PCI Pharma Services Invests $100M in New CDMO Facility

• PCI Pharma Services is installing key equipment at its new sterile fill-finish facility in Bedford, NH, part of a multi-year $100 million investment project.

• The facility is scheduled for engineering and validation runs in late fall, with the line ready for GMP production in 1Q25.

PCI Pharma Services, a global contract development and manufacturing organization (CDMO), has initiated the installation of crucial equipment for its latest sterile fill-finish facility at its Bedford, New Hampshire campus. This development is part of a multi-year $100 million investment project, with additional equipment set to be incorporated in the coming weeks.

This site represents the third high-throughput, isolator-based commercial sterile fill-finish facility that PCI has constructed in the past three years. This aligns with the company’s objectives to significantly enhance sterile fill-finish capacity and production capabilities. Since the plant’s groundbreaking in 2022, PCI has developed aseptic-by-design processes as part of its fully isolated high-volume vial filling and lyophilization services.

The new facility will offer increased capacity using Annex 1-compliant technology. This includes 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. This provides 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 for late fall, with the line ready for GMP production in first quarter of 2025. This marks a significant milestone in PCI’s ongoing expansion and commitment to contract manufacturing.

John Ross, Senior Vice President Drug Development and Manufacturing for PCI Pharma Services, commented on the development, “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.” This statement underscores PCI’s dedication to delivering complex, time-sensitive capital projects and their commitment to innovation in the pharmaceutical industry.