Drug development relies on ligand binding assays (LBAs), which are bioanalytical procedures widely used to measure the immunogenicity of biotherapeutic molecules and determine drug concentrations for pharmacokinetic analyses. The accuracy and performance of LBAs, however, depends on the quality of key reagents, called critical reagents. The following recommendations and best practices can be used to ensure the consistent characterization of these reagents in bioanalytical laboratories, particularly during the early stages of drug development.

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