Informed Bioanalysis of Biomarkers
We perform in-house GLP and GcLP sample analysis with optimized methods targeted to your compound needs. To ensure that biomarkers are decision-making for drug development, we deliver not only method and data, but also strategy and data interpretation in collaboration with our clinical research and PKPD modeling teams.
- Immunogenicity risk assessment and clinical immunogenicity strategy
- Assay development/validation
- Sample testing (anti-drug antibody screening, confirmation, titration, neutralization capacity, domain specificity, isotyping)
- Data analysis in the clinical setting (effect of anti-drug antibody on pharmacokinetics/pharmacodynamics, efficacy and adverse reactions)
- Regulatory submission documentation (e.g., integrated summary of immunogenicity, 2.7.1, 2.7.2, CSR etc.).