Drug Discovery & Development

Application Notes

Presentations

Stability Characterization and Formulations Optimization

To arrive at the correct liquid formulation quickly is of paramount concern for the biopharmaceutical industry.  Regulatory agencies call for the use of stability indicating assays in the assessment of biotherapeutic stability.  Differential Scanning Calorimetry (DSC) enables rapid, accurate, and easy to perform measurement of the thermal transition midpoint (T_m), which has proven to be exceptionally good indicator of the relative stability of liquid formulations.  Used as a stability-indicating assay, DSC can identify good formulations candidates earlier for further downstream processing and eliminate those that are more likely to fail.  DSC saves time and money by culling formulations that are likely to fail early and focus on those that are more viable for real time and accelerated stability studies.

DSC can quickly rank order both excipient and buffer stability contributions to a formulation thus making candidate decisions easier. In the example shown above, DSC was used to rapidly screen formulations conditions for a monoclonal antibody (Data and images courtesy of Alex Tracy, KBI Biopharma).

Why use DSC for biopharmaceutical formulations development?

• Easily determine optimum solution conditions
• Rapidly reduce the number of formulations processed downstream
• Save time and money spent on drug substance and complex analytics
• Expedite the development of a biotherapeutic using optimized formulations for accelerated and real-time stability studies