Adeno-associated virus (AAV) production for gene therapy applications has become increasingly important, yet the downstream processing (DSP) of AAV remains a complex and cumbersome series of steps, each contributing to reduced overall yield and extended processing time. Current methodologies generally consist of seven or more individual steps: DNase treatment > Clarification > TFF1 > Capture step > TFF2 > Polishing step > Formulation and filtration. The resulting low yields and prolonged timelines hinder the scalability and efficiency of AAV production, posing significant challenges to manufacturing. This study proposes a streamlined alternative to traditional AAV downstream processing, focusing on reducing the number of steps while simultaneously improving both recovery and process efficiency. We demonstrate a novel approach comprising just five integrated steps shown to work on various serotypes (AAV2, AAV8, AAV9).
