Applications of Isothermal Titration Calorimetry and differential scanning calorimetry in biopharmaceutical
This application note presents an example of how calorimetry aided the formulation development for ProX by providing insight into excipient-protein interactions. Polysorbate-80 and phenol are examined here as potential additives to the formulation buffer for ProX.
Applications of Isothermal Titration Calorimetry and Differential Scanning Calorimetry in Biopharmaceutical Development
This application note presents an example of how calorimetry aided the formulation development for ProX by providing insight into excipient-protein interactions. Polysorbate-80 and phenol are examined here as potential additives to the formulation buffer for ProX. Polysorbate-80 is a commonly used surfactant to prevent non-specific adsorption and aggregation of proteins and has been shown previously to interact with proteins (2, 3). It protects the protein against surface-induced aggregation by binding to exposed hydrophobic regions on the protein molecule surface (3). The most commonly used levels of polysorbate-80 are 0.002 to 0.1% (w/v). Phenol is used as an antimicrobial agent for formulations intended to be dosed more than once from the same container. Phenol is toxic and therefore the concentration used in the formulation buffer must be minimized. The most commonly used levels are 0.3 to 0.5% (v/v).
