Stability Studies

The Analytical and Stability Center provides storage and testing for API and drug product GMP batches for both small molecule drugs and large molecule products.

To ensure continuous, high-quality performance, our stability rooms and chambers are operated using multiple types of power supplies and are qualified (IQ/OQ/PQ and mapping), calibrated and subjected to performance reviews on an annual basis. We also have dedicated chamber managers for qualification and preventive maintenance.

Our dedicated project managers and experienced stability scientists are equipped with appropriate software that allows for secure data entry and tracking with a door-to-door chain of custody. Procedures have also been implemented to guarantee protection of intellectual property.

As one of the largest stability storage and testing facilities in the world, we have the capacity and resources to accelerate studies for IND and NDA applications for all drug development phases and study types. With our location in China, we can also potentially provide significant tax savings for registration/commercial programs.

+ Primary registration stability
+ Formal stability study
+ Long-term stability study
+ Photostability
+ Freeze-thaw stability
+ Cycling stability
+ In-use stability and formulation compatibility
+ Hold time and temperature excursion stability
+ Post approval commitment / commercial stability
+ API and clinical trial material stability study