High throughput prediction of the long-term stability of pharmaceutical macromolecules from short-term multi-instrument spectroscopic data.

Changes in the measurements of a macromolecular biopharmaceutical's physical form are often used to predict changes in the drug's long-term stability. These can in turn be used as important markers of changes to a drug's efficacy and safety. Such stability estimates traditionally require human judgment and are frequently tentative.

A critical evaluation of microcalorimetry as a predictive tool for long term stability of liquid protein formulations: granulocyte colony stimulating factor (GCSF).

Microcalorimetry is frequently used as a high throughput predictive method in order to screen different formulations for their storage stability. However, the predictive power of measuring unfolding temperatures (Tm), although studied for the stability of proteins under stress, has not been investigated systematically for long term stability of pharmaceutical proteins yet. In this study, the microcalorimetric Tm is evaluated as a predictive tool for long term stability of 24 liquid formulations of Granulocyte Colony Stimulating Factor.