Immunogenicity

• Pre-clinical and clinical studies
• Biosimilar studies
• Bridging and direct binding based assays
• Cell based and Ligand binding based neutralization assays
• Isotyping assays
• Supporting confirmation assays
• Anti-PEG assessment

Dedicated Immunogenicity laboratory

• Method Development
  • Custom drug labeling
  • PC characterization
  • Optimal MRD and drug tolerance
  • ACE and SPEAD adapted methods
  • Pre-validation cut point assessment
• Validation
  • Balanced design
  • Cut point setting
• Sample Analysis
  • In study cut point assessment