How Do You Validate ADA Screening Assays?
Immunogenicity can reshape a biologic’s exposure, efficacy, and safety profile, so anti-drug antibody (ADA) screening must be both sensitive and specific before it reaches the clinic. Regulators (FDA/EMA/NMPA) expect a fit-for-purpose validation that proves the assay works across real patient matrices and under routine conditions. The roadmap below distills best practices, from cut-point statistics to…
