PCI Pharma Expands U.S. Sterile Manufacturing Capacity

PCI Pharma Services

PHILADELPHIA, PA — PCI Pharma Services announced more than $1 billion in infrastructure investments across its U.S. and European operations, including expanded sterile fill-finish manufacturing, drug-device assembly, and pharmaceutical development capabilities.

The company said the investments are intended to support growing demand for domestic pharmaceutical manufacturing and supply chain resilience.

A central component of the expansion includes a $100 million project at PCI Pharma Services’ San Diego campus, where the company plans to add a high-speed isolator filling line for ready-to-use prefilled syringes and cartridges.

The new San Diego line is scheduled to begin operations in the first half of 2028 and is expected to more than double syringe and cartridge filling capacity at the facility, according to the company.

PCI Pharma Services said the San Diego campus currently supports production of more than 45 FDA-approved products and provides aseptic filling capabilities for injectables including mRNA, monoclonal antibodies, proteins, peptides, and highly potent compounds.

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In Bedford, New Hampshire, the company said it is commissioning a GMP-ready isolator vial and lyophilization line capable of producing up to 300,000 vials per batch at rates of 400 units per minute.

The Bedford operation is expected to support annual production of approximately 33 million vials.

PCI Pharma Services also said it is expanding drug-device combination assembly and packaging operations at facilities in Philadelphia and Rockford, Illinois.

The company said upgrades scheduled over the next six months will increase autoinjector and combination device assembly capacity, with a third autoinjector line planned for 2027.

Once complete, the company said its U.S. autoinjector and device assembly operations will support more than 250 million units annually.

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Philadelphia and Rockford also serve as the company’s U.S. packaging centers for injectable and oral-dose pharmaceutical products, including cold-chain storage operations.

The company said those facilities currently support annual packaging capacity of 40 million blister units, 70 million bottles, and 75 million vials.

PCI Pharma Services also announced new pharmaceutical development centers in Bedford and León, Spain, focused on formulation development, lyophilization, analytical support, ophthalmic products, and long-acting injectables.

The Bedford development center is expected to open this month, followed by the León facility in June.

Chief Executive Officer Salim Haffar said pharmaceutical manufacturers are increasingly seeking U.S.-based development and manufacturing partners with established regulatory and production infrastructure.

“The pharmaceutical industry is at an inflection point, with manufacturers seeking trusted US-based partners to provide scale, expedience, and established quality and compliance track records,” Haffar said.

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