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The administration of therapeutic proteins, such as monoclonal antibodies (mAbs) may result in the formation of anti-drug antibodies (ADA), but there is limited publicly available data for biotherapeutics with exogenous targets or with targets in low abundance systemically. ADAs can impact a biotherapeutic’s safety, efficacy, and pharmacokinetics, so evaluation of immunogenicity is required for all therapeutic proteins. This a...
Hierarchical foraging strategies of migratory short-tailed shearwaters during the non-breeding stageNARA Subscribed
Foraging specialisations are common in animal populations, because they increase the rate at which individuals acquire food from a known and reliable source. Foraging plasticity, however, may also be important in variable or changing environments. To better understand how seabirds might respond to changing environmental conditions, we assessed how plastic the foraging behaviours of short-tailed shearwaters ( Ardenna tenuirostr...
Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody AssayNARA Subscribed
Twenty percent of baseline patient samples exhibited a pre-existing response in a bridging anti-drug antibody (ADA) assay for a human IgG4 monoclonal antibody (mAb) therapeutic. In some cases, assay signals were more than 100-fold higher than background, potentially confounding detection of true treatment-emergent ADA responses. The pre-existing reactivity was mapped by competitive inhibition experiments using recombinant prot...
Monoclonal antibodies (mAbs) are a leading class of biotherapeutics. In oncology, patients often fail on early lines of biologic therapy to a specific target. Some patients may then enroll in a new clinical trial with a mAb specific for the same target. Therefore, immunoassays designed to quantify the current mAb therapy or assess immunogenicity to the drug may be susceptible to cross-reactivity or interference with residual p...
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