Advanced Course Outline

Introductory Outline >

LATEST ADVANCES IN THE STABILIZATION AND FORMULATION OF PROTEINS AND PEPTIDES

EUROPEAN CONTINUING EDUCATION COLLEGE
LONDON, UK

COURSE OUTLINE

Overview of Formulation Strategies

Physical Stability of Polypeptides

• Conformational Instability
• Colloidal Instability and Solubility Issues (including phase separation and opalescence)
• Interfacial Instability

Recent Advances on the Chemical Instability of Peptides and Proteins

Protein Aggregation

• Aggregation Kinetics
• Mechanisms of Aggregation
• Controlling Aggregation
• Detailed Overview of Methods for Characterization and Quantitation of Aggregates

Rational Design of Protein Formulations

• Frozen Formulations
• Liquid Dosage Forms
• Lyophilised Dosage Forms
• Other Dried Dosage Forms

Strategies for Excipient Selection

• Liquid Dosage Forms
• Lyophilised Dosage Forms

Analytical Methods

• Spectroscopic Methods (e.g., IR, CD, fluorescence, NMR, etc.)
• Methods for Characterization of Lyophilised Powders
• Methods for Monitoring Denaturation
• Methods for Detecting and Quantifying Aggregation

Special Topics

• High Concentration Formulations and Alternative Delivery Systems
• Packaging of Biopharmaceuticals
• Peptide Formulation Challenges
• Stability Issues during Processing (purification, filtration, etc.)