Harmonizing Regulatory Guidelines for Assay Validation

This technical report discusses the harmonization of regulatory guidelines for assay validation, specifically focusing on kinetics-based assays using Octet® BLI systems. It outlines the importance of assay validation in ensuring accurate and reliable data in scientific research, clinical diagnostics, and pharmaceutical decision-making. The document aims to provide a common set of parameters applicable to kinetics-based assays, addressing the limitations of existing guidelines that primarily cover end-point assays. It details the process of validating ligand binding assays (LBAs) and emphasizes the necessity for a lifecycle approach to validation, considering changes in reagents and instrumentation over time. The report also highlights the critical parameters for assay validation, including fit-for-purpose criteria, variability in measurements, and the impact of sample handling on data reliability. Additionally, it discusses the role of Octet® BLI systems in providing real-time kinetics and the importance of understanding current regulatory guidelines for successful assay validation.