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, NH campus.
Enhanced capabilities
Twin lyophilisers and a large-scale isolator filling line are currently being installed at the forthcoming 50,000 sqft plant as foundational components of a multi-year USD $100m capital investment project.
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.
The facility will provide increased capacity using Annex 1-compliant technology, including an aseptic fill-finish line within a fully isolated containment system. This is complete with twin 430 sqft 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 late phase clinical and commercial small molecules and biologics.
This includes 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 production capacity.
“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 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.”
