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Risk assessment of trade lanes, commercial scaleup are concerns
Cryoport (Irvine, CA), which has pioneered a liquid-nitrogen-based cryogenic shipping container as well as the logistics services surround it, is now adding a consulting service to its offerings. It will be led by Tamie Joeckel, a 25-year veteran of the life sciences logistics industry, including time spent at Parexel, a leading contract research organization. As SVP, client services, she will manage the new Temperature Controlled Logistics Consulting Div., as well as Logistics, Client Care and Program Management.
“The cellular therapy, and more broadly, life sciences industry is investing billions of dollars to advance therapies that are changing the face of modern medicine. It is imperative that companies in this space confer with experts in cold chain logistics as early as possible for feasibility and program execution planning required to help mitigate risk and ensure success in global programs,” she said, in a statement. “Whether in Phase I, II or III in clinical trials or planning for commercial launch of a new therapy, global planning is critical. We recognized this as a great opportunity for Cryoport.”
Besides evaluating client quality control processes and systems, trade lanes and the like, Joeckel notes that shipments aren’t a simple matter of dropping samples into Cryoport containers. For one thing, even though the containers can maintain cryogenic conditions for upwards of 10 days, some types of cells only have a limited number of hours of potency after being cryopreserved. For another, the scaling up from trial stages to commercialization—which could happen as soon as 2017 for some of the latest biotherapies—will call for newly adopted volume distribution of products, she tells Pharmaceutical Commerce.