RT Journal Article
SR Electronic
T1 Session 1.1 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 pdajpst.2018.009100
DO 10.5731/pdajpst.2018.009100
A1 Chen, Dayue
A1 Bolton, Glen
YR 2018
UL http://journal.pda.org/content/early/2018/07/03/pdajpst.2018.009100.abstract
AB "Cell lines such as CHO, C127, BHK and murine hybridoma cell lines have frequently been used as substrates for drug production with no reported safety problems related to viral contamination of the products" (ICH Q5A). However, viral contamination events in GMP cell culture processes, while rare, do sometimes occur. When contamination happens, it could result in serious consequences, including supply risk of life-saving drugs and substantial financial loss. To mitigate the potential risk of viral contamination, one of the approaches taken by 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 [1], [2], [3], [4]. In recent years, nanofiltration commonly used in downstream purification processes has been evaluated for potential use as a virus barrier alternative to HTST [1]. Several companies shared their data and experience from evaluation of using nanofiltration for viral barrier purpose upstream in Session 1 Part 2: Virus Barrier. These presentations are summarized below.