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