ArticleThe AAPS journal2025
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules.
Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
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Corrections and comments
- Erratum issued
Authors and funding
17 authors.
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Abstract
Formation of anti-drug antibodies (ADA) and, in particular, neutralizing antibodies (NAb), is a major risk to the development of biotherapeutics. Cell-based assays, which can reflect the mechanistic interactions among the drug, target, and NAb, are often most suitable for the detection of NAb. We report the development and validation of cell-based platform assays for a class of incretin molecules. An affinity capture elution step was employed to improve drug tolerance of a cell-based cyclic adenosine monophosphate (cAMP) assay. Assay conditions and procedures, including acid elution, cell density, and TAG labeled cAMP (cAMP-TAG) incubation time and concentration, were thoroughly optimized. Delta percent (Δ%) Neutralization was used to reduce assay variability during validation and sample analysis. This platform method has been applied to several incretin molecules and has demonstrated desired sensitivity, drug tolerance, and robustness.
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