Webinar Overview
Viral clearance (VC) studies are mandatory for biological treatments derived from human and/or animal sources like recombinant proteins, blood products, vaccines, and critical medical devices. These studies examine the potential removal and/or inactivation of adventitious and endogenous viruses during certain steps of the manufacturing purification process and ensure they’re safe for use in humans.
However, despite existing regulatory guidelines, designing a VC study is often not as straightforward as you might expect. In this webinar you’ll be given an in-depth look at some of the challenges you may encounter and the steps you can take to ensure viral clearance study success.
View this webinar to learn more about:
- Critical issues including how VC guidelines can differ based on product
- Major challenges such as method transfer contaminated test materials
- Other test material roadblocks like import restrictions or having a limited supply
Webinar Presenters
Anja Tessarz, PhD
Associate Director R&D & SME Viral Clearance
Charles River
Tareq Jaber, PhD
Associate Director, Process Evaluation
Charles River