Challenges with current technology for the detection, measurement and characterization of antibodies against biological therapeutics.

The primary concern with immunogenicity of biological products for manufacturers, regulatory agencies and clinicians is whether antibodies produced by patients receiving the product have clinical sequelae. However, the assessment of this concern is entirely dependent on the appropriate detection, measurement and characterisation of antibodies against biological therapeutics. The current assays for antibodies in biological fluids are prone to a wide range of technical difficulties in addition to scientific challenges in their interpretation. Problems such as matrix effects, selecting controls, antibody affinity, neutralizing capacity, antigen presentation and antigen/antibody complexes all require consideration in the design of antibody assays. Following the design of antibody assays, rigorous validation must be carried out to assure that the results they produce are meaningful. The relevance of quantitative measurement is particularly difficult to assess, as is the comparability of assay results between laboratories. Therefore considerable care is required in the design, execution, analysis and interpretation of antibody assays.