AAV Gene Therapy | Preclinical Testing & Device Services

Accelerating AAV Gene Therapy Manufacturing for CGT Programs

Efficient, scalable, and data-driven AAV Gene Therapy manufacturing is essential for advancing gene therapies from discovery to clinical trials. By combining a robust, multi-serotype AAV platform with targeted manufacturing feasibility studies, developers can rapidly assess the manufacturability and scalability of their gene therapy candidates. Pharmaron delivers actionable insights into viral yield, process robustness, and product quality in as little as six weeks, empowering gene therapy developers to make informed, early-stage decisions.

Utilizing Ambr®250 bioreactors and a proprietary suspension HEK293 cell line, Pharmaron’s approach enables production of multiple AAV serotypes through a triple transfection system. This system allows for side-by-side comparison of multiple gene therapy candidates under scalable, process-relevant conditions. Early separation of ‘Full’ and ‘Empty’ viral particles — a common challenge in AAV development — is achieved through targeted analytics, helping to ensure optimal product quality and yield.

Data generated from the manufacturing feasibility study provides critical information on upstream reproducibility, downstream purification performance, and identifies process steps requiring optimization. This focused approach avoids unnecessary full-scale development when not required and accelerates progression to GMP manufacturing while controlling both time and cost.

Enabling GMP-Ready AAV Manufacturing with Targeted Process Development

The manufacturing feasibility program is designed to reduce risk and de-risk manufacturing strategies before GMP production. Process data from upstream production, downstream chromatography purification, and full/empty virus separation guide teams to either fast-track the product to GMP manufacturing or make targeted optimizations using Pharmaron’s High-Throughput Process Development (HTPD) and Design of Experiments (DoE) capabilities.

With platform experience across a wide range of AAV serotypes and product types, the team consistently delivers reproducible viral titers, genome titers, and process robustness, providing confidence in scalability for clinical manufacturing.

This fast and flexible platform ensures that gene therapy developers receive the critical data they need to advance therapies rapidly and efficiently to first-in-human studies..

Why Choose Pharmaron for AAV Manufacturing?

6-Week Feasibility Timeline — Rapid turnaround from project initiation to actionable manufacturing data.
Proprietary HEK293 Suspension Platform — Robust and scalable system supporting multiple AAV serotypes.
Full/Empty Virus Resolution — Early insight into critical product quality attributes.
Tailored Process Optimization — Only optimize what is needed, saving time and resources.
GMP Manufacturing Readiness — Smooth transition from feasibility to clinical-grade manufacturing.

Pharmaron’s expertise and platform capabilities enable gene therapy innovators to bring safe, effective AAV-based therapies to patients faster and more reliably. Download this Poster to learn more about advancing gene therapy.

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