Harmonizing Regulatory Guidelines for Assay Validation: A Focus on Kinetics-Based Assays Using Octet® BLI Systems
Last updated: December 20, 2023
Overview
Validation of an assay is a key part in ensuring accurate and reliable data, which is crucial in scientific research, clinical diagnostics, and pharmaceutical industries decision making. This document represents an attempt to harmonize the current regulatory guidelines for assay validation and apply them to a kinetic-based assay in order to derive a common set of parameters. Although the focus of this document is the Octet® BLI systems the overarching recommendations and assay validation parameters are applicable to all label-free, real-time assay formats, such as surface plasmon resonance (SPR).
- Document type: Guidelines
- Page count: 26
- Read time: 60 minutes
Key Takeaways
- Validation Process of a Ligand Binding Assay
- Assay Validation Lifecycle
- Assay Design and Development
- Assay Development Considerations
This Resource is Designed for:
- Lab Researchers
- Lab Managers
- Analytical Scientists
- QC
Applications Supported:
- Label-free biomolecular interaction analysis
Figure 1. Cover of Application Note.
