Introduction
The leading CDMO is currently installing key equipment for its latest sterile fill-finish facility, including twin lyophilizers and a state-of-the-art large-scale isolator filling line.
Features
This marks PCI's third high-throughput, isolator-based commercial sterile fill-finish facility in three years, aimed at substantially increasing its sterile fill-finish capacity and production capabilities.
The facility features Annex 1-compliant technology, including a fully isolated containment system with an aseptic fill-finish line.
This facility represents a significant $100 million capital investment project spanning 50,000 square feet.
It includes twin 430-square-foot lyophilizers with automated loading and unloading systems and an integrated filler capable of manufacturing batch sizes of up to 300,000 vials at a rate of up to 400 vials per minute.
Engineering and validation runs are scheduled for late fall, with GMP production set to begin in Q1 2025.
PCI plans to invite current and potential clients to tour the facility starting this summer, offering opportunities to reserve production capacity.
PCI Pharma Services is nearing completion of construction and validation activities at its Bedford, NH campus for its latest sterile fill-finish facility.
PCI Pharma Services aims to enhance its capabilities in product lifecycle management with this new facility, reinforcing its commitment to delivering complex drug development projects efficiently and reliably.
Specification
Name PCI Pharma Services
Type New Facility Expansion
Year 2025
