Protein Formulation and Stability for Successful Protein Therapeutics

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.

Aceasta referinta acopera stabilitatea si formularea proteinelor, concentrandu-se pe conexiunea dintre degradarile proteinelor si proiectarea formularii pentru a maximiza stabilitatea proteinelor. Subiectele includ utilizarea studiilor de screening pentru identificarea problemelor de stabilitate in stadiul preclinic; folosind tehnici biofizice, cum ar fi spectroscopia UV-VIS, spectroscopia florescentei, spectroscopia circulara cu dicroism si spectroscopia FT-IR si Raman pentru a analiza structurile proteinelor; tehnici precum analiza particulelor, tehnici de imprastiere a luminii si centrifugare ultraanalitica; HPLC, cartografiere peptidica si spectrometrie de masa; metode pentru minimizarea degradarilor fizice si chimice; si studii terapeutice si formulari bio-similare necesare pentru a dezvolta cu succes bio-similare.