Do we have a mature LC–MS/MS methodology for therapeutic monoclonal antibody bioanalysis?

生物分析 单克隆抗体 化学 色谱法 计算生物学 抗体 医学 生物 免疫学
作者
Omnia A. Ismaiel,William Mylott,Rand Jenkins
出处
期刊:Bioanalysis [Newlands Press Ltd]
卷期号:9 (17): 1289-1292 被引量:6
标识
DOI:10.4155/bio-2017-4983
摘要

BioanalysisVol. 9, No. 17 CommentaryDo we have a mature LC–MS/MS methodology for therapeutic monoclonal antibody bioanalysis?Omnia A Ismaiel, William R Mylott & Rand G JenkinsOmnia A Ismaiel*Author for correspondence: E-mail Address: oismaiel@yahoo.com Chromatographic Sciences Department, PPD Laboratories, Richmond, Virginia, USA Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Egypt, William R Mylott Chromatographic Sciences Department, PPD Laboratories, Richmond, Virginia, USA & Rand G Jenkins Chromatographic Sciences Department, PPD Laboratories, Richmond, Virginia, USAPublished Online:13 Sep 2017https://doi.org/10.4155/bio-2017-4983AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: acceptance criteriaADCsmAbssignature and universal peptideSIL-ISReferences1 Sandra K, Vanhoenacker G, Vandenheede I, Steenbeke M, Joseph M, Sandra P. Multiple heart-cutting and comprehensive two-dimensional liquid chromatography hyphenated to mass spectrometry for the characterization of the antibody-drug conjugate ado-trastuzumab emtansine. J. Chromatogr. B 1032, 119–130 (2016).Crossref, Medline, CAS, Google Scholar2 Sarrut M, Corgier A, Fekete S et al. Analysis of antibody-drug conjugates by comprehensive on-line two-dimensional hydrophobic interaction chromatography x reversed phase liquid chromatography hyphenated to high resolution mass spectrometry. I-Optimization of separation conditions. J. Chromatogr. B 1032, 103–111 (2016).Crossref, Medline, Google Scholar3 Ezan E, Bitsch F. Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies. Bioanalysis 1(8) 1375–1388 (2009).Link, CAS, Google Scholar4 Halquist MS, Karnes HT. Quantitative liquid chromatography tandem mass spectrometry analysis of macromolecules using signature peptides in biological fluids. Biomed. Chromatogr. 25(1–2), 47–58 (2011).Crossref, Medline, CAS, Google Scholar5 Li H, Ortiz R, Tran L et al. General LC–MS/MS method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studies. Anal. Chem. 84(3), 1267–1273 (2012).Crossref, Medline, CAS, Google Scholar6 Furlong MT, Zhao S, Mylott W et al. Dual universal peptide approach to bioanalysis of human monoclonal antibody protein drug candidates in animal studies. Bioanalysis 5(11), 1363–1376 (2013).Link, CAS, Google Scholar7 Furlong MT, Titsch C, Xu W, Jiang H, Jemal M, Zeng J. An exploratory universal LC–MS/MS assay for bioanalysis of hinge region-stabilized human IgG4 mAbs in clinical studies. Bioanalysis 6(13), 1747–1758 (2014).Link, CAS, Google Scholar8 Faria M, Halquist MS, Yuan M, Mylott M, Jenkins RG, Karnes HT. Comparison of a stable isotope labeled (SIL) peptide and an extended SIL peptide as internal standards to track digestion variability of an unstable signature peptide during quantification of a cancer biomarker, human osteopontin, from plasma using capillary microflow LC–MS/MS. J. Chromatogr. B 1001, 156–168 (2015).Medline, Google Scholar9 Faria M, Halquist MS, Yuan M, Mylott M, Jenkins RG, Karnes HT. An extended stable isotope-labeled signature peptide internal standard for tracking immunocapture of human plasma osteopontin for LC–MS/MS quantification. Biomed. Chromatogr. 29(11), 1780–1782 (2015).Crossref, Medline, CAS, Google Scholar10 Halquist MS, Karnes HT. Quantification of alefacept, an immunosuppressive fusion protein in human plasma using a protein analogue internal standard, trypsin cleaved signature peptides and liquid chromatography tandem mass spectrometry. J. Chromatogr. B 879(11), 789–798 (2011).Crossref, Medline, CAS, Google Scholar11 Kaur S, Liu L, Cortes DF et al. Validation of a biotherapeutic immunoaffinity-LC–MS/MS assay in monkey serum: 'plug-and-play' across seven molecules. Bioanalysis 8(15), 1565–1577 (2016).Link, CAS, Google Scholar12 US FDA. US Food and Drug Administration guidance for industry: bioanalytical method validation (2001). www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdfGoogle Scholar13 Jenkins R, Duggan J, Aubry AF et al. Recommendations for validation of LC–MS/MS bioanalytical methods for protein biotherapeutics. AAPS J. 17(1), 1–16 (2015).Crossref, Medline, CAS, Google Scholar14 Duggan JX, Vazvaei F, Jenkins R. Bioanalytical method validation considerations for LC–MS/MS assays of therapeutic proteins. Bioanalysis 7(11), 1389–1395 (2015).Link, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByAn Introduction to Bioanalysis of Monoclonal Antibodies24 August 2022Hybrid Ligand Binding Immunoaffinity-Liquid Chromatography/Mass Spectrometry for Biotherapeutics and Biomarker Quantitation: How to develop a hybrid LBA-LC-MS/MS method for a protein?1 October 2019 | Reviews in Separation Sciences, Vol. 1, No. 1Recent advances in mass spectrometry-based approaches for proteomics and biologics: Great contribution for developing therapeutic antibodiesPharmacology & Therapeutics, Vol. 185Bismuth ferrite-based photoactive materials for the photoelectrochemical detection of disease biomarkers coupled with multifunctional mesoporous silica nanoparticles1 January 2017 | Journal of Materials Chemistry B, Vol. 5, No. 48 Vol. 9, No. 17 Follow us on social media for the latest updates Metrics Downloaded 284 times History Published online 13 September 2017 Published in print September 2017 Information© 2017 Future Science LtdKeywordsacceptance criteriaADCsmAbssignature and universal peptideSIL-ISAcknowledgementsThe authors acknowledge MT Furlong (PPD) for careful review of and comments on this manuscript.Financial & competing interests disclosureThe authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

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