Immunogenicity assays stability

A merging of chemistry and biology is essential to effectively probe the immune system for catalytic antibodies (Fig. 3). Haptens that are successful in eliciting catalytic antibodies are variations of the central theme that transition state stabilization in the antibody combining site will yield functional catalysts for a desired chemical reaction. The evolution of hapten design will be discussed further in subsequent sections. Once the hapten is selected and synthesized, it is attached to an immunogenic carrier protein, usually via an amide bond, for hyperimmunization. A preliminary screen for antibodies that bind the hapten using an enzyme-linked immunosorbent assay (ELISA) is followed by another screen for catalysis of the reaction for which the hapten... 

The optimization and validation of immunoassays for immunogenicity (ADA) testing has been described in detail in several publications [9,14,33,34]. In this section, we will describe the evaluation of relevant performance characteristics (validation parameters) that require the most effort. Some of these are different from the validation of traditional bioanalytical pharmacokinetic (PK) methods for macromolecules [35 37]. Precision, specificity, robustness, and ruggedness are determined similarly between ADA and PK methods. However, recovery/accuracy, sensitivity, stability, linearity, system suitability controls, and selectivity are treated differently between these two types of assays. 

---