Aenova, the German-based contract manufacturer for the pharmaceutical and healthcare industry, has announced a major expansion of its microbiology quality control (QC) laboratory at its Latina site in Italy.

The project will add around 500 square meters of new laboratory space, bringing the facility to a total of 800 square meters. Scheduled for completion in the third quarter of 2025, the new laboratory represents a significant milestone in the site’s ongoing development.

With the implementation of the expanded QC lab, Aenova will gain new and advanced laboratory capabilities, including sterility testing for biologics using isolator technology, collection and trending of environmental monitoring data, bacterial ID technologies, and cutting-edge techniques for monitoring viable particles, bioburden, and endotoxins.

Operational workflows will be optimised through automation, which will enhance data reliability, ensure compliance with data integrity principles, and reduce cycle times.

Furthermore, the project is expected to create positions for over 20 specialised analysts and technicians, enabling the site to test more than 1,000 batches per year.  The company noted that the project will fully comply with international regulatory requirements, including those of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

“With the new microbiology laboratory, Aenova Latina consolidates its role as a strategic partner for pharmaceutical companies, ensuring faster and more effective microbiological testing. This investment allows us to further raise quality standards and reduce time to market for our customers,” said Vittorio Tonus, Head of Quality Operations at Aenova´s Latina site.

The QC laboratory expansion is part of the wider “Expansion Latina” project, which also includes a cold chain warehouse (expected to be operational in Q1 2026) and a second fill-and-finish line for sterile injectables and biologics. Together, these initiatives are designed to strengthen the site’s infrastructure, increase production capacity, and attract new customers seeking expertise in sterile manufacturing.

Regulatory approval by local authorities is anticipated in the fourth quarter of 2025, after which the laboratory will become fully operational.

The Latina facility is one of the largest in Aenova’s network of 14 manufacturing and development sites across Europe and the US. The site supports multiple business segments, including biologics and small molecules, betalactam sterile fillings, penicillins oral solids, conventional oral solids, and oral solid parasiticides, serving both human and veterinary markets worldwide.

The Aenova site in Starnberg near Munich is the headquarter of the Aenova Group and houses all important corporate functions.