Immunogenicity assay development for biopharmaceuticals requires a case-by-case approach
EBF Focus meeting 2011
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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).