ArticleCytotherapy2023
Digital polymerase chain reaction strategies for accurate and precise detection of vector copy number in chimeric antigen receptor T-cell products.
Article in Cytotherapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Hydrodynamic dispersion drives viral-cellular contact for gene delivery in porous media.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- A single-cell multi-omics assay for simultaneous measurement of vector copy number and protein expression in CAR T cells.Molecular therapy. Advances · 2026Article
- Allogeneic stem cell-engineered EGFRvIII-specific CAR-NKT cells for treating glioblastoma with enhanced efficacy and safety.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Article
- Targeting orthotopic and metastatic pancreatic cancer with allogeneic stem cell-engineered mesothelin-redirected CAR-NKT cells.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Characterization of a multiplex digital PCR assay to quantify total T cells relative to chimeric antigen receptor-positive T cells.Molecular therapy. Oncology · 2025Article
- Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products.Journal of translational medicine · 2025Review
- An adjusted droplet digital PCR assay for quantification of vector copy number in CAR-T cell and TCR-T cell products.Immuno-oncology technology · 2025Article
- New insights on potency assays from recent advances and discoveries in CAR T-cell therapy.Frontiers in immunology · 2025Review
- A bioluminescent reporter bioassay for in-process assessment of chimeric antigen receptor lentiviral vector potency.Antibody therapeutics · 2025Article
- Article
- The Current Landscape of Secondary Malignancies after CAR T-Cell Therapies: How Could Malignancies Be Prevented?International journal of molecular sciences · 2024Review
- Advancing Pathogen Identification: The Role of Digital PCR in Enhancing Diagnostic Power in Different Settings.Diagnostics (Basel, Switzerland) · 2024Review
- A fatty acid elongase complex regulates cell membrane integrity and septin-dependent host infection by the rice blast fungus.Molecular plant pathology · 2024Article
- An Analysis of Monitoring Solutions for CAR T Cell Production.Healthcare technology lettersReview
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Authors and funding
8 authors.
Funding
Abstract
BACKGROUND
aimsVector copy number (VCN), an average quantification of transgene copies unique to a chimeric antigen receptor (CAR) T-cell product, is a characteristic that must be reported prior to patient administration, as high VCN increases the risk of insertional mutagenesis. Historically, VCN assessment in CAR T-cell products has been performed via quantitative polymerase chain reaction (qPCR). qPCR is reliable along a broad range of concentrations, but quantification requires use of a standard curve and precision is limited. Digital PCR (dPCR) methods were developed for absolute quantification of target sequences by counting nucleic acid molecules encapsulated in discrete, volumetrically defined partitions. Advantages of dPCR compared with qPCR include simplicity, reproducibility, sensitivity and lack of dependency on a standard curve for definitive quantification. In the present study, the authors describe a dPCR assay developed for analysis of the novel bicistronic CD19 × CD22 CAR T-cell construct.
methodsThe authors compared the performance of the dPCR assay with qPCR on both the QX200 droplet dPCR (ddPCR) system (Bio-Rad Laboratories, Inc, Hercules, CA, USA) and the QIAcuity nanoplate-based dPCR (ndPCR) system (QIAGEN Sciences, Inc, Germantown, MD, USA). The primer-probe assay was validated with qPCR, ndPCR and ddPCR using patient samples from pre-clinical CAR T-cell manufacturing production runs as well as Jurkat cell subclones, which stably express this bicistronic CAR construct.
resultsddPCR confirmed the specificity of this assay to detect only the bicistronic CAR product. Additionally, the authors' assay gave accurate, precise and reproducible CAR T-cell VCN measurements across qPCR, ndPCR and ddPCR modalities.
conclusionsThe authors demonstrate that dPCR strategies can be utilized for absolute quantification of CAR transgenes and VCN measurements, with improved test-retest reliability, and that specific assays can be developed for detection of unique constructs.
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