Patheon Completes Sterile Expansion Project At Greenville, NC Manufacturing Site

DURHAM, N.C.--(BUSINESS WIRE)--Patheon N.V (NYSE: PTHN), a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors, announced that it has completed an expansion project at its Greenville, NC manufacturing site. The company invested approximately $26 million to update one of its sterile Pharmaceutical Development Services (PDS) suites and to build a state-of-the-art, fully integrated sterile PDS suite which are compliant with regulatory authorities. The PDS Suites 1 and 2 provide 7,000-square-feet in GMP steriles manufacturing space.

“As the industry continues to innovate, customers will require even more advanced solutions, integrating development and commercial service, to meet their business needs”

The newly built PDS suite will manufacture sterile liquid and lyophilized drug products. It features freeze dryers and a fully integrated filling line fitted with a Restricted Access Barrier System (RABS) for sterile drug products. The company has made the investment in disposable manufacturing in this suite eliminating the need for cleaning verification for liquid filling, reducing set up time/product losses and enhancing sterility assurance. This suite is highly sophisticated, fully integrated and designed for products in clinical development with the ability to scale up to much larger batch sizes via Patheon’s network of commercial scale capabilities either co-existing within the Greenville facility, or in Europe.

“As the industry continues to innovate, customers will require even more advanced solutions, integrating development and commercial service, to meet their business needs,” said Franco Negron, president of Patheon’s drug product and pharmaceutical development services for North America. “The increasing focus on pharma to reduce costs will lead forward-thinking companies to capitalize on their core competencies – focusing on what they do best, while strategically partnering with companies such as Patheon to deliver the expertise, customized solutions and technical capabilities to support the production of their small and large molecule products.”

Patheon’s Greenville, NC manufacturing site is a large multi-purpose pharmaceutical manufacturing and packaging campus. The facility provides both solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules. Another exciting development in Greenville, NC is the installation of a state of the art continuous manufacturing suite.

About Patheon
Patheon is a leading global provider of pharmaceutical development and manufacturing services. With approximately 9,100 employees and contractors worldwide, Patheon provides a comprehensive, integrated and highly customizable set of solutions to help clients of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle. A Healthier World. Delivered. www.patheon.com

Editors’ Notes: Glossary of Terms

Aseptic processing is the process by which a sterile (aseptic) product (a pharmaceutical) is packaged in a sterile container in a way that maintains sterility.

Freeze-drying—technically known as lyophilisation, lyophilization, or cryodesiccation—is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Freeze-drying works by freezing the material and then reducing the surrounding pressure to allow the frozen water in the material to sublimate directly from the solid phase to the gas phase.

cGMP Facility: cGMP refers to current Good Manufacturing Practices, a rigorous set of manufacturing guidelines the U.S Food and Drug Administration (FDA) uses to document and ensure the products it regulates are produced safely and consistently.

Sublimation is the transition of a substance directly from the solid to the gas phase without passing through the intermediate liquid phase.