PCI Pharma Services will use the BIO International Convention, June 16-19 in Boston, as a platform to introduce our new purpose-built facility for large-scale sterile fill-finish operations at our campus in nearby Bedford, NH.
At Booth 1979, our 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, we have commenced qualification activities for the Bedford plant’s sophisticated, 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 our 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 we have built in the last four years. As it comes online, the new facility further bolsters our 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.
We are also expanding our 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 our development, manufacturing and packaging services by strengthening our 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).
Aligning with our strategic development of aseptic-by-design processes, the new Bedford facility’s inaugural GMP production runs will come just months after our May acquisition of San Diego-based Ajinomoto Althea, Inc, broadening our manufacturing capabilities from coast to coast. In the sterile fill-finish category, the acquisition brought us additional assets for high potent vial filling with lyophilization, as well as high-volume prefilled syringe and cartridge filling with isolator technology – complementing our existing advanced drug delivery technologies, such as device assembly and final packaging. Notably, the move makes us one of the few CDMO’s capable of high potent vial filling and prefilled syringe manufacturing in the United States.
PCI has over 25 years of experience in lyophilization and sterile fill-finish manufacturing, offering deep technical expertise in the end-to-end processing of innovative and complex products. The new high-volume lyophilization and liquid filling facility will add to PCI’s ability to provide full product lifecycle management – from formulation and lyo cycle development through clinical stages and large commercial-scale sterile manufacturing. In addition, the company’s legacy skillsets, organic growth and recent acquisition activities combine to cement our leadership in prefilled syringes and other advanced drug delivery platforms.
“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.”
