Biologics Cell & Gene Therapy
Stability Program
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IN THIS SECTION
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ICH Compliant Stability Facility for Cell and Gene Therapy Products
- Regular and Ongoing Stability
- Walk-in and reach-in stability chambers for standard storage conditions with approximately 10,000 total cubic feet capacity.
- In-Use Stability
- Drug product in-use stability.
- ICH Global Temperature and Storage
- Temperature-controlled units in line with ICH storage guidelines
- Freeze-Thaw Stability.
- Assessment of product resilience during multiple freeze-thaw cycles
- Forced Degradation and Photostability.
- Meeting ICH accelerated light exposed study requirement.
- 24/7 Monitoring: Automated monitoring with instant deviation alerts.
- Secure Access: Advanced biosecurity with biometric controls.
- Data Integrity and Traceability: Secure stability data storage with comprehensive product traceability.
Resources To Consider
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Gene & Cell Therapy Analytical Services
Frontage offers custom development and platform assays, technology transfers, and stabilit…
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Biologics Analytical Testing Services
Frontage CMC biologics analytical team is experienced in supporting projects in various ph…
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