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Downstream AAV Production: Tools for Efficient and Reliable Gene Therapy Manufacturing

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Downstream AAV Production: Tools for Efficient and Reliable Gene Therapy Manufacturing

Designing an efficient, reproducible downstream AAV process remains one of the greatest hurdles in gene therapy manufacturing. This white paper outlines a framework for building scalable purification workflows, starting in early R&D and optimized through to clinical and commercial production. Through real AAV data and process examples, it explores how to overcome key challenges such as low yield, impurity removal, and empty | full capsid separation.

Learn how technologies like Sartoclear® depth filters, CIMmultus® monolithic chromatography, and Vivaflow® SU TFF membranes improve process robustness, recovery, and scalability, with studies showing up to 3.5-fold higher filter capacity, 30% more doses recovered, and 95% viral genome recovery.

Key Takeaways:

  1. Identify and address major downstream AAV challenges—from turbidity and impurity removal to capsid separation and scale-up.

  2. Explore real-world data showing performance gains using Sartoclear®, CIMmultus®, and Vivaflow® technologies across multiple AAV serotypes.

  3. Learn how early adoption of scalable purification and analytical tools can streamline development, accelerate regulatory approval, and reduce time to market.
     

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