Validating biomarkers Online xxx audio chatings
Cell-based anti-drug neutralizing antibody (NAb) assays for safety and efficacy assessment of biologics Cell-based assays mimic the mechanism by which the neutralizing antibodies (NAbs) exert their effect in vivo and are the regulatory authorities’ preferred method to detect NAb presence.It is important to detect the presence of NAbs as they may potentially inhibit biological activity of the therapeutic drug product impacting safety and efficacy of the biopharmaceutical.His ongoing research program probes the immunologic and genetic factors that shape the natural history and clinical outcomes of TB and influenza infection, whilst maintaining a strong translational theme by developing and validating novel biomarkers of infection, disease and treatment response.
Frontage Labs, having installed Quanterix’ fully automated Simoa™ HD-1 system for performing immunoassays, has now successfully validated its use.Cell-based neutralizing antibody assays can be difficult to develop as the selection of the most suitable assay type (indirect or direct) and format depends on thorough understanding of the drug’s mechanism of action.Each assay must be target specific, reproducible, minimally affected by matrix effects, and be able to detect the NAb in the presence of the therapeutic.Drug Tolerance Assessment and Improvement in Cell Based NAb Assays Using Response Data Modeling Learn more Bioanalysis and Toxicology Challenges with ADC: How are They Different and New?Ajit Lalvani is Chair of Infectious Diseases, National Institute of Health Research Senior Investigator and Wellcome Senior Clinical Research Fellow at Imperial College London and Founding Director of the Tuberculosis Research Centre.
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Ajit qualified in medicine from the Universities of Oxford and London followed by specialty medical training in London, Cambridge, Basel and Oxford.