Germany-based Axplora, a contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), announced plans to invest approximately $38 million (€35 million) to expand its Farmabios API manufacturing site in Gropello Cairoli, Italy.
The project, scheduled for completion in 2026, will add 667,000 square feet of new development space, bringing the site’s total footprint to over 1.16 million square feet, according to the company.
Axplora said the expansion is designed to scale up manufacturing capacity, particularly for high-potency APIs (HPAPIs), and support increasing demand for complex pharmaceutical ingredients. The company has already invested more than $49 million (€45 million) at the site over the past five years, with recent upgrades that include a new micronization department, expanded warehouse space, and the RS40 building — a dedicated high-containment facility for potent compounds.
The RS40 unit includes segregated processing suites built to OEB5 containment standards and supports occupational exposure limits as low as 10 nanograms per cubic meter, the company said. Each unit is designed with stand-alone workshops and fully isolated process rooms to mitigate cross-contamination risks. The micronization areas are equipped with isolators specifically designed for HPAPI handling.
Between 2020 and 2024, the Farmabios site nearly doubled its headcount, growing from roughly 150 to nearly 300 employees. Axplora indicated the new expansion is expected to support continued workforce growth and increase the site's role in the company’s global manufacturing network.
The facility also incorporates regenerative thermal oxidizers (RTOs) to improve air emissions control as part of Axplora’s environmental strategy. The company stated that these sustainability efforts contributed to the site receiving a Platinum EcoVadis rating in 2024.
Axplora said the new expansion will support flexible production needs, align with international regulatory requirements, and strengthen its position as a partner for complex API manufacturing. The Farmabios investment follows other recent projects within Axplora’s network.
ADC, GLP-1 manufacturing capabilities
Axplora recently expanded commercial antibody-drug conjugate (ADC) payload production at its Le Mans, France site. The expansion includes a new GMP-compliant payload manufacturing workshop, designed to enhance capacity and meet the industry’s growing demand for ADCs.
The company is also making an investment in GLP-1 manufacturing at its Mourenx, France site. Axplora argues that the capital expenditure will solidify its capabilities in peptide purification in biologics and support the development of next-generation therapies, including GLP-1s. Construction and infrastructure development has started, with the first supplies of GLP-1 therapies expected in 2026.
Martin Meeson, the former CEO of Fujifilm Diosynth Biotechnologies who took the helm of Axplora in April 2024, contends that to handle the complexities of API development and manufacturing for such innovative drugs there is a need for high-purity standards and chemical processes, as well as the ability to scale production.
“It’s really about scaling out the things that we are really good at,” Meeson told Pharma Manufacturing. “In ADCs and GLP-1s, we’re scaling in terms of volume and in areas where it’s not as visible, such as skills around the adjacent services like conjugation and the increasing complexity within the synthetic chemistry molecules.”