Therapeutic Monoclonal Antibody─Antidrug Antibody Affinity Constant Determination Using Capillary Electrophoresis-Tandem Mass Spectrometry.
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DOI: 10.1021/acs.analchem.4c02932
Abstract: Monoclonal antibody (mAbs) therapeutics cannot evade the occurrence of adverse effects. Thus, mAbs are commonly triggering immune responses corresponding to the expression of antidrug antibodies. Antidrug antibodies can neutralize mAbs, leading to their inhibition and… read more here.
Keywords: monoclonal antibody; antidrug antibody; capillary electrophoresis; antibody ... See more keywords
Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products.
Sign Up to like & getrecommendations! Published in 2019 at "Bioanalysis"
DOI: 10.4155/bio-2019-0241
Abstract: Therapeutic proteins have the potential to induce unwanted immune responses. The potential impact of immunogenicity on pharmacokinetics, pharmacodynamics, safety and efficacy are well established. Here, we analyze key aspects of current US FDA and EMA… read more here.
Keywords: regulatory guidance; antidrug antibody; analysis regulatory; guidance antidrug ... See more keywords