PHILADELPHIA -- PCI Pharma Services, (“PCI”) a leading global contract development and manufacturing organization (CDMO) focused on biopharma’s most complex therapies, is investing more than $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. Comprising new and expanded facilities in both Europe and North America, the effort is part of PCI’s global investment plan, is anchored and funded by recent new business, and is designed to augment and accommodate future growth.

For 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, the 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.

New US Center of Excellence

In the United States, PCI has plans for 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 the 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 houses 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, complete with sophisticated top-open cartoning technology and extensive final assembly and functional product testing to ISO standards.

PCI also is announcing plans for a further 70,000-square-foot expansion dedicated to advanced drug delivery and patient-centric drug-device combination assembly and packaging. 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 brought online in two phases, with operations expected to commence in Q3 2025.

All totaled, PCI’s goal is to be among the first CDMOs to bring whole-lifespan development of these advanced drug delivery and drug-device combination products under one roof. The company aims to marry efficiencies and streamline the journey from clinical stages through launch and commercialization, supported by cold chain storage solutions providing end-to-end service.

Expanded EU Operations

Additionally, PCI is amplifying its presence and impact around the world with a newly acquired built-for-purpose pharmaceutical packaging and device assembly facility near Dublin, Ireland providing large-scale temperature-controlled storage capabilities. Operations are scheduled to commence in Q4 2024, with the facility providing commercial-scale packaging and assembly operations for injectables as well as oral solid dose (OSD) drug products.

Elsewhere in Ireland, PCI has broken ground on a new packaging and device assembly services facility at its CityNorth Dublin campus. Slated to begin 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. The facility also will include cold chain packaging for injectable and biologic products, as well as associated temperature-controlled storage.

Both new EU facilities will leverage PCI’s established multi-disciplinary 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.

Supporting these growing operations, with recent HPRA approval PCI has opened a further large-scale warehouse in Dublin incorporating cold chain storage capabilities to support customer demand. 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.

“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,” said Salim Haffar, CEO of PCI Pharma Services. “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.”