The Importance of Viral Clearance and Characterization in Gene Therapy Products

Logo
Presented by

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

About this talk

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
Related topics:

More from this channel

Upcoming talks (25)
On-demand talks (369)
Subscribers (36870)
BioPharma Webinars aims to keep its global audience abreast of all developments in the areas of Drug Development, Manufacturing, Quality Assurance, Outsourcing and Regulatory Affairs, with only the highest quality webinars, presented by the most respected people, working with companies in Pharmaceutical, Biopharmaceutical, Biologics and Biotech Industry.