RT Journal Article
SR Electronic
T1 Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 462
OP 469
DO 10.5731/pdajpst.2018.009100
VO 72
IS 5
A1 Chen, Dayue
A1 Bolton, Glen
YR 2018
UL http://journal.pda.org/content/72/5/462.abstract
AB 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.