PCI Clinical Services has added cryogenic storage capabilities at its Rockford, IL facilities, complementing those currently in place at the company’s Bridgend, UK Center of Excellence for Clinical Trial Services. The expansion supports research and development of cell-based therapies, explains Brian Keesee, Executive Director, Clinical Services at PCI. “Many of these products are in development, but represent an exciting new field of medicine,” he tells PMP News.
“The cryogenic storage is quite versatile and applicable to many fields of biologic research, commonly Advanced Medicinal Therapeutic Products (ATMP),” Keesee continues. “These may be used to support cell- or gene-based therapies and may include master cell banks, stem cells and cell lines, human or animal tissues or tissue engineered products, blood products, or other fluids.”
Cryogenic storage potentially may be needed for some medical devices, too, but Keesee says that his team sees “the initial demand for cell- and tissue-based products.”
The new storage is located at the 93,000-sq-ft Logistics Parkway building on the Rockford campus, which PCI built in 2015 to support clinical trials material storage and distribution. It is one of seven facilities at the Rockford Center of Excellence.
“Having capability both in North America and Europe allows us to support the emerging research community dedicated to advancing these exciting new breakthrough therapies both with logistics as well as site redundancy to help mitigate risk,” Keesee says. “The cryogenic storage is further complemented by storage at -80°C, -40°C, -20°C, and custom storage conditions as required by our clients. We also have extensive storage at 2-8°C for biotech products in the pharmaceutical supply chain, both for investigational/clinical medicines as well as commercial products we package.”
PCI also maintains special packaging capabilities that can be used to support cryogenic storage. “As you would expect, handling of products at cryogenic temperatures does require a significant level of sophistication,” he says. “We are commonly asked to label and prepare materials prior to distribution to the research site. The materials that we are handling are invaluable and in fact may be the only sample, so our precision and attention to detail are paramount to ensure success.”
PCI’s network includes capabilities for supporting temperature-sensitive drug product at Controlled Ambient 15-25°C; 2-8°C; down to -20°C, -30°C -40°C, -60°C to -90°C; liquid nitrogen vapor phase storage at -196°C for Advanced Therapeutic Medicinal Products (ATMPs); and bespoke refrigerated and frozen temperatures according to client needs.
“Over the last decade, PCI has been actively involved in expanding its experience and specialized knowledge across the segment of gene therapies, somatic cell therapies and ATMPs,” said Keesee in a news release. “The new facility is an example of our dedication to testing and validating the newest technologies and storage capabilities to ensure they are using the most effective methods for clients.”
“We have a proven track record with dry ice and nitrogen shipping and storage systems, an extensive global distribution network and expertise in handling, storage and distribution of temperature-sensitive products,” he added. “PCI’s continued investment in this area allows our clients to realize a safe and secure supply chain, ensuring their life-saving treatments are stored safely for patients around the world with the highest degree of confidence and assurance.”
To find out more about PCI, please visit www.pciservices.com.
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