Stabilitarians may be well-served by the Navy motto: “Don’t give up the ship!”
We are used to being the anchor of the medical product supply chain by assuring the stability of outgoing products. We also keep an eye on incoming API’s, key intermediates and excipients known to contribute to stability problems as projects evolve. With supply chains being threatened by the pandemic, and the trend toward mail delivery of prescriptions soaring, attention is returning to the impact of shipping on those items reaching the hands of patients. Product shipments can encounter delays and extended pauses that expose them to conditions more severe than those recommended for the product.
There are several ways to gain confidence in products when they face these shipping challenges; studies with a range of static conditions that bracket those found in the supply chain; cycling studies that cover those times when temperatures undergo drastic changes several days in a row; and studies that closely match conditions recorded over the course of the standard supply route. Which is best? It may be the one which most closely challenges the liabilities of your product, but it is definitely the one for which you can offer the best justification. Often they are the same, but upon occasion a regulator may not agree with “We’ve always done it this way and it’s never failed” as a justification.
StabilityHub recommends a ThermoFisher Scientific article recently featured in the Cell & Gene Newsletter titled Enhanced Cold Chain Capabilities that reviews the latest in shipping technologies.