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
  • Immunologix Scientists and Principal Investigators have demonstrated experience and proficiency with Immunogenicity assays.

    Immunogenicity - Immunologix Laboratories
  • Dedicated Critical Reagent group prepares and characterizes all conjugates and PCs.

    Immunogenicity - Immunologix Laboratories
  • Dedicated Sample handling and operations group.

    Immunogenicity - Immunologix Laboratories