Complete system for AAV production for clinical production: part 1 – upstream

Abstract

Gibco™ Cell Therapy system (CTS) products are designed to enable clinical and commercial cell and gene therapy manufacturing. All reagents are manufactured under cGMP guidance, with cell and gene therapy specific intended use statements, extensive safety testing, and proactive regulatory documentation. These measures enable the provision of quality materials to help minimize risk, ease the burden on quality systems, and support regulatory submissions. This article will explore the scalable, high titer production of adeno-associated virus (AAV) within the Gibco CTS AAV-MAX production system.