Gene therapy platforming: optimizing TFF for downstream AAV processing

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Gene therapy platforming: optimizing TFF for downstream AAV processing

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

As monoclonal antibody (mAb) platforms evolved, the roles for each tangential flow filtration (TFF) format settled into place. Upstream applications take advantage of the low shear environment in hollow fibers to recirculate cells without impacting product quality. Downstream, flat sheet cassettes are typically used, as their higher turbulence allows faster processing in smaller footprints. However, for viral vector-based gene therapies, platform processes are still in their infancy, with the roles for TFF technologies not yet defined.

New modalities such as viral vector-based therapies have unique product and process requirements compared to mAbs. For example, lower product stability may necessitate faster and gentler processing. More challenging adventitious agent clearance may increase the need for closed processing. With these requirements in mind, is there an ‘optimal’ TFF option?

his webinar will address this question with a comparison of TFF technology, including format (hollow fiber and flat sheet) and membrane chemistry. Focusing on AAV and using data from several common serotypes at multiple steps along the downstream process, technical data comparing key performance outputs such as flux, purity, and yield will be shared. Additionally, flow and pressure limits based on product quality (i.e., shear sensitivity of the viral vector) will be defined. Finally, manufacturing considerations including footprint, process economy, scalability, and options for closed processing will be addressed.

Attend this webinar to:

Get guidance for process optimization of UF/DF for novel modalities
Explore the differences between hollow fibers and flat sheets
Understand the stability of AAV within TFF systems
See how two TFF steps compare in the downstream AAV process

Luke McCarney

Filtration Engineer at Cytiva

Luke holds an MS in Chemical Engineering from the University of Rochester and has 3 years of experience working as a downstream processing applications engineer at Cytiva.