Best Practices for Biomarker Assay Validation in Tissues
Accurate biomarker analysis in tissue samples is critical for understanding drug effects, supporting clinical decisions, and advancing therapeutic development. Yet validating these assays can be complex, especially given the diversity of tissue types, biomarker molecules, and analytical platforms.
The Global CRO Council (GCC) has released a comprehensive white paper detailing current recommendations for biomarker assay validation (BAV) in tissues. Drawing on survey results from 20 leading CROs and discussions from the 16th and 17th GCC Closed Forums, this white paper addresses key challenges—from tissue collection and homogenization to assay selection, QC preparation, and long-term stability testing. It also highlights best practices for handling rare tissue matrices, normalizing biomarker content, and applying fit-for-purpose versus full validation approaches.
Whether you’re working with small molecules, proteins, oligonucleotides, or complex biologics, this resource provides actionable guidance to help ensure your biomarker data are reliable, reproducible, and regulatory-ready. Download the GCC white paper now to explore practical recommendations for assay validation, regulatory compliance, and tissue bioanalysis workflows.
