Immunoassays

Synexa provides assay development, validation and clinical sample analysis services across a range of immunoassay platforms including:

  • ELISA
  • Meso Scale Discovery (Electrochemiluminescence)
  • Cytometric Bead Array
  • Nephelometry
  • Fluorescence and Luminescence
  • NanoString

Our de novo assay development services includes soluble biomarkers (metabolites, peptides, proteins, phosphoproteins and activity assays), pharmacokinetic assays for biologicals, binding and neutralizing anti-drug antibody assays. We have substantial expertise in:

  • Defining optimum antibody pairs
  • Enhancing assay sensitivity
  • Suppression of background interference
  • Studying impact of pre-analytical factors on assay robustness
  • Methods for sample stabilization
  • Generating material for QCs (e.g. phosphoprotein containing cell lysates)

The validation of a PK and primary or secondary biomarker immunoassays requires determination of:

  • Inter-day Variability
  • Intra-day Variability
  • Dilution linearity
  • Freeze/Thaw Stability
  • On bench Stability
  • Spiking & Recovery
  • Long term stability (start and end date)

The validation of binding and neutralizing anti-drug antibody assays requires determination of:

  • Inter-day Variability
  • Intra-day Variability
  • MRD (20 blanks in duplicate: 10 male sera and 10 female sera, each diluted 6 times)
  • Assay cut-point (50 sera, each run 3 times in 3 separate assays each in duplicate)
  • Low positive
  • Spiking & Recovery
  • Titer Determination
  • Drug Tolerance Determination
  • Specificity Cut Point Determination(25 male sera and 25 female sera, spiked versus unspiked)
  • Stabilities (fresh)
  • Freeze/Thaw
  • On Bench Stability
  • Long Term Stability at 2 conditions and 4 time points