OLON Group, a company that develops and produces active pharmaceutical ingredients (APIs) for contract development and manufacturing organizations (CDMO) and general markets, started construction of a new facility at its Rodano site in Milan, Italy.

The facility will be entirely dedicated to managing and producing ultra-potent compounds, used for example as payloads and payload-linkers for antibody-drug conjugates (ADCs), one of the most promising emerging cancer therapies, which combines the effective killing power of small molecule cytotoxins and the highly specific targeting ability of monoclonal antibodies (mAbs).

“Actually, about 80 percent of the ADCs either approved or under development contains this type of payload, such as Dolastatins or Maytansnoids,” said Giorgio Bertolini, senior vice president R&D Olon Group. “And there are also other highly strategic classes of cytotoxic payloads, such as Anthracyclines, Camptothecin and Calicheamicin.”

The Italian group, with years of expertise in HPAPIs, has invested €22 million in a new facility dedicated to these ultra-potent compounds. The ultra-high-containment production line will produce high-potency and toxic products and will therefore reach containment level OEB6 (target OEL 10 ng/m³).

According to the company, the new project foresees the complete construction of a new building, within which a second ‘shell’ will be built, containing the production facility and the quality control and research and development areas, as well as all auxiliary facilities. This complete, closed-loop system will include all steps of the process: synthesis, isolation, drying and analysis: an ultra-high-containment plant.

The first phase of the construction, to build the payload research and development area, has already begun and completion is foreseen by H1, 2024. Once completed, the company will move on to the second stage of finalizing the production line by creating the QC and GMP Production areas, with the installation of industrial production equipment.

For the Italian-based CDMO which has worked with highly-potent APIs (HPAPIs)—including anti-cancer drugs and cytotoxic—for over half a century, the decline of the blockbuster, high-volume model in oncology and the rise of niche therapies based on precision medicine are creating new opportunities for continued growth.

In a statement, Olon said that is one of few suppliers in the global API market able to integrate every level of containment from the initial API development to commercial manufacturing and from a few grams to hundreds of kilograms.