End-to-end bioanalytical and bioassay expertise for drug discovery and development.
Bioanalytical testing is routinely conducted for compounds in discovery and preclinical and clinical development. For regulatory submissions, GLP-compliant bioanalysis using fully validated methods for blood, urine, and other matrices are performed. The highly experienced team is capable of offering various bio-analysis including end-to-end development, validation, and sample analysis, method transfer and validation, optimization of commercial kits, and sample analysis. Intox is equipped with high-end precision instrumentation, assays, and WinNonlin software for conducting kinetic analysis.
- Toxicokinetic/pharmacokinetic analysis for small and large molecules, peptides, peptibodies, hormoens, enzyme replacement therapeutics, Mabs, ADCs, mRNA therapeutics
- Method development/Validation/Sample analysis in blood, urine, and other matrices
- WinNonlin software for analysis and reporting
- Immunogenicity (Anti-drug antibodies)
- Biodistribution – vaccines (DNA/RNA), cell therapeutics, gene therapeutics
- Bioassay
- Biomarker analysis
- Vaccine immunogenicity assessment (humoral and cell mediated immunogenicity)
- Peptide impurity testing using human PBMCs
