Harmonizing Regulatory Guidelines for Assay Validation: A Focus on Kinetics-Based Assays

Ensuring accurate and reliable data is critical in scientific research, clinical diagnostics, and decision-making within the pharmaceutical industry. Assay validation plays a vital role in this process. While current regulatory guidelines focus on end-point, potency-based assays and provide a framework for assay design and validation, they often do not address many key parameters relevant to kinetics-based assays.

This document aims to harmonize existing regulatory guidelines for assay validation, applying them specifically to a kinetic-based assay. Although it focuses on the Octet® BLI platform, the general recommendations and validation parameters discussed are relevant to all label-free, real-time assay formats, including surface plasmon resonance. Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.