HOW WE DO IT

Aava™: Your name to know for premier AAV gene therapy manufacturing

Aava is the high-performance, real-world-ready AAV manufacturing platform that can get your high-potential gene therapies to market quickly and efficiently.

The gene therapy manufacturing platform up to every challenge

Aava exists because Viralgen is all in on AAV—it’s all we do, all day, every day. As a result, our manufacturing platform, and our Pro10™ cell line, have amassed an impressive 15-years-and-counting record of success for biotech and pharmaceutical partners large and small, from early construct optimization to small feasibility studies to full-on commercial campaigns.

We’ve produced more than 30 AAV serotypes, created upwards of 1,500 AAV batches, and been involved in over four dozen clinical trials.

All of which means you can count on Aava to deliver the perfect combination of speed, scale, predictability, and performance to maximize your opportunities to get life-changing therapies to patients.

Sponsor Plasmid GOI Drug Product
Aava process diagram

Pro10™ Cell Line
Proprietary Pro1O™ is an animal origin-free, suspension-adapted cell line, derived from HEK293 cells. Pro1O™ is a unique, high-yield universal system that can produce all serotypes and chimeric forms of rAAV.

Upstream Process
Plasmid-based triple transfection, 50 to 2000L, single-use stirred-tank bioreactors

Downstream Process
Viralgen has the capability of processing 50 to 2000L batches with depth filtration, affinity and ion exchange chromatography and tangential flow filtration, as well as ultracentrifugation for full/empty separation.

Fill & Finish
Fully automated isolator

QC Release & CMC
>80% performed in-house

Put Aava to the test.

Want to see exactly what Aava can do for your AAV-based gene therapy projects?

Proven cell line technology optimized for high yields

Gene therapies will find their clearest, shortest paths to success when manufacturing processes can reliably deliver increased production and lower costs. That’s precisely why our Aava manufacturing platform relies on Pro10™, a proprietary cell line technology licensed exclusively from AskBio.
 
Introduced in 2010, Pro10™ has demonstrated best-in-class speed to scale (think six months to cGMP instead of 18 months), so timelines can be met without compromising quality. Derived from HEK293 cells and maintained and cultured in serum-free suspension media, Pro10™ is a unique high-yield universal technology that our team has used to produce more than 30 AAV serotypes.

Group 108

What can Aava do for you? Exactly what you need.

Each generation of Aava is fine-tuned to meet specific strategic needs, whether that’s reducing risk on your way into the clinic or pushing efficiency up to drive costs down. 

And every generation is developed through a process of continuous improvement, so no matter which path you choose, you can count on implementing the most advanced and innovative solution.

Mendi Gen 2.0

Speed + Stability

Pro10™ Cell Line

Helper Plasmid DNA

250-2000L cGMP Production

DNAse-Free Harvest

Downstream Ultracentrifugation

Aava Detail
A proven platform with 100% success rate on IND/IMPD dossier submissions (42/42)
Predictably and efficiently produce enough material to start your journey quickly
Opportunities for low-cost, small-scale startup to generate data
Iturri Gen 3.0

Scale + Efficiency

Pro10™ Cell Line

Helper Plasmid DNA

Upstream High Cell Density Perfusion

DNAse-Free Harvest

Downstream AEX Chromatography

Aava Detail
A groundbreaking, one-of-one approach to strategically bending the cost curve
Lower cost barriers to market adoption for large-scale, more customized gene therapies
Innovate and optimize early to future-proof your path to commercialization
Diagram of the Triple-Plasmid Transfection process

Triple transfection crafted to multiply upstream efficiencies

At Viralgen, we’ve optimized RepCap and helper plasmids for use as a part of our Aava platform. After expansion, Pro10™ cells are co-transfected with: (a) the transgene plasmid, (b) a plasmid carrying pAAVrep2capX; and (c) a helper plasmid carrying the adenoviral genes needed for AAV production. The resulting triple transfection delivers valuable functional and production advantages, while simultaneously enhancing safety by preventing unwanted viral genomes from replicating.

Aava: Everything you’re looking for in an AAV platform.

Better Predictability icon

Better Predictability

Aava has been used to produce 1,500+ batches — meaning all of that data can be used as a “digital bioreactor” to signal early predictability of your construct

Superior Speed icon

Superior
Speed

Aava offers fast scalability from research to clinical to commercial, all while reducing your process development and validation timelines

Deeper Data icon

Deeper
Data

Aava delivers value where it counts: Access to our CMC package and data management simplifies and de-risks the registration process

Aava’s story by the numbers.

100% IND/IMP Dossier Success Rate
IND/IMP Dossier Success Rate
41 Ongoing Phase 1-3 Clinical Trials
Ongoing Phase 1-3 Clinical Trials
60+ Gene Therapy Customers
Gene Therapy Customers
100+ cGMP runs at 250/500L scale
cGMP runs at 250/500L scale
1,500+ AAV Batches
AAV Batches

Ready to Start?

Process matters. We’re confident you’ll like ours.

Discover it firsthand by connecting with our team and describing what gene therapy manufacturing hurdles you want to clear first.

Please review the following rules: