Scalable AAV Manufacturing, without the Detours

From research-grade plasmids to IND-ready vectors, Andelyn accelerates your gene therapy program with speed, flexibility, and a seamless path from early-phase through commercialization.

Commercial Development is Complex. Your Path Forward Shouldn't Be.

Moving from discovery to IND demands a partner who understands your science, delivers high-quality AAV, and keeps your future scale-up in mind from day one. At Andelyn, we’re built to support exactly that. Whether you’re an academic innovator or a biopharma trailblazer, we offer the technical depth and manufacturing agility to advance your program.

Process diagram showing the gene therapy manufacturing journey from plasmid production through commercial AAV manufacturing.
Process diagram showing the gene therapy manufacturing journey from plasmid production through commercial AAV manufacturing.

Fewer Handoffs. A More Direct Path to Commercialization.

Fragmented development can turn the path from discovery to manufacturing into a series of technology transfers and potential delays. Andelyn brings development and manufacturing together with the AAV Curator Platform, supporting a more continuous path from early development through IND and commercial production.

Andelyn Maze animation

Andelyn Partners with Ultragenyx on AAV Commercial Manufacturing

Following FDA approval for MPS IIIA, Andelyn Biosciences is manufacturing Ultragenyx’s UX111 for commercial supply in Columbus, Ohio. This marks the first FDA-approved gene therapy produced using the Andelyn AAV Curator® Platform.

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Why Teams Trust Andelyn from Day One

Our history, flexibility, integrated model, and rare-disease mission make us the ideal AAV partner for early-stage developers who need more than a just a vendor.

Speed Meets Flexibility

Rapid delivery of research and TOX grade AAV backed by a team that adapts to your needs.

Built to Scale with You

Our AAV Curator Platform minimizes rework and streamlines transition from bench to BLA, with no tech transfer friction.

One Partner All Phases

From plasmid and viral vector manufacturing to GMP and regulatory support one MSA with one trusted path to IND and beyond.

build for the journey to commercial manufacturing

AAV Curator® from Early Development to Commercial Production

AAV Curator® combines a proven platform foundation with program-specific process optimization, helping you move efficiently from early development toward scalable GMP and comercial production.

One platform. One continuous development path.
Early
Development

Explore AAV designs and establish initial process foundation

Process optimizations

Data-driven optimization across upstream, downstream, materials, analytics and quality

AAV Curator™ platform

Developed on the same manufacturing foundation used to scale forward

Clinical manufacturing

Consistent, robust process performance to support clinical supply

Commercial production

Scalable, reliable manufacturing designed for long-term commercial success

Configurable process
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Data and analytics
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Established materials and supply chains
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Integrated quality systems

See Vector Production Details

Download our Full-Spectrum Gene Therapy Partner document to get additional details about our capabilities to support your  early-phase AAV manufacturing needs.

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