The Space to Build What’s Next in AAV
All In on Infrastructure That Moves You Forward
At Viralgen, being all in on AAV begins with a commitment to our facilities. Built from the ground up to support AAV gene therapies exclusively, our two manufacturing sites in San Sebastián, Spain deliver the flexibility, scale, and speed your therapy needs.
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Clinical Operations
- 4 cGMP suites (250–500L per run; up to 1,500L per batch)
- Dedicated fill/finish suites
- EMA cGMP certified through Phase 3
- Integrated QC and development labs
- 45,000 square feet of clinical-stage infrastructure
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Commercial Operations
- 3 modules, with capability of up to 3 production trains
- Up to 2,000L single-use bioreactors per suite
- Dedicated fill/finish suites
- EMA cGMP certified through Phase 3
- Integrated QC and development labs
- 300,000+ square feet of commercial readiness
Scale Up — From Cell to Vial
At Viralgen, our facilities reflect deep experience and deliberate design. The modules within our commercial facilities operate as a fully self-contained unit — equipped for upstream, downstream, fill-finish, and quality control — enabling seamless scale-up and minimizing complexity.
Inside a production module, you’ll find:
- Industrial scale serum-free suspension culture system: manufacturing process based on triple transfection of Pro10™ cell line
- Dedicated seed train area with 3 sub-areas, 6 incubators, and biosafety cabinets
- Modular bioreactor capacity: Each module of our commercial facility has 3x 500L and 3x 2000L single use bioreactors
- Dedicated seed train area with 3 sub-areas, 6 incubators, and biosafety cabinets
- Ultracentrifugation, depth filtration, chromatography skids, and TFF systems
- Automated isolator-based fill-finish for precision and sterility
- Buffer prep room, drug product storage, in-process control lab
- 2–8 °C and -20 °C chambers, raw material sampling, weighing, and dispensing areas
- 16,000L WFI system and waste management infrastructure
- Generator + emergency system + battery-powered SAI per module
- Independent gas, steam, and utility support
- Multi-room warehouse with separate incoming and outgoing spaces, ensuring product safety from start to finish
- Segregated labs for microbiology, physicochemical testing, ELISA, and DNA analysis
- Dedicated areas for sample prep, amplification, and material/buffer handling
- The latest quality control technologies for product analytical characterization
- 1000m2 MSAT cGMP-like Laboratory
- USP and DSP manufacturing labs that reproduce commercial manufacturing process using a validated scale-down model
- 25 full time technical staff across process and analytics labs
- High throughput capabilities with 24x250mL single-use bioreactor (Ambr250 HT system) to run 24 experiments in parallel and additional 2L, 5L and 50L bioreactors capacities
- Industrial scale serum-free suspension culture system: manufacturing process based on triple transfection of Pro10™ cell line
- Dedicated seed train area with 3 sub-areas, 6 incubators, and biosafety cabinets
- Modular bioreactor capacity: Each module of our commercial facility has 3x 500L and 3x 2000L single use bioreactors
- Dedicated seed train area with 3 sub-areas, 6 incubators, and biosafety cabinets
- Ultracentrifugation, depth filtration, chromatography skids, and TFF systems
- Automated isolator-based fill-finish for precision and sterility
- Buffer prep room, drug product storage, in-process control lab
- 2–8 °C and -20 °C chambers, raw material sampling, weighing, and dispensing areas
- 16,000L WFI system and waste management infrastructure
- Generator + emergency system + battery-powered SAI per module
- Independent gas, steam, and utility support
- Multi-room warehouse with separate incoming and outgoing spaces, ensuring product safety from start to finish
- Segregated labs for microbiology, physicochemical testing, ELISA, and DNA analysis
- Dedicated areas for sample prep, amplification, and material/buffer handling
- The latest quality control technologies for product analytical characterization
- 1000m2 MSAT cGMP-like Laboratory
- USP and DSP manufacturing labs that reproduce commercial manufacturing process using a validated scale-down model
- 25 full time technical staff across process and analytics labs
- High throughput capabilities with 24x250mL single-use bioreactor (Ambr250 HT system) to run 24 experiments in parallel and additional 2L, 5L and 50L bioreactors capacities
Inside the MSAT Lab:
Precision in Every Parameter
To advance AAV therapies at scale, you need more than manufacturing power — you need scientific precision. That’s the role of our MSAT Laboratory: a 1,000m² cGMP-like environment built to troubleshoot, refine, and optimize your process in real time.
Using validated scale-down models and advanced analytics, we replicate full-scale conditions to resolve issues, reduce risk, and ensure your product performs as intended.
Manufacturing to Match Your Ambition
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.
Purpose-Built Infrastructure
Designed from the ground up for AAV—modular, flexible, and GMP-certified from seed train to final fill.
Risk Reduction
by Design
Segregated material, personnel, and product flows reduce contamination risks and regulatory headaches.
Operational
Efficiency
High bioreactor utilization and platform-based seed train workflows reduce timelines and COGS.
In-House
Control
85% of QC testing handled onsite—streamlining oversight, reducing vendor friction, and accelerating results.
Let’s Build What’s Next—Together
From tech transfer to commercial scale, we’re all in on making your therapy a success. Let’s talk about how our team, infrastructure, and expertise can support your next milestone.
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