Design and Execution of Stability Studies for Biologics 2016

Stability of biologics is necessary to ensure safety of products throughout their shelf life. This presentation looks at the design of stability studies in accordance with ICH guidance and regulatory expectations. Recommendations will be provided on the types of methods that should and should not be included on stability based on degradation pathways and how to set appropriate specifications. There will be a discussion of what testing is required to determine that the methods are actually stability indicating, as well as how to interpret data that is obtained during stability studies.

Objectives of the Presentation
• To obtain a better understanding of what is required to successfully execute stability studies
• To understand what the most likely degradation pathways are for biologics
• Selecting analytical methods for the assessment of degradation across shelf life
• To learn what it means for a method to be stability indicating and how to demonstrate that the method is performing as intended
• Setting appropriate acceptance criteria to support claims of product stability at different stages of the development program
• Evaluating data obtained

Why Should you Attend
• To obtain a better understanding of what is required to successfully execute stability studies
• To understand what the most likely degradation pathways are for biologics and what analytical methods are applied to evaluate degradation across shelf life
• To learn what it means for a method to be stability indicating and how to demonstrate that the method is performing as intended

Topic Background
This topic relates to regulatory expectations as outlined in the ICH guidance on stability. The topic includes further explanation of what is described in the document, as well as information not specifically covered within the guidance. The goal is to help the attendee to better understand how to align the science and regulatory requirements in order to improve safety for patients.