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Integrated software platforms provide chain of custody and chain of compliance
Vineti, a leader in software to manage cellular and genetic therapy (CGT) processes, and Cryoport, a leader in tailored temperature-controlled containers along with logistics software and services, are partnering to simplify the overall process of managing CGT delivery. On paper, the two offerings overlap, but according to Jerrell Shelton, Cryoport CEO, “the two of us are complementary; with the pre-integrated system we will offer, end-to-end traceability is possible with a seamless network.”
Broadly speaking, Vineti’s software “orchestrates” (Vineti’s term) the patient experience leading up and after administration of therapy; Cryoport’s software platform, Cryoportal, provides traceability not only of the CGT therapy (which is usually tied to individual patients) but also the equipment (containers, monitors, etc.) that were used in the delivery. For some of the CGTs currently commercialized, a patient’s own cells are extracted, sent to a manufacturing site for manipulation, then returned a few days later to be administered to the patient.
According to the companies’ joint statement, Vineti’s solution will be installed at 300 clinical centers over the course of the next year, and Cryoport is currently supporting 400 clinical trials, and three commercialized CGTs.
A few days after the Cryoport/Vineti announcement, McKesson and TrakCel, a competitor to Vineti, announced their own partnership. The two pairings aren’t identical—McKesson provides 3PL services along with direct patient support, while Cryoport specializes in CGT logistics—but they indicate how energetically the pharma supply chain is being aligned for coming CGT activity. (Both TrakCel and Vineti have announced multiple partnering arrangements previously with a variety of companies in logistics services and patient support.) The McKesson-TrakCel partnership is specific to “CGT late-stage developers,” and will involve integrating TrakCel’s software into the McKesson patient-support structure. The end result is to be a validated chain-of-identity tracking system.