Authentication of human cell-based products: the role of a new consensus standard
Abstract
Authentication of human tissues, cell lines and primary cell cultures (including stem cell preparations) used as therapeutic modalities is often performed using phenotyping and technologies capable of assessing identity to the species level (e.g., isoenzyme analysis and/or karyotyping). This authentication paradigm alone cannot provide assurance that the correct human cell preparation is administered, so careful labeling and tracking of cells from the donor, during manufacture and as part of the final product are also employed. Precise, accurate identification of human cells to the individual donor level could, however, significantly reduce the risks of exposing human subjects to misidentified cells. The availability of a standardized method for achieving this will provide a way to improve the safety profile of human cell-based products by providing assurance that a given lot of cells originated from the intended donor and were not inadvertently mixed or replaced with cells from other donors. In support of this goal, an international team of scientists has prepared a consensus standard on authentication of human cells using short tandem repeat profiling. Associated with the standard itself will be the establishment and maintenance of a public database of short tandem repeat profiles for commonly used cell lines.
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STR profiling is well established with standard protocols published by the American National Standards Institute, relatively inexpensive, and flexible.
“Adopted by pharmaceutical companies and academia for the characterization of primary and immortalized cells [11,19], STR profiling is well established with standard protocols published by the American National Standards Institute (”
From The history, landscape, and outlook of human cell line authentication and security (2024) · cites this paper as [21]
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 [21]
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- Authors
- Kerrigan, L., & Nims, R. W.
- Affiliations
- American Type Culture Collection (US)
- ORCID
- Nims, Raymond W
- Venue
- Regenerative Medicine
- Publisher
- Informa UK Limited
- Published
- 2011-03
- Volume
- 6
- Issue
- 2
- Pages
- 255-260
- ISSN
- 1746-0751 (ISSN-L)
- 1746-076X
- OpenAlex
- W2154984692
- Cited by
- 23
- References
- 14
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 2 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 3 · 2019: 1 · 2018: 2 · 2017: 1 · 2016: 1 · 2015: 2 · 2014: 1 · 2012: 2
- FWCI
- 0.65
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Regenerative Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Pluripotent Stem Cells Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Identification and Quantification in Food
- Keywords
- short tandem repeat profiling, cell line identification, cell therapy, cell tracking, product safety
- MeSH terms
- Biological Products, Cells, Consensus Statements as Topic, Consensus Development Conferences as Topic, Equipment Contamination, Humans, Reference Standards, Stem Cells, Sequence Analysis, DNA, Microsatellite Repeats, Cell Culture Techniques, Gene Expression Profiling, Consensus, Biometric Identification
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