The field of adeno-associated virus (AAV)-based gene therapy is rapidly expanding beyond rare diseases to address more prevalent conditions such as cardiovascular and neurological disorders. This scale-up requires optimized manufacturing to maintain batch consistency, quality, and yield while mitigating risks. Process development is costly and time-consuming, making partnerships with contract development and manufacturing organizations (CDMOs) crucial. Leveraging established production platforms improves quality, increases yield of fully packaged capsids, and reduces costs per dose, enhancing commercial viability in a challenging macroeconomic environment.