A cell therapy clinical trial can fail for any number of reasons many of which are unavoidable. Many of these failures can be avoided by understanding the basic laws of nature and taking appropriate action to eliminate or minimize their effect.
If you are manufacturing a cell-based therapy, then the protection of your products and the patients who receive them requires that you ensure temperature compliance. In the graph below, the data depicts and explains why each and every dry shipper should be tested and qualified for the specific product (payload) and manner in which it is used.
For instance, to do their job, dry shippers must be packed, monitored, and handled in a manner that does not sabotage their performance, and this in turn requires an understanding of their innate variability as well as the conditions that serve to further decrease their static hold time. And dry shippers do vary considerably—not only between different sizes and models, but between shippers of the same model and even the same lot. The static hold time of identical, newly manufactured units can vary by as much as 30 percent.
Hold time can be further reduced by the installation of the temperature monitor, as the probe allows wicking of heat into the unit. The size and placement of the payload also adds to the variability observed in static hold time. Another culprit is the intrusion of ambient air while in transit: dry shippers transported in the cargo hold of a plane are subject to changes in air pressure that can result in in-gassing.
Transport is perhaps the most difficult to control and document, as there is typically no way of knowing exactly what happens when a shipper is in transit. A unit that ends up on its side, despite all warnings to keep it right side up, can lose static hold time rapidly, and one placed upside down can lose days of hold time in only a few hours.
However, there are ways of managing these issues: specifically, planning, preparation, and execution needed to get consistent, reproducible results when using these shippers to deliver products. In the video below, I walk you through a discussion of the challenges presented when attempting to overcome some of the most fundamental physical laws in the pursuit of delivering cell based drug product from manufacturer to the patient.