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Use of a standardized MxA protein measurement-based assay for validation of assays for the assessment of neutralizing antibodies against interferon-β.
Wadhwa M, Subramanyam M, Goelz S, Goyal J, Jethwa V, Jones W, Files JG, Kramer D, Bird C, Dilger P, Tovey M, Lallemand C, Thorpe R. Wadhwa M, et al. Among authors: kramer d. J Interferon Cytokine Res. 2013 Nov;33(11):660-71. doi: 10.1089/jir.2012.0079. Epub 2013 Jul 13. J Interferon Cytokine Res. 2013. PMID: 23848523 Free PMC article.
Development and validation of cell-based luciferase reporter gene assays for measuring neutralizing anti-drug antibodies against interferon beta.
Hermanrud C, Ryner M, Luft T, Jensen PE, Ingenhoven K, Rat D, Deisenhammer F, Sørensen PS, Pallardy M, Sikkema D, Bertotti E, Kramer D, Creeke P, Fogdell-Hahn A; ABIRISK Consortium. Hermanrud C, et al. Among authors: kramer d. J Immunol Methods. 2016 Mar;430:1-9. doi: 10.1016/j.jim.2016.01.004. Epub 2016 Jan 11. J Immunol Methods. 2016. PMID: 26779831
Taking immunogenicity assessment of therapeutic proteins to the next level.
Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, Subramanyam M, Thorpe R, Trouvin JH, Weise M, Windisch J, Schneider CK. Büttel IC, et al. Among authors: kramer d. Biologicals. 2011 Mar;39(2):100-9. doi: 10.1016/j.biologicals.2011.01.006. Epub 2011 Feb 24. Biologicals. 2011. PMID: 21353596
Detection and kinetics of persistent neutralizing anti-interferon-beta antibodies in patients with multiple sclerosis. Results from the ABIRISK prospective cohort study.
Jensen PEH, Warnke C, Ingenhoven K, Piccoli L, Gasis M, Hermanrud C, Fernandez-Rodriguez BM, Ryner M, Kramer D, Link J, Ramanujam R, Auer M, Buck D, Grummel V, Bertotti E, Fissolo N, Oliver-Martos B, Nytrova P, Khalil M, Guger M, Rathmaier S, Sievers-Stober C, Lindberg RLP, Hässler S, Bachelet D, Aktas O, Donnellan N, Lawton A, Hemmer B, Havrdova EK, Kieseier B, Hartung HP, Comabella M, Montalban X, Derfuss T, Sellebjerg F, Dönnes P, Pallardy M, Spindeldreher S, Broët P, Deisenhammer F, Fogdell-Hahn A, Sorensen PS; ABIRISK Consortium. Jensen PEH, et al. Among authors: kramer d. J Neuroimmunol. 2019 Jan 15;326:19-27. doi: 10.1016/j.jneuroim.2018.11.002. Epub 2018 Nov 7. J Neuroimmunol. 2019. PMID: 30447419
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
Lotz GP, Benstein K, Bloem K, Buddiger H, Calonder C, Elm S, Fernandez E, Goodman J, Gorovits B, Grudzinska-Goebel J, Janssen M, Jawa V, Kramer D, Luo L, Malisauskas M, Michaut L, Schäfer M, Spindeldreher S, Ullmann M, Nana Weldingh K, Kromminga A, Snoeck V. Lotz GP, et al. Among authors: kramer d. AAPS J. 2022 May 12;24(3):68. doi: 10.1208/s12248-022-00712-2. AAPS J. 2022. PMID: 35554731
Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
Goodman J, Cowen S, Devanarayan V, Egging D, Emrich T, Golob M, Kramer D, McNally J, Munday J, Nelson R, Pedras-Vasconcelos JA, Piironen T, Sickert D, Skibeli V, Fjording MS, Timmerman P. Goodman J, et al. Among authors: kramer d. Bioanalysis. 2018 Feb;10(4):197-204. doi: 10.4155/bio-2017-4971. Epub 2018 Jan 18. Bioanalysis. 2018. PMID: 29345496
Development and Validation of an Enzyme-Linked Immunosorbent Assay for the Detection of Binding Anti-Drug Antibodies against Interferon Beta.
Ingenhoven K, Kramer D, Jensen PE, Hermanrud C, Ryner M, Deisenhammer F, Pallardy M, Menge T, Hartung HP, Kieseier BC, Bertotti E, Creeke P, Fogdell-Hahn A, Warnke C. Ingenhoven K, et al. Among authors: kramer d. Front Neurol. 2017 Jul 6;8:305. doi: 10.3389/fneur.2017.00305. eCollection 2017. Front Neurol. 2017. PMID: 28729851 Free PMC article.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Richards S, et al. Among authors: kramer d. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512
Longitudinal analysis of anti-drug antibody development in multiple sclerosis patients treated with interferon beta-1a (Rebif™) using B cell receptor repertoire analysis.
van der Weele L, Pollastro S, van Schaik BDC, van Kampen AHC, Niewold ITG, Kuijpers TW, Warnke C, Jensen PEH, Kramer D, Ryner M, Hermanrud C, Dönnes P, Pallardy M, Spindeldreher S, Deisenhammer F, Fogdell-Hahn A, de Vries N; ABIRISK Consortium. van der Weele L, et al. Among authors: kramer d. J Neuroimmunol. 2022 Sep 15;370:577932. doi: 10.1016/j.jneuroim.2022.577932. Epub 2022 Jul 14. J Neuroimmunol. 2022. PMID: 35853357 Free article.
1,429 results