GMP AAV manufacturing platform with access to qualified raw materials that meets the highest regulatory standards for vector production
uBriGene’s talented technical and regulatory teams have extensive experience in the GMP manufacturing and release of AAV vectors to gene therapy development.
Our GMP AAV production platform offers clients access to qualified 293 suspension cell banks and AAV helper plasmids (DMFs on file with FDA) to help accelerate AAV development and manufacturing. Additionally, uBriGene offers a GMP plasmid manufacturing platform that can produce all AAV plasmids required for vector production in an efficient and cost-effective manner.
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Automated closed-system technology for manufacturing ensures sterility with functionally closed disposables, minimizes operator errors through pre-programmed steps, and enhances consistency by reducing variability. It also reduces technician hands-on time and lowers production costs.
50+ AAV GMP manufacturing batches
Active DMF with FDA
Successful AAV IND clearance
Off the shelf
GMP pHelper & pRC plasmids
Active DMF with FDA
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Ask the AAV Expert
uBriGene has developed 293XS, a proprietary high-yield AAV suspension production cell line. The suspension AAV production platform is serum free and animal component free. The advantage of suspension production cell lines in GMP AAV manufacturing is the scalability, much easier to scale up.
Our fully qualified 293XS cell bank is specifically selected for its exceptional productivity and quality in AAV vector manufacturing, helping to reduce costs for your clinical therapeutic programs.
Serum-free, animal component free
Good Growth at density of 1E7 cells/mL
High AAV productivity, 1E14 vg/L
DMF on file with the FDA
GMP AAV production received FDA IND clearance
Scalable AAV production up to 2,000 L
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.
As a leading GMP AAV manufacturer, uBriGene offers comprehensive CDMO services, forming seamless strategic partnerships with AAV gene therapy developers. Our GMP plasmid production platform enables high-quality plasmid process development and manufacturing as the foundation for GMP AAV production. We support every step, from AAV proof-of-concept production and process/analytical method development to AAV engineering, GMP manufacturing, QC release testing, and regulatory support.
Diagram of uBriGene’s comprehensive AAV CDMO Services
Request a quoteAt uBrigene, our GMP AAV vector manufacturing platform is based on the transient transfection of AAV packaging plasmids and genes of interest into HEK293 cells. The AAV vector upstream process using our GMP qualified suspension cell bank, 293XS, has been optimized for high titer production and the downstream process involves a purification scheme that maximizes yield of genome containing particles.
Request a quoteuBriGene’s analytical teams can support development of AAV specific analytical methods and routinely releases GMP AAV vectors using well established in-house assays.
| Test Items | Method | |
|---|---|---|
| Identity | Capsid ID | ELISA |
| Target sequence analysis | Sanger sequencing* | |
| General/physical Properties | Appearance | Visual inspection |
| Particle size and distribution analysis | DLS | |
| Chemical Properties | pH | pH measurement |
| Osmolality | freezing-point depression test | |
| Potency | TBD | TBD |
| Contents | Viral particle (VP) titer | ELISA |
| Viral genome (VG) titer | ddPCR | |
| Infectious titer | TCID50 | |
| Purity | Capsid protein purity | SDS-PAGE/CE |
| Empty capsid ratio | AUC | |
| TEM examination* | ||
| Impurity | Residual HCP | ELISA |
| Residual HCD | qPCR | |
| Residual Tween-20 | HPLC | |
| Residual affinity ligand | ELISA | |
| Residual Plasmids | qPCR | |
| Residual endonuclease | ELISA | |
| Residual DNAs, E1A | qPCR法 | |
| Safety | Endotoxin | USP<85> |
| Replication competent AAV | Culture+qPCR | |
| Sterility | USP<71> | |
| Mycoplasma | USP<63> | |
*Outsourced testing
Fig. 1. High-quality GMP AAV9 with a high percentage of full capsids produced. A 2-step chromatographic purification process for AAV9 was performed following 200L upstream production. High-purity AAV9, including both full and empty capsids, was purified using affinity chromatography. AAV9 full capsids were enriched through AEX chromatography, achieving 85% full capsids, as measured by the analytical ultracentrifugation (AUC) method.
Fig. 2. AAV full/empty capsid ratio measured by AUC method.
Fig. 2. AAV full/empty capsid ratio measured by AUC method.
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Although uBriGene’s helper plasmids are in stock and have an active DMF with the FDA, we can also use your custom helper plasmids. Our GMP AAV plug-and-play manufacturing platform has been optimized with our pHelper and pRep/Cap plasmids, but the manufacturing process will need fine-tuning to accommodate your custom AAV helper plasmids.
The estimated timeline for AAV process development to GMP manufacturing is approximately five months. However, this may vary depending on the specific scale.
We have GMP AAV production facilities in both APAC and USA.
uBriGene can support GMP AAV manufacturing at scales ranging from 50L to 2,000L.
Yes, our QC technical team can support AAV analytical method development and routine QC release assays.
We do provide GMP plasmids up to grams in scale.
60+ GMP AAV projects have been successfully delivered.
Yes, uBriGene provides both research grade and GMP grade AAV production.
AAV remains a leading vector platform for the treatment of genetic diseases due to its safety and effectiveness. Its low immunogenicity, tissue specificity, and ability to achieve long-term gene expression make AAV the vector of choice for many gene therapy programs.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of AAV.
AAV suspension production cell bank
Streamlined platform-based processes
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Ask the Expert
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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.
