Quality of cell products: authenticity, identity, genomic stability and status of differentiation
Open accessAbstract
Cellular therapies that either use modifications of a patient's own cells or allogeneic cell lines are becoming in vogue. Besides the technical issues of optimal isolation, cultivation and modification, quality control of the generated cellular products are increasingly being considered to be more important. This is not only relevant for the cell's therapeutic application but also for cell science in general. Recent changes in editorial policies of respected journals, which now require proof of authenticity when cell lines are used, demonstrate that the subject of the present paper is not a virtual problem at all. In this article we provide 2 examples of contaminated cell lines followed by a review of the recent developments used to verify cell lines, stem cells and modifications of autologous cells. With relative simple techniques one can now prove the authenticity and the quality of the cellular material of interest and therefore improve the scientific basis for the development of cells for therapeutic applications. The future of advanced cellular therapies will require production and characterization of cells under GMP and GLP conditions, which include proof of identity, safety and functionality and absence of contamination.
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High-loci STR assays have prevailed as the current institutional technique.
“RFLP, AmpFLP, and STR profiling have all been popular, but high-loci STR assays have prevailed as the current institutional technique [21,36,78,79,109,110].”
From The history, landscape, and outlook of human cell line authentication and security (2024) · cites this paper as [109]
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- Authors
- Dittmar, K. E. J., Simann, M., Zghoul, N., Schön, O., Meyring, W., Hannig, H., Macke, L., Dirks, W. G., Miller, K., Garritsen, H. S. P., & Lindenmaier, W.
- Affiliations
- Helmholtz Centre for Infection Research (DE)
- Klinikum Braunschweig (DE)
- Leibniz Institute DSMZ – German Collection of Microorganisms and Cell Cultures (DE)
- Medizinische Hochschule Hannover (DE)
- Venue
- Transfusion Medicine and Hemotherapy
- Publisher
- S. Karger AG
- Published
- 2010
- Volume
- 37
- Issue
- 2
- Pages
- 2-2
- ISSN
- 1660-3796 (ISSN-L)
- 1660-3818
- PMC
- PMC2914413
- OpenAlex
- W2038374837
- Cited by
- 24
- References
- 72
- Citations by year
- 2025: 4 · 2024: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 3 · 2017: 1 · 2015: 2 · 2013: 1 · 2012: 2
- FWCI
- 1.04
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Transfusion Medicine and Hemotherapy (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- HZI (Helmholtz Centre for Infection Research) (submittedVersion)
- Funders
- Bundesministerium für Wirtschaft und Technologie
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Pluripotent Stem Cells Research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Viral Infectious Diseases and Gene Expression in Insects
- Keywords
- cell therapy, cell line authentication, genome stability, stem cells, contamination, good manufacturing practices, GLP, cell identity
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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