Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST

Abstract

Various mammalian cell lines are used as substrates for drug production without safety issues concerning viral contamination. However, viral contamination events in good manufacturing practice (GMP) cell culture processes, while rare, do sometimes occur. When contamination happens, it can result in serious consequences, including supply risk of life-saving drugs and substantial financial loss. To mitigate the potential risk of viral contamination, one approach taken by the industry is to implement preventative measures upstream. High-temperature short-time (HTST) treatment of culture media, at the point of use, was implemented as a virus barrier following murine minute virus (MMV) contamination. In recent years, nanofiltration, commonly used in downstream purification processes, has been evaluated for potential use as a virus barrier alternative to HTST. Several companies shared their data and experience in evaluating nanofiltration for viral barrier purpose upstream in Session 1, Part 2: Virus Barrier. These presentations are summarized below.

LAY ABSTRACT: Viral contamination events in GMP cell culture processes, while rare, do sometimes occur. When contamination happens, it can result in serious consequences, including supply risk of life-saving drugs and substantial financial loss. To mitigate the potential risk of viral contamination, one approach taken by the industry is to implement preventative measures upstream. Several companies shared their data and experience in evaluating virus-retentive filtration for viral barrier purpose upstream.