No Cut-Point, No Cry: Validating Preclinical Anti-Drug Antibody (ADA) Assays Without Generating a Statistical Cut-Point

Immunogenicity assays that are developed and validated to support preclinical studies are often validated in the same way as clinical assays, even though the purpose of the data is very different. Unlike a clinical assay, the preclinical ADA data is only used to interpret the pharmacokinetics (PK)/toxicokinetics (TK) and pharmacodynamics (PD) data.