PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global healthcare industry, has completed a purpose-built -40°C storage and distribution facility at its North American Clinical Services Center of Excellence.
The site, located in Rockford, IL, features packaging and labeling services, logistical services for global storage and distribution, as well as onsite analytical laboratory services. PCI’s Rockford location provides end-to-end support for cold chain requirements, with temperatures including 15°-25°C, 2°-8°C, -20°C, -40°C, -80°C as well as cryogenic storage at -196°C and is one of eight global locations supporting medicines destined to more than 100 countries around the world.
PCI initiated the design of the dedicated -40° facility with specific requirements based on the unique infrastructure needs set forth by the client. With a collaborative approach, PCI provided insights and expertise to ensure conformance to the drug requirements as well as mitigate various risk factors in the global supply chain.
The completed specialized cold chain storage facility spans more than 10,000 sq-ft and features a 300-pallet controlled storage capacity designed to provide planned redundancies for the critical storage needs of the life-saving drug product.
PCI’s Director of Facilities Engineering, Russ Stevens, the principle lead on the specialized project build, says, “We have decades of experience with controlled temperature infrastructure, both controlled temperature packaging and controlled temperature storage, across a broad range of environmental conditions. It is noteworthy that each temperature parameter provides for unique considerations in managing the conditions and mitigating risks. We engineered a multitude of installed mechanisms to assure continuity of supply, with redundancies in freezers and control units, as well as incorporating protections for infrastructure, fire, power, and many other factors, to the extent that we even took very specialized approaches to the engineering of the concrete foundation. It is truly cutting edge, to the degree that we are utilizing predictive technologies to help mitigate potential failure modes. It has been an amazing collaboration.”
PCI Vice President and General Manager Global Clinical Operations & Supply, Brian Keesee adds, “The new -40°C facility not only demonstrates the cold chain expertise of the team here at PCI, but also our dedication to our clients and the lengths we go to accommodate the needs of their specialized medicines—no matter the challenge. This particular application had some distinctly unique requirements. Being trusted to help support such an important therapy for patients in need around the world, the team really embraced the opportunity. The positive client feedback has been very gratifying and validated our goal to provide the industry leading customer experience.”
This facilities installation announcement is the latest reflects PCI’s commitment to ongoing expansion and investment in global cold chain infrastructure, as well as continuing to make considerable capital investments in facilities and capacity expansion. PCI’s Philadelphia facility has recently completed a considerable build out of its 2°-8°C Cold Chain storage, complementing other 2°-8°C investments across the existing PCI cold chain network around the world. Other investments have expanded PCI’s frozen and cryogenic storage across its vast supply network.
PCI anticipates further capacity expansions for cold chain and ultra cold chain as demand continues to be strong for biologically derived medicines as well as the emerging market for cell and gene therapies. It is estimated that close to 40% of all medicines in pipeline development are new molecular entity biologics, as well as more than 50 distinct biosimilar compounds targeted towards existing medicines losing patent expiry.