PCI Pharma Services, a global contract development and manufacturing organization (CDMO), has begun installation of key equipment for its newest sterile fill-finish facility at its Bedford, NH campus. Twin lyophilizers and a state-of-the-art large-scale isolator filling line are currently being installed at the new 50,000-sq.-ft. plant, as part of a multi-year $100 million 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 its goals to substantially increase sterile fill-finish capacity and production capabilities. Since the plant’s 2022 groundbreaking, PCI has developed aseptic-by-design processes as part of its fully isolated high-volume vial filling and lyophilization services. 
 
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-sq.-ft. 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 – including high-value drug products such as mAbs, oligonucleotides, fusion proteins and peptides.
 
Engineering and validation runs at the new facility are scheduled in late fall, with the line ready for GMP production in 1Q25. 
 
“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.”