Conformational analysis is becoming more critical in the development of generic biopharmaceuticals. This book describes methods used to establish comparability between potentially identical products. It provides researchers with a critical description of studies drawn from the current literature. The text covers physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation, as well as chemical methods, including hydrogen-deuterium exchange and trace labeling. The author shows how these methods support comparability claims for generic…mehr
Conformational analysis is becoming more critical in the development of generic biopharmaceuticals. This book describes methods used to establish comparability between potentially identical products. It provides researchers with a critical description of studies drawn from the current literature. The text covers physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation, as well as chemical methods, including hydrogen-deuterium exchange and trace labeling. The author shows how these methods support comparability claims for generic biologicals and assure structural integrity of active pharmaceutical ingredients in final drug products.
After postdoctoral work at Rockefeller University, New York, Dr. Roger L. Lundblad joined the faculty of the University of North Carolina at Chapel Hill in 1968. He joined the Hyland division of Baxter Healthcare in 1990. Currently, he is an independent consultant and biotechnology writer based in Chapel Hill, North Carolina. He is an adjunct professor of pathology at the University of North Carolina at Chapel Hill and an editor in chief of the Internet Journal of Genomics and Proteomics.
Inhaltsangabe
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 Biomolecular 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. The Use of Mid-Infrared and Fourier Transform Infrared Spectroscopy to Study Conformation of Biomacromolecules. Use of Raman Spectroscopy to Evaluate Biopharmaceutical Conformation. 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 Modifi cation for the Conformational Analysis of Biopharmaceuticals. Use of Immunology to Characterize Biopharmaceutical Conformation. Use of Limited Proteolysis to Study the Conformation of Proteins of Biotechnology 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.
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 Biomolecular 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. The Use of Mid-Infrared and Fourier Transform Infrared Spectroscopy to Study Conformation of Biomacromolecules. Use of Raman Spectroscopy to Evaluate Biopharmaceutical Conformation. 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 Modifi cation for the Conformational Analysis of Biopharmaceuticals. Use of Immunology to Characterize Biopharmaceutical Conformation. Use of Limited Proteolysis to Study the Conformation of Proteins of Biotechnology 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.
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