LATEST ADVANCES IN THE STABILISATION AND FORMULATION OF PROTEINS AND PEPTIDES
OCTOBER 6-7, 2010
EUROPEAN CONTINUING EDUCTAION 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.)
