January 24, 2019 | FDA Release New Method Validation Guidance

Finalizing a draft guidance first issued in April 2016, the FDA have this week released a new final guidance for the validation of Assays for the detection of anti-drug antibodies (ADA’s).

Called ‘Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection’, the new Guidance offers further recommendations on the fundamental parameters for Assay Validation (cut-point, sensitivity and drug tolerance, specificity and selectivity, precision, reproducibility, robustness and in-use stability) based on ‘common issues encountered by the Agency upon review of immunogenicity submissions.’

Recommendations given also pertain to the validation of Screening Assays, Confirmatory Assays, Titration Assays and Neutralization Assays for the detection of anti-drug antibodies and some peptides and oligonucleotides.

Though unenforceable, the recommendations outline the FDA’s current thinking of best practice around Assay validation.