Bioanalysis and Biomarker Services That Support Every Drug Development Phase
With more than l00 years of combined industry experience of our leadership team and three GLP compliant laboratories, we are ready for all your current and emerging bioanalytical needs.
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.).