Search

Chinese

Biologics Cell & Gene Therapy

Stability Program

Biologics Cell & Gene Therapy
Services & Solutions / CMC-Product Development & Manufacturing / Biologics Cell & Gene Therapy / Stability Program
IN THIS SECTION
Drug Discovery
Chemistry
Custom Synthesis Medicinal Chemistry Process Chemistry Services & Manufacturing
Biology
ADME • Tox Screening
Metabolic Stability CYP Interaction Permeability & Transporters Physicochemical Properties Protein Binding Metabolite Identification Discovery PK & Toxicology
Pharmacology
Drug Development
Drug Metabolism & Pharmacokinetics (DMPK)
In Vitro Services In Vivo Services
Safety Assessment & Toxicology
Safety Pharmacology Genetic Toxicology Toxicology Global Pathology Services Toxicokinetics Standard for Exchange of Nonclinical Data (SEND)
Clinical Services
About the Clinic Clinical Study Experience Biometrics
Laboratory Testing Services
Bioanalytical – Small & Large Molecules
Method Development & Validation Modalities Technology Platforms Services Assays List Finder
Genomics
Oncology Pharmacogenetics Metagenomics & Microbiome
Central Lab Services
Histology & Pathology Safety Testing & Specialty Lab Testing Biorepository Services Clinical Trial Logistics Services Clinical Sample Processing Biospecimen Data Services Central Lab e-Portal Sample Management Central Lab Clinical Trial Request Intake Form
Biomarkers & Precision Medicine
CMC-Product Development & Manufacturing
Product Development
Formulation Development Clinical Trial Material (CTM) Manufacturing Commercial Manufacturing
Analytical Services
Analytical Small Molecule Microbiological Services
Biologics Cell & Gene Therapy
Biologics Services Cell & Gene Therapy Services GMP Routine Testing Services Stability Program
Agrochemical

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

Left arrow
Gene & Cell Therapy Analytical Services
brochure

Gene & Cell Therapy Analytical Services
Frontage offers custom development and platform assays, technology transfers, and stabilit…
Access Resource
Biologics Analytical Testing Services
brochure

Biologics Analytical Testing Services
Frontage CMC biologics analytical team is experienced in supporting projects in various ph…
Access Resource
Right arrow