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The ability to develop protein therapeutics within the aggressive timelines often requested by sponsors requires that contract development organizations employ a structured approach to preformulation development. A key component in this strategy is the ability to rapidly characterize the thermal and chemical stability of a biomolecule and capillary differential scanning calorimetry (DSC) has proven to be an excellent tool that provides this data in real or near-real time. This paper provides an overview of the workflow typically associated with preformulation projects at a contract development organization as well as provides a general framework for conducting preformulation studies that leverages the application of biophysical techniques such as DSC and traditional analytics by employing statistical design. A case study involving the formulation development of a monoclonal antibody is presented to detail the utility and potential limitations of DSC in support of preformulation for a variety of protein products.
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