{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T18:05:22Z","timestamp":1763748322102},"reference-count":43,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,1,16]],"date-time":"2021-01-16T00:00:00Z","timestamp":1610755200000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cytometry Part B Clinical"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The advent of time\u2010of\u2010flight mass cytometry (CyTOF) has enabled high dimensional and unbiased examination of the immune system to simultaneous interrogate a multitude of parameters and gain a better understanding of immunologic data from clinical trial samples. Here we describe the development and validation of a 33\u2010marker mass cytometry workflow for measuring gastrointestinal (GI) trafficking peripheral blood mononuclear cells (PBMCs) in patients with celiac disease (CeD). This panel builds upon identification of well\u2010characterized immune cells and expands to include markers modulated in response to gluten challenge in patients with CeD. The CeD panel was optimized and validated according to accepted industry practice for validation of flow cytometry assays and builds upon established sample processing workflows for mass cytometry studies. Several critical parameters were evaluated during the assay development phase of this study including optimization of the sample processing steps, antibody specificity, and ensuring the panel as a whole performed to expectation. The panel was then validated using a fit\u2010for\u2010purpose approach tailored to the intended use of the data in the clinical trial. Validation included assessment of analytical parameters essential to understanding the reliability and robustness of the CeD panel such as intra\u2010assay precision, inter\u2010assay precision, inter\u2010operator precision and sample processing stability. Together, this validated mass cytometry workstream provides robust and reproducible high\u2010dimensional analysis of human peripheral blood immune cells to characterize patient samples from clinical trials.<\/jats:p>","DOI":"10.1002\/cyto.b.21986","type":"journal-article","created":{"date-parts":[[2021,1,16]],"date-time":"2021-01-16T09:40:20Z","timestamp":1610790020000},"page":"92-102","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Development and validation of a <scp>high\u2010parameter<\/scp> mass cytometry workflow to decipher immunomodulatory changes in celiac disease"],"prefix":"10.1002","volume":"100","author":[{"given":"Jose","family":"Estevam","sequence":"first","affiliation":[{"name":"Clinical Biomarker Innovation &amp; Development Takeda Pharmaceuticals Inc. Co  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Krutzik","sequence":"additional","affiliation":[{"name":"Primity Bio, Inc.  Fremont California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Vander Tuig","sequence":"additional","affiliation":[{"name":"Primity Bio, Inc.  Fremont California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J.","family":"McAuliffe","sequence":"additional","affiliation":[{"name":"Clinical Biomarker Innovation &amp; Development Takeda Pharmaceuticals Inc. Co  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Glennda","family":"Smithson","sequence":"additional","affiliation":[{"name":"Gastroenterology Drug Discovery Unit Takeda Pharmaceuticals Inc. Co  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,1,16]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1021\/ac901049w"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21743"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.it.2012.02.010"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1198704"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1189\/jlb.0705414"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpim.31"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.a.23752"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cels.2018.02.010"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2017.02.015"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-009-9972-5"},{"key":"e_1_2_6_12_1","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1038\/ni.3702","article-title":"CyTOF analysis of anti\u2010tumor responses","volume":"18","author":"Dempsey L.","year":"2017","journal-title":"Nature Immunology"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymeth.2015.05.008"},{"key":"e_1_2_6_14_1","unstructured":"Escobar D.L.B. Estevam J. Leipold M. Adeeb H. R. Jonathan I. James L. Brice G. Nima A. Elena W. Y. Hsieh G. B. Christopher O. C. Radhika R. Christopher G.\"WS05: How to ensure robustness and reproducibility when using mass cytometry for clinical trials\" Cyt\u2010Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2019 Conference Workshops(2019);1264\u20101268."},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/ni.1780"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2019.00415"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-008-0501-x"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1311861110"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.celrep.2019.06.049"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e31821a23d0"},{"key":"e_1_2_6_21_1","first-page":"1","article-title":"High\u2010dimensional single\u2010cell cancer biology","volume":"377","author":"Irish J. 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