Piramal Pharma Solutions has opened a new microbiology laboratory at its sterile injectable manufacturing facility in Lexington, Kentucky, as part of an $85m expansion to increase commercial-scale production capabilities.
The new facility more than triples the site’s existing microbiology testing space and is expected to reduce testing times by up to 50%, helping accelerate batch releases and reduce bottlenecks.
Piramal Pharma Solutions is the contract development and manufacturing organisation (CDMO) business of Piramal Pharma, providing pharmaceutical development and manufacturing services across North America, Europe and Asia.
The new laboratory includes a dedicated sterility testing suite with a Grade A isolator in a Grade C background environment, upgrading the site’s previous non-classified testing area.
The laboratory was released for routine Good Manufacturing Practice (GMP) use on 11 September 2026, with the sterility testing suite conditionally approved shortly afterwards.
Grade A isolator doubles sterility testing capacity
The dedicated sterility testing suite features a fully integrated Grade A isolator designed to support both open and closed filtration methods.
The isolator doubles the site’s sterility testing capacity and allows multiple samples to be processed simultaneously, providing greater flexibility for different product testing requirements.
Built-in pass-throughs enable samples to be transferred directly from manufacturing areas into the laboratory, reducing handling and the potential for contamination.
The wider laboratory includes three new biosafety cabinets to support concurrent testing and reduce sample queue times. Incubators previously distributed across the site have also been consolidated within the laboratory to improve workflow, monitoring and accessibility.
The additional capacity is intended to support programmes progressing from clinical development to commercial manufacturing, while strengthening contamination control and sterility assurance.
"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.”
Full expansion due in late 2027
The laboratory is one of the first major components of the Lexington expansion to become operational.
The wider project includes an additional 24,000 sqft of manufacturing space and new equipment to support commercial-scale sterile injectable production.
Planned additions include a new filling line, two commercial-scale lyophilisers, a capping machine and an external vial washer.
The expansion is designed to increase annual production capacity from 104 batches to more than 240, according to the company’s original investment announcement.
The full manufacturing expansion, including commercial-scale fill-and-finish operations, is expected to be operational in late 2027.
