Viral vector processing: Scalable ultra/diafiltration for improved process efficiency and viral recovery

Adeno-associated virus (AAV) & lentivirus (LV) are the most common vectors used for delivering genetic material in viral gene therapy and CAR-T cell therapy applications. There is currently no scalable, high yield and high throughput, platform approach for viral vector purification. Self-contained, pre-sterilized tangential flow filtration (TFF) filters with scalable and reliable performance offer opportunities for efficient viral vector UF/DF processing operations.

This study evaluated the performance of 100 and 300 kDa regenerated cellulose membranes for concentrating AAV and LV feed streams. TMP control (typical antibody applications) and permeate control (microfiltration applications) are two operating modes for batch TFF processes. The 100 and 300 kDa membrane cut-offs lie between these two applications.

This presentation compares two operating control strategies for the UF/DF with the 100 and 300 kDa membranes. We also show how a 50 cm2 lab-scale device can predict performance of large-scale devices, providing a starting point for process development with viral vectors. Additional comparison between flat sheet filters and hollow fiber modules with LV feed streams will also be presented.