PCI Pharma Services is set to introduce its new purpose-built sterile fill-finish manufacturing facility at the BIO International Convention in Boston, marking a significant expansion of the company's biologic production capabilities. The 50,000-square-foot facility at PCI's Bedford, NH campus is approaching full-scale GMP production this summer, representing the company's third high-throughput, isolator-based commercial sterile fill-finish facility built in the last four years.
Advanced Manufacturing Capabilities
The new Bedford facility showcases Annex 1-compliant sterile fill-finish manufacturing technologies, featuring an aseptic vial fill-finish line within a fully isolated containment system. The facility houses twin 430-square-foot lyophilizers equipped with automatic loading and unloading systems, designed to accommodate PCI's recent and anticipated growth in biologic manufacturing.
The robust, high-speed integrated filler can produce batches of up to 300,000 vials at speeds up to 400 per minute. Additional production infrastructure includes Smart Fill modules that maximize product usage and prevent underfills, SKANFOG decontamination technology, and comprehensive quality control systems featuring 100% checkweighing and inline camera inspection.
Enhanced Biologic Production Portfolio
The facility is specifically designed to bolster PCI's capacity and capabilities for sterile fill-finish of late-phase clinical and large-scale commercial small molecule and biologic drugs. The facility will handle life-changing, high-value drug products including monoclonal antibodies (mAbs), fusion proteins, and peptides.
"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.
Development Center of Excellence
PCI is simultaneously expanding its pharmaceutical development capabilities at the Bedford campus through the establishment of a dedicated Development Center of Excellence (CoE). The initiative involves repurposing an existing building to provide formulation, analytical and process development, as well as stability testing services.
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). This expansion further integrates PCI's development, manufacturing and packaging services by strengthening its agility, technical partnership and agnostic sterile development profiles.
Strategic Growth and Regulatory Recognition
The new facility's launch comes months after PCI's May acquisition of San Diego-based Ajinomoto Althea, Inc, which broadened PCI's manufacturing capabilities from coast to coast. The acquisition brought additional assets for high potent vial filling with lyophilization, as well as high-volume prefilled syringe and cartridge filling with isolator technology, making PCI one of the few CDMOs capable of high potent vial filling and prefilled syringe manufacturing in the United States.
In August 2024, the Bedford campus successfully completed the multi-agency inspection process of the International Coalition of Medicines Regulatory Authorities (ICMRA), making PCI the first drug contract development and manufacturing organization to navigate ICMRA's new Collaborative Hybrid Inspection Pilot program.
Industry Leadership Position
With over 25 years of experience in lyophilization and sterile fill-finish manufacturing, PCI offers deep technical expertise in the end-to-end processing of innovative and complex products. The new facility adds 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.
Haffar emphasized that the new Bedford site aligns with PCI's recent efforts to strengthen its production portfolio in the United States, "creating additional synergies, efficiencies and redundancies throughout our supply chains and customer service arrangements."
PCI currently operates 38 sites across seven countries and employs over 7,500 people working to bring life-changing therapies to patients, with more than 90 successful product launches each year.
