Differential scanning calorimetry (µDSC)
µDSC is an important and frequently used technique for the determination of the thermal stability of proteins.
During µDSC analysis, the protein of interest is exposed to a temperature ramp, where the required thermal energy for each temperature increase is recorded in correlation to a reference sample (e.g., formulation buffer). As a result, protein unfolding events can be observed and the melting temperature (Tm) of each event can be determined. Also, the unfolding enthalpy (ΔH) of the protein or individual protein domains can be calculated from the area under the melting curve. µDSC is also employed to study the reversibility of unfolding events and can give insight into higher-order structures. µDSC is considered an “absolute technique”, as it does not rely on any reference standards to obtain quantitative results. However, µDSC requires much more time to analyze one sample than the orthogonal technique nanoDSF.
Quality & biosafety level of this method
We provide all our analytical services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this technology with the following quality and biosafety level:
Standardized methods or dedicated method development
For common sample types, we can often apply standardized methods with little setup effort. On top of this, our experienced analytical scientists perform in-depth method development or method optimization tailored to your drug substance, product type and development phase.
During method development, we tailor sample preparation, method settings, and data analysis to the needs of your project and sample.
For this purpose, we include a representative sample and, where available, suitable reference standards and stressed/degraded materials. This way, our analytical scientists can design a method that is highly suitable for your needs, stability indicating, as well as robust and repeatable. Upon request, we compile a detailed method description for your records
A method qualification is the initial assessment of the performance of an analytical procedure to show that it is suitable for the intended purpose.
During method qualification, our analytical scientists perform a documented testing that demonstrates that the analytical procedure meets certain acceptance criteria in several categories. These may include repeatability, linearity, intermediate precision, robustness and more. We compile a qualification plan and a qualification report including all relevant data.
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