Publications by authors named "Isabelle Cludts"

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The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring.
Meenu Wadhwa, Isabelle Cludts, Eleanor Atkinson, Peter Rigsby

Front Immunol· May 2025

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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, Meenu Wadhwa, Katherine Block, Isabelle Cludts

Bioanalysis· June 2024

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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Mike Baratta, Wenying Jian, Shawna Hengel, Surinder Kaur, Jennifer Cunliffe, Isabelle Cludts

Bioanalysis· June 2024

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2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Johanna Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu, Michael Partridge, Isabelle Cludts

Bioanalysis· April 2024

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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Isabelle Cludts

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Isabelle Cludts

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Luying Pan, Johanna Mora, Karl Walravens, Leslie Wagner, Shirley Hopper, Isabelle Cludts

Bioanalysis· July 2023

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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Lina Loo, Shannon Harris, Mark Milton, Meena, Wibke Lembke, Isabelle Cludts

Bioanalysis· June 2022

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2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Sarah Hersey, Steve Keller, Joel Mathews, Lindsay King, Abbas Bandukwala, Isabelle Cludts

Bioanalysis· May 2022

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &  - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Surinder Kaur, Stephen C Alley, Matt Szapacs, Amanda Wilson, Eugene Ciccimaro, Isabelle Cludts

Bioanalysis· May 2022

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The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring.
Meenu Wadhwa, Chris Bird, Eleanor Atkinson, Isabelle Cludts, Peter Rigsby

Front Immunol· September 2021

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Isabelle Cludts

Bioanalysis· March 2021

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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, Ivo Sonderegger, Andrew Exley, Isabelle Cludts

Bioanalysis· March 2021

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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Lauren Stevenson, Susan Richards, Renuka Pillutla, Albert Torri, John Kamerud, Isabelle Cludts

Bioanalysis· December 2018

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Hendrik Neubert, Timothy Olah, Anita Lee, Stephanie Fraser, Robert Dodge, Isabelle Cludts

Bioanalysis· December 2018

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2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Jan Welink, Yuanxin Xu, Eric Yang, Amanda Wilson, Neil Henderson, Isabelle Cludts

Bioanalysis· November 2018

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Reprint of "Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab".
Isabelle Cludts, Francesca Romana Spinelli, Francesca Morello, Jason Hockley, Guido Valesini

Cytokine· January 2018

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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Isabelle Cludts

Bioanalysis· December 2017

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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Shalini Gupta, Susan Richards, Lakshmi Amaravadi, Steven Piccoli, Binodh Desilva, Isabelle Cludts

Bioanalysis· December 2017

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Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab.
Isabelle Cludts, Francesca Romana Spinelli, Francesca Morello, Jason Hockley, Guido Valesini

Cytokine· August 2017

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Development and characterization of a non-cell-based assay to assess the presence of neutralizing antibodies to interferon-beta in clinical samples.
Isabelle Cludts, Anthony Meager, Robin Thorpe, Meenu Wadhwa

J Immunol Methods· September 2013

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Detection of neutralizing interleukin-17 antibodies in autoimmune polyendocrinopathy syndrome-1 (APS-1) patients using a novel non-cell based electrochemiluminescence assay.
Isabelle Cludts, Anthony Meager, Robin Thorpe, Meenu Wadhwa

Cytokine· May 2010

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Are neutralizing anti-GM-CSF autoantibodies present in all healthy persons?
Anthony Meager, Isabelle Cludts, Robin Thorpe, Meenu Wadhwa

Blood· January 2010

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"Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics.
Richard Stebbings, Lucy Findlay, Cherry Edwards, David Eastwood, Chris Bird, Isabelle Cludts

J Immunol· September 2007

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