Characterization of biopharmaceutical stability with Differential Scanning Calorimetry: Process development and manufacturing support

DSC is an established analytcal tool used during process development and manufacturing of biopharmaceuticals. Rank ordering of thermal transition midpoints (TMs) and other parameters from DSC  is commonly used to screen process conditions like buffers, pH and ionic strength. The typical correlation is the higher the TM, the  more stable the protein is and less likely to aggregate.  DSC is also used as a comparability assay to make sure different lots of the the same protein drug are "highly similar" in thermal stability.


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