{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T07:06:52Z","timestamp":1779088012027,"version":"3.51.4"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T00:00:00Z","timestamp":1778025600000},"content-version":"vor","delay-in-days":35,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cytometry Pt A"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Flow cytometry\u2010based TBNK immunophenotyping is widely used to assess immune status in research, clinical diagnostics, and cell therapy development. Biological control materials such as PBMCs often serve as physiologically relevant controls, but suffer from considerable variability due to donor differences, limited stability, and fluctuations in antigen expression levels between lots. These factors make it challenging to achieve consistent assay performance, especially in longitudinal or multi\u2010site environments. TBNK Cell Mimic (synthetic controls in PhenoCyte product line,\u00a0developed by Slingshot Biosciences; henceforth referred to as TBNK Cell Mimic in this manuscript) are polymer\u2010based cell mimics engineered to provide defined scatter properties, controlled antigen density, and stable subset ratios. Their scatter profiles are designed to be biologically relevant and comparable to those of native leukocyte populations. In this study, we performed a comprehensive analytical validation of a TBNK immunophenotyping assay using these TBNK Cell Mimics as standardized reference controls. Validation parameters included repeatability, intermediate precision, accuracy, linearity, specificity, robustness, stability, and carryover. The TBNK Cell Mimic met all predefined acceptance criteria, demonstrating \u2264\u20095% CV for intra\u2010 and inter\u2010assay precision and\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    values &gt;\u20090.998 across the linearity range. Accelerated stability studies performed at 25\u00b0C and 37\u00b0C showed &lt;\u20095% variation in population frequencies, supporting the material's suitability for extended quality monitoring. These results indicate that TBNK Cell Mimic provides a consistent and reproducible reference material that can support assay validation and routine performance assessment. While not a replacement for biological samples when evaluating donor\u2010specific or viability\u2010dependent biology, their stability and lot\u2010to\u2010lot consistency offer a practical tool for reducing technical variability and improving harmonization across instruments, operators, and testing sites.\n                  <\/jats:p>","DOI":"10.1002\/cyto.a.70031","type":"journal-article","created":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T07:02:37Z","timestamp":1778050957000},"page":"290-306","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Beyond\n                    <scp>PBMCs<\/scp>\n                    : Polymer\u2010Based Cell Mimics for Robust\n                    <scp>TBNK<\/scp>\n                    Immunophenotyping Assay Validation"],"prefix":"10.1002","volume":"109","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-7712-8170","authenticated-orcid":false,"given":"Swetha Pratyusha","family":"Gunturu","sequence":"first","affiliation":[{"name":"Slingshot Biosciences  Emeryville California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Subhanip","family":"Biswas","sequence":"additional","affiliation":[{"name":"Slingshot Biosciences  Emeryville California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Armando","family":"Martinez","sequence":"additional","affiliation":[{"name":"Slingshot Biosciences  Emeryville California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Kerfs","sequence":"additional","affiliation":[{"name":"Slingshot Biosciences  Emeryville California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kanwal","family":"Palla","sequence":"additional","affiliation":[{"name":"Slingshot Biosciences  Emeryville California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louisa","family":"D'Lima","sequence":"additional","affiliation":[{"name":"Slingshot Biosciences  Emeryville California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,5,6]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.14219"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.01271"},{"key":"e_1_2_11_4_1","unstructured":"Clinical and Laboratory Standards Institute (CLSI) Validation of Assays Performed by Flow Cytometry (CLSI Guideline I\/LA\u201033) 2023."},{"key":"e_1_2_11_5_1","unstructured":"U.S. Food and Drug Administration Bioanalytical Method Validation: Guidance for Industry 2018."},{"issue":"5","key":"e_1_2_11_6_1","first-page":"315","article-title":"ICCS\/ICSH Guidelines for Validation of Flow Cytometry Methods","volume":"84","author":"International Clinical Cytometry 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