Aenova, a global contract development and manufacturing organization (CDMO), is investing in its sterile manufacturing capabilities with the installation of another fill & finish (F&F) line at its Latina, Italy site. This expansion marks a significant step in meeting the growing global demand for biologics manufacturing, particularly in late clinical and commercial phases.

The Latina site is the Aenova Group’s central sterile site, with many years of experience in sterile processing. The new fill & finish line will support a broad range of container formats, including vials ranging from 2R to 50R, pre-filled syringes (PFS) from 0.5mL to 50mL, and pre-filled cartridges (PFC) from 1mL to 20mL. This flexibility enables the site to accommodate a wide variety of product types and batch sizes.

The new line will operate under isolator technology to ensure the highest standards of sterility and containment. It will be capable of processing a wide range of biologics, including monoclonal antibodies (mAbs), peptides, and vaccines. The fill & finish line will add an annual capacity of 30 to 40 million units. In total, the Latina site will be capable of producing over 100 million units per year, significantly enhancing its role as a strategic partner for biotech companies worldwide.

Construction is currently underway, with the installation of the equipment planned for 2026, and the qualification and start of GMP manufacturing scheduled in Q3 2027.

Patients, partners, and clients will benefit from the site’s ability to handle highly sensitive and niche products, supported by a dedicated team of experts in tech transfer and scale-up who will ensure robust process implementation, regulatory compliance, and first-time-right approvals.

This expansion is part of a broader investment strategy, with approximately €100 million allocated over the next three years to enhance capacity and capabilities at the Latina site. In addition to the new line, this investment includes a cold chain warehouse and a comprehensively expanded QC laboratory. The expansion will also bring a strong focus on workforce development. During the project, nearly 100 new positions will be established, including positions in engineering, project management, equipment qualification, quality assurance and client services. The site will continue to strengthen its technical expertise in biologics fill & finish, placing a strong emphasis on client management and regulatory excellence.

“Our investment in the Latina site reflects our unwavering commitment to expanding our technology offering in sterile fill and finish capacity and capabilities,” said Jan Kengelbach, CEO of the Aenova Group. “By combining cutting-edge technology with our extensive expertise, we are developing a facility that is ready for the future and will meet the evolving needs of the biologics market.”