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Can LC–MS/MS and ligand-binding assays live in harmony for large-molecule bioanalysis?

2014; Future Science Ltd; Volume: 6; Issue: 13 Linguagem: Inglês

10.4155/bio.14.144

1757-6199

Apollon Papadimitriou, Surendra K. Bansal, Julia Heinrich, Roland F. Staack,

Monoclonal and Polyclonal Antibodies Research

BioanalysisVol. 6, No. 13 EditorialCan LC–MS/MS and ligand-binding assays live in harmony for large-molecule bioanalysis?Apollon Papadimitriou, Surendra Bansal, Julia Heinrich & Roland F StaackApollon Papadimitriou*Author for correspondence: E-mail Address: apollon.papadimitriou@roche.comRoche Pharma Research & Early Development, Roche Innovation Center Penzberg, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany, Surendra BansalRoche Pharma Research & Early Development, Roche Innovation Center New York, Roche TCRC Inc., 430 East 29th St., New York, NY 10016, USA, Julia HeinrichRoche Pharma Research & Early Development, Roche Innovation Center Penzberg, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany & Roland F StaackRoche Pharma Research & Early Development, Roche Innovation Center Penzberg, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, GermanyPublished Online:26 Aug 2014https://doi.org/10.4155/bio.14.144AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: assay developmentbioanalyticsbiologicfree druglarge moleculeligand-binding assaymass spectrometryReferences1 Kozlowski S, Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv. Drug Deliv. Rev. 58(5–6), 707–722 (2006).Crossref, Medline, CAS, Google Scholar2 Harris RJ. Heterogeneity of recombinant antibodies: linking structure to function. Dev. Biol. (Basel) 122, 117–127 (2005).Medline, CAS, Google Scholar3 Roskos LK, Schneider A, Vainshtein I et al. PK–PD modeling of protein drugs: implications in assay development. Bioanalysis 3(6), 659–675 (2011).Link, CAS, Google Scholar4 Staack RF, Jordan G, Heinrich J. Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification. Bioanalysis 4(4), 381–395 (2012).Link, CAS, Google Scholar5 Stubenrauch K, Wessels U, Lenz H. Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates. J. Pharm. Biomed. Anal. 49(4), 1003–1008 (2009).Crossref, Medline, CAS, Google Scholar6 Stubenrauch K, Wessels U, Essig U, Kowalewsky F, Vogel R, Heinrich J. Characterization of murine anti-human Fab antibodies for use in an immunoassay for generic quantification of human Fab fragments in non-human serum samples including cynomolgus monkey samples. J. Pharm. Biomed. Anal. 72, 208–215 (2013).Crossref, Medline, CAS, Google Scholar7 van de Merbel NC, Bronsema KJ, Nemansky M. Protein quantification using LC–MS: can it make a difference? Bioanalysis 4(17), 2113–2116 (2012).Link, Google Scholar8 Staack RF, Jordan G, Dahl U, Heinrich J. Free analyte QC concept: a novel approach to prove correct quantification of free therapeutic protein drug/biomarker concentrations. Bioanalysis 6(4), 485–496 (2014).Link, CAS, Google Scholar9 Dudal S, Staack RF, Stoellner D et al. How the bioanalyst plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum. Bioanalysis 6(10), 1339–1348 (2014).Link, Google Scholar10 Kay RG, Roberts A. Bioanalysis of biotherapeutic proteins and peptides: immunological or MS approach? Bioanalysis 4(8), 857–860 (2012).Link, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByREGEN-COV® antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantificationSusan C Irvin, Samit Ganguly, Rachel Weiss, Chinnasamy Elango, Xuefei Zhong, Yuan Mao, Hong Yan, Ning Li, Giane Sumner, Kenneth C Turner, John D Davis, A Thomas DiCioccio, Matthew D Andisik, Michael A Partridge & Albert Torri8 November 2021 | Bioanalysis, Vol. 13, No. 24Development of an automated, interference-free, 2D-LC–MS/MS assay for quantification of a therapeutic mAb in human seraFilip K Sucharski, Simon Meier, Christian Miess, Morty Razavi, Matt Pope, Richard Yip, N Leigh Anderson, Terry W Pearson, Andrew Paul Warren & Carsten Krantz4 July 2018 | Bioanalysis, Vol. 10, No. 13Evaluation of the potential use of hybrid LC–MS/MS for active drug quantification applying the 'free analyte QC concept'Gregor Jordan, Ichio Onami, Julia Heinrich & Roland F Staack27 September 2017 | Bioanalysis, Vol. 9, No. 21Technologies and strategies for bioanalysis of biopharmaceuticalsYan J Zhang & Hyun Joo An28 September 2017 | Bioanalysis, Vol. 9, No. 18Practical considerations in enhancing LC–MS sensitivity for therapeutic protein bioanalysisShaolian Zhou, Faye Vazvaei, Luca Ferrari & Jun Qu28 September 2017 | Bioanalysis, Vol. 9, No. 18In Vivo Biotransformation of the Fusion Protein Tetranectin-Apolipoprotein A1 Analyzed by Ligand-Binding Mass Spectrometry Combined with Quantitation by ELISA18 November 2016 | Analytical Chemistry, Vol. 88, No. 23Validation of a ligand-binding assay for active protein drug quantification following the 'free analyte QC concept'Eginhard Schick, Roland F Staack, Markus Haak, Gregor Jordan, Uwe Dahl, Julia Heinrich, Herbert Birnboeck & Apollon Papadimitriou3 November 2016 | Bioanalysis, Vol. 8, No. 24Immunoaffinity-coupled MS: best of both technologiesBinodh DeSilva11 July 2016 | Bioanalysis, Vol. 8, No. 15Platform switching from ELISA to Gyrolab™: a novel generic reagent omits the need to change critical reagentsGregor Jordan, Miriam Moheysen-Zadeh, Julia Heinrich & Roland F Staack15 March 2016 | Bioanalysis, Vol. 8, No. 8An ex vivo potency assay to assess active drug levels of a GLP-1 agonistic peptide during preclinical safety studiesMartin Schäfer, Steven Challand, Eginhard Schick, Sabine Bader, Dominik Hainzl, Katja Heinig, Lutz Müller, Apollon Papadimitriou & Julia Heinrich6 October 2015 | Bioanalysis, Vol. 7, No. 24Quantification of a bifunctional drug in the presence of an immune response: a ligand-binding assay specific for 'active' drugRoland F Staack, Gregor Jordan, Maria Viert, Martin Schäfer, Apollon Papadimitriou & Julia Heinrich20 October 2015 | Bioanalysis, Vol. 7, No. 24Special Focus Issue: Bioanalysis of Large Molecules by LC–MSFaye Vazvaei & Fabio Garofolo26 August 2014 | Bioanalysis, Vol. 6, No. 13 Vol. 6, No. 13 STAY CONNECTED Metrics Downloaded 388 times History Published online 26 August 2014 Published in print July 2014 Information© Future Science LtdKeywordsassay developmentbioanalyticsbiologicfree druglarge moleculeligand-binding assaymass spectrometryFinancial & competing interests disclosureAll authors are employed by F Hoffmann-La Roche, Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download