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Conformational analysis is becoming more critical in the development of generic biopharmaceuticals. This book describes methods used to establish comparability between potentially identical products, providing 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…mehr

Produktbeschreibung
Conformational analysis is becoming more critical in the development of generic biopharmaceuticals. This book describes methods used to establish comparability between potentially identical products, providing 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.

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Autorenporträt
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.