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Research ArticleConference Report

Meeting Report: 2015 PDA Virus & TSE Safety Forum

Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569
Hannelore Willkommen
aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany
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Johannes Blümel
bPaul-Ehrlich Institut, Langen, Germany
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Kurt Brorson
cCDER/FDA, Silver Spring MD, USA
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  • For correspondence: Kurt.Brorson@fda.hhs.gov
Dayue Chen
dEli Lilly and Company, Indianapolis, IN, USA
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Qi Chen
eGenentech Inc., South San Francisco, CA, USA
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Albrecht Gröner
fPathoGuard Consult, Seeheim-Jugenheim, Germany
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Thomas R. Kreil
gBaxalta, Vienna, Austria
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Michel Ruffing
hBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany
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Sol Ruiz
iSpanish Medicines Agency (AEMPS), Madrid, Spain
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Dorothy Scott
jCBER/FDA, Silver Spring MD, USA
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Glenda Silvester
kEuropean Medicines Agency, London, UK
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References

  1. 1.↵
    Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus. 28–29 October 2015, European Medicines Agency, London http://www.ema.europa.eu
  2. 2.↵
    EMA/CHMP/BWP/723009/2014: Reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus. End of consultation (deadline for comments) 30 September 2015 http://www.ema.europa.eu
  3. 3.↵
    EMA/CHMP/BWP/548524/2008. Rev 1: Guideline on epidemiological data on blood transmissible infections. End of consultation (deadline for comments) 31 August 2015 http://www.ema.europa.eu
  4. 4.↵
    EMA/CHMP/BWP/26802/2012 Guideline on the adventitious agent safety of urine-derived medicinal products. 26 May 2015 http://www.ema.europa.eu
  5. 5.↵
    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC OJ L158 of 27 May 2014, pp 1–76.
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    EMA/CHMP/BWP/398498/2005 Guideline on virus safety evaluation of biotechnological investigational medicinal products, http://www.ema.europa.eu
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    1. Ma H.,
    2. Galvin T. A.,
    3. Glasner D. R.,
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    5. Khan A. S.
    Identification of a novel rhabdovirus in Spodoptera frugiperda cell lines. J. Virol. 2014, 88 (12), 6576–6585.
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    1. Pfaender S.,
    2. Brown R. J. P.,
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    Natural reservoirs for homologs of hepatitis C virus. Emerg. Microbes Infect. 2014, 3 (3), e21.
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    1. Miesegaes G.,
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    Analysis of viral clearance unit operations for monoclonal antibodies. Biotechnol. Bioeng. 2010, 106 (2), 238–246.
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    IDT Biologika GmbH, Dessau-Rosslau Germany, website: http://www.idt-biologika.de/index.php?lang=2.
  11. 11.↵
    1. Chen C.-C.,
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    Estimation of the exposure of the UK population to the bovine spongiform encephalopathy agent through dietary intake during the period 1980 to 1996. PLoS one 2014, 9 (4), e94020.
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PDA Journal of Pharmaceutical Science and Technology: 70 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 2
March/April 2016
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Meeting Report: 2015 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 177-188; DOI: 10.5731/pdajpst.2016.006569

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Meeting Report: 2015 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 177-188; DOI: 10.5731/pdajpst.2016.006569
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Keywords

  • Virus
  • TSE
  • Safety
  • Biotechnology
  • Plasma derivatives
  • Regulatory affairs
  • Virus clearance

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