Workshop: Key considerations for late-phase and commercial AAV gene therapy manufacturing

Adeno-associated virus (AAV) remains the predominant viral vector in gene therapy, with recent funding trends favoring de-risked programs supported by strong clinical data and commercial viability. To mitigate late-stage challenges and accelerate the path to clinical and market approval, sponsors must proactively address key manufacturing considerations early in development. Critical factors influencing phase progression include supply chain and raw material sourcing, platform approach, process scalability, analytical robustness, project timelines, regulatory compliance, and the strategic choice between in-house and outsourced manufacturing. Incorporating these factors into early-phase planning helps reduce risks and ensures a seamless transition to late-phase and commercial manufacturing.