A Guide to Biologic Stability Testing
Stability testing demonstrates how the quality of a drug substance or drug product may be influenced by temperature, light, humidity and other environmental factors, and is used to establish shelf life and recommended storage conditions. Studies to evaluate any physical, chemical, biological, and microbiological attributes that may change during storage can be complex and costly.
This article provides a complete view of stability studies on biologics. The end goal is to help drug developers save unnecessary costs and delays in their timelines, and facilitate getting safer medicines to patients.