Overcoming drug interference in an IND-Track ADA assay

17 Sept 2026

Reliable anti-drug antibody (ADA) detection is essential for advancing biotherapeutics through development and regulatory review. High drug levels in patient samples can interfere with ADA assays, masking immune responses and creating false negatives that threaten assay reproducibility, delay validation, and put critical submission timelines at risk.

Explore in this resource how Prolytix overcame drug interference in an Investigational New Drug (IND)-track ADA assay using a custom approach that combined acid dissociation with the Affinity Capture Elution (ACE) method. Discover how by exposing bound ADA and reducing drug-driven interference, the assay restored sensitivity and delivered consistent, reproducible performance even in the presence of high drug levels. The result is a robust, drug-tolerant ADA workflow that supports regulatory confidence and helps keep biotherapeutic development programmes on track.

Resource details:

Resource type: Application note
Page count: 4
Read time: 5 mins

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