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Protein and Peptide Formulation and Stabilization Course Outline


 


Formulation Strategies


 


Introduction to Protein and Peptide Formulation; Basics of Protein Chemistry


 


Immunogenicity Issues with Polypeptides


 


Chemical Stability of Polypeptides


 


Protein Denaturation


 


Surface Behavior


 


Protein Solubility


 


Protein Aggregation


            Kinetics


            Mechanisms


Analytical Methods for Monitoring Aggregation


 


Liquid Formulations


Strategies


Excipient Choices for Liquid Formulations


Overview of Analytical Methods for Proteins in


Aqueous Solution


 


High Concentration Formulations


 


Lyophilized Formulations


            Basic Principles


            Strategies


            Excipient Choices for Lyophilized Formulations


            Analytical Methods for Characterizing Solids


 


Peptide Formulation


 


Stability Issues during Processing


 


Packaging Considerations for Biopharmaceuticals




Formulation of Chemically Modified Proteins