Gene Therapy Characterisation and Release Testing

Product description

Gene therapy characterisation and release testing supporting CMC requirements for IND applications and commercial release including expert analysis and stability services. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity and ensure the product safety, quality, purity, potency and strength of your gene therapy product.
  • GMP analysis
  • GCP/GLP bioanalysis
  •  ICH stability storage and testing 
  • Method development and validation 
  • General compendial testing 
  • Viral vector characterisation 
  • Viral vector identity 
  • Virology assays
  • Aggregation analysis
  • Host cell and residual plasmid DNA
  • Cell-based assays / potency testing
  • QC release testing
  • Advanced delivery technology analytical support
  • Reagent QC analysis and residual reagent determination
  • Excipient concentration and QC
  • Determination of Residual proteins, DNA, RNA, cytokines, growth factors, serum, antibodies and solvents
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Specifications

Categories BiopharmaceuticalsCell & Gene therapy; Contract Services - Analytical & Lab Services; BiopharmaceuticalsCritical quality attributes
Sales markets Western Europe; Eastern Europe; Middle East Region (e.g. UAE); Asia; Oceania; North America (USA, Canada); Africa; Central/South America
Supplied from United Kingdom

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