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.