作者：Karen Liao ; ^{karen.x.liao@gsk.com} ; Erik Meyer ; Thomas N. Lee ; Amy Loercher ; Daniel Sikkema

关键词：Anti-drug antibodies (ADA) ; Immunogenicity ; IL-5 ; Mepolizumab

刊名：Journal of Immunological Methods

出版年：2017

作者：Johanna Sigaux^a ; ^b ; ^c ; ¹ ; Moustafa Hamze^d ; ¹ ; Claire Daien^e ; ^f ; Jacques Morel^e ; ^f ; Roman Krzysiek^g ; ^h ; ⁱ ; Marc Pallardy^j ; Bernard Maillere^d ; Xavier Mariette^a ; ^b ; ^c ; ² ; Corinne Miceli-Richard^a ; ^b ; ^c ; ² ; ^{corinne.miceli@aphp.fr}

关键词：Immunogenicity ; Tocilizumab ; Rheumatoid arthritis

刊名：Joint Bone Spine

出版年：2017

作者：Christian Vettermann¹ ; Jessica Ortiz ; Stephanie Lee ; Sergio Sanchez ; Hannah P. Victor ; Mark Ma ; Timothy Heath ; Shalini Gupta ; ^{shalinig@amgen.com" class="auth_mail" title="E-mail the corresponding author}

关键词：ADA ; anti-drug antibody ; ACP ; assay cutpoint ; CDM ; compact disc microstructures ; CDR ; complementary determining region ; Fc ; Fragment crystallizable ; F/T ; ratio of free to total drug concentrations ; iNAb ; indirect NAb assessment ; LLRD ; lower limit of reliable detection ; LLOQ ; lower limit of quantification ; NAb ; neutralizing anti-drug antibody ; PCS ; pooled cynomolgus monkey serum ; QC ; quality control ; PK ; pharmacokinetic ; RLU ; relative luminescence unit ; SEM ; standard error of the mean ; STD ; stand

刊名：Journal of Immunological Methods

出版年：2016

作者：Priya S. Kishnani^a ; ^{priya.kishnani@duke.edu" class="auth_mail" title="E-mail the corresponding author} ; Patricia I. Dickson^b ; ^{pdickson@labiomed.org" class="auth_mail" title="E-mail the corresponding author} ; Laurie Muldowney^c ; ^{laurie.muldowney@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Jessica J. Lee^c ; ^{jessica.j.lee@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Amy Rosenberg^d ; ^{amy.rosenberg@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Rekha Abichandani^e ; ^{rabichan@shire.com" class="auth_mail" title="E-mail the corresponding author} ; Jeffrey A. Bluestone^f ; ^{jeff.bluestone@ucsf.edu" class="auth_mail" title="E-mail the corresponding author} ; Barbara K. Burton^g ; ^{bburton@luriechildrens.org" class="auth_mail" title="E-mail the corresponding author} ; Maureen Dewey^c ; ^{maureen.dewey@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Alexandra Freitas^h ; ^{afreitas@rarediseases.org" class="auth_mail" title="E-mail the corresponding author} ; Derek Gavin^h ; ^{dgavin@rarediseases.org" class="auth_mail" title="E-mail the corresponding author} ; Donna Griebel^c ; ^{donna.griebel@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Melissa Hoganⁱ ; ^{melissa@savingcase.com" class="auth_mail" title="E-mail the corresponding author} ; Stephen Holland^j ; ^{steve.holland@thomsonreuters.com" class="auth_mail" title="E-mail the corresponding author} ; Pranoot Tanpaiboon^k ; ^{ptanpaib@childrensnational.org" class="auth_mail" title="E-mail the corresponding author} ; Laurence A. Turka^l ; ^{lturka@partners.org" class="auth_mail" title="E-mail the corresponding author} ; Jeanine J. Utz^m ; ^{utz002@umn.edu" class="auth_mail" title="E-mail the corresponding author} ; Yow-Ming Wangⁿ ; ^{yowming.wang@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Chester B. Whitley^m ; ^{whitley@umn.edu" class="auth_mail" title="E-mail the corresponding author} ; Zoheb B. Kazi^a ; ^{zoheb.kazi@dm.duke.edu" class="auth_mail" title="E-mail the corresponding author} ; Anne R. Pariser^o ; ^{anne.pariser@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author}

关键词：Ab ; antibody ; ADAs ; anti-drug antibodies ; Ag ; antigen ; BiPAP ; bilevel positive airway pressure ; CDER ; Center for Drug Evaluation and Research ; CNS ; central nervous system ; CRIM ; cross-reactive immunologic material ; DGIEP ; Division of Gastroenterology and Inborn Errors of Metabolism ; ERT ; enzyme replacement therapy ; FcR ; Fc receptor ; FDA ; Food and Drug Administration ; GAA ; acid alpha glucosidase ; GAG ; glycosaminoglycans ; HLA ; human leukocyte antigen ; HSAT ; high and sustained anti-rhGAA IgG antibo

