title: Meeting Report: 2013 PDA Virus & TSE Safety Forum.
abstract: The report provides a summary of the presentations and discussions at the Virus & TSE Safety Forum 2013 organized by the Parenteral Drug Association (PDA) and held in Berlin, Germany, from June 4 to 6, 2013. The conference was accompanied by a workshop, "Virus Spike Preparations and Virus Removal by Filtration: New Trends and Developments". The presentations and the discussion at the workshop are summarized in a separate report that will be published in this issue of the journal as well. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2013 provided again an excellent opportunity to exchange information and opinions between the industry, research organizations, and regulatory bodies. Updates on regulatory considerations related to virus and transmissible spongiform encephalopathy (TSE) safety of biopharmaceuticals were provided by agencies of the European Union (EU), the United States (US), and Singapore. The epidemiology and detection methods of new emerging pathogens like hepatitis E virus and parvovirus (PARV 4) were exemplified, and the risk of contamination of animal-derived raw materials like trypsin was considered in particular. The benefit of using new sequence-based virus detection methods was discussed. Events of bioreactor contaminations in the past drew the attention to root cause investigations and preventive actions, which were illustrated by several examples. Virus clearance data of specific unit operations were provided; the discussion focused on the mechanism of virus clearance and on the strategic concept of viral clearance integration. As in previous years, the virus safety section was followed by a TSE section that covered recent scientific findings that may influence the risk assessment of blood and cell substrates. These included the realization that interspecies transmission of TSE by blood components in sheep is greater than predicted by assays in transgenic mice. Also, the pathogenesis and possibility of productive TSE infection of cell substrates were considered, and cell-based assays that may be suitable for use in TSE clearance studies were discussed. The current report provides an overview about the outcomes of the 2013 PDA Virus & TSE Safety Forum, a unique event in this field.
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: 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: 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: 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; and.
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; D003257:Consumer Product Safety; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D007263:Infusions, Parenteral; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011050:Policy Making; D017096:Prion Diseases / Q000517:prevention & control* / Q000635:transmission; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods*; D014773:Virology / Q000331:legislation & jurisprudence / Q000379:methods*; D014780:Viruses / Q000302:isolation & purification*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Biotechnology; Plasma derivatives; Regulatory affairs; Safety; TSE; Virus; Virus clearance