Publications by authors named "Kay Stubenrauch"

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Comparable immunogenicity of new modality biotherapeutics delivered subcutaneously or intravenously in non-human primates.
Victoria Koch, Martin Lechmann, Katharine Bray-French, Matthias Füth, Elisabeth Husar, Kay Stubenrauch

J Immunotoxicol· December 2025

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Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control.
Uwe Wessels, Florian Neff, Julia Fakhiri, Klaus Mayer, Ulrich Brinkmann, Kay Stubenrauch

Bioanalysis· June 2024

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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, Kay Stubenrauch

Bioanalysis· June 2022

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Ocular Pharmacokinetics of Intravitreally Injected Protein Therapeutics: Comparison among Standard-of-Care Formats.
Paulina Jakubiak, Rubén Alvarez-Sánchez, Matthias Fueth, Olaf Broders, Hubert Kettenberger, Kay Stubenrauch

Mol Pharm· June 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, Kay Stubenrauch

Bioanalysis· March 2021

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Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control.
Christian Künzel, Afsaneh Abdolzade-Bavil, Alfred M Engel, Mirko Pleitner, Eginhard Schick, Kay Stubenrauch

Bioanalysis· February 2021

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Novel bioanalytical method for the characterization of the immune response directed against a bispecific F(ab) fragment.
Olaf Broders, Uwe Wessels, Markus Zadak, Roland Beckmann, Kay Stubenrauch

Bioanalysis· April 2020

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P329G-CAR-J: a novel Jurkat-NFAT-based CAR-T reporter system recognizing the P329G Fc mutation.
Diana Darowski, Christian Jost, Kay Stubenrauch, Uwe Wessels, Jörg Benz

Protein Eng Des Sel· December 2019

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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, John Allinson, Shashi Amur, Kay Stubenrauch

Bioanalysis· December 2019

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Targeting key angiogenic pathways with a bispecific CrossMAb optimized for neovascular eye diseases.
Jörg T Regula, Peter Lundh von Leithner, Richard Foxton, Veluchamy A Barathi, Gemmy Cheung Chui Ming, Kay G Stubenrauch

EMBO Mol Med· May 2019

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Use of Ella to facilitate drug quantification and antidrug antibody detection in preclinical studies.
Uwe Wessels, Klaus Mackeben, Kay Stubenrauch

Bioanalysis· February 2019

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Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection.
Uwe Wessels, Markus Zadak, Astrid Reiser, Janis Brockhaus, Mirko Ritter, Kay Stubenrauch

Bioanalysis· June 2018

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First-in-Human Phase I Study of Single-agent Vanucizumab, A First-in-Class Bispecific Anti-Angiopoietin-2/Anti-VEGF-A Antibody, in Adult Patients with Advanced Solid Tumors.
Manuel Hidalgo, Maria Martinez-Garcia, Christophe Le Tourneau, Christophe Massard, Elena Garralda, Kay Stubenrauch

Clin Cancer Res· April 2018

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Targeting key angiogenic pathways with a bispecific CrossMAb optimized for neovascular eye diseases.
Jörg T Regula, Peter Lundh von Leithner, Richard Foxton, Veluchamy A Barathi, Chui Ming Gemmy Cheung, Kay G Stubenrauch

EMBO Mol Med· July 2017

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Low immunogenicity of tocilizumab in patients with rheumatoid arthritis.
Gerd R Burmester, Ernest Choy, Alan Kivitz, Atsushi Ogata, Min Bao, Kay Stubenrauch

Ann Rheum Dis· June 2017

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Novel drug and soluble target tolerant antidrug antibody assay for therapeutic antibodies bearing the P329G mutation.
Uwe Wessels, Eginhard Schick, Mirko Ritter, Frank Kowalewsky, Julia Heinrich, Kay Stubenrauch

Bioanalysis· June 2017

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Targeting key angiogenic pathways with a bispecific CrossMAb optimized for neovascular eye diseases.
Jörg T Regula, Peter Lundh von Leithner, Richard Foxton, Veluchamy A Barathi, Chui Ming Gemmy Cheung, Kay G Stubenrauch

EMBO Mol Med· November 2016

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Detection of antidrug antibodies against human therapeutic antibodies lacking Fc-effector functions by usage of soluble Fcγ receptor I.
Uwe Wessels, Alexander Poehler, Miriam Moheysen-Zadeh, Markus Zadak, Roland F Staack, Kay Stubenrauch

Bioanalysis· October 2016

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Ang-2/VEGF bispecific antibody reprograms macrophages and resident microglia to anti-tumor phenotype and prolongs glioblastoma survival.
Jonas Kloepper, Lars Riedemann, Zohreh Amoozgar, Giorgio Seano, Katharina Susek, Kay G Stubenrauch

Proc Natl Acad Sci U S A· April 2016

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Epitope characterization of the ADA response directed against a targeted immunocytokine.
Kay Stubenrauch, Christian Künzel, Rudolf Vogel, Dietrich Tuerck, Eginhard Schick

J Pharm Biomed Anal· October 2015

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An immunodepletion procedure advances free angiopoietin-2 determination in human plasma samples during anti-cancer therapy with bispecific anti-Ang2/VEGF CrossMab.
Kay Stubenrauch, Uwe Wessels, Ulrich Essig, Rudolf Vogel, Harald Waltenberger

J Pharm Biomed Anal· January 2015

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Progress in overcoming the chain association issue in bispecific heterodimeric IgG antibodies.
Christian Klein, Claudio Sustmann, Markus Thomas, Kay Stubenrauch, Rebecca Croasdale

MAbs· January 2014

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PK modulation of haptenylated peptides via non-covalent antibody complexation.
Eike Hoffmann, Anish Konkar, Sebastian Dziadek, Hans-Peter Josel, Karin Conde-Knape, Kay Stubenrauch

J Control Release· October 2013

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Characterization of murine anti-human Fab antibodies for use in an immunoassay for generic quantification of human Fab fragments in non-human serum samples including cynomolgus monkey samples.
Kay Stubenrauch, Uwe Wessels, Ulrich Essig, Frank Kowalewsky, Rudolf Vogel

J Pharm Biomed Anal· January 2013

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Generic anti-drug antibody assay with drug tolerance in serum samples from mice exposed to human antibodies.
Kay Stubenrauch, Klaus Mackeben, Rudolf Vogel, Julia Heinrich

Anal Biochem· November 2012

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