See how you can use DSC to save you money in your contract development lab.

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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