Immunogenicity Testing (ADA & NAb)
Immunogenicity is a critical component of biologics and vaccine development. Our comprehensive strategies assess both binding and functional immune responses to ensure patient safety and therapeutic efficacy.
ADA Capabilities
- Screening, confirmatory, and titration assays
- Bridging ECL and direct ELISA formats
- Cut point establishment, sensitivity, and drug tolerance evaluation
- Mitigation of drug, target, and matrix interference
- Experience with interference issues, mitigation strategies, and/or binding components
- Acid dissociation, SPEAD, ACE, PandA
- Physical separation by size exclusion or magnetic protein A/G
- In-house labeling of antigen with biotin and sulfo-TAG
- Assay validation in line with FDA immunogenicity guidance
