CordenPharma plans to invest €80 million, or about $94 million, over multiple years to expand sterile injectable manufacturing at its Caponago site near Milan, Italy, with projected capacity of up to 500 million units annually.
The contract development and manufacturing organization is expanding its aseptic fill-finish operations through the purchase of an adjacent commercial building and land, along with installation of two new isolator-based filling lines at its existing facility.
CordenPharma paid €13 million, or about $15 million, for an 11,000-square-meter commercial building and 26,000 square meters of land adjacent to its late-stage aseptic fill-finish area. The acquisition closed July 28 and increases the site’s footprint by more than 50%.
The new building is intended to house at least four aseptic fill-finish lines, four visual-inspection lines and four packaging lines. The space may also accommodate customer-owned production lines, large-scale lyophilization capacity and auto-injector assembly.
The company is adding a clinical and small-scale commercial combination line from Bausch & Ströbel for prefilled syringes, vials and cartridges. It is also adding a high-speed Syntegon line for prefilled syringes and cartridges that can produce more than 500,000 units daily.
The new isolator lines are expected to be completed in mid-2027 and 2028, respectively. CordenPharma is also expanding its automated secondary-packaging area for prefilled syringes, vials and ampoules, while doubling analytical capacity to support a larger project pipeline.
The Caponago facility is approved by the U.S. Food and Drug Administration and European Medicines Agency. CordenPharma said the expansion will support injectable formats including prefilled syringes, liquid or lyophilized vials, cartridges and auto-injectors.
The site also includes lipid nanoparticle manufacturing capabilities. The company said the expanded operations will support products ranging from peptides and oligonucleotides to small molecules, biologics and lipid nanoparticle-based therapies.
CordenPharma said the additional capacity is intended to address demand for outsourced sterile injectable manufacturing in oncology, obesity, diabetes and inflammatory diseases.