{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T11:29:12Z","timestamp":1775215752646,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T00:00:00Z","timestamp":1751241600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Clinical scale manufacturing for cell therapies requires reliable methods to purify specific cell types. Few microfluidic chip\u2010based cell sorters have been integrated into manufacturing processes of therapeutic cells. Reports have highlighted the need to assess current requirements and explore areas for improvement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>We evaluated Highway1, a new microfluidic chip\u2010based cell sorter in the context of good manufacturing practice (GMP)\u2010compliant manufacturing processes involving purification of CD4 T cell subsets. Tests explored throughput and processing time limits, as required in GMP\u2010compliant purification of regulatory T cells (Tregs) and of CD4 T cells free of CD4 Tregs. Findings were used to establish conditions with the best balance between processing time and yield.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Best average recovery (60%) was obtained when processed at 1\u20131.5\u2009million cells\/mL, purifying a target population of 33%. Weighing recovery against processing time, a sample concentration of 2.0\u2009million cells\/mL offers the optimum condition for sorting CD4 T cells free of CD4 Tregs from healthy blood. Similar tests also show that this device allows for shorter overall processing times to purify CD4 Tregs than previously reported for other microfluidic chip\u2010based sorters, with the additional benefit of an essentially user intervention\u2010free operation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The Highway1 allows for reliable selection of a highly pure subpopulation of CD4 T cells in a GMP\u2010compliant, cell therapy manufacturing setting. As with conventional sorters, the purification process for Tregs still needs to be preceded by a pre\u2010enrichment process to keep the total processing time within an acceptable range for clinical\u2010grade cell manufacturing.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.18324","type":"journal-article","created":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T06:23:32Z","timestamp":1751264612000},"page":"1502-1508","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of a microfluidic chip\u2010based cell sorter in clinical manufacturing processes to deplete or isolate CD4 regulatory T cells"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6873-0243","authenticated-orcid":false,"given":"Ruud","family":"Hulspas","sequence":"first","affiliation":[{"name":"Connell and O'Reilly Families Call Manipulation Core Facility Dana Farber Cancer Institute  Boston Massachusetts USA"},{"name":"Department of Medicine Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. 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