At Viralgen, we’re proud to be known for just one thing: Being a world leader in rAAV-based gene therapy manufacturing.
Earning the privilege to make your gene therapy
We’re all in on AAV; it’s all we do, all day, every day. And as an independently operated CDMO and subsidiary of AskBio, Viralgen delivers cGMP rAAV gene therapy manufacturing that grows as our clients do – from early construct optimization to small feasibility studies to full-on commercial campaigns.
We built our business on foundational science in AAVs and are home to the world’s largest manufacturing capacity dedicated to AAV for one reason: To get patients with genetic diseases a step closer to the therapies that can make a life-changing and, in some cases, life-saving, difference.
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What’s Happening in AAV Gene Therapy Now
VIEW ALLWebinar: Comparing ultracentrifugation versus AEX for successful AAV purification
Displacement Chromatography for Enrichment of rAAV Genome-Containing Capsids using Weak Organic Acid
Improving Scalability and Productivity of Transient Transfection AAV Production
Reflections on Inclusion and Diversity with Sonia Guirado from Eurofirms Foundation
Why we’re trusted for AAV success
When your vision is to change the world with a gene therapy, you need to enlist a team that knows how to help that vision become reality for patients predictably, efficiently, and with the confidence that can only come from experience.
That’s precisely what you’ll find at Viralgen. In the last five years alone, we’ve been at the center of more global regulatory submissions using a single-platform process than other gene therapy manufacturer. Which means we can predict with clarity, adapt with surety, and advance with urgency. The bottom line of all that? Scale quickly. Future-proof your manufacturing. Start optimizing for cost of goods from day one. And mitigate downside risk.
Why we make the short list
To get to patients, your innovation has to be built on sound science and sound economics. We have a lot to offer on both fronts.
RESPECTED FOR THE RIGHT SCIENCE
Your CMC team will love how we work. For starters, we know the standards of quality and analytics are rising in gene therapy and we can help you meet them. Our platform has produced an ocean of data to help guide decisions, set specifications, and take the right phase-appropriate approach to your journey through the clinic. Plus, our business model doesn't put you on the clock every time you need a question answered or need to get support from our team.
CHERISHED FOR THE RIGHT CUSTOMER EXPERIENCE
We provide a full spectrum of services – regulatory support, quality release testing, scalability testing and more – to help get you ready for what's next, whether it is picking a construct, filing your IND, or preparing your BLA. We make the economics work for you through fixed-cost packages, all-inclusive pricing models, and freedom to operate with the technologies we use for your program. And since we know the science of creating a gene therapy is unbelievably hard, we make the process of working with a team that’s focused on you.
Our numbers only matter if they help you hit yours
Successful Dossier Ratio (as of September 2024)
AAV Batches Run
AAV Serotypes Produced
cGMP Runs at 250/500 L Scale
Gene Therapy Customers
Foundations Supported via Compassionate Manufacturing
Well-equipped to advance your gene therapy
Serving as the world’s manufacturing center of excellence for AAV demands all the right resources be right at hand. And at Viralgen, they are. That uniquely positions us to help our clients find a more direct path to commercialization based on our proven science, new-fashioned thinking, focused capacity, and a true-to-target track record.
Put 343,255 square feet of AAV manufacturing to work
Located in San Sebastian, Spain, our GMP-accredited facilities are home to more than 400 talented professionals – and to the technology innovations required to drive best-in-class development, risk reduction, and scale-up. Our cGMP production suites promote segregation and control (including material flows, personnel flows and product flows), while our platform (including our seed train) promotes high utilization that helps you drive lower COGS.
Services designed to keep you moving
Our array of services at Viralgen meet you right where you are – and then help you advance your gene therapy faster and better.
We specialize in the production of AAV gene therapy vectors using our proprietary suspension, triple transfection platform. It features the AskBio Pro10™ HEK293 cell line, which has a well-earned industry reputation for delivering high yields. Pro10™ is the heart of our platform, but just as important is everything around it: robust production and purification processes from 100ml to 2,000L, fill and finish across a broad range of formats, integrated QC and release support with >85% of methods done in-house, and globally compliant regulatory support for CMC filings at every stage of the process.
CONSTRUCT OPTIMIZATIONAND PLATFORM FIT
ManufacturingPlatforms
ClinicalProduction
CommercialProduction
Let’s talk success: Yours.
We know that to provide curative medicines to people with rare genetic and pathway diseases, we have to first fully understand the needs of our clients. So we’re eager to listen and learn more about your goals and aspirations. Just complete the form below and we’ll contact you to get a conversation started.
