Piramal Pharma Solutions (PPS), a global Contract Development and Manufacturing Organization and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), has opened a new microbiology laboratory at its sterile injectable facility in Lexington, Kentucky.

Laboratory Released for GMP Use as Expansion Advances

The laboratory was released for routine 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 company's ongoing USD 85 million Lexington expansion.

The new microbiology laboratory and sterility testing suite are designed for GMP drug product applications. The remainder of the expansion, including commercial-scale fill/finish capabilities, is expected to be online in late 2027.

Tripled Testing Space and Streamlined Workflow

The new laboratory 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 three new biosafety cabinets, which allow PPS to run concurrent tests and reduce sample queue times.

All incubators have been consolidated within the new lab, further streamlining workflow and improving monitoring and accessibility across testing activities.

Upgraded Sterility Testing Suite

A key element of the new lab is a dedicated sterility testing suite with a Grade C background environment, a major upgrade from the previously non-classified area.

At the center of the suite 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. The isolator supports both open and closed filtration methods, providing greater flexibility to meet a wider range of product testing requirements.

The area also includes built-in pass-throughs that move samples directly from the manufacturing floor to the lab, reducing contamination risk and protecting product integrity.

Faster Testing, Faster Batch Releases

According to the company, these enhancements are expected to reduce testing times by up to 50 percent, accelerating batch releases, minimizing 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.

Company Commentary

"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 company states that the new microbiology lab solidifies PPS' position as a leader in sterile injectables, enabling the Lexington site to deliver services to small molecule, bioconjugate, and peptide modality clients worldwide.

About Piramal Pharma Solutions and Piramal Pharma Limited

Piramal Pharma Solutions is a Contract Development and Manufacturing Organization offering end-to-end development and manufacturing solutions across the drug life cycle.

The company serves customers through a globally integrated network of facilities in North America, Europe, and Asia, offering services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms.

PPS also provides specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products, along with development and manufacturing services for biologics, including vaccines and gene therapies, through Piramal Pharma Limited's subsidiary, Yapan Bio Private Limited.

Piramam Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.

PPL includes Piramal Pharma Solutions, an integrated contract development and manufacturing organization; Piramal Critical Care, a complex hospital generics business; and the Piramal Consumer Healthcare business, which sells over-the-counter consumer and wellness products.

One of PPL's associate companies, Abbvie Therapeutics India Private Limited, a joint venture between Abbvie and PPL, has emerged as one of the market leaders in its segment.

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