Approaches to the Conformational Analysis of Biopharmaceuticals

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.