Characterization of seed nuclei in glucagon aggregation using light scattering methods and field-flow fractionation.

Background: Glucagon is a peptide hormone with many uses as a therapeutic agent, including the emergency treatment of hypoglycemia. Physical instability of glucagon in solution leads to problems with the manufacture, formulation, and delivery of this pharmaceutical product. Glucagon has been shown to aggregate and form fibrils and gels in vitro.

Characterization methods for the physical stability of biopharmaceuticals.

The characterization of protein aggregation and gelation using various methods, including scanning and transmission electron microscopy, small angle X-ray scattering, static light scattering, dynamic light scattering. infrared spectroscopy, Raman spectroscopy, rheology, and size exclusion chromatography (coupled with on-line laser light scattering, refractive index, and ultraviolet absorbance detection), are described in terms of theory and applications.