GMP LVV
As the number and types of clinical trials for cell and gene therapy increase year by year, so does the demand for GMP lentivirus. As a pioneer in entiviral production, uBriGene has rich experience in lentiviral production and a flexible collection of manufacturing technologies. We provide you with services tailored for your need to help you expand and accelerate your gene therapy projects in clinical and commercial applications.
Production Workflow
uBriGene’s GMP Lentiviral production is carried out in a Grade C+A clean room (Cleanroom Classifications according to EU GMP Standard). The production process involves cell culture, plasmid transfection and supernatant harvest, as well as downstream purification, aseptic filling and storage.
Production Technique Highlights
Our self-innovated 293TY cell line adherent or suspension culture
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Our self-innovated 293TY cell line adherent or suspension culture
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All sera required for cell culture are tested for viral factors
Fully developed cell bank system
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Traceable 293TY cell bank
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All cell banks are assay-validated saving development time
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Highly stable cell bank with stability studies conducted over 60 passages
Out own patented cryopreservation formula improves product stability
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Significantly improved thaw viability compared to PBS or other commercially available formulations
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Titer does not decrease: after 5 or 10 freeze-thaw cycles; when kept for five days at 4°C; when kept for 6 months at -80°C
Comprehensive methodology development and validation
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Comprehensive methodology development and validation
LVV Packaging
Wildly used in gene therapy applications such as CAR-T therapy, Lentivirus is one of the most efficient methods for gene delivery due to its large packaging capacity and its ability to infect non-dividing cells and integrate into the host genome. uBriGene offers LVV packaging service with customizable scales and grades. Relative downstream LVV services are also available.
uBriGene’s LVV Packaging Workflow
Comparison with Other Viruses
Characteristic | AAV | Adenovirus | Lentivirus |
|---|---|---|---|
Origin | AAV-2 | Adenovirus type 5 | HIV-1 |
Genome | 4.8 kb (ssDNA) | 36 kb (dsDNA) | 9 kb (ssRNA) |
Packaging capacity | 4.7 kb | 7.5 kb | 9 kb |
Infection | Most dividing and non-dividing cells | Most dividing and non-dividing cells | Most dividing and non-dividing cells |
Transduction efficiency | Moderate | High | Moderate |
Integration | Non-integrating | Non-integrating | Integrating |
Expression | Transient or stable | Transient | Stable |
Immunogenicity | Very low | High | Low |
Biosafety | BSL-1 | BSL-2 | BSL-2 |
Advantages | High transduction efficiency, Wide range of applications, Stable hereditary | High transduction efficiency, Large capacity, High titer | Low immunogenicity, High safety, High specificity |
Project Cycle
uBriGene has rich experience in GMP lentivirus production and release, and provides complete clinical-grade virus production and technique development services, including cell bank construction, Process development, methodology development, stability research, pilot batch production, etc. We offer customized services based on project needs. In order to meet the requirements of IND application, we can provide batch production records, batch inspection records and relevant verification materials. The approximate project cycle for lentivirus production is as follows:
