Poster

Toward A Gene Therapy Platform: What's The Best Format Of Tangential Flow Filtration (TFF)?

Source: Cytiva
Embracing Ongoing Process Verification in Cleaning Validation

As gene therapies, particularly those using adeno-associated viruses (AAV), grow in importance, the selection of tangential flow filtration (TFF) technologies for downstream processes becomes critical. Unlike monoclonal antibodies (mAbs), which have established TFF platforms, viral vector-based therapies introduce unique challenges, such as lower product stability and stricter adventitious agent clearance requirements, necessitating faster, gentler, and closed processing.

This study compares two TFF formats—hollow fiber and flat sheet—alongside membrane chemistries, focusing on their application to AAV purification. Data from two common AAV serotypes and multiple points in the downstream process were analyzed to evaluate key performance metrics, including flux, yield, and purity. Hollow fiber membranes, known for their low-shear environment, are well-suited for applications requiring gentle processing, while flat sheet membranes provide higher turbulence and faster throughput within smaller footprints.

Additionally, the study explores manufacturing considerations like scalability, process economy, and adaptability to closed processing systems, addressing the evolving needs of gene therapy production. The findings highlight the trade-offs between the two formats, offering insights into how each can be optimized for specific stages of AAV processing.

By comparing performance metrics and manufacturing implications, this work provides valuable guidance for selecting TFF technologies tailored to the unique demands of viral vector-based therapies, aiding in the development of robust, scalable, and efficient downstream processes for AAV production.

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