Evidence map›Paper›PMID 40346766›Full record

ArticleBiotechnology journal2025

Development and Characterization of the NISTCHO Reference Cell Line.

Hussain Dahodwala, Irfan Hodzic, Alexei Slesarev, Benjamin Cutak, Alexander Kuzin, Rahul Lal, Jiajian Liu, James Mahon, Rajagopalan Lakshmi Narasimhan, Jaya Onuska and 10 more

Abstract read
In one paragraph

Article in Biotechnology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Review
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  5. Article
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Hussain DahodwalaNational Institute for Innovation in Manufacturing Biopharmaceuticals, University of Delaware, Newark, Delaware, USA.
Irfan HodzicProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.
Alexei SlesarevLife Science Services, MilliporeSigma, Rockville, Maryland, USA.
Benjamin CutakCentral Analytics, MilliporeSigma, St. Louis, Missouri, USA.
Alexander KuzinLife Science Services, MilliporeSigma, Rockville, Maryland, USA.
Rahul LalBioinformatics, IT R&D Applications, Sigma-Aldrich Chemicals Pvt. Ltd., A subsidiary of Merck KGaA, Darmstadt, Germany, Bangalore, India.
Jiajian LiuBioinformatics, Analytics Center of Excellence, MilliporeSigma, St. Louis, Missouri, USA.
James MahonProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.
Rajagopalan Lakshmi NarasimhanBioinformatics, IT R&D Applications, Sigma-Aldrich Chemicals Pvt. Ltd., A subsidiary of Merck KGaA, Darmstadt, Germany, Bangalore, India.
Jaya OnuskaLife Science Services, MilliporeSigma, Rockville, Maryland, USA.
James RavelletteProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.
Kelsey RegerProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.
Sadie SakuradaProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.
Floy StewartProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.
Trissa BorgschulteProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.ORCID https://orcid.org/0009-0004-3940-9038
Colette CoteLife Science Services, MilliporeSigma, Rockville, Maryland, USA.
Kelvin H LeeNational Institute for Innovation in Manufacturing Biopharmaceuticals, University of Delaware, Newark, Delaware, USA.ORCID https://orcid.org/0000-0003-0908-2981
William B O'DellBiomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland, USA.
Zvi KelmanBiomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland, USA.ORCID https://orcid.org/0000-0003-4774-3963
Britta A AndersonProcess Solutions, MilliporeSigma, St. Louis, Missouri, USA.ORCID https://orcid.org/0000-0002-9890-9399

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Well-characterized 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-batch 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-based analysis of the transgene integration sites, and a base-pair resolution map of the transgene integration site was developed and verified using PCR-based 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.

Indexed as

Immunoglobulin GAnimalsBatch Cell Culture TechniquesCHO CellsCricetinaeCricetulusRecombinant ProteinsReference StandardsTransgenesImmunoglobulin GRecombinant Proteinscell culturecell line developmentmonoclonal antibodyNISTCHOreference cell linetransgene integration sites

Identifiers

PMID40346766
PMCPMC12064881

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.