Strategy and validation of a nonclinicalgeneric plug-and-play antidrug antibodymethod for human monoclonal antibodybiotherapeutics: supplementary tables

The measurement of antidrug antibodies (ADA) in nonclinical studies provides limited value because theformation and incidence of nonclinical ADA does not translate to clinical experience. The formation andpresence of ADA in nonclinical species can, however, correlate to reduced drug exposure and safetyobservations including vasculitis and immune complex disease. Generic ADA methods for humanizedmonoclonal antibody biotherapeutics mitigate the need to develop bespoke ADA methods duringnonclinical drug development. A drug-tolerant, sensitive, generic ADA immunoassay has been developedand validated for measuring ADA in cynomolgus monkey serum samples, allowing for immediatequalification of future monoclonal antibody biotherapeutics. This approach allows us to differentiatecomplexed and free ADA in a rapidly deployable manner when needed.