Axplora, a global CDMO Partner, has reached a major milestone in its $60 million investment program 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-story 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. Once operational, the new facility will increase development and analytical throughput, reduce technology transfer complexity and compress timelines from early development to commercial production.

The new facility will house 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 specialized site eliminates multi-site delays, improves scale-up efficiency and enhances overall program 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 programs.

Martin Meeson, CEO 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: “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.”

Construction is underway, with completion targeted for February 2027.