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.
Nguyen
Lida T
LT
Pharmaceutics Division, College of Pharmacy, Biochemical Engineering Department, The University of Iowa, Iowa City, IA 52242-1112, USA.
Wiencek
John M
JM
Kirsch
Lee E
LE
D000818:Animals; D004355:Drug Stability; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
D004364:Pharmaceutical Preparations