ArticleGene therapy2012
Scale-up and manufacturing of clinical-grade self-inactivating γ-retroviral vectors by transient transfection.
Article in Gene therapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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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.
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Who cites it
19 citing papers in PubMed.
- Advances in viral vector-based delivery systems for gene therapy: a comprehensive review.3 Biotech · 2025Review
- CAR T cells as micropharmacies against solid cancers: Combining effector T-cell mediated cell death with vascular targeting in a one-step engineering process.Cancer gene therapy · 2023Article
- Process intensification for lentiviral vector manufacturing using tangential flow depth filtration.Molecular therapy. Methods & clinical development · 2023Article
- T cell-responsive macroporous hydrogels for in situ T cell expansion and enhanced antitumor efficacy.Biomaterials · 2023Article
- Scalable Manufacturing of CAR T cells for Cancer Immunotherapy.Blood cancer discovery · 2021Review
- Efficient Pseudotyping of Different Retroviral Vectors Using a Novel, Codon-Optimized Gene for Chimeric GALV Envelope.Viruses · 2021Article
- HEK293 Cell Line as a Platform to Produce Recombinant Proteins and Viral Vectors.Frontiers in bioengineering and biotechnology · 2021Review
- Generation of High-Titer Self-Inactivated γ-Retroviral Vector Producer Cells.Molecular therapy. Methods & clinical development · 2019Article
- Transfection by cationic gemini lipids and surfactants.MedChemComm · 2018Review
- Rapid expansion in the WAVE bioreactor of clinical scale cells for tumor immunotherapy.Human vaccines & immunotherapeutics · 2018Article
- Carbohydrates-chitosan composite carrier for Vero cell culture.Cytotechnology · 2016Article
- Progress and challenges in viral vector manufacturing.Human molecular genetics · 2016Review
- Production and purification of high-titer foamy virus vector for the treatment of leukocyte adhesion deficiency.Molecular therapy. Methods & clinical development · 2016Article
- Simple viral/minimal piggyBac hybrid vectors for stable production of self-inactivating gamma-retroviruses.BMC research notes · 2015Article
- Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.Cancer gene therapy · 2015Review
- Article
- Curing genetic disease with gene therapy.Transactions of the American Clinical and Climatological Association · 2014Article
- Critical variables affecting clinical-grade production of the self-inactivating gamma-retroviral vector for the treatment of X-linked severe combined immunodeficiency.Gene therapy · 2012Article
- Gene Therapy.Advances in biochemical engineering/biotechnologyReview
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
The need for γ-retroviral (gRV) vectors with a self-inactivating (SIN) design for clinical application has prompted a shift in methodology of vector manufacturing from the traditional use of stable producer lines to transient transfection-based techniques. Herein, we set out to define and optimize a scalable manufacturing process for the production of gRV vectors using transfection in a closed-system bioreactor in compliance with current good manufacturing practices (cGMP). The process was based on transient transfection of 293T cells on Fibra-Cel disks in the Wave Bioreactor. Cells were harvested from tissue culture flasks and transferred to the bioreactor containing Fibra-Cel in the presence of vector plasmid, packaging plasmids and calcium-phosphate in Dulbecco's modified Eagle's medium and 10% fetal bovine serum. Virus supernatant was harvested at 10-14 h intervals. Using optimized procedures, a total of five ecotropic cGMP-grade gRV vectors were produced (9 liters each) with titers up to 3.6 × 10(7) infectious units per milliliter on 3T3 cells. One GMP preparation of vector-like particles was also produced. These results describe an optimized process for the generation of SIN viral vectors by transfection using a disposable platform that allows for the generation of clinical-grade viral vectors without the need for cleaning validation in a cost-effective manner.
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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.