Proceedings of the 2017 viral clearance symposium, Session 6: Ensuring viral safety in continuous processing

SA Johnson, D Roush - PDA Journal of Pharmaceutical Science …, 2018 - journal.pda.org
To ensure successful scale-up of continuous processing to large-scale production, it is
necessary to seamlessly incorporate viral testing and clearance/inactivation into …

Proceedings of the 2019 Viral Clearance Symposium, Session 3: Continuous Processing

S Lute, R Specht - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
Successful implementation of continuous processing requires an understanding of how to
incorporate viral testing and clearance/inactivation into the process via representative small …

Proceedings of the 2023 Viral Clearance Symposium, Session 4: Continuous Processing

J Fisher, S Lute - PDA Journal of Pharmaceutical Science and …, 2024 - journal.pda.org
The continuous processing session at the 2023 Viral Clearance Symposium (VCS) focused
on understanding how to effectively design viral clearance operations for use in continuous …

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 …

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 …

Virus filtration and flow variation: an approach to evaluate any potential impact on virus retention

A Wieser, A Berting, C Medek, G Poelsler… - PDA journal of …, 2016 - journal.pda.org
Virus removal by filtration has been an important improvement for the safety margins of
plasma-derived medicinal products and has become a standard manufacturing process step …

Integrated viral clearance strategies—reflecting on the present, projecting to the future

DJ Roush - Current opinion in biotechnology, 2018 - Elsevier
Viral clearance and inactivation are critical steps in ensuring the safety of biological products
derived from mammalian cell culture and are a component of an adventitious agent control …

Adapting viral safety assurance strategies to continuous processing of biological products

SA Johnson, MR Brown, SC Lute… - Biotechnology and …, 2017 - Wiley Online Library
There has been a recent drive in commercial large‐scale production of biotechnology
products to convert current batch mode processing to continuous processing manufacturing …

[PDF][PDF] Viral clearance for biopharmaceutical downstream processes

AA Shukla, H Aranha - Pharmaceutical Bioprocessing, 2015 - academia.edu
Viral clearance studies are mandated prior to entering clinical trials and for commercial
launch of biopharmaceuticals. These studies are a key component of risk mitigation to …

Continuous low pH viral inactivation: Operation and scaling strategy informs viral clearance study

M Brown, S Godfrey, A Creasy, J Salm… - Biotechnology and …, 2022 - Wiley Online Library
A continuous viral inactivation (CVI) tubular reactor was designed for low pH viral
inactivation within a continuous downstream system across multiple scales of operation. The …