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Bioanalytical and bioassay expertise for drug discovery and development.

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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 scientific 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. Aragen BioSafety Solutions 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, hormones, 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