PCI Pharma Services begins installation of sterile fill-finish line
03 May 2024
PCI Pharma Services, a contract development and manufacturing organisation (CDMO), has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus.
Twin lyophiliers and a 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 $100 million 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 developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilization 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 lyophilizers 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 lyophilization and sterile fill-finish manufacturing, offering deep technical expertise in the end-to-end processing of innovative and complex products. The new high-volume lyophilization 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 drug development and manufacturing for PCI Pharma Services. “Our soon-to-open and newest sterile fill-finish and lyophilization 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.”
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