IQVIA Laboratories Biosciences partnered with a biopharmaceutical sponsor to address a stability challenge in ligand binding assay–based PK analysis of a novel antibody–drug conjugate (ADC). During method development, concentration dependent bias caused by protein aggregation was identified. By reformulating the sample diluent with ATP and magnesium chloride, the team eliminated assay bias and restored accuracy, precision, and stability without compromising performance. This science driven approach offers a scalable strategy for mitigating aggregation related artifacts in ADC bioanalysis and enabling reliable clinical PK data.
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