ArticleAntibodies (Basel, Switzerland)2026
Development and Validation of Cell-Based Bioassay for the Detection of Neutralizing Antibodies to Ocrelizumab in Human Serum Using Antibody-Dependent Cell-Mediated Cytotoxicity Test in a Reporter Cell Line Expressing FcγRIIIa.
Article in Antibodies (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND/
objectivesOcrelizumab is a humanized monoclonal antibody targeting CD20, approved for the treatment of adult patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The neutralizing activity of anti-drug antibodies (ADAs), especially neutralizing ADAs (nADAs) activity, should be examined considering that it can alter pharmacokinetic (PK) and pharmacodynamic (PD) profiles, reduce drug efficacy, and lead to life-threatening adverse events.
methodsThis article presents data on the development and validation of an assay for neutralizing anti-drug antibodies (nADA) based on ADCC reporter cells for the analysis of patient sera in the context of ocrelizumab clinical studies.
resultsCritical steps and conditions to minimize assay variability were identified. The lower limit of detection was 549.6 ng/mL. The cutoff for nonspecific neutralization was determined as 19.7%. The presence of 0.37-3.0 μg/mL ocrelizumab in a biological sample enables the detection of 1.1-10.0 μg/mL polyclonal anti-ocrelizumab idiotype antibodies, respectively.
conclusionsThe developed method can be used for immunogenicity studies of medicinal products containing ocrelizumab.
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