Process and quality considerations for recombinant adeno-associated virus manufacturing platforms

Recombinant adeno-associated virus (AAV) is a prominent gene therapy vector, offering a strong safety profile and sustained gene expression. Scaling up AAV manufacturing remains challenging due to its complex processes, high development costs, and the need for rigorous quality control. This review examines the most common AAV suspension production platforms, specifically transfection, infection, and stable producer cell lines (PCLs). For each platform, a list of common unit operations and typical ranges for critical operating parameters is provided, along with high-level product quality specifications. This review aims to offer insights into the advantages and challenges of each manufacturing platform, providing a framework for accelerated process development and informed selection of suitable production platform based on intended clinical use and target product profile.