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Dry vapor shipping dewars used for transport of critical temperature-controlled biomaterials and lifesaving materials, such CAR-T and other regenerative medicines, can be purchased and used by anyone.
These dewars are qualified and validated by their manufacturers to generally have a 10+ day hold time. However, this cannot be assumed to always be the case—as they can be variable in their actual performance, both initially and over time. In fact, not only is there variability in initial hold time performance, but in-transit events invisible to the human eye can have dramatic impacts on the hold time of the dewar during its next use and beyond.
Additionally, dewars do “age” and have reduced hold times as they get older. Most organizations using these dewars do very little or nothing at all to track, test and document past or future potential performance.
The global commercial approval of the first CAR-T therapies (Kymriah® and Yescarta®) has intensified the need for the clear and uninterrupted flow of data from before the patient is ever treated to the mining of data that takes place years after the patient has received their therapy. This requires collaboration and integration between several different software systems that are involved in the process.