabios site in Gropello Cairoli, Italy. The latest phase centers on construction of a new 4,500 m², three-storey R&D and laboratory hub designed to accelerate development, increase execution capacity, and support cost-efficient high-potency manufacturing at scale. The project adds to recent investments across Axplora’s network, including a multi-million-euro lyophilization expansion at its Le Mans, France site, which is described as one of the world’s leading facilities for antibody-drug conjugate (ADC) and cytotoxic drug production.
According to the company, HPAPI molecules now account for more than 30% of the global drug development pipeline, with over 1,000 highly potent small molecules in development. The new hub at Gropello Cairoli will house R&D laboratories, Quality Control laboratories, Microbiology laboratories, and integrated support areas that are directly connected to existing manufacturing operations. Axplora states that co-locating development, analytics, and large-scale HPAPI production at a single specialized site is intended to eliminate multi-site delays, improve scale-up efficiency, and enhance overall program economics.
Farmabios currently operates what the company describes as one of Europe’s largest HPAPI manufacturing workshops, built to an OEB 5 containment strategy. The site includes five independent manufacturing lines and 105 m³ of installed capacity, supporting batch sizes ranging from 0.5 to 300 kilograms. This existing platform is fully operational and supports immediate execution of high-volume, high-potency projects while the new R&D and laboratory hub is under construction.
Axplora positions the investment as a response to increasingly potent and complex pipelines and a need to reduce delays linked to fragmented supply chains. By expanding R&D, analytical, and quality capabilities alongside large-scale HPAPI manufacturing at Farmabios, the company aims to shorten development cycles, help customers manage costs, and accelerate time to market. Axplora also notes that it currently manufactures 6 of the 14 FDA-approved commercial ADCs and reports continued momentum across ADC and other high-potency programs, stating that additional HPAPI capacity in Gropello Cairoli is intended to stay ahead of demand.
For HPAPI customers, Axplora highlights demand for integrated, end-to-end programs that maintain speed without compromising quality. The company indicates that the new R&D hub is designed to strengthen its ability to deliver such programs within a single site by reducing complexity and avoiding unnecessary technology transfers, with the goal of improving both timeline predictability and overall program costs. Construction of the new facility is underway, with completion targeted for February 2027, while the underlying HPAPI manufacturing capacity at Farmabios is already qualified and operational, and initial projects are reported to be in progress.