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Differential scanning calorimetry (DSC) has been extensively used in the biopharmaceutical industry to characterize protein thermal stability and domain folding integrity. Recently, nano differential scanning fluorimetry (nanoDSF) has emerged as a powerful tool for thermal stability analysis and studies of protein domain unfolding. Due to increased interests in the qualification of characterization methods, we are in this study presenting the qualification results for the comparability studies of thermal stability analysis using nanoDSF. The results show that nanoDSF is able to detect thermal transition signals for mAbs, BiTE® molecules, and cytokines at a wide concentration range with high precision, clearly indicating that nanoDSF is suitable for characterization including comparability studies of therapeutic proteins. Compared to the current recognized industry standard DSC, the nanoDSF method enables thermal stability analysis over a much wider concentration range, consumes considerably less materials, and provides significantly higher throughput.
This article was published in the following journal.
Name: Analytical biochemistry
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Differential thermal analysis in which the sample compartment of the apparatus is a differential calorimeter, allowing an exact measure of the heat of transition independent of the specific heat, thermal conductivity, and other variables of the sample.
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