White Paper

Immunogenicity Risk Assessment in Drug Candidate Selection

Immunogenicity Risk Assessment in Drug Candidate Selection

Pages 10 Pages

Abzena emphasizes early, integrated immunogenicity risk assessment in drug development to identify and mitigate anti-drug immune responses. Using tools like iTope-AI, TCED™, and the EpiScreen® 2.0 platform, Abzena combines in silico prediction with ex vivo validation to map T cell epitopes and assess CD4+/CD8+ activation and cytokine release. This approach improves candidate selection, supports regulatory compliance, and enables safer biologic therapies. Tailored strategies address challenges for antibodies, ADCs, and gene/cell therapies. Case studies with TGN1412, natalizumab, and Vatreptacog Alfa show the value of predictive testing in preventing adverse immune reactions.

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