Octet® BLI Kinetics Assay: Method Development Guideline
Overview
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:
- General Assay Development Sequence
- Ligand and Biosensor Selection
- Biosensor Hydration
- Ligand Density Scouting
- Assay Buffer Optimization
- Analyte Binding
- Data Analysis
- Qualifying Assay Parameters
