ArticleMolecular therapy. Methods & clinical development2024
Long-term stability of clinical-grade lentiviral vectors for cell therapy.
Article in Molecular therapy. Methods & clinical development, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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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.
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Who cites it
11 citing papers in PubMed.
- Advancing In Vivo Chimeric Antigen Receptor T-Cell Engineering to Accelerate Clinical Translation.MedComm · 2026Review
- Modulating viscosity improves lentiviral transduction of NK cells: A simple solution to a persistent problem.Molecular therapy. Advances · 2026Article
- Challenges and Opportunities in Lentivirus Viral Vector Manufacturing for In Vivo Applications.Biomedicines · 2026Review
- Developing a process of lentivirus purification from recombinant fluids using peptide affinity ligands.Bioengineering & translational medicine · 2025Article
- Identification of the conditions and minimum requirements necessary for the release of autologous fresh CAR T-cell products under hospital exemption: a position paper from the WP-bioproduction of the UNITC consortium.Bone marrow transplantation · 2025Article
- Long-term safety of lentiviral or gammaretroviral gene-modified T cell therapies.Nature medicine · 2025Article
- Protein nanoparticles as potent delivery vehicles for polycytosine RNA-binding protein one.World journal of diabetes · 2025Article
- A bioluminescent reporter bioassay for in-process assessment of chimeric antigen receptor lentiviral vector potency.Antibody therapeutics · 2025Article
- Establishment and Characterization of a Stable Producer Cell Line Generation Platform for the Manufacturing of Clinical-Grade Lentiviral Vectors.Biomedicines · 2024Article
- The very stable lentiviral vector.Molecular therapy. Methods & clinical development · 2024Article
- ReCARving the future: bridging CAR T-cell therapy gaps with synthetic biology, engineering, and economic insights.Frontiers in immunology · 2024Review
Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
The use of lentiviral vectors in cell and gene therapy is steadily increasing, both in commercial and investigational therapies. Although existing data increasingly support the usefulness and safety of clinical-grade lentiviral vectors used in cell manufacturing, comprehensive studies specifically addressing their long-term stability are currently lacking. This is significant considering the high cost of producing and testing GMP-grade vectors, the limited number of production facilities, and lengthy queue for production slots. Therefore, an extended shelf life is a critical attribute to justify the investment in large vector lots for investigational cell therapies. This study offers a thorough examination of essential stability attributes, including vector titer, transduction efficiency, and potency for a series of clinical-grade vector lots, each assessed at a minimum of 36 months following their date of manufacture. The 13 vector lots included in this study were used for cell product manufacturing in 16 different clinical trials, and at the time of the analysis had a maximum storage time at -80°C of up to 8 years. The results emphasize the long-term durability and efficacy of GMP-grade lentiviral vectors for use in
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