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 the
formation and incidence of nonclinical ADA does not translate to clinical experience. The formation and
presence of ADA in nonclinical species can, however, correlate to reduced drug exposure and safety
observations including vasculitis and immune complex disease. Generic ADA methods for humanized
monoclonal antibody biotherapeutics mitigate the need to develop bespoke ADA methods during
nonclinical drug development. A drug-tolerant, sensitive, generic ADA immunoassay has been developed
and validated for measuring ADA in cynomolgus monkey serum samples, allowing for immediate
qualification of future monoclonal antibody biotherapeutics. This approach allows us to differentiate
complexed and free ADA in a rapidly deployable manner when needed.