Octet® BLI Kinetics Assay: Method Development Guideline


Design and development of biological assays that conform to USP <1032> requires parameters for specificity, accuracy, precision, linearity and range to be established. This document is intended as a general guideline for developing product‑specific ligand binding kinetics assays on Octet® R series instruments.

Careful design, development and qualification of biological assays allows the user to subsequently evaluate CQA in factors such as a change in production process, reference material or critical reagents. Therefore, the time, effort and resources used in developing a USP <1032> compliant assay can yield many benefits in its future use.

This Technical Note provides insight into the procedure for developing and qualifying biological ligand binding kinetics assays on Octet® R series instruments.

Document type: Technical Note
Page count: 7
Read time: 12 minutes

This Technical Note Covers the Following:

  1. General Assay Development Sequence
  2. Ligand and Biosensor Selection
  3. Biosensor Hydration
  4. Ligand Density Scouting
  5. Assay Buffer Optimization
  6. Analyte Binding
  7. Data Analysis
  8. Qualifying Assay Parameters

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