PCI Pharma Services will use the BIO International Convention, 16-19th June in Boston, as a platform to introduce its new purpose-built facility for large-scale sterile fill-finish operations at its campus in nearby Bedford, NH.
PCI Pharma Services
At Booth 1979, PCI experts will provide attendees with key updates as the 50,000-square-foot facility approaches full-scale GMP production this summer.
With site construction and infrastructure installation now complete, PCI has commenced qualification activities for the Bedford plant’s Annex 1-compliant sterile fill-finish manufacturing technologies. Among other highlights, the facility houses an aseptic vial fill-finish line within a fully isolated containment system, equipped with twin 430-sq-ft lyophilisers featuring automatic loading and unloading systems. Providing additional capacity to accommodate PCI’s recent and anticipated growth, the robust, high-speed integrated filler can produce batches of up to 300,000 vials at speeds up to 400 per minute.
The site constitutes the third high-throughput, isolator-based commercial sterile fill-finish facility that PCI has built in the last four years. As it comes online, the new facility further improves PCI’s capacity and capabilities for the sterile fill-finish of late-phase clinical and large-scale commercial small molecule and biologic drugs – including life-changing, high-value drug products such as mAbs, fusion proteins and peptides.
PCI also is expanding its pharmaceutical development capabilities at its Bedford campus. The initiative’s highlights include repurposing an existing building into a dedicated Development Center of Excellence (CoE) providing formulation, analytical and process development, as well as stability testing.