Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1-Cell Bank and Bulk Harvest Testing

PDA Journal of Pharmaceutical Science and Technology
Glen Bolton, Dayue Chen

Abstract

Monoclonal antibodies (mAbs) are typically produced using mammalian cell lines, which are known to express endogenous retrovirus-like particles (RVLPs) and also have the potential to be infected by viruses. This session focused on the detection and measurement of these viruses and RVLPs. In the first session, it was shown that next-generation sequencing (NGS) can detect, with a similar sensitivity as polymerase chain reaction (PCR), viruses in cells without a priori knowledge of the specific virus and more importantly that a specific NGS approach can decipher whether the signal corresponds to a replicating virus. The second session provided data showing that the PCR assay for detection of ecotropic recombinant virus (ERV) genome is an alternative to quantification by transmission electron microscopy (qTEM) for quantification of RVLP. In addition, the potential use of a harvest filter for RVLP retention in a perfusion process was discussed. In the third session, RVLP data from 67 different Pfizer programs spanning different conditions were presented. No single factor had a significant impact on the level of RVLPs. It was suggested that a "generic" or "worst-case" RVLP value, derived from a well-characterized platform cell cultur...Continue Reading

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