ABSTRACT
Among the many biophysical techniques that may be considered, microcalorimetry offers some clear advantages. It can directly measure enthalpic change and is useful for defining important thermodynamic parameters (i.e., thermostability, heat capacity, free energies, entropies, binding affinities) that can aid the discovery, upstream, downstream, and formulation development operations. As more knowledge about the physicochemical characteristics of a broad array of protein therapeutics is amassed, it should be possible to bioengineer a protein therapeutic with the right properties that make it efficacious, robust to the stresses of the process, and stable in the desired dosage form. This is the end result of biopharmaceutical development. If successful in the prediction of a well-characterized product, this approach could greatly reduce bottlenecks in the manufacturing sector.
