Characterization methods for the physical stability of biopharmaceuticals.

PDA J Pharm Sci Technol

Pharmaceutics Division, College of Pharmacy, Biochemical Engineering Department, The University of Iowa, Iowa City, IA 52242-1112, USA.

Published: March 2004

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.

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