RE: Stability Testing then CE2 May 2021 20:31
Was just reading about it and found the following on DCN’s website. Affimers temperature range should offer an advantage in stability testing as they will hopefully be able to go higher, getting a better result in a shorter timeframe.
“One of the strategies used to extend stability dating beyond actual real-time stability is accelerated stability testing, which is often done at elevated temperatures. This is based on the observation that chemical reaction rates double with each 10o C rise in temperature if the reaction mechanism does not change. To estimate that a product is stable at 4o C for six months, it could be tested and shown to be stable for 3 months at 14o C, 1.5 months at 24o C, or 3 weeks at 34o C. In practice, only the 24o C (room temperature) and elevated temperature (37o C) are done. Higher temperatures (such as 45o C) are sometimes done, but potential changes in reaction mechanisms make this option riskier for mammalian proteins that have evolved to be stable at about 37o C. Note that real time stability data gathering and analysis continue after the product is released on the basis of accelerated stability data.”