By Andrea Wagner, PhD
SVP, Business Development Berkshire Sterile MFG
The use of dry ice to ship protein products that need to be kept frozen is ever increasing but the risks of such transport are not well known. In some research, on the web, Fisher Bioservices, posted a blog by Dan H. O’Donnell that speaks to this issue and offers some ways to mitigate it before it affects your protein. They found, as did West Pharma in their seal integrity study that was presented at the Annual PDA conference, which the issue of container integrity is often caused by the temperature effects on the seal. The seals can contract with exposure to such low temperatures causing ingress of the CO2 on the precious protein.
The CO2 concentrations can exceed 2,500 ug/mL inside a given shipper. There is some good news to report though. You can mitigate damage to the shipment and protein by this ever more popular method of keep things frozen by normalizing the shipment in a -80 C for 96 hours (Murphy et al in the April 2013 issue of Nature Methods [Murphy, B.; Swarts, S.; Mueller, B.; van der Geer, P.; Manning, M. & Fitchmun, M., 10, pp. 278–279 (2013)). If this is not available to you then you can remove the lid on the container prior to thawing to allow the CO2 to escape to protect your product.
To learn more about this see Dan’s blog at http://blog.fisherbioservices.com/testing-samples-shipped-on-dry-ice-beware-of-ph-shift.