Application of Multiplexed Pharmacokinetic Immunoassay to Quantify
            <i>In Vivo</i>
            Drug Forms and Coadministered Biologics

Woodbury, Nicole; Bald, Eric; Geist, Brian; Yang, Tong‐Yuan

doi:10.4155/bio-2019-0147

Cited by 5 publications

(3 citation statements)

References 22 publications

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“…The multiplex assay is very flexible and fast to run. The U-PLEX platform is typically used as a sandwich assay [ 32 ] and mostly for the detection and quantification of biomarkers, such as interleukins [ 33 ]. However, it is possible to use any biotinylated molecules for coating as we did in this study.…”

Section: Discussionmentioning

confidence: 99%

Multiplexed High-Throughput Serological Assay for Human Enteroviruses

et al. 2020

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Immunological assays detecting antibodies against enteroviruses typically use a single enterovirus serotype as antigen. This limits the ability of such assays to detect antibodies against different enterovirus types and to detect possible type-specific variation in antibody responses. We set out to develop a multiplexed assay for simultaneous detection of antibodies against multiple enterovirus and rhinovirus types encompassing all human infecting species. Seven recombinant VP1 proteins from enteroviruses EV-A to EV-D and rhinoviruses RV-A to RV-C species were produced. Using Meso Scale Diagnostics U-PLEX platform we were able to study antibody reactions against these proteins as well as non-structural enterovirus proteins in a single well with 140 human serum samples. Adults had on average 33-fold stronger antibody responses to these antigens (p < 10−11) compared to children, but children had less cross-reactivity between different enterovirus types. The results suggest that this new high-throughput assay offers clear benefits in the evaluation of humoral enterovirus immunity in children, giving more exact information than assays that are based on a single enterovirus type as antigen.

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Section: Discussionmentioning

confidence: 99%

Multiplexed High-Throughput Serological Assay for Human Enteroviruses

et al. 2020

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“…Typically the systemic concentration of TPs is determined in blood, plasma or serum sampled from the relevant animal species, quantified using ligand-binding assays such as enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence (ECL) (Woodbury et al, 2019;Eangoor, 2020), or mass spectrometry assays such as liquid chromatography-tandem mass spectrometry (LC-MS/MS) 10 or liquid chromatography-high-resolution mass spectrometry (LC-HRMS) (Chang et al, 2021;Khaowroongrueng et al, 2021). For TPs with targets in non-systemic locations, while systemic exposure can sometimes be considered a surrogate for exposure at the target site, it may be essential to characterize the biodistribution of the TP to the site of action and/or other tissues or fluids to aid translational PK/PD modeling or proof of mechanism of action.…”

Section: Measurement Of Pk and Biodistribution Of Tpsmentioning

confidence: 99%

Characterizing the Pharmacokinetics and Biodistribution of Therapeutic Proteins: An Industry White Paper

et al. 2022

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The Innovation & Quality Consortium (IQ) Translational and ADME Sciences Leadership Group (TALG) working group for the ADME of therapeutic proteins evaluates the current practices, recent advances, and challenges in characterizing the PK and biodistribution of therapeutic proteins during drug development, and proposes recommendations to address these issues. Incorporating the in vitro, in vivo and in silico approaches discussed herein may provide a pragmatic framework to increase early understanding of PK/PD relationships, and aid translational modelling for first-in-human dose predictions.

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“…Electrochemiluminescence immuno assay (ECLIA): The electrochemiluminescence immunoassay (ECLIA) is a relatively newly developed method that provides ultrasensitive detection of the analyte without the complex protocols required in ELISA [80][81][82][83][84]. In ECLIA, it is not the enzyme cycles but the electrochemical redox cycles that produce a large number of the luminescent species from the substrate.…”

Section: The Antibody-based Assaymentioning

confidence: 99%

Recent progress in the development of ultra high-sensitive and rapid detection systems for pathogens of emerging infectious diseases

Kawahara¹,

Ishida²

2020

Int Med Care

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Pathogens of Emerging Infectious Diseases (EIDs) have sometimes caused serious public health threats. Researchers have put in significant efforts to not only explore and improve the existing therapeutic methods but also prevent the spread of the pathogen. The present COVID-19 pandemic requires administrators and healthcare professionals to make unprecedentedly difficult and rapid countermeasures. The most difficult challenge is that asymptomatic people with infection can sometimes cause clusters of infections. Identification and tracking have always been delayed since diagnostic confirmation relies solely on real-time reverse transcription polymerase chain reaction (RT-PCR) analysis, which requires a long time for the analysis and sometimes gives false positive or negative results, creating further confusion to administrators and healthcare professionals and increasing the risk of infection. This fact indicates that one of the most important keys of infection control when encountering a new EID, including the latest COVID-19, is the extensive use of an effective diagnostic device that can rapidly characterize the pathogen and provide quantitative information. It should be noted that serious respiratory infections, such as COVID-19 and SARS, and also some foodborne, zoonotic, animal, and plant infectious diseases, are a serious threat to the general public. In particular, mutations in zoonotic pathogens that cause human diseases such as H5N1 and H1N1 would be a greater threat to the human society both now and in the future. Countermeasures against these infectious diseases will strongly rely on rapid and precise diagnosis, and the development of diagnostic devices is very crucial. This review describes the requirements and the issues pertaining to diagnostic devices, strategies to achieve ultra-high sensistivity, and the principles of the recently developed analytic methods, for the benefit of frontline users, including healthcare professionals and the representatives of the diagnostic equipment at the institutions.

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Application of Multiplexed Pharmacokinetic Immunoassay to Quantify In Vivo Drug Forms and Coadministered Biologics

Cited by 5 publications

References 22 publications

Multiplexed High-Throughput Serological Assay for Human Enteroviruses

Multiplexed High-Throughput Serological Assay for Human Enteroviruses

Characterizing the Pharmacokinetics and Biodistribution of Therapeutic Proteins: An Industry White Paper

Recent progress in the development of ultra high-sensitive and rapid detection systems for pathogens of emerging infectious diseases

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