The impact of ligand binding based assays critical reagent characterization and storage

Biological critical reagents are the foundation of many bioanalytical methods and often chemically modified or conjugated with various chemical tags. As such, the quality and performance of these methods are inherently tied to the quality and stability of critical reagents. This article will outline recommendations for conjugated critical reagent development and characterization. Examples of the impact of regent quality will be discussed for the two common bioanalytical assays in support of drug development for biotherapeutics. Finally, a brief discussion of conjugated reagent stability and recommendations for storage and testing will be presented.

Automated summary

Biological critical reagents are essential for bioanalytical methods and their quality and performance are closely linked to the stability of these reagents. This article outlines recommendations for the development and characterization of conjugated critical reagents and discusses examples of how reagent quality impacts bioanalytical assays for drug development. It also includes a brief discussion on conjugated reagent stability and provides recommendations for storage and testing.