The boom in clinical research in cellular and related therapies is generating new demand for refrigerated or colder cold-chain services, in part because the research involves living cells. Clinical development and manufacturing organizations (CDMOs) in turn, are responding with new capacity and various temperature ranges, including cryogenic storage with liquid nitrogen.
In Catalent’s case, the expansion is occurring at its Kansas City, MO, facility, where 70,000 cu. ft of pallet and high-density storage, in the 2-8°C range—a fivefold increase in controlled-temperature capacity, according to the firm. As that site handles analytical work, oral solids manufacturing and clinical supply services, clients will have opportunities to manage clinical drug supplies from one location. Meanwhile, at PCI, a 400% increase in cryogenic storage at its Rockford, IL, facility will support clinical trial services for cellular and related therapies. Temperature ranges include controlled room temperature (CRT), 2-8°C, and frozen ranges from -20 to -140°C, employing liquid nitrogen. Storage configurations for vials and blood bags have been installed. Rockford underwent an earlier expansion of cryogenic capabilities last year, and another PCI site, Bridgend, UK, had a dedicated -40° facility installed. Packaging, labeling and clinical logistics services are also available.
“PCI has gained significant experience and specialized knowledge across the segment of gene therapies, somatic cell therapies and ATMPs over the past ten years,” said Brian Keesee, GM, US Clinical Services for PCI. “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.”
“Customers have benefitted from our Kansas City campus’ integrated analytical, oral solid manufacturing, and clinical supply services, and now we can offer them expanded cold storage and packaging services as well,” commented Tom Moon, GM of Clinical Supply Services for Catalent. Overall, Catalent’s global clinical supply network features 50 depots on six continents, 1 million cu. ft. of CRT space, 250,000 cu. ft. of refrigerated space and 21,000 cu. ft. of frozen space. Shipments to 75 countries have been facilitated through the network.