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GMP AAV Production Services

GMP AAV manufacturing platform with access to qualified raw materials that meets the highest regulatory standards for vector production

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GMP AAV Manufacturing Platform

uBriGene’s talented technical and regulatory teams have extensive experience in the GMP manufacturing and release of AAV vectors to gene therapy development.

GMP AAV Production Platform Highlights

uBriGene’s AAV production suspension cell line 293

GMP released MCB
High productivity
Active DMF with FDA

In stock GMP grade AAV packaging plasmids

Manufactured according to the FDA regulatory standards
Active DMF with FDA

Streamlined GMP AAV production platform processes

Scalable AAV suspension production cell line, 293XS
AAV upstream yield: E12 vg/mL, 50% full/empty capsid ratio
Two-step downstream purification: 30-50% recovery, 70-90% full/empty capsid ratio

Extensive GMP AAV production experience

50+ Batches of GMP AAV successfully released
Proprietary cryopreservation solution formulation for prolonged stability

Service Features

Feature Headline

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Feature Headline

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Need GMP AAV Production?

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

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Need GMP AAV Helper Plasmids?

Off the shelf

GMP pHelper & pRC plasmids

Active DMF with FDA

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AAV GMP Production Cell Line, 293XS

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

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Comparison of Membrane Chromatography with Resin Chromatography

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.

uBriGene's AAV GMP manufacturing services diagram.

Diagram of uBriGene’s comprehensive AAV CDMO Services

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GMP AAV Production Platform Workflow

uBriGene's AAV GMP manufacturing workflow.Request a quote

AAV QC Release Assays

Test ItemsMethod
IdentityCapsid IDELISA
Target sequence analysisSanger sequencing*
General/physical PropertiesAppearanceVisual inspection
Particle size and distribution analysisDLS
Chemical PropertiespHpH measurement
Osmolalityfreezing-point depression test
Potency TBDTBD
Contents Viral particle (VP) titerELISA
Viral genome (VG) titerddPCR
Infectious titerTCID50
PurityCapsid protein puritySDS-PAGE/CE
Empty capsid ratioAUC
 TEM examination*
Impurity Residual HCPELISA
Residual HCDqPCR
Residual Tween-20HPLC
Residual affinity ligandELISA
Residual PlasmidsqPCR
Residual endonucleaseELISA
Residual DNAs, E1AqPCR
SafetyEndotoxinUSP<85>
Replication competent AAVCulture+qPCR
SterilityUSP<71>
MycoplasmaUSP<63>

*Outsourced testing

High Quality and High Percentage of Full Capsids AAV Produced after Downstream Purification

Chromatography results showing the high-quality and purity of GMP AAV9 with a high percentage of full capsids.

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.

AAV Full/Empty Capsids Ratio Measured by AUC

Ratio of AAV full, partial, aggregate, and empty capsids.

Fig. 2. AAV full/empty capsid ratio measured by AUC method.

Fast-Track Your GMP AAV Therapeutic Programs in Seven Months

Seven-month timeline for GMP AAV therapeutics projects.

Fig. 2. AAV full/empty capsid ratio measured by AUC method.

Frequently asked questions

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.

Need GMP AAV Production?

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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Needs GMP Plasmids?

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.

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