CordenPharma expands sterile injectable capacity in Italy

The $94 million investment will add manufacturing space and two aseptic fill-finish lines at its Caponago site, with total capacity to reach 500 million units annually.

CordenPharma, a Basel, Switzerland-based contract development and manufacturing organization (CDMO), is investing €80 million (about $94 million) over multiple years to expand sterile injectable manufacturing at its Caponago, Italy site near Milan.

The expansion includes the acquisition of an 11,000-square-meter commercial building and 26,000 square meters of adjacent land for €13 million. Completed July 28, the acquisition increases the site’s footprint by more than 50%, according to the company.

The new facility will accommodate at least four aseptic fill-finish lines, four visual inspection lines, and four additional packaging lines. The space can also support customer-owned manufacturing lines, large-scale lyophilization, and auto-injector assembly. Planned production formats include prefilled syringes, liquid and lyophilized vials, cartridges, and autoinjectors.

The expansion also adds two aseptic fill-finish isolator lines to an existing operational area at Caponago. A clinical and small-scale commercial line will support prefilled syringes, vials, and cartridges, while a high-speed line will produce prefilled syringes and cartridges at more than 500,000 units per day. Completion of the two lines is targeted for mid-2027 and 2028, respectively.

CordenPharma is also expanding secondary packaging for prefilled syringes, vials, and ampoules and doubling analytical capacity to support additional manufacturing programs.

Once the projects are completed, the CDMO projects total Caponago capacity of up to 500 million sterile injectable units per year. The expanded site will support injectable products based on peptides, lipid nanoparticles, small molecules, biologics, and oligonucleotides, according to announcement.

The facility will also complement CordenPharma’s broader drug substance capabilities, allowing customers to access integrated manufacturing services across its global network.

The Caponago expansion is part of CordenPharma’s broader investment in manufacturing capacity for complex drug products and drug substances. In August, the company completed its acquisition of AmbioPharm, adding peptide manufacturing facilities in North Augusta, South Carolina, and Shanghai, China. The acquisition expanded the CDMO’s peptide active pharmaceutical ingredient (API) network and added capabilities spanning peptide development, clinical supply, and commercial production.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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