RT Journal Article
SR Electronic
T1 Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 215
OP 220
DO 10.5731/pdajpst.2014.00981
VO 68
IS 3
A1 Hannelore Willkommen
A1 Johannes Blümel
A1 Kurt Brorson
A1 Dayue Chen
A1 Qi Chen
A1 Albrecht Gröner
A1 Brian R. Hubbard
A1 Thomas R. Kreil
A1 Michael Ruffing
A1 Sol Ruiz
A1 Dorothy Scott
A1 Glenda Silvester
YR 2014
UL http://journal.pda.org/content/68/3/215.abstract
AB This workshop was held on June 3, 2013, in Berlin, Germany, in conjunction with the PDA Virus & TSE Safety Forum 2013. A total of nine speakers presented on key considerations of virus filtration, including a historical overview and emerging trends in evaluating parvovirus filters. Several talks addressed understanding the mechanism of virus capture and breakthrough by filters, as well as addressing this risk by carefully controlling transmembrane pressure. Improvements to validation studies were proposed via the use of highly purified virus preparations, more relevant models such as Chinese Hamster Ovary retrovirus-like particles, as well as new assays for virus quantification. The workshop ended with a panel discussion covering a range of topics including virus breakthrough, up-stream media treatment, virus spike preparation quality control, and regulatory expectations.