GMP lentivirus manufacturing platform with access to qualified raw materials that meets the highest regulatory standards for vector production.
As a lentivirus CDMO, uBriGene’s talented technical and regulatory teams have extensive experience in the GMP manufacturing and releasing of lentiviral vectors to support cell therapies.
Our GMP lentivirus manufacturing platform is a mature, 3rd generation GMP-ready platform that offers clients access to qualified 293T cell banks and lentivirus helper plasmids (DMFs on file with FDA) to help accelerate lentivirus development and manufacturing.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of lentiviral vectors.
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GMP grade
Activated DMF on file with the FDA
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Contact the ExpertsuBriGene’s GMP lentivirus production platform has evolved from v1.0 to v3.0, transitioning from adherent cells to our qualified suspension 293TH cells.
Our fully qualified 293TH cell bank has been selected for its high productivity and quality in lentiviral vector production, translating to lower costs for your clinical therapeutic programs. The suspension lentivirus production platform is serum free and much easier to scale up.
The advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
The lysates are clarified through scalable, fully closed depth filtration, followed by a cost-effective two-step purification process using anion exchange (AEX) and hydrophobic interaction chromatography (HIC). For larger-scale production membrane matrix chromatography allows for higher flow rates.
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Request a quoteOur GMP lentivirus production platform is based on the transient transfection of lentiviral vector packaging plasmids and genes of interest into HEK293T cells. Our GMP plasmid manufacturing platform that can produce all lentivirus plasmids needed in an efficient and cost-effective manner.
In addition to our adherent cell platform, we have developed a highly productive suspension lentivirus production cell line that is scalable and animal component free. Our two-step chromatography purification process ensures high-yield and highly potent lentiviral vectors.
Request a quoteuBriGene offers a full suite of in-house and custom lentivirus specific assays to support lentiviral vector process development and manufacturing including QC release and stability indicating test methods.
| Test Items | Method | |
|---|---|---|
| Identity | Sanger sequencing* | |
| Physical property | Appearance | Visual inspection |
| Chemical property | pH | pH measurement |
| Content | Physical titer by p24 | ELISA |
| Infectivity | LTI calculation | |
| Transduction titer | Flow cytometry | |
| Purity | Residual host DNA | qPCR |
| Residual plasmid DNA | qPCR | |
| Residual host protein | ELISA | |
| Residual Benzonase | ELISA | |
| Residual host DNA (SV40 Large T antigen) | ddPCR | |
| Residual host DNA (E1A) | ddPCR | |
| Safety | Endotoxin | Gel-clot assay |
| Sterility | Membrane filtration method | |
| Mycoplasma | Culture method | |
| RCL (EOPC & UPB) * | Culture method | |
*Outsourced testing
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Fig. 1. Comparison of lentivirus productivity of HEK293T adherent cells and uBriGene’s 293TH suspension cells. Four different GOIs were used for this study. The transduction units were analyzed using flow cytometry after transducing Jurkat cells with the lentiviral vectors produced from HEK293T adherent cells and our suspension 293TH cells.
Request a quoteuBriGene brings high-level technical expertise to your lentivirus production plans. Given our experience in developing our own platform, we can rapidly assess your GMP lentivirus production with our current platform to help focus on process and analytical development.
Fig. 2. Lentivirus production platform process development. Through a series of upstream optimizations, the transduction titer has increased by over seven folds.
uBriGene brings high-level technical expertise to your lentivirus production plans. Given our experience in developing our own platform, we can rapidly assess your GMP lentivirus production with our current platform to help focus on process and analytical development.
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Lentiviral vector remains a leading vector platform for gene-modification of both dividing and non-dividing cell types, and its deployment in the clinical development of cell therapies is an area of active investigation.
We provide the 3rd generation of lentiviral packaging systems for improved safety. If you need 2nd generation lentivirus production, we can also provide that service.
Our GMP-grade lentiviral packaging plasmids are in stock and have an activated DMF with the FDA, which will significantly accelerate IND filing.
It takes about two months for GMP lentivirus production (excluding time for GMP plasmids production).
We have lentivirus production facilities in both APAC and USA.
Yes, we perform the full spectrum of lentiviral vector quality release testing in-house, except for the RCL assay.
We perform flow cytometry after transducing Jurkat cells with lentivirus using target specific antibody.
We do provide GMP plasmids up to grams in scale.
The overall yield for a GMP lentiviral vector production batch is typically around 10%-20%, but unfortunately, at least 50% of the lentivirus is often lost during sterile filtration.
20+ GMP lentiviral vector production projects have been successfully delivered.
Yes, uBriGene provides both research grade lentivirus packaging and GMP lentivirus production.
End-to-end CDMO services with streamlined timelines and cost-effective processes.
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
