PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO) announced a major expansion of capabilities and capacity in aseptic liquid fill-finish and sterile lyophilization technology, an important manufacturing process commonly used with injectable and biologic therapies, with the investment of 100 Million USD into the construction and enhancement of world-class facilities, at its Bedford, New Hampshire campus.
Following PCI’s acquisition of Lyophilization Services of New England, Inc. (LSNE) in December 2021, this expansion plan includes a 50,000 square foot facility, which will allow PCI to grow its breadth of services as a global CDMO, building on its expertise in biologics packaging and specialty manufacturing with a multi-product facility to service new and existing clients. The building will contain state of the art technology, including an aseptic fill-finish line with a fully isolated containment system. It will also hold twin lyophilizers with auto-loading and unloading systems, with the capacity to complete 400 vials per minute on a sterile fill-finish line, helping accelerate speed to market so that patients receive therapies faster.
The Bedford facility will allow PCI to stay ahead of growing demands for integrated large and small molecule solutions for clinical and commercial clients. Following PCI’s recently announced construction of the New England Clinical Center of Excellence in Bridgewater, MA, the Bedford location is well-positioned to create a centralized hub for its Northeast clients. PCI will also expand three additional Bedford-based facilities with more aseptic fill-finish and lyophilization capabilities to deliver market and dedicated client-based needs.
“We are excited to introduce clients to our newest facility, which is part of our broader strategy to provide integrated end-to-end drug development, manufacturing and packaging capabilities,” said Salim Haffar, Chief Executive Officer, PCI Pharma Services. “Our investment in these facilities will ensure that PCI continues to leverage new capabilities in complex formulations, aseptic fill-finish, and lyophilization to meet the needs of our global clients, particularly as biologics continue their strong growth trajectory.”
This announcement marks the latest in a series of worldwide expansions the company has made across multiple continents and five other sites, including Berlin; San Diego; Rockford, Illinois; and Melbourne, Australia. PCI sites in San Diego and Melbourne added state of the art equipment with aseptic fill-finish capabilities in February 2022 to enhance global offerings and deliver much-needed capacity to early phase clients. The new Bedford facility is dedicated to high-volume lyophilization, liquid filling, and multi-product handling from one format to another. PCI will also continue to further increase capacity and capabilities of their other aseptic fill-finish facilities, including Leon, Spain and Madison, Wisconsin, with plans to hire additional manufacturing teams, deploy capital investment and increase the delivery of life-changing therapies to patients.