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