Scalable Solution for Cost-effective AAV Production

System supports seamless transition from gene therapy research to manufacturing

The Gibco CTS AAV-MAX Helper-Free AAV Production System from Thermo Fisher Scientific is a new all-in-one solution designed to help meet clinical and commercial demands for cost-effective and scalable development of adeno-associated virus (AAV)-based gene therapies. To date, it is the only product of its kind that is manufactured under cGMP conditions to enable large-scale applications.

AAV is used in 82% of viral vector-based gene therapies in the pipeline, and scaled production is critical to accelerate the transition from research to commercialisation to bring gene therapies to market faster and at lower costs. By delivering high titre AAV production, the system can save manufacturers up to 50% on production costs compared to alternative polyethyleneimine (PEI)-based suspension systems and help reduce plasmid DNA costs by 25%. It features a mammalian-based suspension system comprised of a clonal HEK293 cell line and animal origin-free reagents that support scalable AAV production from shake flask to bioreactor scale.

“Building on 60 years of trusted Gibco solutions, the CTS AAV-MAX System is the latest addition to our fit-for-purpose line of scalable solutions for commercial manufacturing of cell and gene therapy applications,” said Amy Butler, President, Biosciences, Thermo Fisher Scientific. “More efficient, cost-effective AAV production is an essential step to streamline gene therapy development, helping drive innovation to serve those who need it most - patients who can benefit from these potentially life-changing therapies.”

As part of Cell Therapy Systems (CTS) solutions, the CTS AAV-MAX System is designed to work within the AAV production workflow, from cell culture and transfection through AAV viral vector production. Researchers can transition seamlessly from research on the Gibco AAV-MAX Helper Free AAV Production System to clinical scale using the CTS AAV-MAX System. Thermo Fisher’s CTS products are cGMP manufactured and include traceability and regulatory documentation, and are regularly used in commercial production to address cell and gene therapy developers’ manufacturing needs.

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