RT Journal Article
SR Electronic
T1 Proceedings of the 2017 Viral Clearance Symposium—
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 453
OP 454
DO 10.5731/pdajpst.2018.009076
VO 72
IS 5
A1 Hepbildikler, Stefan
A1 Nothelfer, Franz
YR 2018
UL http://journal.pda.org/content/72/5/453.abstract
AB 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.