ArticleGene therapy2006
Production scale-up and validation of packaging cell clearance of clinical-grade retroviral vector stocks produced in cell factories.
Article in Gene therapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- CAR T-Cell-Based gene therapy for cancers: new perspectives, challenges, and clinical developments.Frontiers in immunology · 2022Review
- Review
- At the Intersection of Biomaterials and Gene Therapy: Progress in Non-viral Delivery of Nucleic Acids.Frontiers in bioengineering and biotechnology · 2019Review
- Continuous production process of retroviral vector for adoptive T- cell therapy.Biochemical engineering journal · 2018Article
- Global Manufacturing of CAR T Cell Therapy.Molecular therapy. Methods & clinical development · 2017Review
- Engineering CAR-T cells.Biomarker research · 2017Review
- Progress and challenges in viral vector manufacturing.Human molecular genetics · 2016Review
- Large-scale clinical-grade retroviral vector production in a fixed-bed bioreactor.Journal of immunotherapy (Hagerstown, Md. : 1997) · 2015Article
- Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.Cancer gene therapy · 2015Review
- Scale-up and manufacturing of clinical-grade self-inactivating γ-retroviral vectors by transient transfection.Gene therapy · 2012Article
- Rapid production of clinical-grade gammaretroviral vectors in expanded surface roller bottles using a "modified" step-filtration process for clearance of packaging cells.Human gene therapy · 2011Article
- Genetic modification of human hematopoietic cells: preclinical optimization of oncoretroviral-mediated gene transfer for clinical trials.Methods in molecular biology (Clifton, N.J.) · 2009Article
- Quantitative analysis of clinically relevant mutations occurring in lymphoid cells harboring gamma-retrovirus-encoded hsvtk suicide genes.Gene therapy · 2008Article
- Generation of a high-titer packaging cell line for the production of retroviral vectors in suspension and serum-free media.Gene therapy · 2007Article
- Manufacturing validation of biologically functional T cells targeted to CD19 antigen for autologous adoptive cell therapy.Journal of immunotherapy (Hagerstown, Md. : 1997)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
The clinical implementation of gene therapy requires large-scale production of viral vector stocks (VS) derived from packaging cell lines. Upon scaling-up, maintenance of high viral titers and filtration of the VS become significantly challenging. Thus, production schemes amenable to straightforward validation must be developed. To this end, we have established a semi-closed process to manufacture batches of 7 l or more of clinical-grade oncoretroviral VS using 10-tray Cell Factories. Using a peristaltic pump, the VS are collected on 3 consecutive days, filtered, pooled and stored frozen. To ensure the absence of viable vector-producing cells (VPCs) from each VS unit-dose, we undertook an orthogonal log-removal validation study to demonstrate the ability of both the filtration system to remove viable cells and the VS freezing process to inactivate them. We demonstrate a total VPC-reduction of 11.6 log, thus insuring the absence of contaminating VPCs in transduced clinical samples. We also show that this production process generates stable VS that can be stored at -80 degrees C for more than 3 years. Importantly, this relatively simple and affordable process can be customized to generating large volume of VS for small animal or non-human primate studies. This methodology is not limited to the generation of cell-free clinical oncoretroviral VS, and can be applied to other types of vectors produced in packaging cell lines, such as lentiviral vectors.
Indexed as
Identifiers
16177816What OpenQuestion holds
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.