Piramal Pharma Opens New Microbiology Lab at US Sterile Injectables Facility

The new laboratory was released for routine Good Manufacturing Practice (GMP) use on September 11, 2026, and its new sterility testing suite was subsequently conditionally approved. The laboratory is among the first major components of the expansion to come online, while the full manufacturing expansion is expected to be operational in late 2027.

The new facility more than triples the site's existing microbiology testing space, providing additional capacity and improving laboratory workflow. It includes three new biosafety cabinets, enabling PPS to conduct concurrent testing and reduce sample queue times.

The company has also consolidated all incubators within the new laboratory to streamline workflow and improve monitoring and accessibility across testing activities.

A key addition is a dedicated sterility testing suite with a Grade C background environment, replacing the site's earlier non-classified area. The suite features a fully integrated Grade A sterility testing isolator, which doubles the site's sterility testing capacity and enables multiple samples to be processed simultaneously.

The new isolator supports both open and closed filtration methods, providing flexibility for different product testing requirements. The area also includes built-in pass-throughs to move samples directly from the manufacturing floor to the laboratory, helping reduce contamination risk and protect product integrity.

According to PPS, the enhancements are expected to reduce testing times by up to 50%, potentially accelerating batch releases and reducing bottlenecks as programs transition from clinical to commercial stages.

The expanded infrastructure is also expected to strengthen the site's contamination control and sterility assurance capabilities while adding capacity to support commercial-scale demand and reduce supply risk.

"The new microbiology laboratory represents an important milestone in our Lexington expansion journey," said Nathan Richardson, VP and Site Head, Piramal Pharma Solutions Lexington. "By enhancing sterility testing and microbiological quality capabilities, we are further strengthening our ability to support clients with high quality, reliable, and responsive services throughout the product life cycle. This investment reflects our continued commitment to operational excellence, patient safety, and the future growth of sterile injectable manufacturing in Lexington."

The new microbiology laboratory will support PPS' sterile injectable operations for small molecule, bioconjugate and peptide modalities, according to the company.

Piramal Pharma Solutions is an integrated CDMO providing development and manufacturing services across the drug life cycle through facilities in North America, Europe and Asia. Its services include drug discovery, process and pharmaceutical development, clinical trial supplies, commercial supply of APIs and finished dosage forms, as well as sterile fill/finish, peptide products and services, highly potent APIs and antibody-drug conjugates.

Piramal Pharma Limited operates 17 global development and manufacturing facilities and has a distribution network covering more than 100 countries. Its businesses include Piramal Pharma Solutions, Piramal Critical Care and Piramal Consumer Healthcare.