title: Meeting Report: 2015 PDA Virus & TSE Safety Forum.
abstract: The report provides a summary of the presentations at the Virus & TSE Safety Forum 2015 organized by the Parenteral Drug Association (PDA) and held in Cascais, Portugal, from 9 to 11 June, 2015. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2015 provided an excellent forum for the exchange of information and opinions between the industry, research organizations, and regulatory bodies. Regulatory updates on virus and TSE safety aspects illustrating current topics of discussion at regulatory agencies in Europe and the United States were provided; the conference covered emerging viruses and new virus detection systems that may be used for the investigation of human pathogenic viruses as well as the virus safety of cell substrates and of raw material of ovine/caprine or human origin. Progress of development and use of next-generation sequencing methods was shown by several examples. Virus clearance data illustrating the effectiveness of inactivation or removal methods were presented and data provided giving insight into the mechanism of action of these technologies. In the transmissible spongiform encephalopathy (TSE) part of the conference, the epidemiology of variant Creutzfeldt-Jakob disease was reviewed and an overview about diagnostic tests provided; current thinking about the spread and propagation of prions was presented and the inactivation of prions by disinfection (equipment) and in production of bovine-derived reagents (heparin) shown. The current report provides an overview about the outcomes of the 2015 PDA Virus & TSE Safety Forum, a unique event in this field.
authors.affiliation: Regulatory Affairs & Biological Safety Consulting, Erzhausen, Germany.
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 Kurt.Brorson@fda.hhs.gov.
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Dayue
authors.initials: D
authors.lastname: Chen
authors.affiliation: Genentech Inc., South San Francisco, CA, USA.
authors.forename: Qi
authors.initials: Q
authors.lastname: Chen
authors.affiliation: PathoGuard Consult, Seeheim-Jugenheim, Germany.
authors.forename: Albrecht
authors.initials: A
authors.lastname: Gröner
authors.affiliation: Baxalta, 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: Michel
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; D003226:Congresses as Topic; D007562:Creutzfeldt-Jakob Syndrome / Q000517:prevention & control / Q000635:transmission; D004267:DNA Viruses; D006801:Humans; D057947:Parenteral Nutrition Solutions / Q000032:analysis / Q000592:standards*; D011174:Portugal; D017096:Prion Diseases / Q000517:prevention & control* / Q000635:transmission*; D058028:Research Report
chemical_list: D057947:Parenteral Nutrition Solutions
keywords: Biotechnology; Plasma derivatives; Regulatory affairs; Safety; TSE; Virus; Virus clearance