Navigating Critical Reagent Challenges in Cell-Based Potency Assays: Case Studies on Variability and Solutions

Purpose

A critical reagent is a key component of an assay that directly impacts the assay’s performance. Critical reagents are often biological molecules like antibodies, proteins, or cell lines. They are the backbone of cell-based potency assays (CBA), as such their variability can create major challenges in assay development, validation, and routine sample testing. Issues such as lot-to-lot inconsistencies, supply chain disruptions, and reagent discontinuation can lead to unexpected changes in assay performance, potentially impacting result consistency over time and regulatory compliance. This poster presents two real-world case studies that highlight these challenges and discuss practical mitigation strategies to ensure long-term assay sustainability and robustness.