The “How” Behind Your “Why” in Gene Therapy Manufacturing
We believe in the power of process and partnerships in gene therapy manufacturing. Here’s a snapshot of our approach to your next success.
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The Discipline to Drive Your Therapy Forward
It’s no big secret that companies with staying power have “a way,” a methodology so acutely honed — and so rigorously adhered to — that it drives certainty like nothing else can.
At Viralgen, we have “a way” for AAV gene therapy manufacturing that has both helped guide our clients to a 100% success rate in dossier submissions and is helping provide an ideal industry model for how to simultaneously increase production and lower costs.
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Our Platform
Formed on the foundation of our processes, technologies, and digital bioreactor data, our platform delivers the predictability that could only come from running more than 1,500 batches of AAV. It’s how you can turn manufacturing into an independent variable for your project, minimizing process development timelines and risks while speeding your time to market.
Our Cell Line
Our proprietary Pro10™ cell line — derived from HEK293 cells and adapted for animal-derived component-free suspension culture — delivers high-yield production across all AAV serotypes and chimeric forms. And, in the process, it delivers highly efficient and scalable AAV manufacturing.
Our Triple-Plasmid Transfection Process
Our Pro10™ cell line is triple-transfected with the transfer plasmid containing your transgene, a helper plasmid providing adenovirus helper genes and a plasmid expressing AAV Rep and Cap genes — all included in our offer to position your transgene for success. It’s a combination primed to deliver robust scalability and functional advantages throughout production.
Our Purification Process
Our purification process ensures process residuals are minimized and full capsids are prioritized with a scalable, agnostic approach. We manage 80% of testing – including NGS – in house, ensuring your product both moves through its journey efficiently and maintains the identity, integrity, and purity required to help get it patient-ready.
How Our Team Positions Yours for Success
Our passion for your success will come through clearly in our first meeting (and in every one after that, for that matter).
As a Viralgen client, you have a right to the distinct knowledge and expertise we’ve accumulated in AAV manufacturing since our founding in 2017. You have the right to have your program managed with high strategic intent through business models designed around your goals, not ours. And you have the right to be treated as a full partner, one who can capitalize on every unique bit of value — technical, strategic, financial — we can offer your team today and tomorrow.
Management
Dedicated Program Managers from post-signature kickoff to completion
Communication
Frequent, consistent and transparent project communication
Support
Built-in technical and regulatory support that gets you ready for submissions
Streamlining Your Path to Market
Our approach at Viralgen ensures the momentum you’ve put behind your gene therapy innovation stays in high gear. As you move through clinical development, we help you anticipate and plan for commercialization, eliminating traditional barriers that can slow gene therapy development.
Your Challenges
High upfront costs and royaltiesOur Solution
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.
