ArticleJournal of immunotherapy (Hagerstown, Md. : 1997)2015
Large-scale clinical-grade retroviral vector production in a fixed-bed bioreactor.
Article in Journal of immunotherapy (Hagerstown, Md. : 1997), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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.
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.
Who cites it
32 citing papers in PubMed, 70 citations in OpenAlex.
- Process Systems Engineering in Precision Medicine: Opportunities in Autologous CAR-T Therapy.Engineering in life sciences · 2026Review
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- Acellular scaffold-based approach for in situ genetic engineering of host T-cells in solid tumor immunotherapy.Military Medical Research · 2024Article
- Optimizing and developing a scalable, chemically defined, animal component-free lentiviral vector production process in a fixed-bed bioreactor.Molecular therapy. Methods & clinical development · 2023Article
- Process intensification for lentiviral vector manufacturing using tangential flow depth filtration.Molecular therapy. Methods & clinical development · 2023Article
- Efficient clinical-grade γ-retroviral vector purification by high-speed centrifugation for CAR T cell manufacturing.Molecular therapy. Methods & clinical development · 2023Article
- T cell-responsive macroporous hydrogels for in situ T cell expansion and enhanced antitumor efficacy.Biomaterials · 2023Article
- Novel suspension retroviral packaging cells generated by transposition using transposase encoding mRNA advance vector yields and enable production in bioreactors.Frontiers in bioengineering and biotechnology · 2023Article
- Accelerating clinical-scale production of BCMA CAR T cells with defined maturation stages.Molecular therapy. Methods & clinical development · 2022Article
- Gene therapy approaches for equine osteoarthritis.Frontiers in veterinary science · 2022Review
- Application of bioreactor technology for cell culture-based viral vaccine production: Present status and future prospects.Frontiers in bioengineering and biotechnology · 2022Review
- Scalable Manufacturing of CAR T cells for Cancer Immunotherapy.Blood cancer discovery · 2021Review
- Lentiviral Vector Bioprocessing.Viruses · 2021Review
- Lentiviral Vector Production from a Stable Packaging Cell Line Using a Packed Bed Bioreactor.Molecular therapy. Methods & clinical development · 2020Article
- Large-Scale Production of Lentiviral Vectors: Current Perspectives and Challenges.Pharmaceutics · 2020Review
- Preclinical Development of Autologous Hematopoietic Stem Cell-Based Gene Therapy for Immune Deficiencies: A Journey from Mouse Cage to Bed Side.Pharmaceutics · 2020Review
- Review
- Benchmarking of Scale-X Bioreactor System in Lentiviral and Adenoviral Vector Production.Human gene therapy · 2020Article
- Generation of High-Titer Self-Inactivated γ-Retroviral Vector Producer Cells.Molecular therapy. Methods & clinical development · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
Abstract
The successful genetic engineering of patient T cells with γ-retroviral vectors expressing chimeric antigen receptors or T-cell receptors for phase II clinical trials and beyond requires the large-scale manufacture of high-titer vector stocks. The production of retroviral vectors from stable packaging cell lines using roller bottles or 10- to 40-layer cell factories is limited by a narrow harvest window, labor intensity, open-system operations, and the requirement for significant incubator space. To circumvent these shortcomings, we optimized the production of vector stocks in a disposable fixed-bed bioreactor using good manufacturing practice-grade packaging cell lines. High-titer vector stocks were harvested over 10 days, representing a much broader harvest window than the 3-day harvest afforded by cell factories. For PG13 and 293Vec packaging cells, the average vector titer and the vector stocks' yield in the bioreactor were higher by 3.2- to 7.3-fold, and 5.6- to 13.1-fold, respectively, than those obtained in cell factories. The vector production was 10.4 and 18.6 times more efficient than in cell factories for PG13 and 293Vec cells, respectively. Furthermore, the vectors produced from the fixed-bed bioreactors passed the release test assays for clinical applications. Therefore, a single vector lot derived from 293Vec is suitable to transduce up to 500 patients cell doses in the context of large clinical trials using chimeric antigen receptors or T-cell receptors. These findings demonstrate for the first time that a robust fixed-bed bioreactor process can be used to produce γ-retroviral vector stocks scalable up to the commercialization phase.
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Registered trials
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.