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This reference covers protein stability and formulation focusing on the connection between protein degradations and design of formulation to maximize protein stability. Topics include using screening studies to identify stability problems at the preclinical stage; using biophysical techniques such as UV–VIS spectroscopy, florescence spectroscopy, Circular Dichroism Spectroscopy, and FT–IR and Raman Spectroscopy to analyze proteins structures; techniques such as particle analysis, light scattering techniques, and ultra–analytical centrifugation; HPLC, Peptide mapping, and mass spectrometry; methods for minimizing physical and chemical degradations; and bio–similar therapeutics and formulation studies required to successfully develop bio–similars.
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