#USA #Lexington #Piramal Pharma #sterile injectables #Microbiology Lab

Piramal Pharma Solutions Unveils New Microbiology Laboratory in Lexington

Piramal Pharma Solutions (PPS), a global leader in contract development and manufacturing (CDMO), has officially inaugurated a state-of-the-art microbiology lab at its sterile injectable manufacturing facility in Lexington, Kentucky. This significant investment is part of an $85 million expansion project aimed at enhancing operational efficiency and production capacity.

The new microbiology laboratory stretches over three times the previous lab space dedicated to microbiological testing, thus allowing for optimized workflow processes and increased future capacity. The facility includes three new biosafety cabinets, enabling PPS to conduct simultaneous analyses and significantly reducing sample wait times. All incubators have also been relocated to this new lab, further streamlining processes and enhancing accessibility for all analytical activities.

One of the notable features of this facility is a dedicated sterility testing room outfitted with a class C environment. This represents a major upgrade from the previous unclassified area. A fully integrated class A sterility control isolator doubles the site's sterility control capacity, allowing for the simultaneous processing of multiple samples. With compatibility for both open and closed-filtration methods, this new isolator offers increased flexibility to meet a broader range of product testing requirements.

Additionally, the layout includes integrated pathways for sample transportation directly from the production area to the laboratory, thereby mitigating contamination risks and preserving product integrity. These improvements are expected to cut testing durations in half, expediting the market-ready process of batches, minimizing bottlenecks, and facilitating smoother transitions from clinical to commercial stages.

By enhancing sterility control and microbiological quality capabilities, the new lab solidifies PPS’s position as a leader in the sterile injectables market, allowing Lexington to offer high-quality, reliable, and patient-centric services to clients worldwide specializing in small molecules, bioconjugates, and peptides.

Nathan Richardson, Vice President and Site Head of Piramal Pharma Solutions in Lexington, emphasized the importance of this new facility, stating, “The new microbiology lab marks a significant milestone in our Lexington expansion project. It further consolidates our ability to support our clients by delivering high-quality, reliable services throughout the product lifecycle. This investment underscores our commitment to operational excellence, patient safety, and the future growth of sterile injectable production in Lexington.”

The complete expansion, including large-scale filling and finishing facilities, is expected to be operational by the end of 2027.

About Piramal Pharma Solutions

Piramal Pharma Solutions provides end-to-end development and manufacturing solutions throughout the drug lifecycle. It addresses customer needs through an integrated network of facilities across North America, Europe, and Asia. This global network enables the provision of comprehensive services, including drug discovery solutions, pharmaceutical process and product development, clinical trial supplies, and commercial supply of active pharmaceutical ingredients and finished dosage forms. PPS also offers specialized services such as the development and manufacturing of highly potent active pharmaceutical ingredients, antibody-drug conjugates, aseptic filling/finishing, peptide products, and oral solid dosage forms. In addition, biological product development and manufacturing services, including vaccines and gene therapies, are offered through Yapan Bio Private Limited, a subsidiary of Piramal Pharma Limited.

For more information, visit Piramal Pharma.