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Singlicate Analysis in Regulated Bioanalysis Using Ligand-Binding Assays: Where are We Heading?

2017; Future Science Ltd; Volume: 9; Issue: 18 Linguagem: Inglês

10.4155/bio-2017-0151

1757-6199

Herbert Birnboeck, Eginhard Schick, Nicole Justies,

Cell Image Analysis Techniques

BioanalysisVol. 9, No. 18 EditorialSinglicate analysis in regulated bioanalysis using ligand-binding assays: where are we heading?Herbert F Birnboeck, Eginhard Schick & Nicole JustiesHerbert F Birnboeck*Author for correspondence: Tel.: +41 61 688 68 61; E-mail Address: herbert.birnboeck@roche.com F. Hoffmann-La Roche Ltd., DMPK & Bioanalytical R&D, pRED Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland, Eginhard Schick F. Hoffmann-La Roche Ltd., DMPK & Bioanalytical R&D, pRED Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland & Nicole Justies F. Hoffmann-La Roche Ltd., DMPK & Bioanalytical R&D, pRED Pharmaceutical Sciences, Roche Innovation Center Basel, SwitzerlandPublished Online:18 Sep 2017https://doi.org/10.4155/bio-2017-0151AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: biotherapeuticsLBAligand-binding assayregulated bioanalysissinglicate analysisReferences1 DeSilva B, Garofolo F, Rocci M et al. 2012 White paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis 4(18), 2213–2226 (2012).Link, CAS, Google Scholar2 Dudal S, Baltrukonis D, Crisino R et al. Assay formats: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team. AAPS J. 16(2), 194–205 (2014).Crossref, Medline, CAS, Google Scholar3 Booth B, Arnold ME, DeSilva B et al. Workshop report: crystal city V – quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance. AAPS J. 17(2), 277–288 (2015).Crossref, Medline, CAS, Google Scholar4 Committee for Medicinal Products for Human Use, European Medicines Agency. Guideline on Bioanalytical Method Validation. EMA/CHMP/EWP/192217/2009, 21 (2011).Google Scholar5 US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry, Bioanalytical Method Validation (2001). https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf.Google Scholar6 US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Draft Guidance for Industry, Bioanalytical Method Validation (2013). https://www.fda.gov/downloads/drugs/guidances/ucm368107.pdf.Google Scholar7 Clark TH, Yates PD, Chunyk AG et al. Feasibility of singlet analysis for ligand-binding assays: a retrospective examination of data generated using the gyrolab platform. AAPS J. 18(5), 1300–1308 (2016).Crossref, Medline, CAS, Google Scholar8 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Official J. European Union 53, 33–79 (2010).Google ScholarFiguresReferencesRelatedDetailsCited ByComparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium12 July 2022 | The AAPS Journal, Vol. 24, No. 4Feasibility of singlicate-based analysis in bridging ADA assay on Meso-Scale Discovery platform: comparison with duplicate analysisZhihua Jiang, John Kamerud, Zhiping You, Soma Basak, Elena Seletskaia, Gregory S Steeno & Boris Gorovits19 July 2021 | Bioanalysis, Vol. 13, No. 14Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspectiveRenuka Pillutla, Boris Gorovits, Carol Gleason, Jorge Quiroz, David Christopher, Manuela Braun, Catherine Brockus, Douglas Donaldson, Tobias Haslberger, Ling He, Mark Qian, Jens Sydor, Enaksha Wickremsinhe & Lakenya Williams19 June 2020 | Bioanalysis, Vol. 12, No. 12European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindsetMatthew Barfield, Joanne Goodman, John Hood & Philip Timmerman24 January 2020 | Bioanalysis, Vol. 12, No. 5Singlicate analysis: should this be the default for biomarker measurements using ligand-binding assays?Zhuqiu Ye, Jing Tu, Krishna Midde, Mike Edwards & Patrick Bennett20 June 2018 | Bioanalysis, Vol. 10, No. 12Technologies and strategies for bioanalysis of biopharmaceuticalsYan J Zhang & Hyun Joo An28 September 2017 | Bioanalysis, Vol. 9, No. 18 Vol. 9, No. 18 Follow us on social media for the latest updates Metrics Downloaded 253 times History Published online 18 September 2017 Published in print September 2017 Information© 2017 Future Science LtdKeywordsbiotherapeuticsLBAligand-binding assayregulated bioanalysissinglicate analysisAcknowledgementsThe authors wish to thank J Gillis and A Papadimitriou for their critical review of the manuscript.Financial & competing interests disclosureAll authors are employees of F. Hoffmann-La Roche Ltd (Basel, Switzerland). One of the authors owns Roche nonvoting equity certificates. 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