Vector copy number quality control testing for CAR T-cells: critical validation parameters
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The mean vector copy number was 1.97 ± 0.35 copies per CAR-T cell, and all products met the requirement of <5 copies per cell.
“with a mean VCN of 1.97 ± 0.35 copies per CAR-T cell (all of which met the requirement of authorities at <5 copies per cell).16”
From Point-of-care manufacturing of anti-CD19 CAR-T cells using a closed production platform: Experiences of an academic in Thailand (2024) · cites this paper as [16]
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Chimeric antigen receptor T‐cells: Properties, production, and quality control
Ramesh, P., Hui, H. Y. L., Brownrigg, L., Fuller, K., & Erber, W. (2023) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.14121 · Cited by 16 · see citing works
Luanpitpong, S., Klaihmon, P., Janan, M., Kungwankiattichai, S., Owattanapanich, W., Kunacheewa, C., Chanthateyanonth, S., Donsakul, N., U-pratya, Y., Warindpong, T., et al. (2024) · Molecular Therapy: Oncology · doi:10.1016/j.omton.2024.200889 · Cited by 17 · see citing works
Bridge, J. E., Johnson, M. J., Kar, B., Kim, J., Wenthe, S. J., Krueger, J. B., Wick, B. J., Kluesner, M. G., Crane, A. T., Bell, J., et al. (2026) · Molecular Therapy · doi:10.1016/j.ymthe.2026.03.007 · Cited by 11 · see citing works
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Ogusuku, I. E. Y., Herbel, V., Lennartz, S., Brandes, C., Argiro, E. M., Fabian, C., Hauck, C., Hoogstraten, C., Veld, S. A. J., Hageman, L., et al. (2024) · Molecular Therapy — Methods & Clinical Development · doi:10.1016/j.omtm.2024.101224 · Cited by 8 · see citing works
An Analysis of Monitoring Solutions for CAR T Cell Production
Shoshi, A., Xia, Y., Fieschi, A., Baumgarten, Y., Gaißler, A., Ackermann, T., Reimann, P., Mitschang, B., Weyrich, M., Bauernhansl, T., et al. (2025) · Healthcare Technology Letters · doi:10.1049/htl2.70012 · Cited by 6 · see citing works
Impact of vector copy number on critical quality attributes of retrovirally engineered T cells
Norberg, S. M., Gund, R., Doubrovina, E. S., Doran, S. L., Fuksenko, T., Liu, H., Ma, J., Franco, Z., & Hinrichs, C. S. (2025) · Molecular Therapy · doi:10.1016/j.ymthe.2025.12.048 · Cited by 3 · see citing works
Optimizing T cell transduction: a novel transduction device for efficient and scalable gene delivery
Lee, K.-Z., Nguyen, T. D., & Liu, D. (2025) · Journal of Translational Medicine · doi:10.1186/s12967-025-06836-1 · Cited by 2 · see citing works
Nguyen, L. T., Nguyen, D. T., Bach, Q. K., Dao, L. T. M., Phan, T. T. K., Nguyen, H. D. N., Dao, H., Pham, T. H., Pham, P. T., Mai, H. T., et al. (2026) · Molecular Therapy Oncology · doi:10.1016/j.omton.2026.201156 · Cited by 2 · see citing works
Immune cell separation for cell therapy: A comprehensive review of techniques, and challenges
Makoui, M. H., Bodaghi, A. B., Razavi, M. A., Taran, A., Akbari, A. P., Bahrami, M., & Esmaeilzadeh, A. (2026) · Journal of Immunological Methods · doi:10.1016/j.jim.2026.114040 · Cited by 2 · see citing works
CAR-T and nanotechnology: A comparative Perspective on autoimmune disease and cancer
Pavithra, A. J., & Ragavendran, C. (2025) · Advances in Biomarker Sciences and Technology · doi:10.1016/j.abst.2025.03.002 · Cited by 1 · see citing works
Page, A., Delles, M., Négre, D., Costa, C., Fusil, F., & Cosset, F. (2024) · Journal of Immunotherapy · doi:10.1097/cji.0000000000000524
Adeniran, A., Handy, S., & Baki, A. (2024) · Springer eBooks · doi:10.1007/978-3-031-62007-2_9
Manufacturing as biology: How T-cell processing shapes therapeutic outcomes
Przybylski, N., Zeng, Q., & Huang, X. (2026) · Advances in pharmacology · doi:10.1016/bs.apha.2026.05.005
- Authors
- Chen, A., Velickovic, Z., & Rasko, J.
- Affiliations
- Royal Prince Alfred Hospital (AU)
- The University of Sydney (AU)
- Corresponding author
- Chen, A.
- Venue
- Cytotherapy
- Publisher
- Elsevier BV
- Published
- 2020-05
- Volume
- 22
- Issue
- 5
- Pages
- S142
- ISSN
- 1465-3249 (ISSN-L)
- OpenAlex
- W3026877625
- Cited by
- 14
- References
- 0
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 5 · 2023: 1
- FWCI
- 0.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Cytotherapy (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › CRISPR and Genetic Engineering
- Keywords
- vector copy number, CAR T-cell therapy, retroviral vectors, lentiviral vectors, quality control, qPCR validation, vector integration, oncogenic risk
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