Process and analytical development during AAV manufacturing platform evolution

Over the past three decades, AAV manufacturing has progressed significantly, from low-yield, adherent cell cultures to scalable, suspension-based systems and single-use bioreactor platforms. Despite these advancements, key challenges remain, including low upstream productivity, inefficient separation of full and empty capsids during downstream processing, and a lack of standardized analytical methodologies. This review summarizes the evolution of AAV production platforms and examines the impact of emerging technologies on process and analytical development. It also highlights current gaps in AAV vector processing and evaluates the importance of platform-based approaches and real-time analytics in improving reproducibility and commercial readiness of gene therapy products.

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