Expanded Microbiology Laboratory Strengthens Sterile Capabilities

Rendering of the expanded QC laboratory at Aenova in Latina, Italy. Image: Courtesy of Aenova

Aenova is marking a new era of quality and capacity at its Latina, Italy site with the expansion of its microbiology quality control (QC) laboratory. The project—part of the company’s broader “Expansion Latina” initiative—adds approximately 500 square meters of new space, bringing the total footprint to around 800 square meters. This major investment reflects Aenova’s strategic commitment to innovation, compliance, and operational excellence in sterile and biologics manufacturing.

A strategic step in sterile manufacturing growth

The Latina facility has long been a cornerstone of Aenova’s global sterile production network. With this expansion, the site gains new and advanced QC capabilities, including sterility testing for biologics using isolator technology, automated data capture, bacterial identification systems, and advanced tools for monitoring viable particles, bioburden, and endotoxins.

“The main objective was to create a state-of-the-art QC Microbiology laboratory fully aligned with Aenova’s ongoing expansion in Fill & Finish activities,” explains Paolo Abbate, managing director, Aenova Latina Site. “The new 800 sqm facility was designed to provide increased capacity, improved contamination control, and the flexibility to support both small and large molecule products.”

Designed with modularity and seamless integration in mind, the new lab directly supports Aenova’s parallel investments in sterile manufacturing infrastructure—including a second Fill & Finish line and a cold-chain warehouse scheduled for completion in early 2026. Together, these projects expand production capacity, ensure robust supply chain performance, and enhance the company’s responsiveness to customer needs.

Designing for advanced contamination control

Rendering of the expanded QC laboratory at Aenova in Latina, Italy. The lab was designed to ensure contamination control, sterility, and full GMP compliance through cleanroom zoning, product segregation, and precisely engineered HVAC and utility systems. Image: Courtesy of Aenova

The laboratory’s design prioritizes contamination control, sterility assurance, and compliance with international GMP standards. Key elements include cleanroom zoning, strict segregation of product classes, and carefully engineered HVAC and utility systems.

“The lab was conceived around the integration of isolator technology to enhance aseptic testing reliability and operator safety,” says Annalisa Barile, vice president of operations with Aenova. “Installing such advanced systems within an existing site footprint required structural reinforcement and careful coordination of utilities, particularly for exhaust management and environmental monitoring.”

Aenova partnered with specialized firms to execute this complex build. Nuova Impas Srl, an Italian company known for its pharmaceutical HVAC systems and finishes, provided critical support in cleanroom integration. Additional contributors included CO.I.M. 2005 Srl for piping and metal works, Gruppo Di Manno Srl for civil construction, and SPD Engineering Srl for construction services.

“Despite the complexity of such a large-scale laboratory project, all external contractors demonstrated resilience and the ability to adapt to new directives with valuable suggestions and innovative ideas that helped to brilliantly overcome the obstacles along the way,” Abbate says.

Automation, data integrity, and digital integration

Automation and digital infrastructure were central to the lab’s design philosophy. “Automation and digital connectivity were major drivers of the layout,” Barile says. “The new lab features a fully digital environmental monitoring system and automated data capture for critical tests. This digital backbone ensures data integrity and real-time visibility across QC operations.”

These systems reduce manual interventions, shorten analysis cycles, and support full traceability of results—key factors in maintaining compliance with EMEA and FDA quality expectations. “Aenova’s global quality framework incorporates both EMEA and FDA expectations from the outset,” Abbate says. “Design reviews were conducted with cross-functional input from QA, validation, and engineering teams to ensure all decisions met international GMP standards.”

The human element was also central to the expansion. From the early planning stages, Aenova engaged QC analysts, microbiologists, and technicians to ensure the new space would promote efficiency, safety, and comfort.

“User involvement was critical,” Abbate says. “Early design workshops with QC analysts and microbiologists provided valuable insights on ergonomics, sample flow, and contamination risk points. Their feedback directly influenced bench heights, equipment placement, and storage design, resulting in a space that enhances both compliance and day-to-day efficiency.”

The new lab is expected to create over 20 specialized positions for analysts and technicians, enabling the site to test more than 1,000 batches per year. This expanded capacity will not only accelerate time to market for clients but also strengthen Aenova’s ability to support new biologics and sterile drug programs.

Built for today, ready for tomorrow

Beyond its immediate operational benefits, the microbiology lab is designed for scalability and seamless integration with future site developments. “Scalability was a cornerstone of the project,” Barile says. “The QC Micro Lab was designed as part of the broader Expansion Latina masterplan, aligning infrastructure and utilities with the new Fill & Finish areas. Shared utilities and data systems ensure operational continuity and efficiency, while the layout allows for future expansion without major disruption to existing activities.”

Completion of construction is anticipated in the third quarter of 2025, with regulatory approval expected by the fourth quarter. Once operational, the laboratory will position Aenova Latina as a premier hub for microbiological testing and sterile production within the company’s global network.