PCI Pharma Services invests over $365 million in pharmaceutical commercialization

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO) focused on the biopharmaceutical industry's most complex therapies, announced that it is investing over $365 million in infrastructure to support the clinical and commercial final assembly and packaging of drug-device combination products using advanced drug delivery systems with a focus on injectable formats. The venture is part of PCI's global investment plan and will be supported and funded by new business lines with new and expanded facilities in Europe and North America, and is designed to support and drive future growth.

PCI's investments are based on over 20 years of experience in the biologics space, a leadership position underscored by the company's world-class Biotech Center of Excellence in Philadelphia. This site uses precision equipment for prefilled syringe handling, syringe assembly and labeling, vial labeling and cartoning, and auto-injector assembly. Recently, PCI has invested heavily in complex, automated, advanced drug delivery technologies to enhance the capabilities and capacity of this facility and ensure it remains at the forefront of innovation.

Together, these new projects strengthen PCI's ability to manage the entire life cycle of such products, from sterile drug product development and manufacturing through clinical trial supply to product launch and commercialization.

In the US, PCI is planning an ambitious 50,000 square meter expansion of its campus in Rockford, Illinois, which will focus on the assembly and packaging of advanced drug delivery systems and drug-device combinations.

The highlight of this phased plan is a comprehensive 45,000 square meter project that includes 345,000 square meters for packaging injectable drugs for advanced delivery and 130,000 square meters of additional storage space for products in all stages of development. The space features more than 20 customer suites with scalable technology for clinical and commercial final assembly and packaging of vials, prefilled syringes, auto-injectors and pen-cartridge combinations. It also features sophisticated top-open cartridge technology and extensive final assembly and functional product testing to ISO standards.

PCI announced a 6,500 square-foot expansion for the assembly and packaging of advanced drug delivery and patient-focused drug and device combinations. In response to customer needs, the facility will support a range of slow to fast packaging technologies for a variety of advanced drug delivery categories, including vials, prefilled syringes, auto-injectors and on-body injectors, among others. The facility is scheduled to come online in two phases, with operations expected to begin in the third quarter of 2025.

PCI's goal is to be among the first CDMOs to bring the entire development of these advanced drug delivery and drug-device combination products under one roof. The company aims to combine efficiencies and streamline the process from clinical phase to launch and commercialization, supported by cold chain storage solutions that provide an end-to-end service.

PCI is also increasing its presence and impact globally through a newly acquired purpose-built pharmaceutical packaging and device assembly facility near Dublin, Ireland, which provides large-scale temperature-controlled storage capacity. The facility, which will perform commercial-scale packaging and assembly operations for injectable and oral solid dose (OSD) drug products, is scheduled to begin operations in the fourth quarter of 2024.

Elsewhere in Ireland, PCI has begun construction of a new packaging and device assembly facility at its CityNorth Dublin campus. The facility is scheduled to be operational in the third quarter of 2025 and will provide increased capacity for the final assembly, labelling and packaging of injectable medicines, including vials, prefilled syringes and drug-device combination products such as auto-injectors. This facility will also include cold chain packaging for injectable and biological products and associated temperature-controlled storage.

These new EU facilities will leverage PCI's proven multidisciplinary expertise in operations, quality, engineering and project management. Scalable, state-of-the-art equipment – ​​as well as production-related services such as in-house dedicated packaging design and analytical laboratories to support manufacturability – will deliver patient-centric packaging solutions and a streamlined time-to-market process.

With the recent HPRA approval, PCI has opened a larger warehouse in Dublin, providing cold chain storage capacity to support customer demand. And overall, PCI's growing presence in Ireland provides enhanced commercial packaging capabilities and opportunities for pharma and biopharma customers around the world, with a focus on the EU markets.

KEY QUOTE:

“This major investment across multiple continents places PCI Pharma Services at the forefront of the global industry for advanced drug delivery solutions and drug-device combination product assembly. The new and expanded facilities and infrastructure demonstrate our commitment to meeting evolving market and customer needs for the final assembly and packaging of drugs and devices from clinical to commercial use, and further PCI's overarching goal of enabling life-changing therapies and patient convenience.”

-Salim Haffar, CEO of PCI Pharma Services