PROCESS DEVELOPMENT

Services designed to move your AAV-based gene therapy manufacturing success from concept to clinic

No matter where you find yourself in your development journey, you’ll find our process development capabilities to be the perfect ally for advancing with confidence.

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Delivering on your product goals from the first cell to the first patient treated

The strategies that guide our development services at Viralgen center on you – your current manufacturing results, your stage of development, and your therapeutic’s unique demands. As we better understand all the factors shaping your success, we take into account the quality, productivity and potency of the vector, while simultaneously keeping a keen eye on the cost implications of every approach we could leverage on your behalf.  

That means that whether we’re supporting you through early-stage development/R&D services or later-stage MSAT services, you can rely on us to help derisk and speed your journey to cGMP through optimized, fit-for-purpose, budget-smart production support.

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Generating the optimal production strategy roadmap for your serotype and indication

Leveraging proven expertise in AAV that’s unique to the industry, we can both improve the manufacturability of your transgene and capsid and help you generate higher titers and better potency, all at scale. In short, you'll find all the elements you need at Viralgen to aggressively take on any COGs challenge.

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Construct Optimization

You bring your gene of interest, and we’ll give back an optimized construct — with the right ITRs, promoters, and regulatory elements needed for success. Manufacturability is evaluated earlier (helping you avoid issues later), and you retain complete freedom to operate with the technologies we deploy for your project.

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Process Optimization

If it's a good fit for your program, our development services can include the product-specific optimization of our upstream process by assessing parameters such as DNA and transfection ratios, as well modular improvements in downstream purification steps, promoting robustness in manufacturability.

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Right-Sized Scaling

When you’re ready to scale, we assess the right approach for your program’s stage. This includes our high cell density production system, which generates higher titers — as much as 10x — in a smaller volume. So you can avoid spending time on scale-up or engineering runs until after you have key clinical data.

Improving yields
through a next-
generation process

Effectively commercializing gene therapies for high-prevalence diseases points naturally toward a need to manufacture a lot of virus. In a field as complex as gene therapy, that leads naturally to an assumption that costs for patients and the healthcare system will stay unreasonably high. 

At Viralgen, we're tackling this problem from multiple angles. Our Pro10™ platform has led the industry in yield and scalability for years; you won't find a stronger track record anywhere of dependability and scale, including in volumes up to 2,000L. But we also see the future as one not just of scaling up, but of better yields in smaller volumes. That can translate directly into shorter runs and better efficiency. It's why we've invested in the next generation of Pro10™ manufacturing — one that includes perfusion-based upstream enrichment and a chromatography-only downstream process. 

These aren't new ideas in biomanufacturing, but they are new for gene therapy. More virus coming out of the bioreactor — and a downstream that scales better without decreasing quality — means we're ideally position to support your large scale success now and in the future. Our commercially-validated technologies and yield improvements are making a real difference in COGS, anywhere from 4-32x in our work so far. We're ready for the future of gene therapy, with transfection or stable cell lines.

Our goal is to future-proof your product and cut your COGS. It's those kinds of practical applications of innovation that have a real impact for our customers and for a healthcare system earnestly seeking ways to safely and cost-effectively generate more efficient volumes.

 

Experiencing the Viralgen Difference

You have options in gene therapy manufacturing. When it comes to process development, here are just four reasons our team and its expertise may represent your best option right from the start.

RICH DATA

Our platform fit approach leverages data from 1,500+ batches, meaning every bit of insight we’ve captured along the way can help both derisk and accelerate your production.

CONTINUOUS INNOVATION

Our platform data drives innovation and supports the expansion of our capabilities with digital tools and advanced analytical methods (via a “QbD” — Quality by Design — approach).

TAILORED SUPPORT

Based on the design or size of your vector and its serotype, we can put plasmid optimization, platform fit optimization and manufacturing intensification strategies to work when they're needed, or quickly plug in to our robust platform ecosystem right away when they aren't.

FREEDOM TO OPERATE

When you collaborate with us, your construct is just that: yours. Your construct remains fully portable, giving you complete freedom to operate, without future royalties.

Give your gene therapy the kickstart it deserves

We have a great transgene. But can I make it work? And if it works, can I make enough of it cost-efficiently? If those are the kinds of questions vexing your team, our development services expertise can provide the answers. And we can start the conversation right here.
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