GMP LVV
The ability of stability transduce cytotoxic lymphocytes is vital in producing effective CAR cells for cell therapy. As the field of cell therapy matures, lentiviruses have become a powerful tool in CAR cell construction and production. Lentiviruses are highly efficient in delivering genetic material to both dividing and non-dividing cells. With the ability of integrating genetic material into target cells, lentiviruses can produce stable CAR expressing cell for cell therapy.
With the increase in number of type of clinical trials in cell and gene therapy, so has the demand for GMP grade lentiviruses. At uBriGene, we have rich experience in lentivirus production and a collection of versatile manufacturing technologies. We are able to provide our clients with tailored manufacturing services to accelerate your cell and gene therapy clinical and commercial projects.
Production Workflow
uBriGene’s GMP lentivirus production is manufactured under Grade C+A clean room standards. Our cleanrooms are qualified to NMPA, FDA and EMA production standards. Our use of single-use bioreactors significantly reduce the risk of cross-contamination. With our high efficiency cell lines and fibra disks, viral production yields are much higher with viral titers per liter 5-10 times higher than traditional layer stack production methods.
Production Technique Highlights
High efficiency cell lines
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High producing 293TY cells
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In-house developed adherent and suspension cultures
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High quality viral factor tested sera
Fully developed cell bank system
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Traceable 293TY cell bank
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Assay-validated cell banks
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Highly stable cell banks tested for over 60 passages
Patented cryopreservation techniques
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Enhanced freeze/thaw methodologies for improved viability
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Highly stable viable viral titers at 4oC; -80oC and multiple freeze/thaw cycles
Methodology and development
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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.
Lenti Workflow
With extensive vial manufacturing and release experience, uBriGene can provide complete clinical-grade viral production services. From cell bank construction, technology, methodology to production and stability testing, our expertise and facilities are here to meet clinical project needs. uBriGene can also provide GMP production documentation, batch inspection records and related certification to assist in IND application filing.
Quality Control and Assurance
With our one-stop shop solution to our client’s cell and gene therapy needs, we provide the highest quality QA and QC support. Our dedicated and experienced quality teams assist our clients in developing testing methods to meet even the most stringent requirements of GMP projects.
Comparison of Gene Therapy Viral Vectors
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 |