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

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Immunologix Scientists and Principal Investigators have demonstrated experience and proficiency with Immunogenicity assays.
Dedicated Critical Reagent group prepares and characterizes all conjugates and PCs.
Dedicated Sample handling and operations group.