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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...
The relationships between flying Antarctic seabirds and their at-sea environments remain poorly understood, particularly outside of the breeding season. Improving our knowledge of how these marine predators use their habitat is a critical step towards conservation of these species. We tracked 27 adult Snow Petrels from two large breeding colonies in East Antarctica during the Austral winter (non-breeding period) – when they ar...
The Southern Ocean is a productive and biodiverse region, but it is also threatened by anthropogenic pressures. Protecting the Southern Ocean should start with well-informed Marine Ecosystem Assessments of the Southern Ocean (MEASO) being performed, a process that will require biodiversity data. In this context, open geospatial biodiversity databases such as OBIS and GBIF provide good avenues, through aggregated geo-referenced...
The statistical assessments needed to establish anti-drug antibody (ADA) assay cut points (CPs) can be challenging for bioanalytical scientists. Poorly established CPs that are too high could potentially miss treatment emergent ADA or, when set too low, result in detection of responses that may have no clinical relevance. We evaluated 16 validation CP datasets generated with ADA assays at Regeneron’s bioanalytical laboratory a...
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...
Responses of Southern Ocean Seafloor Habitats and Communities to Global and Local Drivers of ChangeOA Marine
Knowledge of life on the Southern Ocean seafloor has substantially grown since the beginning of this century with increasing ship-based surveys and regular monitoring sites, new technologies and greatly enhanced data sharing. However, seafloor habitats and their communities exhibit high spatial variability and heterogeneity that challenges the way in which we assess the state of the Southern Ocean benthos on larger scales. The...
Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass SpectrometryNARA Subscribed
There is an urgent demand to develop new technologies to characterize immunogenicity to biotherapeutics. Here, we developed an immunocapture LC-MS assay to isotype and semi-quantify monkey anti-drug antibodies (ADAs) to fully human monoclonal antibody (mAb) drugs. ADAs were isolated from serum samples using an immunocapture step with the Fab of the full-length mAb cross-linked to magnetic beads to minimize matrix interference....
Reproductive performance and diving behaviour share a common sea‐ice concentration optimum in Adélie penguins ( Pygoscelis adeliae )NARA Subscribed
The Southern Ocean is currently experiencing major environmental changes, including in sea‐ice cover. Such changes strongly influence ecosystem structure and functioning and affect the survival and reproduction of predators such as seabirds. These effects are likely mediated by reduced availability of food resources. As such, seabirds are reliable eco‐indicators of environmental conditions in the Antarctic region. Here, based...
Cooperative breeding decreases the direct reproductive output of subordinate individuals, but cooperation can be evolutionarily favored when there are challenges or constraints to breeding independently. Environmental factors, including temperature, precipitation, latitude, high seasonality, and environmental harshness have been hypothesized to correlate with the presence of cooperative breeding. However, to test the relations...
Decadal changes in habitat characteristics influence population trajectories of southern elephant sealsNARA Subscribed
Understanding divergent biological responses to climate change is important for predicting ecosystem level consequences. We use species habitat models to predict the winter foraging habitats of female southern elephant seals and investigate how changes in environmental variables within these habitats may be related to observed decreases in the Macquarie Island population. There were three main groups of seals that specialized...
Climate change and Southern Ocean ecosystems I: how changes in physical habitats directly affect marine biotaNARA Subscribed
Antarctic and Southern Ocean ( ASO ) marine ecosystems have been changing for at least the last 30 years, including in response to increasing ocean temperatures and changes in the extent and seasonality of sea ice; the magnitude and direction of these changes differ between regions around Antarctica that could see populations of the same species changing differently in different regions. This article reviews current and expect...
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