PCI Pharma Services Begins Installation of Sterile Fill-Finish and Lyophilisation Line as Part of $100m New Facility Expansion
May 2, 2024 – BioManufacturing, Manufacturing and Packing – PCI Pharma Services, facility expansion, lyophilisation
Construction and validation activities at leading CDMO’s Bedford, New Hampshire, US, campus will conclude later this year, with GMP production commencing early 2025
2 May 2023 — Pennsylvania, US — PCI Pharma Services, a world leading global contract development and manufacturing organisation (CDMO), has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, New Hampshire, US, campus. Twin lyophilisers and a state-of-the-art large-scale isolator filling line are currently being installed at the forthcoming 50,000-square-foot plant, as foundational components of a previously announced, multi-year $100m capital investment project. Additional equipment will be incorporated in the coming weeks.
The site constitutes the third high-throughput, isolator-based commercial sterile fill-finish facility that PCI has built in the last three years, aligning with the CDMO’s goals of substantially increasing its sterile fill-finish capacity and production capabilities. Since the plant’s 2022 groundbreaking, PCI has methodically developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilisation solutions.
The facility will provide increased capacity using Annex 1-compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin 430-square-foot lyophilisers featuring automatic loading and unloading systems. The integrated filler will be capable of manufacturing batch sizes of up to 300,000 vials at a rate of up to 400 vials per minute, providing large-scale capacity for the filling of life changing, late phase clinical and commercial small molecules and biologics – including high-value drug products such as mAbs, oligonucleotides, fusion proteins and peptides.
Engineering and validation runs at the new facility are scheduled to occur in late fall, with the line ready for GMP production in Q1 2025. Starting this summer, PCI will be inviting current and potential clients to visit the plant, providing the opportunity to reserve valuable production capacity.
PCI has over 25 years of experience in lyophilisation and sterile fill-finish manufacturing, offering deep technical expertise in the end-to-end processing of innovative and complex products. The new high-volume lyophilisation and liquid filling facility will add to PCI’s ability to provide full product lifecycle management – from formulation and lyo cycle development through clinical stages and large commercial-scale sterile manufacturing.
“PCI’s expert technical, engineering and project management teams – working closely with our long-term contractor partners – are among the industry’s most experienced when it comes to delivering complex, time-sensitive capital projects,” said John Ross, senior vice president of Drug Development and Manufacturing for PCI Pharma Services. “Our soon-to-open and newest sterile fill-finish and lyophilisation facility at our expansive Bedford campus will continue to showcase these strengths, and serve to significantly expand our offering in bringing novel medicines to patients.”
About PCI Pharma Services
PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, US, Ireland, Wales, Germany and Spain), and over 6,000 employees working to bring life-changing therapies to patients. Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialisation. Its clients utilise PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients’ lives. For more information, visit pci.com.
