PCI Clinical Services announces site expansion to support growth and flexibility 15th November 2018
PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the 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 US-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 features highly 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, demonstrating PCI’s commitment to investment in a leading position to support clients’ global Clinical trial supply needs.
Brian Keesee, Vice President and General Manager, at PCI, said: “We are extremely excited to see the initial construction begin on our Clinical facility expansion at the Rockford site. 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.
“PCI’s continued investment in infrastructure and staff allows our clients to realize a safe and secure supply chain, ensuring their life-saving treatments are delivered on time to patients around the world. The flexible and scalable suites will aid in continuing to deliver on our number one commitment to clients: to provide the industry’s leading customer experience.”
PCI’s investment at the Rockford location is the latest in a series of strategic investments across the US, Europe and Asia Pacific regions providing localized and responsive services for global clinical studies. PCI recently announced the construction of a purpose-built and dedicated -40°C facility at the Rockford location. The announcement of further facilities expansion in Rockford complements similar investment in PCI’s Bridgend, UK location, as well as the acquisition of Sherpa Clinical Packaging in San Diego, CA. PCI also announced acquisitions over the past year leading to geographic expansions in Dublin, Ireland, providing expanded access and proactive mitigation for potential Brexit outcomes, as well as Melbourne, Australia, further expanding access for clients to emerging market locations.