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Assay Development

With an applied experience portfolio spanning over 100 years, our consultant leadership possesses a breadth of applied knowledge around biotherapeutic drug development activities, including pharmacokinetics, pharmacodynamics, toxicokinetics, and Chemistry, Manufacturing and Controls (CMC) clinical supply chain requirements. As a team, we strive to design an assay that enables clients to make data-driven decisions to optimize outcomes.

B2S offers services that range from early-stage assay development (including an optimized matched-pair of antibodies), to supporting regulatory-compliant bioanalysis PK/PD assessments. These include, but are not limited to:

 

  • PK, ADA, biomarker method development
  • Prototype assay and method qualification
  • Coated assay plates (i.e. ELISA, ECLIA, etc.) and assay kit development
  • Method transfer to GLP contract research organization for sample analysis
  • Bioanalytical assay and reagent life-cycle management