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 …
research presented at the 2019 Viral Clearance Symposium 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 …
Viral Clearance Symposium in Penzberg, Germany, addressed regulatory perspectives …
Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding
K Brorson, S O'Donnell - PDA Journal of Pharmaceutical Science …, 2024 - journal.pda.org
Session 5 of the 2023 Viral Clearance Symposium reviewed the strategy and process
understanding of viral clearance testing. Topics included learnings from the past, leveraging …
understanding of viral clearance testing. Topics included learnings from the past, leveraging …
Proceedings of the 2023 Viral Clearance Symposium, Session 7: Up-and Downstream Virus Retentive Filtration
X Zhu, S O'Donnell - PDA Journal of Pharmaceutical Science and …, 2024 - journal.pda.org
Session 7 of the 2023 Viral Clearance Symposium reviewed progresses in virus retentive
filtrations applied to both upstream and downstream processing. Upstream topics included …
filtrations applied to both upstream and downstream processing. Upstream topics included …
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 …
Clearance Symposium Session 4 on the utilization of knowledge, both from within and …
Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
TR Kreil, D Roush - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
The manufacturing processes of biological medicinal products are expected to be capable of
removing and/or inactivating viruses, to primarily provide for adequate safety margins to …
removing and/or inactivating viruses, to primarily provide for adequate safety margins to …
Proceedings of the 2019 Viral Clearance Symposium, Session 5: Viral Inactivation
J Ma - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
Viral inactivation has been demonstrated to be an effective viral clearance step in the
biologics purification processes. In the 2019 Viral Clearance Symposium, the topics were …
biologics purification processes. In the 2019 Viral Clearance Symposium, the topics were …
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 …
incorporate viral testing and clearance/inactivation into the process via representative small …
[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 …
launch of biopharmaceuticals. These studies are a key component of risk mitigation to …
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 …
necessary to seamlessly incorporate viral testing and clearance/inactivation into …