ACT 2024 -- The T cell-dependent antibody response (TDAR) assay is an in vivo functional assay capable of characterizing the immune response to an immunogen. It is used for safety assessments, in conjunction with other toxicologic endpoints, to evaluate test article-induced immune modulation. The TDAR assay is a critical component in preclinical safety assessments of large-molecule biologics and routinely performed in rodents, dogs and nonhuman primates. In this method development study, we seek to establish a TDAR assay in juvenile rabbits. Rabbits were chosen for this study because they are sensitive to a number of agents known to cause reproductive or developmental toxicity. Rabbits historically have been used as the second species in safety evaluation studies of this type (evaluating potentially teratogenic agents) and are recommended by appropriate regulatory agencies. The New Zealand white rabbit was selected based on availability of historical control data and susceptibility to known developmental toxicants.

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