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mAbs Volume 13, 2021 - Issue 1
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The impact of immunogenicity on therapeutic antibody pharmacokinetics: A preclinical evaluation of the effect of immune complex formation and antibody effector function on clearance

Eugenia Opolka-Hoffmanna Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, GermanyView further author information
,
Gregor Jordana Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, GermanyView further author information
,
Michael Ottenederb Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Basel, SwitzerlandView further author information
,
Robin Kieferlea Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, GermanyView further author information
,
Martin Lechmanna Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, GermanyView further author information
,
Gerhard Winterc Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-University, Munich, GermanyView further author information
&
Roland F. Staacka Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, GermanyCorrespondence[email protected]
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Article: 1995929 | Received 09 Aug 2021, Accepted 15 Oct 2021, Published online: 11 Nov 2021

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Jerome Egli, Stefan Heiler, Felix Weber, Guido Steiner, Timo Schwandt, Katharine Bray-French, Christian Klein, Sebastian Fenn, Gregor P. Lotz, Eugenia Opolka-Hoffmann, Thomas E. Kraft, Laetitia Petersen, Rebecca Moser, Jonathan DeGeer, Michel Siegel, Daniela Finke, Juliana Bessa & Antonio Iglesias. (2022) Enhanced immunogenic potential of cancer immunotherapy antibodies in human IgG1 transgenic mice. mAbs 14:1.
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Xingyan Yu, Tao Li, Zhiyuan Shen, Hongyan Jing, Xiulong Xie, Xiaofei Zhou, Yuelei Shen & Yi Yang. (2023) The establishment of B cell-deficient Igh-J KO mouse model by gene editing and efficacy evaluation. International Immunopharmacology 116, pages 109704.
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Marie Fichter, Gesa Richter, Alexander Bepperling & Paul Wassmann. (2022) Pre-Clinical In-Vitro Studies on Parameters Governing Immune Complex Formation. Pharmaceutics 14:6, pages 1254.
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Lina Loo, Shannon Harris, Mark Milton, Meena, Wibke Lembke, Flora Berisha, Sylvie Bertholet, Francis Dessy, Robert Dodge, Xiaodong Fang, Michele Fiscella, Fabio Garofolo, Boris Gorovits, Soumi Gupta, Vibha Jawa, Akiko Ishii-Watabe, Brian Long, Yanmei Lu, Timothy Mack, Kristina McGuire, Katrina Nolan, Luying Pan, Bernd Potthoff, Shobha Purushothama, Dean Smith, Therese Solstad, Ivo Sonderegger, Frank Taddeo, Shabnam Tangri, Leslie Wagner, Bonnie Wu, Yuanxin Xu, Susan Kirshner, Daniela Verthelyi, Haoheng Yan, Kimberly Maxfield, Joao Pedras-Vasconcelos, Mohsen Rajabi Abhari, Swati Gupta, Yuling Wu, Manoj Rajadhyaksha, Matthew Andisik, Daniel Baltrukonis, Elana Cherry, Isabelle Cludts, George Gunn, Anders Holm Millner, Gregor Jordan, Sumit Kar, Robert Kubiak, Gregor P Lotz, Rachel Palmer, Kun Peng, Johann Poetzl, Susan Richards, Natasha Savoie, Roland F Staack, Kay Stubenrauch, Meenu Wadhwa, Günter Waxenecker, Tong-Yuan Yang & Lucia Zhang. (2022) 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 ( Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization) . Bioanalysis 14:11, pages 737-793.
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