Nonclinical immunogenicity risk assessment for knobs-into-holes bispecific IgG1 antibodies
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DOI: 10.1080/19420862.2024.2362789
Abstract: ABSTRACT Bispecific antibodies, including bispecific IgG, are emerging as an important new class of antibody therapeutics. As a result, we, as well as others, have developed engineering strategies designed to facilitate the efficient production of… read more here.
Keywords: bispecific igg1; risk; immunogenicity risk; immunogenicity ... See more keywords
Immunogenicity Risk Assessment of Spontaneously Occurring Therapeutic Monoclonal Antibody Aggregates
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DOI: 10.3389/fimmu.2022.915412
Abstract: Aggregates of therapeutic proteins have been associated with increased immunogenicity in pre-clinical models as well as in human patients. Recent studies to understand aggregates and their immunogenicity risks use artificial stress methods to induce high… read more here.
Keywords: antibody aggregates; immunogenicity; occurring therapeutic; spontaneously occurring ... See more keywords
Individual and population-level variability in HLA-DR associated immunogenicity risk of biologics used for the treatment of rheumatoid arthritis
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DOI: 10.3389/fimmu.2024.1377911
Abstract: Hypothesis While conventional in silico immunogenicity risk assessments focus on measuring immunogenicity based on the potential of therapeutic proteins to be processed and presented by a global population-wide set of human leukocyte antigen (HLA) alleles… read more here.
Keywords: hla; immunogenicity risk; population; rheumatoid arthritis ... See more keywords
Preclinical immunogenicity risk assessment of biotherapeutics using CD4 T cell assays
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DOI: 10.3389/fimmu.2024.1406040
Abstract: T-cell dependent antibody responses to biotherapeutics remain a challenge to the optimal clinical application of biotherapeutics because of their capacity to impair drug efficacy and their potential to cause safety issues. To minimize this clinical… read more here.
Keywords: cd4 cell; immunogenicity risk; cell; clinical immunogenicity ... See more keywords
Immunogenicity Risk Assessment of Biotherapeutics Using an Ex Vivo B Cell Assay
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DOI: 10.3390/antib14030062
Abstract: Background/Objectives: Anti-drug antibody (ADA) formation can impact the safety, pharmacokinetics, and/or efficacy of biotherapeutics, including monoclonal antibodies (mAbs). Current strategies for ADA/immunogenicity risk prediction of mAbs include in silico algorithms, T cell proliferation assays, MHC-associated… read more here.
Keywords: risk prediction; immunogenicity risk; cell; cell assay ... See more keywords
Introducing dendritic cell antibody internalization as an immunogenicity risk assessment tool.
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DOI: 10.4155/bio-2022-0024
Abstract: Aim: Immunogenicity risk assessment assays are powerful tools that assess the relative immunogenicity of potential biotherapeutics. We detail here the development of a novel assay that measures the degree of antibody internalization by antigen-presenting cells… read more here.
Keywords: immunogenicity; antibody internalization; risk assessment; immunogenicity risk ... See more keywords