title: Meeting report-workshop on spike characterizations and virus removal by filtration: trends and new developments.
abstract: 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.
authors.affiliation: Regulatory Affairs & Biological Safety Consulting, Erzhausen, Germany; hannelore.willkommen@gmx.de.
authors.forename: Hannelore
authors.initials: H
authors.lastname: Willkommen
authors.affiliation: Paul-Ehrlich-Institut, Langen, Germany;
authors.forename: Johannes
authors.initials: J
authors.lastname: Blümel
authors.affiliation: CDER/FDA, Silver Spring MD, USA;
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
authors.affiliation: Genentech Inc., South San Francisco, CA, USA;
authors.forename: Dayue
authors.initials: D
authors.lastname: Chen
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA;
authors.forename: Qi
authors.initials: Q
authors.lastname: Chen
authors.affiliation: CSL Behring GmbH, Marburg, Germany;
authors.forename: Albrecht
authors.initials: A
authors.lastname: Gröner
authors.affiliation: Amgen Inc., Thousand Oaks, CA, USA;
authors.forename: Brian R
authors.initials: BR
authors.lastname: Hubbard
authors.affiliation: Baxter BioScience, Vienna, Austria;
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Kreil
authors.affiliation: Boehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;
authors.forename: Michael
authors.initials: M
authors.lastname: Ruffing
authors.affiliation: Spanish Medicines Agency (AEMPS), Madrid, Spain;
authors.forename: Sol
authors.initials: S
authors.lastname: Ruiz
authors.affiliation: CBER/FDA, Silver Spring MD, USA;
authors.forename: Dorothy
authors.initials: D
authors.lastname: Scott
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: Glenda
authors.initials: G
authors.lastname: Silvester
mesh_terms: D000818:Animals; D001702:Biopharmaceutics / Q000379:methods* / Q000639:trends; D004059:Diffusion of Innovation; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000379:methods* / Q000639:trends; D005374:Filtration / Q000379:methods* / Q000639:trends; D006801:Humans; D007263:Infusions, Parenteral; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000639:trends; D014773:Virology / Q000379:methods* / Q000639:trends; D014780:Viruses / Q000302:isolation & purification*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Biopharmaceuticals; Filtration; Safety; Virus; Virus removal