Biologics Cell & Gene Therapy

Stability Program

Biologics Cell & Gene Therapy

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.