PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO) focused on biopharma’s most complex therapies, announced it is investing over $365 million in infrastructure supporting the clinical and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced drug delivery systems, with an emphasis on injectable formats. The effort is part of PCI’s global investment plan, anchored and funded by recent new business featuring new and expanded facilities in Europe and North America. It is designed to augment and accommodate future growth.
Through PCI, the investments build upon 20-plus years of biologics expertise, a leadership position highlighted by the company’s world-class Biotech Center of Excellence in Philadelphia. That location employs precision handling equipment for prefilled syringes, syringe assembly and labeling, vial labeling and cartoning, and autoinjector assembly. Recently, PCI heavily invested in complex, automated advanced drug delivery technologies to enhance capabilities and capacities at this facility, ensuring it remains at the forefront of innovation.
Combined, these new projects further bolster PCI’s ability to manage the full lifespan of such products, from sterile drug product development and manufacturing through clinical trial supply, product launch, and commercialization.
In the US, PCI plans an ambitious 545,000-square-foot expansion at its campus in Rockford, Illinois, dedicated to advanced drug delivery and drug-device combination assembly and packaging.
Highlighting this phased plan is a comprehensive 475,000-square-foot project comprising 345,000 square feet for advanced drug delivery injectable packaging and 130,000 square feet of additional warehousing for products in all development phases. The space has over 20 customer suites, with scalable technology for the clinical and commercial-scale final assembly and packaging of vials, prefilled syringes, autoinjectors, and pen-cartridge combinations. It also features sophisticated top-open cartooning technology and extensive final assembly and functional product testing to ISO standards.
PCI announced a 70,000-square-foot expansion for advanced drug delivery and patient-centric drug-device combination assembly and packaging. As a response to customer needs, the facility will support a range of low- to high-speed packaging technologies for a variety of advanced drug delivery categories, including but not limited to vials, prefilled syringes, autoinjectors, and on-body injectors. The plant is intended to be online in two phases, with operations expected to commence in Q3 2025.
PCI’s goal is to be among the first CDMOs to bring the whole-lifespan development of these advanced drug delivery and drug-device combination products under one roof. The company aims to combine efficiencies and streamline the journey from clinical stages through launch and commercialization, supported by cold chain storage solutions that provide end-to-end service.
PCI is also amplifying its presence and impact around the world with a newly acquired built-for-purpose pharmaceutical packaging and device assembly facility near Dublin, Ireland, which provides large-scale temperature-controlled storage capabilities. The facility, which will provide commercial-scale packaging and assembly operations for injectables as well as oral solid dose (OSD) drug products, is scheduled to commence operations in Q4 2024.
PCI has broken ground elsewhere in Ireland on a new packaging and device assembly services facility at its CityNorth Dublin campus. Slated to start operations in Q3 2025, the plant will provide increased capacity for the final assembly, labeling, and packaging of injectable drug products, including vials, prefilled syringes, and drug-device combination products such as autoinjectors. This facility will also include cold chain packaging for injectable and biologic products and associated temperature-controlled storage.
These new EU facilities will utilize PCI’s established multidisciplinary expertise across operations, quality, engineering, and project management. Scalable state-of-the-art equipment—as well as production-adjacent services such as dedicated in-house packaging design and analytical laboratories to support manufacturability—will deliver patient-centric packaging solutions and a streamlined commercial launch process.
With recent HPRA approval, PCI has opened a larger warehouse in Dublin that incorporates cold chain storage capabilities to support customer demand. And overall, PCI’s growing footprint in Ireland provides enhanced commercial packaging capabilities and capacity for pharma and biopharma customers around the world, with a focus on the EU markets.
KEY QUOTE:
“This substantial, multi-continent investment places PCI Pharma Services at the forefront of the global advanced drug delivery solutions and drug-device combination product assembly landscape. The new and expanded facilities and infrastructure showcase our commitment to meeting evolving market and customer needs for clinical-to-commercial drug-device final assembly and packaging, and furthers PCI’s overarching purpose of enabling life-changing therapies and patient convenience.”
-Salim Haffar, CEO of PCI Pharma Services
