Bücher der Reihe Protein Science

A comprehensive assessment of the use of biomarkers in diagnostics and prognostics, this book covers the history and current application of biomarkers, explores the technology used for the validation and study of biomarkers, and compares the various technologies used to identify and measure biomarkers. It investigates the evolution of the underlying technology and discusses the translation of basic science to clinical laboratory use and potential commercial applications. He also covers proteomics and proteomic technologies and their applications in the identification of biomarkers.

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.