Drug Discovery & Development
Predicting Long-Term Stability
During formulation development, the design of traditional long-term solution stability studies involves the storage of protein solutions of different concentrations in various buffer systems (with or without added excipients) under several stress temperature and/or lighting conditions. Samples of the solutions are then withdrawn periodically for analysis by one or more methods such as size exclusion chromatography, gel electrophoresis, and/or ELISA. This process can require several weeks or months and grams of bulk drug substance to complete. In an effort to improve the efficiency of solution stability investigations for biologics, Differential Scanning Calorimetry (DSC) can be used as a predictive tool for the long-term stability of a biotherapeutic and resolve possible physical stability issues. Because stability predictions made with DSC correspond well with what is predicted by longer-term SEC aggregation studies, microcalorimetry has become an invaluable tool to rapidly screening protein stability in solution.
DSC can be used to predict long term stability. In the example above DSC data correlates well with the long term stability predictions made with SEC-HPLC; an industry standard in stability predictions (Data and images courtesy of Jie Wen, Amgen, Inc). Why use DSC for assessing long-term stability?
- Predictive tool that corresponds well to industry standards for assessing long-term stability
- Predict the stability of a biotherapeutic under certain conditions before long-term stability studies
- Predict the tendency to aggregate
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