A gold standard method for the evaluation of antibody-based materials functionality: Approach to forced degradation studies.

Journal of Pharmaceutical and Biomedical Analysis(2018)

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摘要
•A gold standard method for evaluating antibody surfaces functionality is proposed.•The Antibody Anti-HorseRadish Peroxidase (A2HRP) method is validated and reliable.•A2HRP accurately quantifies 0.04–2.98 1012 functional antibody binding sites.•A2HRP evaluates the resistance of antibody surfaces under stress conditions.•The A2HRP principles are applicable to others antibody-based materials and formats.
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关键词
Antibody materials,Functional characterization,Bioanalytical method validation,Biosensors,Gold standard,Stress
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