WHAT WE DO

Leading rAAV-based gene therapy manufacturing services

From a proven cell line all the way to QC and release, Viralgen gives your innovation the full end-to-end manufacturing development and production excellence it deserves.

Scale. Speed. And the spark for gene therapy success.

Our value to clients, in its simplest terms, is this: We can deliver your team fast scalability from research to clinical to commercial grade material with high yield and quality. We meet that promise through comprehensive services based on a platform that’s proven to both lower risk and accelerate clinical entry and progression.

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Process Development

If you’re advancing an early-stage innovation, you’ll find our development and R&D services – including platform fit, construction optimization and production strategy – to be of particular value. If you’re already in late-stage production, we can put our expertise in MSAT services to work through comparability studies, next-generation process transition and process characterization/PPQ. From start to finish, our development programs focus on the quality, productivity and potency of the vector, while simultaneously considering the cost implications of every strategy we deploy.

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Manufacturing Platforms

From our first meeting forward, you’ll hear us talk about the science behind our proprietary mammalian cell-based production platform, which results in an optimization rate of more than 70% compared to other cell lines. At its heart is Pro10™: An HEK293-derived cell line in serum-free suspension media with triple plasmid transfection. By leveraging our platform – which has been used to produce more than 1,500 batches at Viralgen – you can capitalize on that rich storehouse of “digital bioreactor” data to predict the production success of your innovation.

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Clinical Production

From lab to clinical supply, Viralgen has you covered, since our flexible approach pivots around your therapeutic indication and volume requirements. You can scale up from 2L screening batches to 50L toxicology batches to 250L-500L cGMP batches for your Phase I clinical needs. Plus, our success producing more than 20 diverse serotypes ideally positions you to capitalize on both data predictability and an experience that delivers a proven CMC track record.

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Commercial Production

Our commercial production proves its benefit whether you’re thinking about how to reach thousands of patients a year or you're working on an ultra-rare indication where a single batch may be all you need for years’ worth of patient treatments. Finding the right mix of scaling up and scaling out to manage demand, timelines and the growing network of regulatory pathways to reach the market isn't getting any easier, but our combination of capacity, capability and data-driven knowledge of our process lets us stay focused on the same goal: To put our process and characterization knowledge to work in a way that both accelerates and de-risks the progress of your product.

Ready to be put to the test

In AAV-based gene therapy manufacturing, you’ll find not all companies are equal. As you evaluate your options, we invite you to do a side-by-side comparison and see how our capabilities at Viralgen stack up against other potential partners.
Capabilities
neDNA™ starting material
Construct optimization
High-cell density production
Platform with 1,500+ batches
Experience with 30+ serotypes
cGMP Production at 2,000L scale
Digital bioreactor (for data predictability)
neDNA™ starting material
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Construct optimization
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High-cell density production
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Platform with 1,500+ batches
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Experience with 30+ serotypes
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cGMP Production at 2,000L scale
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Digital bioreactor (for data predictability)
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Other Manufacturers
neDNA™ starting material
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Construct optimization
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High-cell density production
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Platform with 1,500+ batches
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Experience with 30+ serotypes
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cGMP Production at 2,000L scale
Layer_1 (1)
Digital bioreactor (for data predictability)
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Purpose-built to drive your gene therapy forward

We’ve designed, engineered and built the largest footprint dedicated exclusively to rAAV manufacturing anywhere in the world. That investment speaks to our commitment both to the foundational science we apply and to ensuring you get the best our team has to offer, today and tomorrow. 

Through more than 340,000 square feet in two EMA GMP-accredited facilities in San Sebastian, Spain (and plans to establish facilities in the US by 2026), we have the room to grow side-by-side with you as you advance from discovery lab to market.

Here’s how what’s under our roof delivers value to your team.

Highly efficient processes from the Pro10™ platform
Improves utilization rates while reducing COGS

Latest upstream and downstream equipment innovations
Drives product development and helps reduce risks

cGMP facilities built with segregation and controls for material, personnel and product flows

De-risks product development while reinforcing a culture of quality

Top-of-the-line utility systems and an uninterrupted power supply

Provides additional layers of protection for raw materials and products in development

Capacity and capabilities to perform 85% of testing in-house

Simplifies vendor management and reduces hand-off errors
Explore more
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October 07, 2024
Inversiones para la creación de un nuevo servicio de caracterización de proceso de fabricación industrial de vectores virales AAV (MSAT)
Viralgen Vector Core, S.L. ha obtenido una vez más apoyo desde el Gobierno Vasco a través del Programa Bilakatu de Ayuda a empresas afectadas por el Covid-19 – Convocatoria 2022. Esta iniciativa está definida para la creación de un nuevo servicio de...
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July 19, 2024
Inversiones para la creación de un nuevo laboratorio de Control de calidad – Askbio Center of Excellence (ACE)
Viralgen Vector Core, S.L. ha obtenido una vez más apoyo desde el Gobierno Vasco a través del Programa Bilakatu de Ayuda a empresas afectadas por el Covid-19 – Convocatoria 2022. Esta iniciativa está definida para la creación de un nuevo laboratorio...
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July 19, 2024

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