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Revisiting the Anti-Drug Antibody Assay Drug Tolerance of a Commercial Biological ProductNARA Subscribed
Drug tolerance (DT) is a critical attribute of anti-drug antibody (ADA) assays for assessing clinical immunogenicity. We present a unique situation where a previously approved commercial product, atezolizumab, required re-assessment of the assay DT to meet an increased drug exposure demand arising from a new route of administration (subcutaneous) and align with updated health authority (HA) regulations. Rather than redevelop t...
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