Immunogenicityunless
Immunogenicityunless is a coined term used in discussions of immunogenic risk assessment. It denotes a precautionary approach in which a substance is treated as potentially immunogenic unless there is robust evidence demonstrating non-immunogenicity. The concept functions as a heuristic rather than an established scientific definition and is not widely adopted in formal guidelines.
Immunogenicityunless implies a default assumption of possible immunogenic potential, prompting early and thorough evaluation of immune
The term appears in academic and policy discussions as a rhetorical device to emphasize caution and rigorous
If applied, immunogenicityunless encourages early asset screening, including assay strategies for anti-drug antibodies, T-cell and B-cell
Immunogenicity; non-immunogenic; immunogenicity risk assessment; adverse immune response; regulatory science.