PCI Pharma Services Introduces New Manufacturing Facility Ahead of BIO 2025
The facility is on the company’s Bedford, NH campus, where another existing building will be repurposed into a Development Center of Excellence.
PCI Pharma Services office in Mississauga, Ontario, Canada on September 19, 2020. PCI is an expert in pharmaceutical and biopharmaceutical supply chain solutions. | Image Credit: © JHVEPhoto - stock.adobe.com
PCI Pharma Services, headquartered in Philadelphia, is providing updates on its new purpose-built facility for large-scale sterile fill/finish operations at its Bedford, NH campus, which company representatives will be on hand to discuss with attendees at the Biotechnology Innovation Organization (BIO) International Convention, to be held June 16–19, 2025 in Boston (1). The 50,000-square-foot facility is expected to approach full-scale good manufacturing practice (GMP) production in summer 2025.
“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 a company press release (1). “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.”
Features of the facility
According to the press release, the new Bedford building—the third high-throughput, isolator-based commercial sterile fill/finish facility PCI Pharma Services has built since 2021—showcases Annex 1-compliant manufacturing technologies, notably including an aseptic vial fill/finish line in a fully isolated containment system, which is equipped with twin 430-square-foot lyophilizers with automatic loading and unloading (1). PCI Pharma says the high-speed integrated filler has the capability to produce batches of up to 300,000 vials, at a speed of up to 400 per minute.
The overarching purpose of the new facility, PCI Pharma said, is to enhance the company’s capacity and capabilities for sterile fill/finish of late-phase clinical and large-scale commercial small molecule and biologic drugs, including but not limited to monoclonal antibodies, fusion proteins, and peptides (1). In August 2024, PCI Pharma announced that the Bedford campus had 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 this particular facet of ICMRA’s new Collaborative Hybrid Inspection Pilot program (2).
Other improvements to the campus
Pharmaceutical development capabilities at the Bedford campus are also being overhauled, such as repurposing an existing building into a dedicated Development Center of Excellence (CoE) (1). This follows PCI’s investment of more than $365 million, announced in September 2024, into numerous facilities in the United States and the European Union, including its Biotech CoE in Philadelphia (3).
Pharmaceutical Technology® Group caught up with PCI Pharma as part of its coverage of BIO 2024 in San Diego, when Jeff Clement, executive director of Technical Sales for the company’s Development and Manufacturing Group, spoke about robotics in sterile processing (4). Click here for the full video interview.
PCI Pharma Services will be stationed at Booth #1979 at BIO 2025.
References
1. PCI Pharma Services. At BIO Show in Boston, PCI Pharma Services to Provide Updates on New Manufacturing Facility at Nearby Bedford, NH Campus. Press Release. June 3, 2025.
2. PCI Pharma Services. PCI Pharma Services’ Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection. Press Release. Aug. 21, 2024.
3. PCI Pharma Services. PCI Pharma Services Invests Over $365 Million in EU, US Facilities for Clinical and Commercial Supply of Advanced Drug Delivery and Drug-Device Combination Products. Press Release. Sept. 24, 2024.
4. Haigney, S. BIO 2024: Robotics in Sterile Processing. BioPharmInternational.com, June 3, 2024.
