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:
- Batch to batch comparability
- 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
Integrity Bio also provides GMP stability studies.