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What determines whether a PK assay succeeds often happens before development ever begins. This article from Immunologix Laboratories, co-authored with Dr. Liz Culyba of the Critical Reagents Group, examines how anti-idiotypic antibody selection, Fc format, affinity, and capture-detection pairing define assay performance, and what rigorous critical reagent planning looks like in practice. Download to explore the science behind getting reagent strategy right from the start.

Years of bioanalytical assay development have established that the quality, consistency, and specificity of assay results depend largely on the critical reagents selected for development.  Today, there is no guidance for the proper characterization of, testing requirements for, or the allowable batch variability in reagents used to support clinical studies.  Because there is no regulatory…