Applications of differential scanning calorimetry in the development of liquid formulations for protein biopharmaceuticals

There is a strong demand on the market for protein biopharmaceuticals that are formulated as liquids. They are easier for the physicians to handle and cheaper for the biopharmaceutical industry to produce as compared to lyophilisates, as no lyophilization step is needed. Optimally, the biopharmaceutical drug product (DP) should have a shelflife of at least two years. Recombinant proteins, however, have limited chemical or physical stability in liquid formulations. Having a multitude of biotechnology products currently in development, it is necessary to use technologies like differential scanning calorimetry (DSC) to efficiently deliver optimized liquid formulations. This application note presents the function that DSC has in the process of liquid formulation development.