PCI Pharma Services Invests in Infrastructure to Bolster Domestic Manufacturing Footprint

PCI Pharma Services, an integrated global contract development and manufacturing organization (CDMO), has announced a series of major infrastructure investments intended to deepen its sterile fill-finish and advanced drug delivery capabilities.

As pharma manufacturers and their development partners increasingly prioritize U.S. supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s U.S. and European operations, reinforcing its ability to provide seamless support for drug product development and manufacturing, clinical trial supply and drug-device combination assembly from clinical stages through commercial launch – all underpinned by global capacity, technical expertise, deep scientific knowledge, and an industry-leading quality and regulatory track record.

At the core of PCI’s investment plan is a $100 million project at its San Diego campus, featuring a high-speed isolator filling line for ready-to-use (RTU) prefilled syringes and cartridges. Scheduled to be operational in the first half of 2028, the line will more than double the site’s existing syringe and cartridge filling capacity. It will be PCI’s second isolator fill-finish line in San Diego, which currently supports and manufactures over 45 FDA-approved products. The campus also hosts large-scale aseptic filling for prefilled syringes and cartridges, alongside specialized capabilities in oligonucleotides, peptides, complex formulations and lyophilization for injectables such as nanoparticles, mRNA, mAbs, proteins, and highly potent products.

Meanwhile, PCI’s Bedford, New Hampshire campus is commissioning a GMP-ready bespoke isolator vial and lyophilization line that, upon commencing full-scale production this month, will be capable of producing batch sizes of up to 300,000 vials at 400 units per minute, for an annual total of 33 million – among the most robust, state-of-the-art setups of its kind in the U.S. The campus also will commission a customer-dedicated high-potent sterile fill-finish line slated to be one of a kind in the U.S.

In both San Diego and Bedford, PCI also has invested in cutting-edge automated visual inspection (AVI) systems for sterile fill-finish applications. In total, PCI’s US-based AVI infrastructure supports more than 70 million prefilled syringes and cartridges and 40 million vials per year, meeting the exacting standards of global pharmaceutical manufacturers.

Upgraded Drug-Device Combination Assembly and Packaging Platforms

PCI has also committed to numerous buildouts of autoinjector and drug-device combination assembly infrastructure at its campuses in Philadelphia, PA and Rockford, IL. Coming online via a phased approach over the next six months, the upgrades will significantly increase both capacity and scale, bolstering PCI’s integrated, clinical-through-commercial capabilities.

In 2027, PCI will add a third autoinjector line to its existing lineup, bringing its U.S. autoinjector and device assembly capacity to more than 250 million units per year. Featuring multi-device tooling technology and flexible change parts, the company’s autoinjector lines provide comprehensive high-speed assembly, while a dedicated prefilled syringe (PFS) safety device line adds labeling and secondary packaging options.

Philadelphia and Rockford also are home to PCI’s U.S. Packaging Centers of Excellence, which offer capacity for oral solid dose and injectable products, as well as cold chain storage. The GMP-compliant facilities can be rapidly mobilized to support programs at clinical or commercial scale; available capacity across the two sites includes annual accommodation for 40 million blister units, 70 million bottles, and 75 million vials.

Pharmaceutical Development Centers of Excellence

In conjunction with expanding its manufacturing platform, PCI is also investing in dedicated Development Centers of Excellence (CoE) in Bedford, NH and León, Spain, which will feature development capabilities spanning lyophilization, formulation, analytical support, drug-device combination assets, long-acting injectables and ophthalmic products. They will handle both highly potent and non-potent small molecule and biologic modalities in vial, prefilled syringe and cartridge presentations. The Bedford Development CoE is expected to be operational this May, with León following in June.

“The pharmaceutical industry is at an inflection point, with manufacturers seeking trusted U.S.-based partners to provide scale, expedience, and established quality and compliance track records to support the development and commercialization of next-generation treatments,” said Salim Haffar, CEO of PCI Pharma Services. “Backed by over $1 billion in global infrastructure investment and decades of operational expertise, PCI’s multi-year journey to bolster its domestic manufacturing footprint allows us to meet growing customer demand for innovative drug product and drug delivery solutions, toward the evergreen goal of delivering life-changing therapies to patients.”