Stability & Shelf Life of Biologics

Topics

• Advantages and limitations of accelerated and stress stability assessment
• Guidance and regulation for stability of biologics with focus on biotech products
• Biochemical and kinetic approaches to product stability
• Biologics degradation by chemical, physical and microbiological factors
• Packaging vs product stability
• Analytical methodology for stability assessment
• Transport and shipping impact on stability and shelf-life
• The role of excipients in stability of biologics
• How to apply accelerated and stress stability assessment to predict your product stability
• Degradation of biologics by chemical, physical and microbiological factors
• How to improve the stability by picking the right excipient
• How to find the correct packaging for biologics with low stability
• A comprehensive overview on stability and shelf-life regulatory landscape
• Requirements for stability testing in Climatic Zones I-IV
• Harmonized ICH stability guidelines: Q1A-F and Q5C