Development of AlphaLISA Technology Assays for the Detection of Neutralizing Antibodies in Human Serum

We have previously demonstrated the application of the AlphaLISA® technology for ADA screening and confirmatory assays.1 The usual step after the screening process is to characterize the ADA response by determining if the ADA could neutralize the activity of the drug. Generally, the ADA binds to the drug without affecting its efficacy. However, the presence of neutralizing ADA (NAb) is of great concern since the efficacy and the pharmacokinetic profile of the biotherapeutic drug could be greatly affected. Another concern will arise if the drug has an endogenous counterpart, since the presence of NAb could lead to an autoimmune-like deficiency.