Presented by: Mathilde Yu
Event: WRIB 2026
Developing anti‑Ad5 total antibody (TAb) assays is uniquely challenging due to the 100% prevalence of pre‑existing anti‑Ad5 antibodies in human serum, which makes traditional ADA screening and confirmatory tiers unusable.
Cerba Research developed a titer‑only assay supported by a custom “TAb‑free” matrix generated through Protein A/G/L depletion and demonstrated that sample dilutions in buffer performed equivalently to matrix‑based dilutions. An empirically selected cut‑point (ratio to NC = 2.0) enabled a reproducible and fit‑for‑purpose method for semi‑quantifying treatment‑boosted anti‑Ad5 antibodies. The validated assay successfully characterized boosted TAb responses in a phase 3 study, despite high baseline immunity
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