We ensure that cGMP compliant testing is conducted with a comprehensive report, supporting you in navigating the regulatory path for your biologic and vaccine therapeutics.
We offer cGMP long-term and accelerated studies for:
- Drug Substance
- Drug Product
Our in-house dedicated stability group can help you design your stability program, evaluates your product’s stability and also the process and product consistency.
We have on-site backup storage units and dedicated capacity with 24/7 monitoring and rapid response systems across all of our sites.
Stability Studies and Storage Capabilities include:
- +5°C storage
- +25°C / 60% relative humidity
- +40°C / 75% relative humidity
- -70°C freezer
- -20°C freezer
- Additional cabinets available to meet custom needs