Proceedings of the 2017 Viral Clearance Symposium

Autor: Franz Nothelfer, Stefan Hepbildikler
Rok vydání: 2018
Předmět:
Zdroj: PDA Journal of Pharmaceutical Science and Technology. 72:453-454
ISSN: 1948-2124
1079-7440
DOI: 10.5731/pdajpst.2018.009076
Popis: This article introduces the white paper from the 2017 Viral Clearance Symposium. The 5th Viral Clearance Symposium in Penzberg, Germany, addressed regulatory perspectives presented by officials from Health Canada, the US Food and Drug Administration, and Paul-Ehrlich-Institut as well as upstream and facility risk mitigation, downstream unit operations, and viral clearance strategies to support novel molecule formats, accelerated scenarios, and continuous processing. LAY ABSTRACT: This article introduces the summarized findings and next steps from the 2017 Viral Clearance Symposium in Penzberg, Germany.
Databáze: OpenAIRE