Critical reagent generation, characterization, handling and storage workflows: impact on ligand binding assays

Oquendo E, Savoie J, Swenson J, Grimaldi C | Bioanalysis, 13(10), 847-860, (2021) Keywords: • biotherapeutics • ELISA • immunoassay • large molecule • LBA • LC–MS • mass spectrometry • method development • proteins • validation Abstract: The foundation of pharmacokinetics and antidrug antibodies assay robustness relies on the use of high quality reagents. Over the past decade, there has been increasing interest within the pharmaceutical industry, as well as regulators, on defining best practices and scientific approaches for generation, characterization and handling of critical reagents. In this review, we will discuss current knowledge and practices on critical reagent...