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

G Bolton, D Chen - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
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 …

Proceedings of the 2017 viral clearance symposium, session 4: submission strategies

A Schwantes, R Specht, Q Chen - PDA journal of pharmaceutical …, 2018 - journal.pda.org
Appropriate performance of virus validation studies and testing of unprocessed bulk
harvests for retrovirus particle count are procedures in the demonstration of an acceptable …

Proceedings of the 2019 Viral Clearance Symposium, Session 7: Cell Banks and US Pharmacopeia

S O'Donnell - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
Adventitious contamination of a manufacturing process is a major concern for
biopharmaceutical manufacturers. This session focused on rapid detection methods for …

Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed …

G Bolton - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
This report provides a high-level summary of the key outcomes and gaps based on the
research presented at the 2019 Viral Clearance Symposium and identifies new areas for …

Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding

D Roush, J Blümel - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
This article describes a summary of discussions and outcomes from the 2019 Viral
Clearance Symposium Session 4 on the utilization of knowledge, both from within and …

Multiplex RT Q-PCR assay for simultaneous quantification of three viruses used for validation of virus clearance by biopharmaceutical production

S Lute, H Wang, D Sanchez, J Barletta, Q Chen… - Biologicals, 2009 - Elsevier
Virus removal studies are used to insure the safety of biopharmaceutical products by
quantitatively estimating the viral clearance capacity by the manufacturing process. Virus …

Proceedings of the 2019 Viral Clearance Symposium: Introduction

S O'Donnell - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
This article introduces the presentations from the 2019 Viral Clearance Symposium, which
was held in Claremont, California. The Viral Clearance Symposium contained regulatory …

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

D Chen, G Bolton - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
Various mammalian cell lines are used as substrates for drug production without safety
issues concerning viral contamination. However, viral contamination events in good …

Proceedings of the 2017 Viral Clearance Symposium: Conclusion

S Hepbildikler, S Johnson, J Bluemel - PDA Journal of …, 2018 - journal.pda.org
This report provides a high-level summary of the key outcomes and gaps based on the
research presented at the Viral Clearance Symposium 2017 and identifies new areas for …

Proceedings of the 2017 Viral Clearance Symposium—

S Hepbildikler, F Nothelfer - PDA Journal of Pharmaceutical …, 2018 - journal.pda.org
This article introduces the white paper from the 2017 Viral Clearance Symposium. The 5th
Viral Clearance Symposium in Penzberg, Germany, addressed regulatory perspectives …