Calorimetric dissolution studies of pharmaceutical protein formulations

摘要

Freeze drying is the process most commonly used to improve the stability and the shelf life of recombinant protein products. However, partial or total inactivation of the protein often occurs during lyophilization. Examination of the physical state (crystalline or amorphous) of the lyoprotectants immediately after lyophilization as well as the study of possible changes occurring with time in the formulation are of great importance for the evaluation of the physical stability of proteins.