Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry.

作者: Hendrik Neubert , Christopher Grace , Klaus Rumpel , Ian James

DOI: 10.1021/AC8005439

关键词: AntibodyPeptideBiochemistryBinding siteChemistryImmunogenicityProtein GImmune systemAntigenImmunoprecipitation

摘要: The administration of biological protein therapeutics can lead to an unwanted immune response resulting in the generation anti-drug antibodies (ADA) with potentially harmful clinical consequences. Hence, develop safe and efficacious biotherapeutics, immunogenic potential needs be examined during development phase. Current assay technologies measuring ADAs are subject interference by high circulating concentrations therapeutic, raising concerns about data reliability since therapeutic-free washout samples not always available. Herein, we report characterization a magnetic bead based immunoprecipitation method followed quantitative LC/MS determine ADA human cynomolgus serum presence therapeutic. Available binding sites saturated addition excess therapeutic G isolation IgG their bound antigens be...

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