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Research ArticleConference Report

Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments

Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michael Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 215-220; DOI: https://doi.org/10.5731/pdajpst.2014.00981
Hannelore Willkommen
aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;
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  • For correspondence: hannelore.willkommen@gmx.de
Johannes Blümel
bPaul-Ehrlich-Institut, Langen, Germany;
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Kurt Brorson
cCDER/FDA, Silver Spring MD, USA;
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Dayue Chen
dGenentech Inc., South San Francisco, CA, USA;
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Qi Chen
eEli Lilly and Company, Indianapolis, IN, USA;
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Albrecht Gröner
fCSL Behring GmbH, Marburg, Germany;
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Brian R. Hubbard
gAmgen Inc., Thousand Oaks, CA, USA;
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Thomas R. Kreil
hBaxter BioScience, Vienna, Austria;
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Michael Ruffing
iBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;
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Sol Ruiz
jSpanish Medicines Agency (AEMPS), Madrid, Spain;
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Dorothy Scott
kCBER/FDA, Silver Spring MD, USA;
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Glenda Silvester
lEuropean Medicines Agency, London, UK
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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.

  • Virus
  • Virus removal
  • Safety
  • Biopharmaceuticals
  • Filtration
  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michael Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 215-220; DOI: 10.5731/pdajpst.2014.00981

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Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michael Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 215-220; DOI: 10.5731/pdajpst.2014.00981
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  • Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
  • Meeting Report: 2015 PDA Virus & TSE Safety Forum
  • PDA Single-Use Systems Cross-Organizational Workshop—Meeting Summary, May 14, 2014—PDA Global Headquarters, Bethesda, MD
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