Aenova to boost cold chain capabilities with warehouse at sterile site in Italy

Germany-headquartered contract development and manufacturing organization Aenova is building a new cold chain warehouse at its sterile site in Latina, Italy, which is slated to be fully operational and gain regulatory acceptance by the first quarter of 2026.

Adjacent and fully connected to the existing manufacturing facility, the capital expenditure is part of Aenova’s strategic expansion in cold chain infrastructure as it looks to provide end-to-end integrated supply chain services for biologics and other temperature-sensitive pharmaceutical products.

The facility will maintain a controlled temperature range of 2°C to 8°C, while continuously monitoring and recording via a SCADA system to ensure full compliance with current Good Manufacturing Practices (cGMP).

“By integrating cold chain storage directly into our manufacturing site, we can now offer our customers secure and streamlined logistics; this is a real competitive advantage in terms of speed, reliability, and compliance,” Paolo Abbate, managing director of the Aenova site in Latina, said in a statement.

Construction of the 6,500-cubic-meter warehouse began earlier this year and is designed to support a wide range of cold chain products without requiring special adaptations for specific APIs or countries, according to the announcement. 

The warehouse, which will be fully automated with an integrated digital system for precise location tracking and pallet movement, will have a total capacity of 1,300 pallet spaces with an additional area to accommodate approximately 100 pallet spaces dedicated to packing, shipping, and final product preparation. 

Created in 2008 as a merger of pharma companies Dragenopharm and Swiss Caps, Aenova offers services from development to commercialization for the common product groups and dosage forms, including solid, semisolid, sterile, and nonsterile liquid. 

The CDMO handles differentiated technologies such as High Potent API (HPAPI) containment, low-dose, modified release formulations, organic granulation, particulate systems, lipid-based formulas, as well as Hot Melt Extrusion (HME) or spray drying for poorly soluble compounds.