{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T03:56:21Z","timestamp":1790913381254,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,5,9]],"date-time":"2025-05-09T00:00:00Z","timestamp":1746748800000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Biotechnology Journal"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Well\u2010characterized reference materials enable successful collaborations within the scientific community by establishing common reagents for benchmarking studies and reducing the barriers to sharing materials and information. Here, we report the development of NISTCHO, a recombinant Chinese hamster ovary cell line expressing a nonoriginator version of the NISTmAb IgG1. We evaluated candidate clonal cell lines in a fed\u2010batch cell culture model to assess growth and productivity of the cell lines and protein quality attributes of the recombinant IgG produced, which demonstrated suitability of multiple candidates. Selection of a preferred candidate was accomplished through sequencing\u2010based analysis of the transgene integration sites, and a base\u2010pair resolution map of the transgene integration site was developed and verified using PCR\u2010based methods. Lastly, a validation study performed by an independent laboratory confirmed the robustness of the preferred candidate, which has been selected for further development as the NISTCHO reference cell line. Together, these results describe the origin of this new reference material and will serve as the foundation for future interlaboratory studies using the NISTCHO cell line.<\/jats:p>","DOI":"10.1002\/biot.70012","type":"journal-article","created":{"date-parts":[[2025,5,10]],"date-time":"2025-05-10T00:24:44Z","timestamp":1746836684000},"source":"Crossref","is-referenced-by-count":12,"title":["Development and Characterization of the NISTCHO Reference Cell Line"],"prefix":"10.1002","volume":"20","author":[{"given":"Hussain","family":"Dahodwala","sequence":"first","affiliation":[{"name":"National Institute for Innovation in Manufacturing Biopharmaceuticals University of Delaware  Newark Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irfan","family":"Hodzic","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexei","family":"Slesarev","sequence":"additional","affiliation":[{"name":"Life Science Services MilliporeSigma  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Cutak","sequence":"additional","affiliation":[{"name":"Central Analytics MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Kuzin","sequence":"additional","affiliation":[{"name":"Life Science Services MilliporeSigma  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rahul","family":"Lal","sequence":"additional","affiliation":[{"name":"Bioinformatics, IT R&amp;D Applications Sigma\u2010Aldrich Chemicals Pvt. Ltd., A subsidiary of Merck KGaA, Darmstadt, Germany  Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiajian","family":"Liu","sequence":"additional","affiliation":[{"name":"Bioinformatics, Analytics Center of Excellence MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Mahon","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajagopalan Lakshmi","family":"Narasimhan","sequence":"additional","affiliation":[{"name":"Bioinformatics, IT R&amp;D Applications Sigma\u2010Aldrich Chemicals Pvt. Ltd., A subsidiary of Merck KGaA, Darmstadt, Germany  Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaya","family":"Onuska","sequence":"additional","affiliation":[{"name":"Life Science Services MilliporeSigma  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Ravellette","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsey","family":"Reger","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sadie","family":"Sakurada","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Floy","family":"Stewart","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-3940-9038","authenticated-orcid":false,"given":"Trissa","family":"Borgschulte","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colette","family":"Cote","sequence":"additional","affiliation":[{"name":"Life Science Services MilliporeSigma  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0908-2981","authenticated-orcid":false,"given":"Kelvin H.","family":"Lee","sequence":"additional","affiliation":[{"name":"National Institute for Innovation in Manufacturing Biopharmaceuticals University of Delaware  Newark Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William B.","family":"O'Dell","sequence":"additional","affiliation":[{"name":"Biomolecular Measurement Division National Institute of Standards and Technology  Gaithersburg Maryland USA"},{"name":"Biomolecular Labeling Laboratory Institute for Bioscience and Biotechnology Research University of Maryland  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4774-3963","authenticated-orcid":false,"given":"Zvi","family":"Kelman","sequence":"additional","affiliation":[{"name":"Biomolecular Measurement Division National Institute of Standards and Technology  Gaithersburg Maryland USA"},{"name":"Biomolecular Labeling Laboratory Institute for Bioscience and Biotechnology Research University of Maryland  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9890-9399","authenticated-orcid":false,"given":"Britta A.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Process Solutions MilliporeSigma  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,9]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Metrological Traceability Frequently Asked Questions and NIST Policy","author":"National Institute of Standards and Technology","year":"2021"},{"key":"e_1_2_9_3_1","volume-title":"NIST Monoclonal Antibody Reference Material 8671|NIST","author":"National Institute of Standards and Technology","year":"2023"},{"key":"e_1_2_9_4_1","volume-title":"Human Cell Line Authentication: Standardization of Short Tandem Repeat (STR) Profiling","author":"Korch C. T.","year":"2021"},{"key":"e_1_2_9_5_1","volume-title":"Assay Guidance Manual","author":"Almeida J. L.","year":"2023"},{"key":"e_1_2_9_6_1","volume-title":"NISTCHO Test Material Guidance Document","author":"National Institute of Standards and Technology","year":"2023"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.2706"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.26904"},{"key":"e_1_2_9_9_1","volume-title":"Improving Fed\u2010Batch Yields By Combining EX\u2010CELL\u00ae Advanced and Cellvento\u00ae Cell Culture Media Portfolios","author":"Kaiser J.","year":"2022"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.copbio.2019.01.011"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pbio.1002476"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010019\u201039667\u20104"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010021\u201003160\u20108"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.26722"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12864\u2010015\u20101391\u2010x"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.28226"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00216\u2010014\u20108108\u2010x"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/8141269"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.6028\/NIST.SP.260-237"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1074\/mcp.ra119.001677"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.28066"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/antib11040073"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.7b05241"},{"key":"e_1_2_9_24_1","volume-title":"Nonproprietary Naming of Biological Products: Update. Guidance for Industry","author":"Food and Drug Administration","year":"2019"},{"key":"e_1_2_9_25_1","unstructured":"M. H.Cleveland I. L.Karageorgos J. P.Marino et\u00a0al. \u201cRecommended Nomenclature Convention for the NISTCHO Cell Line and its Product Monoclonal Antibody CNISTmAb \u201d mAbs (accepted for publication)."},{"key":"e_1_2_9_26_1","volume-title":"CHOZN Platform Technical Bulletin","author":"MilliporeSigma","year":"2011"},{"key":"e_1_2_9_27_1","volume-title":"Reference Material\u00ae 8671 NISTmAb, Humanized IgG1\u03ba Monoclonal Antibody","author":"National Institute of Standards and Technology","year":"2022"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkv1189"}],"container-title":["Biotechnology Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/biot.70012","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T18:14:37Z","timestamp":1759947277000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/biot.70012"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":27,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1002\/biot.70012"],"URL":"https:\/\/doi.org\/10.1002\/biot.70012","archive":["Portico"],"relation":{},"ISSN":["1860-6768","1860-7314"],"issn-type":[{"value":"1860-6768","type":"print"},{"value":"1860-7314","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5]]},"article-number":"e70012"}}