刊名：Molecular Genetics and Metabolism

出版年：2016

作者：Yan Q. Chen ; Thomas G. Pottanat ; Quincy L. Carter ; Jason S. Troutt ; Robert J. Konrad ; John H. Sloan

关键词：MSD ; MesoScale Discovery ; ECL ; electrochemiluminescence ; ACE ; affinity capture elution ; ADA ; anti-drug antibody ; TAb ; therapeutic antibody ; MRD ; minimum require dilution ; TMB ; 3 ; 3&prime5 ; 5&prime ; tetramethylbenzidine ; HRP ; horseradish peroxidase ; NHS ; normal human serum ; TBS ; Tris-buffered saline ; SEM ; standard error of the mean

刊名：Journal of Immunological Methods

出版年：2016

作者：Yong Xue^a ; ^{yong.xue@genzyme.com" class="auth_mail" title="E-mail the corresponding author} ; Susan M. Richards^b ; ^{susan.richards@genzyme.com" class="auth_mail" title="E-mail the corresponding author} ; Asif Mahmood^c ; ^{asif.mahmood@genzyme.com" class="auth_mail" title="E-mail the corresponding author} ; Gerald F. Cox^d ; ^{gerald.cox@genzyme.com" class="auth_mail" title="E-mail the corresponding author}

关键词：% Predicted FVC ; percent of predicted normal forced vital capacity ; 6MWT ; six-minute walk test ; ADA ; anti-drug antibody ; AE ; adverse events ; AUC/time ; area under the curve over time (reflects a weighted average of exposure over a period from baseline through a specific timepoint &ndash ; see Section 2.4) ; GAG ; glycosaminoglycan ; IV ; intravenous ; RIP ; radioimmunoprecipitation ; uGAG ; urinary glycosaminoglycan ; ULN ; upper limit of normal

刊名：Molecular Genetics and Metabolism

出版年：2016

作者：Alessandra Cusumano^a ; Davy Guillarme^b ; Alain Beck^c ; ¹ ; Szabolcs Fekete^b ; ^{szabolcs.fekete@unige.ch" class="auth_mail" title="E-mail the corresponding author}

关键词：Hydrophobic interaction chromatography ; Monoclonal antibody ; Antibody-drug-conjugate ; Method development ; Brentuximab-vedotin

刊名：Journal of Pharmaceutical and Biomedical Analysis

出版年：2016

作者：Pauline A. van Schouwenburg^a ; ¹ ; Simone Kruithof^a ; Gertjan Wolbink^a ; ^b ; Diana Wouters^a ; Theo Rispens^a ; ^{t.rispens@sanquin.nl" class="auth_mail" title="E-mail the corresponding author}

关键词：Adalimumab ; Immunogenicity ; Anti-drug antibodies ; Human monoclonal antibodies ; Anti-idiotype Antibodies

刊名：Journal of Pharmaceutical and Biomedical Analysis

出版年：2016

作者：Gregory M. Pastores^a ; ^{gpastores@mater.ie" class="auth_mail" title="E-mail the corresponding author} ; Hadhami Ben Turkia^b ; ^{hadhami.baili@laposte.net" class="auth_mail" title="E-mail the corresponding author} ; Derlis E. Gonzalez^c ; ^{gderlis@conexion.com.py" class="auth_mail" title="E-mail the corresponding author} ; Hiroyuki Ida^d ; ^{hiroy@jikei.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; Azza A.G. Tantawy^e ; ^{azazaghloul@yahoo.com" class="auth_mail" title="E-mail the corresponding author} ; Yulin Qin^f ; ^{yqin@shire.com" class="auth_mail" title="E-mail the corresponding author} ; Yongchang Qiu^f ; ^{yqiu@shire.com" class="auth_mail" title="E-mail the corresponding author} ; Quinn Dinh^f ; ^{qdinh@shire.com" class="auth_mail" title="E-mail the corresponding author} ; Ari Zimran^g ; ^{azimran@gmail.com" class="auth_mail" title="E-mail the corresponding author}

关键词：ADA ; anti-drug antibody ; AE ; adverse event ; CCL18 ; chemokine (C-C motif) ligand 18 ; ECL ; electrochemiluminescence ; ELISA ; enzyme-linked immunosorbent assay ; ERT ; enzyme replacement therapy ; GD ; Gaucher disease ; RIP ; radioimmunoprecipitation ; TEAE ; treatment emergent adverse event

刊名：Blood Cells, Molecules and Diseases

出版年：2016

作者：Jad Zoghbi ; ^{jad.zoghbi@genzyme.com" class="auth_mail" title="E-mail the corresponding author} ; Yuanxin Xu ; Ryan Grabert ; Valerie Theobald ; Susan Richards

关键词：Immunogenicity ; Anti-drug antibody ; ADA ; Drug interference ; Drug tolerance ; Target interference ; Immunoassay ; Ligand binding assays

刊名：Journal of Immunological Methods

出版年：2015