Journal ArticleDOI
A novel method for detecting neutralizing antibodies against therapeutic proteins by measuring gene expression.
Yanbin Yu,Christopher Piddington,Dan Fitzpatrick,Brian Twomey,Ren Xu,Steven J. Swanson,Shuqian Jing +6 more
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TLDR
This work has established a novel and non-radioactive bioassay system using branched DNA (bDNA) technology for detecting protein-therapeutic neutralizing antibodies in patient serum that measures the variations of target gene expression that reflect the biologic effect of the therapeutic agent and the capability of the antibodies, if present, to neutralize the therapeutics.About:
This article is published in Journal of Immunological Methods.The article was published on 2006-10-30. It has received 9 citations till now. The article focuses on the topics: Neutralizing antibody.read more
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Reporter gene assay for the quantification of the activity and neutralizing antibody response to TNFα antagonists.
Christophe Lallemand,Nadia Kavrochorianou,Casper Steenholdt,Klaus Bendtzen,Mark A. Ainsworth,Jean-François Meritet,Brigitte Blanchard,Pierre Lebon,Peter C. Taylor,Peter Charles,Saba Alzabin,Michael G. Tovey +11 more
TL;DR: A cell-based assay has been developed for the quantification of the activity of TNFα antagonists based on human erythroleukemic K562 cells transfected with a NFκB regulated firefly luciferase reporter-gene construct, which allows residual drug levels or anti-drug neutralizing antibodies to be quantified even in serum samples with a relatively high degree of cytotoxicity.
Journal ArticleDOI
Unwanted immunogenicity: lessons learned and future challenges
Meenu Wadhwa,Robin Thorpe +1 more
TL;DR: An overview of the bioanalytical methods that are currently being used for assessment of immunogenicity of biotherapeutic and the guidance available along with some of the challenges facing the industry are discussed in this review.
Journal ArticleDOI
Measurement of neutralising antibodies to type I interferons by gene expression assays specific for type 1 interferon-inducible 6-16 mRNA
TL;DR: Two approaches are used, quantitative reverse transcription-polymerase chain reaction (qPCR) and branched DNA, to develop efficient, sensitive and robust non-viral assays to quantify type I IFNs per se and NAbs in sera from patients treated with either IFNbeta or IFNalpha2a, which show rapid and potentially automatable performance.
Journal ArticleDOI
Development of an enzymatic assay for the detection of neutralizing antibodies against therapeutic angiotensin-converting enzyme 2 (ACE2)
TL;DR: An enzymatic NAb assay which detects neutralizing antibodies to both recombinant and endogenous angiotensin-converting enzyme 2 (ACE2) and assess NAb cross-reactivity to the native endogenous enzyme is described.
Journal ArticleDOI
Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity
Francesca Civoli,Mark A. Kroenke,Kaz O Reynhardt,Yao Zhuang,Arunan Kaliyaperumal,Shalini Gupta +5 more
TL;DR: Concerns and current best practices for developing assays to detect neutralizing antibodies to protein therapeutics are described and sensitive and robust assays are developed for detection of clinically relevantneutralizing antibodies.
References
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A specific inhibitor of phosphatidylinositol 3-kinase, 2-(4-morpholinyl)-8-phenyl-4H-1-benzopyran-4-one (LY294002).
TL;DR: One such compound, 2-(4-morpholinyl)-8-phenyl-4H-1-benzopyran-4-one, LY294002, completely and specifically abolished PtdIns 3-kinase activity, which may be beneficial in the treatment of proliferative diseases as well as in elucidating the biological role of the kinase in cellular proliferation and growth factor response.
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Growth factor signaling by receptor tyrosine kinases
Joseph Schlessinger,Axel Ullrich +1 more
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Cytokine signal transduction
TL;DR: Clinical Cancer Research is published monthly, one volume per year, by the American Association for Cancer Research, Inc.
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Cytokine receptor signalling
TL;DR: Many cell functions are regulated by members of the cytokine receptor superfamily, a family of transcription factors that contribute to the diversity of cytokine responses.
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Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
Nicole Casadevall,Joelle Nataf,Beatrice Viron,Amir Kolta,Jean-Jacques Kiladjian,Philippe Martin-Dupont,Patrick Michaud,Thomas Papo,Valérie Ugo,Irène Teyssandier,Bruno Varet,Patrick Mayeux +11 more
TL;DR: In this article, the authors identified 13 patients in whom pure red-cell aplasia developed during treatment with recombinant human erythropoietin (epoetin), and investigated whether there was an immunologic basis for the anemia in these patients.