Module 9 2021

22/03/2021

Integrated strategy for immunogenicity assessment

Patient samples taken at appropriate time-points

Screening Assay

negative samples rejected

positive samples

Confirmatory Assay

Confirmed positive samples

Neutralisation Assay bioassay or CLB assay

Characterisation titer, isotype, affinity

Assess correlation of ADAs with clinical responses to biotherapeutic

Assays for clinical markers Assessment of clinical response in patients

The Organisation for Professionals in Regulatory Affairs

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Immunogenicity Testing - How?

Detection of anti-drug antibodies (ADA): Prevalent formats: Binding characteristics • Binding assays

ELISA (colorimetric detection method) ECL assays (electrochemiluminescence) Surface Plasmon Resonance assays – SPR

Neutralising characteristics • Bioassays • Competitive ligand binding assays (non-cell based assays)

The Organisation for Professionals in Regulatory Affairs

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