ArticleHuman gene therapy2011
Rapid production of clinical-grade gammaretroviral vectors in expanded surface roller bottles using a "modified" step-filtration process for clearance of packaging cells.
Article in Human gene therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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The trial behind it
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Who cites it
13 citing papers in PubMed.
- Head-to-head comparison of in-house produced CD19 CAR-T cell in ALL and NHL patients.Journal for immunotherapy of cancer · 2020Trial
- Efficient clinical-grade γ-retroviral vector purification by high-speed centrifugation for CAR T cell manufacturing.Molecular therapy. Methods & clinical development · 2023Article
- Impact of cryopreservation on CAR T production and clinical response.Frontiers in oncology · 2022Article
- Evaluation of Single-Cell Cytokine Secretion and Cell-Cell Interactions with a Hierarchical Loading Microwell Chip.Cell reports · 2020Article
- Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma.Nature medicine · 2020Article
- Continuous production process of retroviral vector for adoptive T- cell therapy.Biochemical engineering journal · 2018Article
- A Rapid Cell Expansion Process for Production of Engineered Autologous CAR-T Cell Therapies.Human gene therapy methods · 2016Article
- Prospects for gene-engineered T cell immunotherapy for solid cancers.Nature medicine · 2016Article
- Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.Cancer gene therapy · 2015Review
- Use of the piggyBac transposon to create stable packaging cell lines for the production of clinical-grade self-inactivating γ-retroviral vectors.Human gene therapy methods · 2014Article
- Clinical-scale selection and viral transduction of human naïve and central memory CD8+ T cells for adoptive cell therapy of cancer patients.Cancer immunology, immunotherapy : CII · 2013Article
- Evaluation of γ-retroviral vectors that mediate the inducible expression of IL-12 for clinical application.Journal of immunotherapy (Hagerstown, Md. : 1997) · 2012Article
- A simple and effective method to generate lentiviral vectors for ex vivo gene delivery to mature human peripheral blood lymphocytes.Human gene therapy methods · 2012Article
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
Production of clinical-grade gammaretroviral vectors for ex vivo gene delivery requires a scalable process that can rapidly generate large amounts of vector supernatant, clear large numbers of residual packaging cells with minimal decreases in vector titer, and satisfy all current regulatory guidelines regarding product biosafety. To that end, we have developed a simplified method that is compliant with current good manufacturing practices for the production of clinical-grade gammaretroviral vectors in a clinical research environment. We validated a large-scale production platform utilizing 1,700-cm(2) expanded surface roller bottles and a "modified" step-filtration process consisting of a 40/150-μm dual-screen filter for aggregate removal followed by a Sepacell 500II leukocyte reduction filter for removal of residual packaging cells. This clarification process can clear at least 2 × 10(9) viable producer cells using a single filter set-up without any significant loss of titer post-filtration. This platform typically generates 18 liters of vector supernatant to support small-scale clinical trials, but can easily be scaled up to 70 liters during a single manufacturing run. To date, this platform has generated five clinical-grade gammaretroviral vector products, four of which are now being used in adoptive cell therapy clinical trials for the treatment of a variety of solid cancers.
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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.