The customized assays that our dedicated scientists create for you are built on our solid analytical capabilities and regulatory compliance experience. That’s how we get you reliable results every time.

Our Bioanalytical Group develops and validates proprietary and non-proprietary analytical methods to identify, quantify and characterize small molecules, new chemical entities, and biologics from many different matrices. Mass spectrometry methods characterize batches of protein biologics throughout the stages of discovery, production and lot release.

Our Bioassay Group develops and validates custom assays to evaluate the therapeutic potential of biological macromolecules. Our bioassays are developed using the latest technologies and employed for all phases of drug development, as well as GMP-lot release testing of biologics destined for the clinic.

Custom Biologics™ maintains a controlled storage facility that can accommodate sample and reagent storage at 2-8°C, -40°C, -80°C, and under liquid nitrogen conditions.

Bioanalytical services

  • Customized LC-MS/MS and HPLC-UV method development and validation
  • Drug-Drug Interference (DDI) assays
  • MRM protein assays
  • Pharmacokinetic/toxicokinetic studies (pre-clinical and clinical)
  • Sample analysis for clinical and non-clinical studies
  • Lot release evaluation
  • Dose formulation analysis
  • Residual contamination testing
  • Plasma protein binding
  • Metabolic stability and profiling

Bioassay services

  • Custom bioassay development, optimization and validation
  • Ligand binding assays (ELISA)
    • Absorbance
    • Fluorescence
    • Luminescence
    • Multiplexing
    • Electrochemiluminescence (MesoScaleDiscovery)
  • Immunogenicity/anti-drug antibody assays
  • Pharmacokinetic/toxicokinetic studies (pre-clinical and clinical)
  • Cell-based bioassays
    • Potency/Cytotoxicity assays (CDC, ADCC)
    • Neutralizing antibody assays
  • Cell line banking
  • Flow cytometry
  • Protein analytical characterization (SDS-PAGE, Western blotting)
  • Residual contaminants/host-cell protein assays
  • Lot release evaluation
  • qPCR
"Custom Biologics™ matched us perfectly. Big companies promise a lot but don't deliver."
– J. W., PhD, Manager, Non-Clinical Discovery