24th September, 2024
Highlights include investment in new CoE for advanced drug-device combination product assembly and packaging
PCI Pharma Services, 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.
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. 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 the third quarter next year.
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. 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.
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