Scaling up the production of viral vectors, particularly adeno-associated virus (AAV), remains wrought with challenges. The issues of low titer and yield, and vector degradation such as unfolding, aggregation and oxidation, need to be better understood and managed by carefully optimizing buffer, pH and excipients. This article addresses key advancements at each step in the workflow — from maximizing titer output at scale upstream to optimized formulation compositions at fill/finish — to support commercial scale.

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Innovative approaches that address current challenges in gene therapy viral vector manufacturing

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