Results obtained from accelerated stability studies are useful for predicting potential degradation products and developing appropriate analytical methods. However, to obtain regulatory approval, accelerated testing is insufficient and must be further supported by real-time storage data of the product under normal storage conditions. Some of the capabilities of Integrity Bio include the performance of stability studies to support the following:
- The selection of alternative excipient vendors
- Manufacturing condition changes
- Performance of delivery devices
- Preparation of backup formulations
- Clinical needs and requirements
- Drug interactions
- Container closure systems
- Excursions from recommended handling conditions
