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11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Islam R, Briscoe C, Bower J, Cape S, Arnold M, Hayes R, Warren M, Karnik S, Stouffer B, Xiao YQ, van der Strate B, Sikkema D, Fang X, Tudoroniu A, Tayyem R, Brant A, Spriggs F, Barry C, Khan M, Keyhani A, Zimmer J, Caturla MC, Couerbe P, Khadang A, Bourdage J, Datin J, Zemo J, Hughes N, Fatmi S, Sheldon C, Fountain S, Satterwhite C, Colletti K, Vija J, Yu M, Stamatopoulos J, Lin J, Wilfahrt J, Dinan A, Ohorodnik S, Hulse J, Patel V, Garofolo W, Savoie N, Brown M, Papac D, Buonarati M, Hristopoulos G, Beaver C, Boudreau N, Williard C, Liu Y, Ray G, Warrino D, Xu A, Green R, Hayward-Sewell J, Marcelletti J, Sanchez C, Kennedy M, Charles JS, Bouhajib M, Nehls C, Tabler E, Tu J, Joyce P, Iordachescu A, DuBey I, Lindsay J, Yamashita J, Wells E. Islam R, et al. Among authors: sikkema d. Bioanalysis. 2018 Apr 1;10(7):433-444. doi: 10.4155/bio-2018-0014. Epub 2018 Apr 27. Bioanalysis. 2018. PMID: 29701066
Clinicogenomic factors of biotherapy immunogenicity in autoimmune disease: A prospective multicohort study of the ABIRISK consortium.
Hässler S, Bachelet D, Duhaze J, Szely N, Gleizes A, Hacein-Bey Abina S, Aktas O, Auer M, Avouac J, Birchler M, Bouhnik Y, Brocq O, Buck-Martin D, Cadiot G, Carbonnel F, Chowers Y, Comabella M, Derfuss T, De Vries N, Donnellan N, Doukani A, Guger M, Hartung HP, Kubala Havrdova E, Hemmer B, Huizinga T, Ingenhoven K, Hyldgaard-Jensen PE, Jury EC, Khalil M, Kieseier B, Laurén A, Lindberg R, Loercher A, Maggi E, Manson J, Mauri C, Mohand Oumoussa B, Montalban X, Nachury M, Nytrova P, Richez C, Ryner M, Sellebjerg F, Sievers C, Sikkema D, Soubrier M, Tourdot S, Trang C, Vultaggio A, Warnke C, Spindeldreher S, Dönnes P, Hickling TP, Hincelin Mery A, Allez M, Deisenhammer F, Fogdell-Hahn A, Mariette X, Pallardy M, Broët P; ABIRISK consortium. Hässler S, et al. Among authors: sikkema d. PLoS Med. 2020 Oct 30;17(10):e1003348. doi: 10.1371/journal.pmed.1003348. eCollection 2020 Oct. PLoS Med. 2020. PMID: 33125391 Free PMC article.
Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.
Rup B, Pallardy M, Sikkema D, Albert T, Allez M, Broet P, Carini C, Creeke P, Davidson J, De Vries N, Finco D, Fogdell-Hahn A, Havrdova E, Hincelin-Mery A, C Holland M, H Jensen PE, Jury EC, Kirby H, Kramer D, Lacroix-Desmazes S, Legrand J, Maggi E, Maillère B, Mariette X, Mauri C, Mikol V, Mulleman D, Oldenburg J, Paintaud G, R Pedersen C, Ruperto N, Seitz R, Spindeldreher S, Deisenhammer F; ABIRISK Consortium. Rup B, et al. Among authors: sikkema d. Clin Exp Immunol. 2015 Sep;181(3):385-400. doi: 10.1111/cei.12652. Epub 2015 Jul 2. Clin Exp Immunol. 2015. PMID: 25959571 Free PMC article. Review.
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: sikkema 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
Occurrence of Anti-Drug Antibodies against Interferon-Beta and Natalizumab in Multiple Sclerosis: A Collaborative Cohort Analysis.
Bachelet D, Hässler S, Mbogning C, Link J, Ryner M, Ramanujam R, Auer M, Hyldgaard Jensen PE, Koch-Henriksen N, Warnke C, Ingenhoven K, Buck D, Grummel V, Lawton A, Donnellan N, Hincelin-Mery A, Sikkema D, Pallardy M, Kieseier B, Hemmer B, Hartung HP, Soelberg Sorensen P, Deisenhammer F, Dönnes P, Davidson J, Fogdell-Hahn A, Broët P; ABIRISK Consortium. Bachelet D, et al. Among authors: sikkema d. PLoS One. 2016 Nov 2;11(11):e0162752. doi: 10.1371/journal.pone.0162752. eCollection 2016. PLoS One. 2016. PMID: 27806057 Free PMC article.
Clinical practice of analysis of anti-drug antibodies against interferon beta and natalizumab in multiple sclerosis patients in Europe: A descriptive study of test results.
Link J, Ramanujam R, Auer M, Ryner M, Hässler S, Bachelet D, Mbogning C, Warnke C, Buck D, Hyldgaard Jensen PE, Sievers C, Ingenhoven K, Fissolo N, Lindberg R, Grummel V, Donnellan N, Comabella M, Montalban X, Kieseier B, Soelberg Sørensen P, Hartung HP, Derfuss T, Lawton A, Sikkema D, Pallardy M, Hemmer B, Deisenhammer F, Broët P, Dönnes P, Davidson J, Fogdell-Hahn A; ABIRISK Consortium. Link J, et al. Among authors: sikkema d. PLoS One. 2017 Feb 7;12(2):e0170395. doi: 10.1371/journal.pone.0170395. eCollection 2017. PLoS One. 2017. PMID: 28170401 Free PMC article.
39 results