Stability & Shelf Life Of Biologics

https://fleming.events/stability-shelf-life-of-biologics/

The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.

• Guidance and regulation for stability of biologics with focus on biotech products
• Advantages and limitations of accelerated and stress stability assessment
• Biologics degradation by chemical, physical and microbiological factors
• Biochemical and kinetic approaches to product stability
• Analytical methodology for stability assessment
• Packaging vs product stability
• The role of excipients in stability of biologics
• Transport and shipping impact on stability and shelf-life

Benefits of attending

Understand

• How to apply accelerated and stress stability assessment to predict your product stability
• How to improve the stability by picking the right excipient
• Degradation of biologics by chemical, physical and microbiological factors
• Bracketing and matrixing to improve your product stability

Learn

• About guidance and expectations for product stability protocol
• To identify proper analytical methods for stability assessment
• How to find the correct packaging for biologics with low stability
• About acceptation of reduced stability data for new formulations

Gain

• A comprehensive overview on stability and shelf-life regulatory landscape
• Harmonized ICH stability guidelines: Q1A-F and Q5C
• Requirements for stability testing in Climatic Zones I-IV
• A contact with key leaders and regulatory authority to build up your network