GMP AAV
AAV vector-based gene therapy is a promising field, but mass-production under serum-free conditions has always been the biggest bottleneck in AAV commercial production. uBriGene's independently developed technology platform for large-scale industrial production has successfully prepared multiple batches of GMP AAV with serum-free suspension. Our platform can greatly increase viral production and ensure high viral purity, while reducing production costs and better assisting your research for novel drugs and development projects.
Production Workflow
uBriGene's AAV preparation platform adopts the serum-free suspension culture method. The production process involves upstream cell culture, plasmid transfection, lysis and clarification, as well as downstream two-step column chromatography, aseptic filling and storage. The whole process is operated in a closed single-use system.
Production Technique Highlights
Well-established serum-free suspension culture system
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Well-established serum-free suspension culture system
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Our own innovated suspension 293XS cell bank
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The cell density can reach 10⁷ cells/mL
Well-developed purification platform for multiple serotypes
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Well-developed purification platform for multiple serotypes including: rAAV2/2, rAAV2/5, rAAV2/8, rAAV2/9
High yield, high purity, low cost, low rate of empty capsids
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High yield, high purity, low cost, low rate of empty capsids
Can be linearly scaled up to 200-500L
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Can be linearly scaled up to 200-500L
AAV Packaging
Adeno-associated virus (AAV) has been a popular viral vector for gene therapy due to its versatile tropism, its non-pathogenicity and low immunogenicity, as well as its ability to transduce dividing and non-dividing cells. Relative downstream AAV services are also available
uBrigene’s AAV Packaging Workflow
Project Cycle - need higher res image
uBriGene has extensive experience in GMP virus production and release, and can provide complete clinical-grade viral product manufacturing services, including cell bank construction, technology and methodology development, stability studies, pilot batch production, and customized services to be provided based on project needs. In addition, in order to meet the requirements of IND application, uBrigene also provides clinical-grade AAV batch production documentation, batch inspection records and related certification. Please see the table below for a typical project cycle outline.
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 |