Piramal Pharma Solutions (PPS) has opened a new microbiology laboratory at its sterile injectable facility in Lexington, Kentucky. This addition marks a significant step forward in PPS' ongoing USD 85 million Lexington expansion, aimed at enhancing commercial-scale capabilities and improving operational efficiency.

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

The new lab more than triples the site's existing microbiology testing space, supporting improved laboratory workflow and providing additional capacity to accommodate future growth. The added space features 3 new biosafety cabinets, allowing PPS to run concurrent tests and reduce sample queue times. All incubators have also been consolidated within the new lab, further streamlining workflow and improving monitoring and accessibility across testing activities.

A key element of the lab is a dedicated sterility testing suite with a Grade C background environment, representing a major upgrade from the previously non-classified area. At its center is a fully integrated, Grade A sterility testing isolator that doubles the site's sterility testing capacity and allows multiple samples to be processed simultaneously.

By supporting both open and closed filtration methods, the new isolator provides greater flexibility to meet a wider range of product testing requirements. The area also includes built-in pass-throughs to move samples directly from the manufacturing floor to the lab, reducing contamination risk and protecting product integrity.

These enhancements are expected to reduce testing times by up to 50 percent, accelerating batch releases, minimising bottlenecks, and smoothing transitions as programs move from clinical to commercial stages. The new infrastructure also reinforces the site's contamination control and sterility assurance capabilities, while the added capacity reduces supply risk and prepares the site for commercial-scale demand. 

Nathan Richardson, VP and Site Head, PPS Lexington, said, "The new microbiology laboratory represents an important milestone in our Lexington expansion journey. 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 lab solidifies PPS' position as a leader in sterile injectables, empowering Lexington to deliver high quality, reliable, and patient-focused services to small molecule, bioconjugate, and peptide modality clients worldwide.