Literature DB >> 16299896

Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies.

Michael Moxness1, Suzanna Tatarewicz, Dohan Weeraratne, Nancy Murakami, Danika Wullner, Dan Mytych, Vibha Jawa, Eugen Koren, Steven J Swanson.   

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Year:  2005        PMID： 16299896     DOI： 10.1373/clinchem.2005.053272

Source DB:  PubMed          Journal:  Clin Chem        ISSN： 0009-9147            Impact factor:   8.327


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  10 in total

1.  Statistical and bioanalytical considerations for establishing a depletion criterion for specificity testing during immunogenicity assessment of a biotherapeutic.

Authors:  R O Driscoll; L Zhou; M Moxness; D Mytych; N Chirmule; V Jawa
Journal:  AAPS J       Date:  2013-08-30       Impact factor: 4.009

Review 2.  Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies.

Authors:  Carmel M Lynch; Bruce W Hart; Iqbal S Grewal
Journal:  MAbs       Date:  2009 Jan-Feb       Impact factor: 5.857

3.  Comparing exponentially weighted moving average and run rules in process control of semiquantitative immunogenicity immunoassays.

Authors:  Troy E Barger; Lei Zhou; Michael Hale; Michael Moxness; Steven J Swanson; Narendra Chirmule
Journal:  AAPS J       Date:  2009-12-10       Impact factor: 4.009

4.  Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics.

Authors:  Lei Zhou; Sarah A Hoofring; Yu Wu; Thuy Vu; Peiming Ma; Steven J Swanson; Narendra Chirmule; Marta Starcevic
Journal:  AAPS J       Date:  2012-10-09       Impact factor: 4.009

Review 5.  Approaches for the detection and analysis of antidrug antibodies to biopharmaceuticals: A review.

Authors:  Kyungah Suh; Isaac Kyei; David S Hage
Journal:  J Sep Sci       Date:  2022-03-10       Impact factor: 3.614

6.  Development, validation, and clinical implementation of an assay to measure total antibody response to naglazyme (galsulfase).

Authors:  Joleen T White; Lisa Argento Martell; Andrea Van Tuyl; Ryan Boyer; Laura Warness; Gary T Taniguchi; Erik Foehr
Journal:  AAPS J       Date:  2008-07-08       Impact factor: 4.009

7.  Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab.

Authors:  Isabelle Cludts; Francesca Romana Spinelli; Francesca Morello; Jason Hockley; Guido Valesini; Meenu Wadhwa
Journal:  Cytokine       Date:  2017-03-06       Impact factor: 3.861

Review 8.  A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501.

Authors:  Richard Markus; Helen J McBride; Monica Ramchandani; Vincent Chow; Jennifer Liu; Dan Mytych; Gary Fanjiang
Journal:  Adv Ther       Date:  2019-06-10       Impact factor: 3.845

9.  Pharmacokinetics, Safety, and Tolerability of NPC-21, an Anti-Cytomegalovirus Monoclonal Antibody, in Healthy Japanese and White Adult Men: A Randomized, Placebo-Controlled, First-in-Human Phase 1 Study.

Authors:  Kenichi Furihata; Izumi Hamada; Takuro Niwa; Tatsuya Watanabe; Sachiko Ezoe
Journal:  Clin Pharmacol Drug Dev       Date:  2022-01-05

10.  A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.

Authors:  Primal Kaur; Vincent Chow; Nan Zhang; Michael Moxness; Arunan Kaliyaperumal; Richard Markus
Journal:  Ann Rheum Dis       Date:  2016-07-27       Impact factor: 19.103
  10 in total

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