As pharma manufacturers prioritize US supply chain resilience, highlights include high-speed isolator filling lines for prefilled syringes, cartridges and vials, and drug-device combination assembly and packaging.
PHILADELPHIA–(BUSINESS WIRE)–PCI Pharma Services (“PCI”) – a world-leading integrated global contract development and manufacturing organization (CDMO) focused on innovative biologic and small molecule therapies – announced a series of major infrastructure investments that substantially deepen its sterile fill-finish and advanced drug delivery capabilities. As pharma manufacturers and their development partners increasingly prioritize US supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s US 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 US. The campus also will commission a customer-dedicated high-potent sterile fill-finish line slated to be one of a kind in the US.
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.
Investments in Drug-Device Combination Assembly and Packaging Platforms
In partnership with leading device manufacturers, PCI has 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 US 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 US Packaging Centers of Excellence, which offer ample capacity for oral solid dose and injectable products, as well as substantial 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 investing in dedicated Development Centers of Excellence (CoE) in Bedford, NH and León, Spain. The CoEs 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 US-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.”
About PCI Pharma Services
PCI is a world-leading CDMO providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 38 sites across seven countries (United States, Canada, United Kingdom, Ireland, Germany, Spain and Australia), and over 7,500 employees working to bring life-changing therapies to patients.
Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients’ lives. For more information, visit pci.com.
Contacts
PCI Pharma Services
Christopher Dale, Turchette Agency
(973) 227-8080, ext. 116; [email protected]
