Drive momentum in early-phase production through agile AAV-based gene therapy manufacturing – and keep it rolling into commercial
When you pick Viralgen as your go-to preclinical and clinical production partner, you access a proven platform purpose-built to accelerate AAV-based gene therapy manufacturing from square one
A platform built for regulatory readiness
It’s a simple fact of life in biopharma manufacturing: Regulators continually raise the bar. What was once considered “optional” can suddenly become “required,” as specifications once proposed only tighten and tighten again. Fortunately, we’re more than ready to help you ace those transitions, no matter where in the world you’re submitting your dossier.
Here’s one powerful, practical reason why: Every time our Pro10™ platform runs, it pours more information into an ever- deepening wellspring of manufacturing data. That database provides robust data analysis, through batch-to-batch comparisons, in-house mathematical models, and other real-time insights. The end result? You can support the specifications and justifications in your CMC documentation and reduce potential pinch points in regulatory approvals.
Right-sized for preclinical and clinical support
The best way to enter Phase III clinical trials on a roll? Generate sustainable momentum during preclinical and Phase I through a highly efficient use of resources. That’s precisely where Viralgen comes in.
If you’re pursuing an AAV-based gene therapy for a rare disease and need a single batch for your toxicology studies, biodistribution studies, stability programs or more, our 50L capacity is an ideal match. Then when you head to clinic in Phase I/II for confirmation of safety studies, we’ll be ready to help with multiple 250L or 500L cGMP batches. So your manufacturing costs stay in-line with the supply you need, and no more.
Leveraging the Viralgen advantage
By capitalizing on data and know-how built from 1,500-plus batches of AAV runs, our clients past and present have capitalized on our platform process to de-risk decision making and to help enable a fast transition (as in, 6-9 months) from research to GMP. Now it’s your turn.
As you evaluate the early-phase production support to match what your gene therapy demands, here’s why we think you’ll find Viralgen to be a partner that’s more than up-to-the-task.
UNIQUE rAAV SUCCESS
The clinical products we’ve produced have a 100% success rate for IND approvals (as of October 2024), so we know exactly what to expect and how to get you ready for it
UNIQUE rAAV CAPACITY
With more than 1,500 batches run and 30+ serotypes produced, you can capitalize on every lesson we’ve learned and every new efficiency we’ve gained
UNIQUE rAAV FOCUS
We’re all-in on AAV – it’s our singular focus, meaning every investment in people, processes and technology is built to ensure our very best remains ready to support yours
Get an early start on early-phase success
Flexibility. Reliability. Integrity. Everything you need to get supply for your preclinical and Phase I/II studies is at-the-ready here at Viralgen. So let’s have a discussion about what success looks like to you – and how we can help you get there quicker and with more confidence.
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