Immunogenicity Risk Assessment & Immunotoxicology
Immunogenicity Risk Assessment & Immunotoxicology
Proactive, multi-tiered strategies to evaluate, predict, and mitigate unwanted immune responses from early lead selection through late-stage clinical trials.
Predictive Preclinical Immunogenicity:
- In vitro T-cell proliferation and DC-T cell assays.
- MHC Class I and Class II binding, stability, and competition assays.
- Physical antigen presentation profiling and B-cell linear epitope mapping for rational deimmunization.
Clinical Immunogenicity Testing:
- Tiered Anti-Drug Antibody (ADA) screening, confirmatory, and titering assays.
- Cell-based (reporter gene, proliferation) and non-cell-based competitive ligand binding Neutralizing Antibody (NAb) assays.
Immunotoxicology & Safety Screening:
- Whole-blood and PBMC-based Cytokine Release Syndrome (CRS) risk evaluation.
- Mixed Lymphocyte Reaction (MLR) and non-specific immune activation profiling.
- Tissue Cross-Reactivity screening across standard frozen human and animal tissue panels.
