BIO 2025

PCI Pharma Services (PCI), a global contract development and manufacturing organization (CDMO), will use the BIO International Convention as a platform to introduce its new purpose-built facility for large-scale sterile fill-finish operations at its campus in nearby Bedford, NH. At the event, 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 lyophilizers 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. Other best-in-class production infrastructure at the new site includes Smart Fill modules that maximize product usage and prevent underfills, SKANFOG decontamination technology, and comprehensive quality control systems such as 100% checkweighing and inline camera inspection.

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 bolsters 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. The effort further integrates PCI’s development, manufacturing and packaging services by strengthening its agility, technical partnership and agnostic sterile development profiles. Expected to be operational in early 2026, the Development CoE will handle both potent and non-potent APIs, small molecules, PROTACs, and a wide range of biologics, including antibody-drug conjugates (ADCs).

“With large-scale GMP manufacturing activities for sterile fill-finish products set to commence, the BIO show is an ideal setting to introduce this new state-of-the-art Bedford campus facility to our pharma company customers and industry colleagues,” said Salim Haffar, CEO of PCI Pharma Services. “In addition to supporting our global commitment to providing fully isolated high-volume vial filling and lyophilization solutions, the new Bedford site aligns with PCI’s recent efforts to strengthen our production portfolio in the United States, creating additional synergies, efficiencies and redundancies throughout our supply chains and customer service arrangements.”