Strategic approaches for assessment and minimization of matrix effect in ligand-binding assays.

Background: Although substantial advances have been made in ligand-binding assays (LBA) for biotherapeutics in the past decade, there are still gaps that need to be addressed, especially in the context of understanding matrix effect and its root causes. Critical and in-depth characterization of matrix effect can provide valuable knowledge of the LBA limitations for proper results interpretation. Results: This article illustrates several strategic approaches with regard to identifying the root cause of matrix effect and practical solutions, including recognizing the confounding factors associated with matrix effect, selection of proper reagents to avoid matrix effect, and a systematic approach in dealing with matrix effect in method development and validation. Conclusion: These strategic approaches have enhanced the management of matrix effect in LBA.