The Importance of Viral Clearance and Characterization in Gene Therapy Products

Ya-Chen Chang, at Regenxbio, Akunna Iheanacho, at Texcell and Maja Leskovec at Sartorius BIA Separations

It is a regulatory requirement (ICH Q5A Revision 2) to demonstrate viral safety of biotechnology product derived from in vitro cell culture, including viral-vector derived products like recombinant Adeno-Associated virus used as a delivery medium for gene therapy products. Viral clearance in gene therapy product poses different challenges from the other non-viral biotechnology product in the viral removal strategies. In this webinar, we will present a case study with a clinically relevant AAV8 downstream process:

1 The rationale of the study design: the choices of virus panel, surrogate and the unit operation for demonstrating viral clearance.

2 Present the clearance achieved in a scaled down model of the process