Principal Scientist Merck & Co., Inc. Kenilworth, New Jersey
Presentation Description: Polyclonal antibodies (pAbs) generated in animals against the therapeutic product have been widely considered as the best representative surrogate positive controls (PCs) for clinical ADA assays. However, monoclonal antibodies (mAbs), with different binding affinities and idiotype epitope specificities, have also been used to better mimic the clinically relevant immune response, such as neutralizing activities. It is obvious that there is no perfect solution when selecting a PC for ADA assessments for preclinical and clinical studies. We will present two case studies addressing the following questions: 1) What is the relevance of ADA data where assay parameters are defined using a single mAb or a mixture of mAbs or a single pAb as the positive control? 2) What are the pros and cons of using a mAb vs a pAb as PC? 3) What would be the next generation PC? What about a human PC generated from clinical trial derived samples?
Upon completion, participant will be able to compare ADA assay performance using different PCs and the clinical relevance of the data generated.
Upon completion, participant will be able to emphasize significance of using appropriate PC for ADA assays.
Upon completion, participant will be able to leverage existing understanding of PC design to support ADA assays for novel modalities.