PCI Pharma Services said that it is investing over $365m to enhance the infrastructure for clinical and commercial-scale assembly and packaging of drug-device combination products.

The investment by the contract development and manufacturing organisation (CDMO) focuses on products that utilise advanced drug delivery systems, particularly in injectable formats.

Part of PCI Pharma Services’ global investment plan, the expansion includes new and expanded facilities in Europe and North America. It also includes investment in the Biotech Center of Excellence in Philadelphia.

In Rockford, Illinois, the CDMO plans a 545,000ft2 expansion at its campus focused on advanced drug delivery and drug-device combination assembly and packaging.

The project includes 475,000ft2 for advanced drug delivery injectable packaging and additional warehousing. It will feature over 20 customer suites equipped for scalable assembly and packaging of vials, prefilled syringes, autoinjectors, and pen-cartridge combinations.

This facility will also include advanced technology for top-open cartons and functional product testing to ISO standards.

Additionally, the CDMO also intends a 70,000ft2 expansion for the assembling of advanced drug delivery and patient-centric drug devices. This expanded facility will offer various packaging technologies, with operations expected to begin in Q3 2025.

Overall, PCI Pharma Services aims to advance in the CDMO sector for the full lifespan development of advanced drug delivery products and drug-device combination products under a single roof. This will ensure efficiency from clinical stages to market launch with cold chain storage solutions.

Furthermore, PCI Pharma Services is enhancing its global presence with a newly acquired pharmaceutical packaging and device assembly plant near Dublin, Ireland.

This facility, designed for large-scale temperature-controlled storage, is set to begin operations in Q4 2024. It will focus on commercial-scale packaging and assembly operations for injectables and oral solid dose (OSD) products.

Additionally, PCI Pharma Services has started construction on a new packaging and device assembly facility at its CityNorth Dublin campus.

Expected to open in Q3 2025, this Irish facility will increase capacity for the final assembly, labelling, and packaging of injectable products. It will also feature cold chain packaging and temperature-controlled storage.

The CDMO has also opened a large-scale warehouse in Dublin, aimed at enhancing cold chain storage capabilities to meet customer demand. This warehouse was recently approved by Ireland’s Health Products Regulatory Authority (HPRA).

PCI Pharma Services CEO Salim Haffar said: “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.”