Includes bibliographical references and index.

Introduction to biopharmaceutical conformational analysis : issues and methods -- Comparability of biotechnological/biological products and biological generics -- Application of native electrophoresis for the study of protein conformation -- Affinity chromatography including hydrophobic interaction chromatography in the study of biopolymer conformation -- Size-exclusion chromatography and bimolecular conformation -- Use of analytical ultracentrifugation to study biomolecular conformation -- Use of differential scanning calorimetry to measure conformational change in proteins and other biomacromolecules -- Light scattering and biomacromolecular conformation -- Use of luminescence to measure conformational change in biopharmaceuticals with emphasis on protein and protein drug products -- Near-infrared spectroscopy and macromolecular conformation -- Use of mid-infrared and Fourier transform infrared spectroscopy to study conformation of biomacromolecules -- Use of Raman spectroscopy to evaluate biopharmaceutical conformation -- The use of UV-VIS spectrophotometry for the characterization of biopharmaceutical products -- Use of optical rotatory dispersion and circular dichroism to study therapeutic biomacromolecule conformation -- Use of nuclear magnetic resonance for the characterization of biotherapeutic products -- Use of chemical probes for the study of protein conformation -- Use of hydrogen exchange in the study of biopharmaceutical conformation -- Use of chemical modification for the conformational analysis of biopharmaceuticals -- Use of immunology to characterize biopharmaceutical conformation -- Use of limited proteolysis to study the conformation of proteins of biotechnological interest -- Other technologies for the characterization of conformational change in biopharmaceuticals -- Development of an experimental approach for the study of the conformation of a biological therapeutic product.