PCI Pharma Services (PCI) has unveiled plans for an expansion of its clinical site at Rockford, IL. Construction of the expanded clinical services facility began on November 12, 2018. The site is one of two U.S.-based PCI locations supporting investigational medicinal products, complementing facilities in the UK, Europe and Australia.

The facility expansion at the Rockford location will provide 30,000 sq. ft. of additional space in support of primary and secondary packaging and labeling operations for investigational medicinal products at the Clinical Services Center of Excellence, including a dedicated 2-8°C packaging suite for cold chain products. PCI offers specialized capability and expertise in supporting temperature-sensitive therapies, including cold chain and ultra cold chain, at temperatures ranging from controlled room temperature (CRT) 15-25°C, 2-8°C, down to -20°C, -30 -40°C, -80°C and including cryogenic storage below -196°C for advanced therapeutic medicinal products (ATMPs) including cell and gene therapies, as well as bespoke refrigerated and frozen temperatures according to client needs.

The expanded building, which is expected to open for business in late 2019 following internal fit-out and a period of validation and licensing, will provide increased flexibility to meet customer needs. Purpose-built for scalable primary and secondary packaging and labeling, the new packaging suites offer maximum flexibility, with the ability to operate on either a stand-alone or integrated basis across suites. The build will feature a state-of-the-art 2-8°C packaging room for cold chain products. Additionally, the expansion will include a reception area and will double the current office space to meet staff growth plans.

“We are extremely excited to see the initial construction begin on our clinical facility expansion at the Rockford site,” said Brian Keesee, vice president and general manager, PCI. “The expansion was a direct result of listening to the needs of our customers. PCI is involved with clinical trials that are being executed all around the world and the ability to react quickly is paramount to ensuring the success of a trial. We are also seeing more focus on specialized medicines with special handling requirements. Particularly with the market growth in biologics and biosimilars, the need for temperature-controlled therapies continues to increase. The new suites will allow us to provide faster turn-around times and increased flexibility.