Aenova, a leading global contract development and manufacturing organisation (CDMO), is significantly expanding its microbiology quality control (QC) laboratory at its Latina site. The project adds approximately 500 square meters of new laboratory space, bringing the total to around 800 square meters, and marks a major milestone in the site’s development.
With the implementation of a significantly expanded new QC laboratory, Aenova will gain new and advanced laboratory capabilities. These include sterility testing for biologics using isolator technology, collection and trending of environmental monitoring data, bacterial ID technologies, and advanced 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. The expansion ensures full alignment with international regulatory standards and adheres to the highest quality standards, including those of the EMEA and FDA. Furthermore, the project creates positions for over 20 specialised analysts and technicians, allowing the laboratory to test more than 1,000 batches per year.
Customers benefit from enhanced regulatory compliance and faster process times
This expansion underscores Aenova’s commitment to innovation, reliability, and quality by design. Customers will benefit from faster and more reliable microbiological testing, improved turnaround times, and enhanced regulatory compliance, further positioning Aenova as a trusted and forward-thinking CDMO partner.
Advanced and expanded sterile manufacturing capabilities at Latina site
The new QC laboratory is part of the broader “Expansion Latina” project, which also includes the implementation of a cold chain warehouse (full operational readiness expected by the first quarter of 2026) and a second fill & finish line for sterile injectable / biologics products. These initiatives aim to increase production capacity, ensure robust infrastructure, and attract new customers through state-of-the-art equipment and operational competence in sterile manufacturing.
Construction of the new QC lab is expected to be completed in the third quarter of 2025. Regulatory approval by local authorities is anticipated in the fourth quarter of 2025, after which the laboratory will become fully operational.
“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,” says Vittorio Tonus, Head of Quality Operations at Aenova´s Latina site.
