PCI Pharma Services Begins Expansion Project
The CDMO’s Bedford, NH facility will welcome a new isolator filling line—along with twin lyophilizers—as part of a multi-year, $100 million capital investment project.
PCI Pharma Services, a contract development and manufacturing organization (CDMO) and biopharma global outsourcing services provider that currently operates 30 sites across seven countries, has started installing new equipment for what will soon be a 50,000 square-foot, sterile fill-finish facility on its Bedford, NH campus. The installation project features a state-of-the-art large-scale isolator filling line, along with twin lyophilizers, additions that comprise a multi-year, $100 million capital investment project. Additional equipment is to come thereafter.
The latest project builds on the momentum that the CDMO gathered after it had previously expressed its interest in significantly boosting its sterile fill-finish capacity and production capabilities; this specific site alone, which became active in 2022, contains the third high-throughput, isolator-based commercial sterile fill-finish facility that PCI has constructed over the last three years.
More specifically, the facility is expected to provide additional capacity using Annex 1-compliant technology, featuring an aseptic fill-finish line that contains fully isolated containment system, and twin 430-square-foot lyophilizers with automatic loading and unloading systems. The integrated filler will have the capacity to produce as many as 300,000 vials at a rate of up to 400 vials per minute, which can be used in large-scale filling capacity for both late-phase clinical and commercial small molecules and biologics. Standard examples include fusion proteins, mAbs, oligonucleotides, and peptides.
The line will be ready for good manufacturing practice production by Q1 2025. In the meantime, PCI will start allowing current and potential clients to visit the facility. The new high-volume lyophilization and liquid filling facility, PCI executives say, will add to PCI’s ability to provide full product lifecycle management.
“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,” commented John Ross, PCI Pharma Services’ SVP of drug development and manufacturing. “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.”
Reference
The Installation of Sterile Fill-Finish and Lyophilization Line as part of New Facility Expansion Begins. PCI Pharma Services. May 2, 2024. Accessed May 9, 2024. https://pci.com/sterile-fill-finish-lyophilization-line-bedford-expansion-begins/
