Only from Viralgen: A platform approach to accelerating commercial gene therapy manufacturing
There is a way to get an early jump on late-phase manufacturing for your gene therapy. It starts with building on a platform that’s already yielded a 100% success rate in IND/IMPD dossier submissions.
A flexible platform powered by a singular vision
There’s plenty to celebrate when your gene therapy successfully advances through early stage clinical trials. But that euphoria can be short-lived if your process isn’t ready to move quickly to late phase or even straight to registration. Your manufacturing shouldn’t slow you down when your therapy is ready to accelerate.
That’s where a platform approach to commercialization of your gene therapy can make a real difference.
At Viralgen, we’ve run our manufacturing process more than 1,500 times, gathering hundreds of data points for each batch along the way. By choosing to perfect an agile platform built on a single process, we’ve generated an ocean of data that you can leverage to derisk and accelerate process characterization, process validation and process performance qualification (PPQ). Every accumulated piece of intelligence and accompanying insights are ready to help you step confidently and briskly into commercial production.
Efficiency-driven and regulatory-aligned
At Viralgen, our goal in late-stage production is simple but crucial: To help you save 9-18 months of time and, in turn, tens of millions of dollars while lowering risk of failure along the way. Late-phase work is often all about generating process data, which typically requires exhaustive studies and making the material to feed them. Here, we’ve already built that data framework, a foundation to build your product-specific approach to characterization by using process data to supplement or even replace typical studies.
That approach dovetails seamlessly with the FDA’s 2024 guidance on platform technologies, which specified that platform processes could be established considering two components: A common production system and/or a related group of products. We put a firm checkmark next to both, relying on a single system to exclusively manufacture AAV-based products, and building serotype-specific databases of process understanding from our work with more than 30 different AAV capsids.
Why 47 might be a new magic number
At its heart, our process is a sequence of 47 data packages across operational units that run the gamut from plasmids to drug product.
That means that when you commercialize your gene therapy with Viralgen, once we agree on the operational unit definitions and steps for your program, all of your platform and serotype processes are prevalidated. With nearly three dozen data packages already in hand, that leaves only your product-specific validation and PPQ batches left to demonstrate requisite process control for regulatory approval.
The bottom line for you? Less risk, since we’ve already absorbed it. Less production time, since essential data for key steps — in characterization, cell expansion, transfection, etc. — has already been secured. And less cost, since you can advance to commercialization faster and avoid expensive missteps.
PACKAGE 1
Platform Knowledge Supplementation
RECORDS
CQA definition by FMEA Risk Assessment
Process Parameter Definition
Process FMEA (Failure Mode and Effect Analysis)
EPOC/LIVCA
Cell line qualification
EPOC/LIVCA
Solution mixing studies
Viral Clearance
PACKAGE 2
Product Specific Validation
Stability Studies (DS and DP)
Mixing Studies (DS)
Leachable & Extractables (DS and DP)
PACKAGE 3
PPQ Batch
Perform PPQ batch(es) to confirm IPC process performance ranges and impurity clearance in comparison with historical platform results for that serotype and to produce material for package 2.
Equipped with the capacity and capability to scale with you
If your team is pursuing a large indication for your commercial or marketed gene therapy, you may start with expectations of large-scale capacity.
But it wouldn’t end there. You’d expect more.
You’d expect MSAT experts at the ready who can perform a seamless technical transfer into their commercial facility. You’d expect to minimize your risk by ensuring your product’s manufactured in a facility that’s regulatory- and audit-ready. And you’d expect the team managing your program to be as invested in its success as you are. When you select Viralgen as your manufacturing partner, you’ll meet all of those expectations — and more.
Equipping you with manufacturing confidence
Quicker, with confidence. That’s how we’ve engineered our commercialization support to help you move, ensuring your final mile seems less like a marathon and more like a sprint.
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