PCI Pharma to Open New Sterile Fill-Finish Facility in USA
Introduction:
PCI Pharma Services plans to open newest sterile fill-finish facility in USA.
Features:
The facility will enhance capacity with Annex 1-compliant technology, featuring an aseptic fill-finish line within a fully isolated containment system, and equipped with twin 430-square-foot lyophilizers with automatic loading and unloading systems.
The new high-volume lyophilisation and liquid filling facility will add to the ability to provide full product lifecycle management from formulation and lyo cycle development through clinical stages and large commercial-scale sterile manufacturing.
The integrated filler will manufacture batch sizes up to 300,000 vials at a rate of up to 400 vials per minute, providing significant 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.
The new facility is slated for completion in late fall, with GMP production expected to commence in Q1 2025.
Specifications:
Name PCI Pharma Services
Type New Construction
Year 2025
