Immunogenicity assay development for biopharmaceuticals requires a case-by-case approach

Justine Fourmeau
Pierre Damien Misson
Stéphanie Pennincx
Benjamin Albertani
Céline Hoareau
Vincent Van Mullem
EBF Focus meeting 2011

Biopharmaceuticals are known to have a greater potential for inducing immune response than conventional small molecule drugs. As a significant safety and efficacy problem, immunogenicity is a major concern for regulatory agencies. Immunogenicity is usually evaluated through the detection and characterization of treatment-induced anti-drug antibodies (ADAs).